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NCT01128439 Clinical Trial

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

Invasive Pneumococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01128439
Other study ID # 6096A1-4005
Secondary ID B1851042
Status Completed
Phase
First received
Last updated
Start date July 2010
Est. completion date April 2015

Study information
Verified date November 2018
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

No sampling as no subjects are enrolled

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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:

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention

Locations
Country Name City State
United States Kaiser Permanente Vaccine Study Center Oakland California

Sponsors (2)
Lead Sponsor Collaborator
Pfizer Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT00853749 - Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine Phase 3
Completed NCT00227188 - Study Evaluating Prevenar in the Prevention of Invasive Pneumococcal Disease (IPD) in the Paediatric Population in Spain. N/A
Recruiting NCT00885625 - 7-valent Pneumococcal Conjugated Vaccination Phase 4
Completed NCT04464291 - An Epidemiological Survey to Establish the Spectrum of Circulating Serotypes of S. Pneumoniae, in Patients Older 18 Years N/A
Completed NCT01083459 - Impact of PCV on Disease and Colonization Among Native American Communities N/A
Completed NCT00371878 - Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Lung Fluid of Adults With and Without HIV Infection Phase 4