Status:

COMPLETED

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Conditions:

Vaccines, Pneumococcal

Eligibility:

All Genders

42-98 years

Phase:

PHASE3

Brief Summary

The purpose of this study will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of ...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Healthy 2 month old infants
  • Available for the duration of the study and reachable by telephone
  • Able to complete two blood drawing procedures during the study
  • Exclusion criteria:
  • Previous vaccination, contraindication or history of allergic reaction to vaccines or vaccine components
  • Bleeding disorder, immune deficiency or significant chronic or congenital disease
  • Previous receipt of blood products or immune globulin

Exclusion

    Key Trial Info

    Start Date :

    May 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2009

    Estimated Enrollment :

    1712 Patients enrolled

    Trial Details

    Trial ID

    NCT00444457

    Start Date

    May 1 2007

    End Date

    June 1 2009

    Last Update

    October 15 2012

    Active Locations (78)

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    Page 1 of 20 (78 locations)

    1

    Benton, Arkansas, United States, 72019

    2

    Conway, Arkansas, United States, 72033

    3

    Fayetteville, Arkansas, United States, 72703

    4

    Jonesboro, Arkansas, United States, 72401