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Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

NCT00464945 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2012-08-15

Study results available
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Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale 13vPnC in healthy infants when given with routine pediatric vaccines.

Conditions

  • Pneumococcal Vaccines

Interventions

BIOLOGICAL

13-valent Pneumococcal Conjugate Vaccine

1 dose at 2,3,4 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 Poland, [email protected]

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
41 Days
Max Age
99 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Poland

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 NCT00464945 on ClinicalTrials.gov