Study Estimating the Impact of Prevnar 13™ (13vPnC) on Invasive Pneumococcal Disease

This study has been completed.
Kaiser Permanente
Information provided by (Responsible Party):
Pfizer Identifier:
First received: May 20, 2010
Last updated: June 9, 2015
Last verified: June 2015
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.

Condition Intervention Phase
Invasive Pneumococcal Disease
Other: No intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Postmarketing Observational Study Estimating The Impact Of Prevnar 13 (Trade Mark) (13vpnc) On Invasive Pneumococcal Disease Caused By Vaccine Serotypes Of Streptococcus Pneumoniae After Introduction Into Routine Pediatric Use

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: July 2010
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Other: No intervention
No intervention

Detailed Description:
No sampling as no subjects are enrolled

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01128439

United States, California
Kaiser Permanente Vaccine Study Center
Oakland, California, United States, 94612
Sponsors and Collaborators
Kaiser Permanente
Study Director: Pfizer Call Center Pfizer
  More Information

Responsible Party: Pfizer Identifier: NCT01128439     History of Changes
Other Study ID Numbers: 6096A1-4005  B1851042 
Study First Received: May 20, 2010
Last Updated: June 9, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
Pneumococcal conjugate vaccine processed this record on May 26, 2016