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

NCT00366678 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 613

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 a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccines in France.

Conditions

  • Vaccines, Pneumococcal

Interventions

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

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

BIOLOGICAL

7-valent pneumococcal conjugate vaccine

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

DRUG

Pentavac

The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).

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 France, [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
2006-10-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • France

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 NCT00366678 on ClinicalTrials.gov