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Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants

NCT00514709 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1843

Last updated 2016-08-02

Study results available
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Summary

DTaP-HB-PRP\~T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and potentially of an increased acceptance.

Primary Objectives:

* To describe the antibody persistence at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP\~T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth.
* To describe the effect of a booster dose of DTaP-HB-PRP\~T on immunogenicity at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP\~T or Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine given at birth.

Secondary Objective:

* To describe the safety profile of the booster dose of the DTaP-HB-PRP\~T vaccine when administered concomitantly with Oral Polio Vaccine (OPV).

Conditions

Interventions

BIOLOGICAL

DTaP-HB PRP~T Combined Vaccine

0.5 mL, Intramuscular (IM)

BIOLOGICAL

DTaP-HB-PRP~T vaccine

0.5 mL, IM

BIOLOGICAL

Oral Polio Vaccine

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
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-12-31
Completion
2009-04-30

Countries

  • Philippines

Study Locations

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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 NCT00514709 on ClinicalTrials.gov