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Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

NCT00348881 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2133

Last updated 2013-10-22

Study results available
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Summary

This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP\~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.

Conditions

Interventions

BIOLOGICAL

DTaP-HB-PRP~T combined vaccine

0.5 mL, Intramuscular

BIOLOGICAL

Tritanrix-HepB/Hib™ vaccine

0.5 mL, Intramuscular

BIOLOGICAL

Oral poliomyelitis vaccine (OPV)

Oral co-administered with study vaccine.

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2007-10-31
Completion
2008-06-30

Countries

  • Philippines

Study Locations

More Related Trials

Entities

Diseases

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 NCT00348881 on ClinicalTrials.gov