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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

NCT00475033 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 603

Last updated 2011-04-21

Study results available
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Summary

The purpose of this study will be to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric vaccinations in Canada. Immune responses induced by the infant series (NeisVac-C® and Pentacel®)and toddler dose(NeisVac-C®)of routine pediatric vaccines when administered with 13-valent pneumococcal conjugate vaccine will be studied for noninferiority to the immune responses when administered with 7-valent pneumococcal conjugate vaccine. Safety profile and immunogenicity of 13-valent pneumococcal conjugate vaccine will also be evaluated.

Conditions

  • Vaccines, Pneumococcal Conjugate Vaccine

Interventions

BIOLOGICAL

13-valent Pneumococcal Conjugate Vaccine

13-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.

BIOLOGICAL

7-valent pneumococcal conjugate vaccine

7-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer

  • Trial Manager · For Canada, [email protected]

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
98 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00475033 on ClinicalTrials.gov