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Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants

NCT00831753 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2016-05-13

Study results available
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Summary

The study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP\~T vaccine has immunological and safety profiles that are comparable to those of the control vaccine that is already marketed (Infanrix®Hexa)

Primary Objective:

To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP\~T combined vaccine induces an immune response that is at least as good as the response following Infanrix®Hexa in terms of seroprotection rates to HB, one month after a three-dose primary series (2, 4 and 6 months)

Secondary Objectives:

* To describe in each group the immunogenicity to vaccine components (for DTaP-IPV-Hep B-PRP\~T and Infanrix®Hexa) one month after the third dose of the primary series.
* To assess the overall safety in each group one month after each dose of the primary series and through the entire study.

Conditions

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

Interventions

BIOLOGICAL

DTaP IPV HB PRP~T vaccine

0.5 mL, Intramuscular

BIOLOGICAL

DTaP-HB-IPV and Haemophilus influenzae type b

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-05-31
Completion
2009-11-30

Countries

  • Peru

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 NCT00831753 on ClinicalTrials.gov