Trial record 4 of 182 for:    Kaiser Permanente | Open Studies

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

This study is currently recruiting participants.
Verified April 2014 by Pfizer
Kaiser Permanente
Information provided by (Responsible Party):
Pfizer Identifier:
First received: May 20, 2010
Last updated: April 11, 2014
Last verified: April 2014

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
Invasive Pneumococcal Disease
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Postmarketing Observational Study Estimating the Impact of Prevnar 13™ (13vPnC) on Invasive Pneumococcal Disease Caused by Vaccine Serotypes of Streptococcus Pneumoniae After Introduction Into Routine Pediatric Use

Resource links provided by NLM:

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 ]

Estimated Enrollment: 0
Study Start Date: June 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (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
Please refer to this study by its identifier: NCT01128439

Contact: Pfizer Call Center 1-800-718-1021

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

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT01128439     History of Changes
Other Study ID Numbers: 6096A1-4005, B1851042
Study First Received: May 20, 2010
Last Updated: April 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
Pneumococcal conjugate vaccine processed this record on April 17, 2014