NCT03656939

Brief Summary

This is an observational study based on a population-based EHR database.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21,240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 27, 2021

Completed
Last Updated

August 27, 2021

Status Verified

July 1, 2021

Enrollment Period

2 years

First QC Date

July 20, 2018

Results QC Date

July 30, 2021

Last Update Submit

July 30, 2021

Conditions

SeizuresUrticaria and AngioedemaApneaFever

Outcome Measures

Primary Outcomes (150)

  • Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 1

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 3 days after Dose 1

  • Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 1

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    4 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 1

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 1

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 3 days after Dose 1

  • Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 1

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    4 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 1

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 3 days after Dose 1

  • Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    4 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 1

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

    0 to 3 days after Dose 1

  • Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 1

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

    4 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 1

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

    0 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 1

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 3 days after Dose 1

  • Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 1

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    4 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 1

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 2

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 3 days after Dose 2

  • Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 2

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    4 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 2

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 2

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 3 days after Dose 2

  • Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 2

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    4 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 2

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 3 days after Dose 2

  • Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    4 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 2

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

    0 to 3 days after Dose 2

  • Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 2

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

    4 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 2

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

    0 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 2

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 3 days after Dose 2

  • Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 2

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    4 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 2

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 3

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 3 days after Dose 3

  • Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 3

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    4 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 3

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 3

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 3 days after Dose 3

  • Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 3

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    4 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 3

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 3 days after Dose 3

  • Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    4 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 3

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

    0 to 3 days after Dose 3

  • Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 3

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

    4 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 3

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

    0 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 3

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 3 days after Dose 3

  • Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 3

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    4 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 3

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After Dose 4

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 3 days after Dose 4

  • Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After Dose 4

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    4 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After Dose 4

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After Dose 4

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 3 days after Dose 4

  • Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After Dose 4

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    4 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After Dose 4

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 3 days after Dose 4

  • Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    4 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After Dose 4

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

    0 to 3 days after Dose 4

  • Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After Dose 4

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

    4 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After Dose 4

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

    0 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After Dose 4

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 3 days after Dose 4

  • Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After Dose 4

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    4 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After Dose 4

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 3 Days After All Doses

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 3 Days after all Doses

  • Incidence Rate (Per 1000 Person Days) of All Seizures Through 4 to 7 Days After All Doses

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    4 to 7 Days after all Doses

  • Incidence Rate (Per 1000 Person Days) of All Seizures Through 0 to 7 Days After All Doses

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 7 Days after all Doses

  • Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 3 Days After All Doses

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 3 Days after all Doses

  • Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 4 to 7 Days After All Doses

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    4 to 7 Days after all Doses

  • Incidence Rate (Per 1000 Person Days) of Febrile Seizures Through 0 to 7 Days After All Doses

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 7 Days after all Doses

  • Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 3 Days After All Doses

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 3 days after all Doses

  • Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 4 to 7 Days After All Doses

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    4 to 7 days after all Doses

  • Incidence Rate (Per 1000 Person Days) of Urticaria and Angioedema Through 0 to 7 Days After All Doses

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 7 days after all Doses

  • Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 3 Days After All Doses

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

    0 to 3 days after all doses

  • Incidence Rate (Per 1000 Person Days) of Apnea Through 4 to 7 Days After All Doses

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

    4 to 7 days after all doses

  • Incidence Rate (Per 1000 Person Days) of Apnea Through 0 to 7 Days After All Doses

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000. Apnea is the cessation of breathing.

    0 to 7 days after all doses

  • Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 3 Days After All Doses

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 3 days after all doses

  • Incidence Rate (Per 1000 Person Days) of Fever Through 4 to 7 Days After All Doses

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    4 to 7 days after all doses

  • Incidence Rate (Per 1000 Person Days) of Fever Through 0 to 7 Days After All Doses

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the observed time at risk, multiply by 1000.

    0 to 7 days after all doses

  • Incidence Rate (IR) (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 1

    IR was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 3 days after Dose 1

  • Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 1

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    4 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 1

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 1

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 3 days after Dose 1

  • Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 1

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    4 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 1

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 1

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 3 days after Dose 1

  • Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 1

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    4 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 1

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 1

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

    0 to 3 days after Dose 1

  • Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 1

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

    4 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 1

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

    0 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 1

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 3 days after Dose 1

  • Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 1

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    4 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 1

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 7 days after Dose 1

  • Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 2

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 3 days after Dose 2

  • Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 2

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    4 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 2

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 2

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 3 days after Dose 2

  • Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 2

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    4 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 2

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 2

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 3 days after Dose 2

  • Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 2

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    4 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 2

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 2

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

    0 to 3 days after Dose 2

  • Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 2

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

    4 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 2

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

    0 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 2

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 3 days after Dose 2

  • Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 2

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    4 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 2

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 7 days after Dose 2

  • Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 3

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 3 days after Dose 3

  • Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 3

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    4 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 3

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 3

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 3 days after Dose 3

  • Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 3

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    4 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 3

