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Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™

NCT00654901 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 881

Last updated 2016-05-13

Study results available
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Summary

This is a follow-up of Study A3L11 (NCT00404651).

Immunogenicity

* To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP\~T or Infanrix hexa™.
* To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP\~T in a subset of subjects.

Safety

\- To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP\~T.

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis
  • Hepatitis B
  • Poliomyelitis
  • Haemophilus Influenzae Type B Infection

Interventions

BIOLOGICAL

DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)

0.5 mL, Intramuscular

BIOLOGICAL

DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)

0.5 mL, Intramuscular

BIOLOGICAL

DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)

0.5 mL, Intramuscular

BIOLOGICAL

Infanrix Hexa™

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-05-31
Completion
2009-07-31

Countries

  • Mexico

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 NCT00654901 on ClinicalTrials.gov