NCT01128439

Brief Summary

This study will estimate the incidence of invasive pneumococcal disease in members of the Northern Kaiser Permanente healthcare system during each of the 5 following introduction of Prevnar 13.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 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

First Submitted

Initial submission to the registry

May 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

December 4, 2018

Status Verified

November 1, 2018

Enrollment Period

4.8 years

First QC Date

May 20, 2010

Last Update Submit

November 30, 2018

Conditions

Invasive Pneumococcal Disease

Keywords

Pneumococcal conjugate vaccine

Outcome Measures

Primary Outcomes (1)

  • Incidence of IPD in the NCKP healthcare system in children 6 weeks through 5 years of age (prior to the sixth birthday) during each of the 5 years following introduction of Prevnar 13.

    5 years

Study Arms (1)

1

Other: No intervention

Interventions

No interventionOTHER

No intervention

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Clinic

You may qualify if:

  • Documented invasive pneumococcal disease (IPD), defined as recovery of an isolate of S pneumoniae from a normally sterile site in a member of the surveillance population.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Vaccine Study Center

Oakland, California, 94612, United States

Location

Related Publications (1)

  • Baxter R, Aukes L, Pelton SI, Yee A, Klein NP, Gruber WC, Scott DA, Center KJ. Impact of the 13-Valent Pneumococcal Conjugate Vaccine on Invasive Pneumococcal Disease After Introduction Into Routine Pediatric Use. J Pediatric Infect Dis Soc. 2021 Mar 26;10(2):141-150. doi: 10.1093/jpids/piaa035.

    PMID: 32415771DERIVED

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2010

First Posted

May 21, 2010

Study Start

July 1, 2010

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

December 4, 2018

Record last verified: 2018-11

Locations

US(1)