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Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

NCT00474539 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 449

Last updated 2013-03-05

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 paediatric vaccinations in Spain.

Conditions

  • Vaccines, Pneumococcal

Interventions

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

1 dose at 2,4,6 and 15 months of age

BIOLOGICAL

7-valent pneumococcal conjugate vaccine

1 dose at 2,4,6 and 15 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 Spain: [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
2007-07-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Spain

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 NCT00474539 on ClinicalTrials.gov