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Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants

NCT00366899 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 605

Last updated 2013-02-22

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 Italy.

Conditions

  • Vaccines, Pneumococcal

Interventions

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

Single 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.

BIOLOGICAL

7 valent pneumococcal conjugate vaccine

Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 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 Italy, [email protected]

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
75 Days
Max Age
105 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Italy

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 NCT00366899 on ClinicalTrials.gov