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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01128439
First received: May 20, 2010
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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

  Eligibility

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

Primary Care Clinic

Criteria

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:

None

  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 ClinicalTrials.gov identifier: NCT01128439

Locations
United States, California
Northern California Kaiser Permanente
Oakland, California, United States, 94612
Sponsors and Collaborators
Pfizer
Kaiser Permanente
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01128439     History of Changes
Other Study ID Numbers: 6096A1-4005, B1851042
Study First Received: May 20, 2010
Last Updated: September 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
Pneumococcal conjugate vaccine

ClinicalTrials.gov processed this record on October 19, 2014