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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants

NCT00444457 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1712

Last updated 2012-10-15

Study results available
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Summary

The purpose of this study will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine.

Conditions

  • Vaccines, Pneumococcal

Interventions

BIOLOGICAL

13-valent Pneumococcal Conjugate Vaccine

0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.

BIOLOGICAL

7vPnC

0.5 mL of study vaccine administered IM at 2, 4, 6, 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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
98 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

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 NCT00444457 on ClinicalTrials.gov