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Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.

NCT00366340 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 604

Last updated 2012-08-08

Study results available
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Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to 7-valent pneumococcal conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months (infant series) and at 11-12 months of age (toddler dose) in Germany.

Conditions

  • Vaccines, Pneumococcal

Interventions

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age

BIOLOGICAL

7-valent pneumococcal conjugate vaccine

Single 0.5mL dose given at 2, 3, 4 and 11 to 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 Germany, [email protected]

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
56 Days
Max Age
112 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Germany

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 NCT00366340 on ClinicalTrials.gov