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 3

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 3 days after Dose 3

  • Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 3

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    4 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 3

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 3

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

    0 to 3 days after Dose 3

  • Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 3

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

    4 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 3

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

    0 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 3

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 3 days after Dose 3

  • Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 3

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    4 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 3

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 7 days after Dose 3

  • Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After Dose 4

    Incidence rate was calculated as the number of all seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 3 days after Dose 4

  • Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After Dose 4

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    4 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After Dose 4

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After Dose 4

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 3 days after Dose 4

  • Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After Dose 4

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    4 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After Dose 4

    Incidence rate was calculated as the number of febrile seizure events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After Dose 4

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 3 days after Dose 4

  • Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After Dose 4

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    4 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After Dose 4

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After Dose 4

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

    0 to 3 days after Dose 4

  • Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After Dose 4

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

    4 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After Dose 4

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

    0 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After Dose 4

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 3 days after Dose 4

  • Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After Dose 4

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    4 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After Dose 4

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 7 days after Dose 4

  • Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 3 Days After All Doses

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 3 days after all doses

  • Incidence Rate (Per 1000 Doses) of All Seizures Through 4 to 7 Days After All Doses

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    4 to 7 days after all doses

  • Incidence Rate (Per 1000 Doses) of All Seizures Through 0 to 7 Days After All Doses

    Incidence rate was calculated as the number of all seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 7 days after all doses

  • Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 3 Days After All Doses

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 3 days after all doses

  • Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 4 to 7 Days After All Doses

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    4 to 7 days after all doses

  • Incidence Rate (Per 1000 Doses) of Febrile Seizures Through 0 to 7 Days After All Doses

    Incidence rate was calculated as the number of febrile seizures events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 7 days after all doses

  • Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 3 Days After All Doses

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 3 days after all Doses

  • Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 4 to 7 Days After All Doses

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    4 to 7 days after all Doses

  • Incidence Rate (Per 1000 Doses) of Urticaria and Angioedema Through 0 to 7 Days After All Doses

    Incidence rate was calculated as the number of urticaria and angioedema events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Urticaria represents an allergic reaction. Angioedema is an area of swelling (edema) of the lower layer of skin and tissue just under the skin or mucous membranes.

    0 to 7 days after all Doses

  • Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 3 Days After All Doses

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

    0 to 3 days after all Doses

  • Incidence Rate (Per 1000 Doses) of Apnea Through 4 to 7 Days After All Doses

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

    4 to 7 days after all Doses

  • Incidence Rate (Per 1000 Doses) of Apnea Through 0 to 7 Days After All Doses

    Incidence rate was calculated as the number of apnea events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000. Apnea is the cessation of breathing.

    0 to 7 days after all Doses

  • Incidence Rate (Per 1000 Doses) of Fever Through 0 to 3 Days After All Doses

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-3 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 3 days after all doses

  • Incidence Rate (Per 1000 Doses) of Fever Through 4 to 7 Days After All Doses

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (4-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    4 to 7 days after all doses

  • Incidence Rate (Per 1000 Doses) of Fever Through 0 to 7 Days After All Doses

    Incidence rate was calculated as the number of fever events experienced during the specified risk window (0-7 days post-vaccination) divided by the number of doses, multiply by 1000.

    0 to 7 days after all doses

Study Arms (1)

Prevenar 13 cohort

This is a non-interventional study. Children in the study receive Prevenar 13 per normal medical practice.

Eligibility Criteria

Age1 Month - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The main study population consists of eligible children aged 1-24 months receiving at least one dose of 13vPnC recorded in Yinzhou EHR database between May 1st, 2017 and July 24th, 2020 (ie, one week prior to the end of the study). For the prospective cohort in a sub-population of the main study, eligible children for the main study must receive the first dose of 13vPnC between August 1st, 2018 and July 24th, 2020. It should be noted that the actual start date for the prospective cohort study is pending on the approval of Human Genetic Resources Administration of China (HGRAC) application.

You may qualify if:

  • To be eligible for the main study, children in Yinzhou population-based EHR database must be aged 1 to 24 months and receive at least one dose of 13vPnC between May 1st, 2017 and July 24th, 2020 where the first dose is received before or on July 24th, 2020 since a 7-day post-vaccination follow-up for each dose in each child receiving 13vPnC is needed. For the prospective cohort in a sub-population of the main study, eligible children for the main study must receive the first dose of 13vPnC between August 1st, 2018 and July 24th, 2020 and an informed consent must be obtained from parents/legal guardians.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Public Health at Fudan University

Shanghai, 200032, China

Location

Related Links

MeSH Terms

Conditions

SeizuresUrticariaAngioedemaApneaFever

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesVascular DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratoryBody Temperature Changes

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2018

First Posted

September 4, 2018

Study Start

August 1, 2018

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

August 27, 2021

Results First Posted

August 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations

CN(1)