Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01128439
First received: May 20, 2010
Last updated: June 9, 2015
Last verified: June 2015
  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 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

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 ]

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
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:

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

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01128439     History of Changes
Other Study ID Numbers: 6096A1-4005
B1851042 ( Other Identifier: Alias Study Number )
Study First Received: May 20, 2010
Last Updated: June 9, 2015

Keywords provided by Pfizer:
Pneumococcal conjugate vaccine

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 25, 2017