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Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™

NCT00534833 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 362

Last updated 2013-11-21

Study results available
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Summary

The present trial is a follow-up of AL203 study (NCT00343889).

Primary Objectives:

To describe the antibody persistence at 15 to 18 months of age and the booster effect of a dose of DTaP-HB-PRP\~T or Tritanrix-HepB/Hib™ (given concomitantly with Oral Polio Vaccine \[OPV\]).

Secondary Objective:

To describe the safety profile of a booster dose of DTaP-HB-PRP\~T or Tritanrix-HepB/Hib™ when administered concomitantly with OPV in each vaccine group.

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis
  • Hepatitis B
  • Haemophilus Influenzae Type b

Interventions

BIOLOGICAL

DTaP-HB-PRP~T vaccine

0.5 mL, Intramuscular

BIOLOGICAL

Tritanrix-HepB/Hib™

0.5 mL, Intramuscular

BIOLOGICAL

Oral Polio Vaccine

0.5 mL, Oral

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-09-30
Completion
2009-03-31

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 NCT00534833 on ClinicalTrials.gov