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

NCT00384059 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2013-01-24

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 vaccines in the United Kingdom.

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

7vPnC

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

BIOLOGICAL

Pediacel

concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age

BIOLOGICAL

NeisVac-C

concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age

BIOLOGICAL

Menitorix

concomitant vaccine, both at arm 1 and at arm 2, at 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

  • Trial Manager · For UK/Great Britian, [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
2008-10-31
Completion
2008-10-31

Countries

  • United Kingdom

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 NCT00384059 on ClinicalTrials.gov