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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil

NCT00676091 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2011-08-08

Study results available
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Summary

The purpose of this study will be to analyze 13-valent pneumococcal vaccine given to healthy infants in Brazil for safety and tolerability, and to determine the immune response to the vaccines.

Conditions

  • Vaccines, Pneumococcal Conjugate Vaccine

Interventions

BIOLOGICAL

13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

BIOLOGICAL

7-Valent Pneumococcal Conjugate Vaccine (7vPnc)

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
54 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Brazil

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 NCT00676091 on ClinicalTrials.gov