NCT01521897

Brief Summary

This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive Prevenar at the age of more than 2 and less than 7 months in routine medical practice. This surveillance will specifically focus on the occurrence of the following:

  1. 1.Local reactions at the injection site
  2. 2.Systemic reactions for each concomitant vaccine (especially fever more than 39C°)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,143

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

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

Study Start

First participant enrolled

September 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 14, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 20, 2016

Completed
Last Updated

January 20, 2016

Status Verified

December 1, 2015

Enrollment Period

2.3 years

First QC Date

September 14, 2011

Results QC Date

December 14, 2015

Last Update Submit

December 14, 2015

Conditions

Pneumococcal VaccineStreptococcus Pneumoniae

Keywords

Pneumococcal VaccinePrevenar7-valentSpecial Use-result surveillance

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Reactions

    An adverse reaction was any untoward medical occurrence which was considered to be related to Prevenar™ (7-valent) in a participant who received Prevenar™ (7-valent). Relatedness to Prevenar™ (7-valent) was assessed by the sponsor (Pfizer Japan Inc.).

    28 days

Secondary Outcomes (4)

  • Number of Participants With Serious Adverse Events

    28 days

  • Number of Participants With Injection Site Reactions

    28 days

  • Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination

    28 days

  • Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination

    28 days

Other Outcomes (4)

  • Number of Participants by Month of Age at Each Vaccination Time

    28 days

  • Number of Participants by Vaccination Sites at Each Vaccination Time

    28 days

  • Number of Participants by Pattern of Concomitant Vaccines

    28 days

  • +1 more other outcomes

Study Arms (1)

7-valent vaccine injection

Infants starting to receive Prevenar at the age of more than 2 and less than 7 months

Biological: 7-valent vaccine injection

Interventions

7-valent vaccine injectionBIOLOGICAL

For primary immunization, three doses of Prevenar 0.5 mL should be injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL should be injected subcutaneously, at least 60 days after the 3rd dose.

Also known as: Prevenar, 7vPnC
7-valent vaccine injection

Eligibility Criteria

Age2 Months - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Infants starting to receive Prevenar at the age of more than 2 and less than 7 months

You may qualify if:

  • Infants at the age of more than 2 and less than 7 months
  • Infants who have been vaccinated with Prevenar for the first time
  • Infants expected to complete four vaccinations with Prevenar

You may not qualify if:

  • Vaccination with Prevenar must not be given to any of the following;
  • History of evident anaphylactic reaction to any component of Prevenar or diphtheria toxoid
  • Evident pyrexia
  • Evident serious acute disease
  • Any other infants or children ineligible for vaccination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yokoyama Children's Clinic

Kasuga, Fukuoka, 816-0801, Japan

Location

Related Links

MeSH Terms

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Intervention Hierarchy (Ancestors)

Pneumococcal VaccinesStreptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

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
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2011

First Posted

January 31, 2012

Study Start

September 1, 2010

Primary Completion

January 1, 2013

Study Completion

April 1, 2015

Last Updated

January 20, 2016

Results First Posted

January 20, 2016

Record last verified: 2015-12

Locations

JP(1)