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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: April 12, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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
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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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: April 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
Pneumococcal conjugate vaccine

ClinicalTrials.gov processed this record on May 16, 2013