Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers

This study has been completed.
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01128426
First received: May 20, 2010
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

The purpose of the study is to expand the understanding of the safety profile of 13vPnC in routine use following licensure and introduction of the vaccine.


Condition Intervention
Pneumococcal Disease
Other: No Intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Postlicensure Observational Safety Study of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) Administered in Routine Use to Infants and Toddlers

Further study details as provided by Pfizer:

Enrollment: 1
Study Start Date: June 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Other: No Intervention
No Intervention

  Eligibility

Ages Eligible for Study:   2 Months to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

60,000 infants total: at least 43,000 infants who receive all 3 primary series doses of 13vPnC plus 15,000 additional infants who receive less than 3 doses of 13vPnC

Criteria

Inclusion Criteria:

  • Infants starting vaccination with 13vPnC in the first 6 months of life who are members of the Northern California Kaiser Permanente healthcase system and who receive at least 1 dose of 13vPnC during the study observation period will be included. Infants must not have had 7vPnC at the time of 13vPnC dose administration.

Exclusion Criteria:

  • Infants and children who were previously vaccinated with any number of doses of 7vPnC will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128426

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: NCT01128426     History of Changes
Other Study ID Numbers: 6096A1-4002, B1851044
Study First Received: May 20, 2010
Last Updated: September 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Pneumococcal conjugate vaccine

ClinicalTrials.gov processed this record on April 20, 2014