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Immunogenicity and Safety of Pentaxim™ in an Indian Population

NCT00259337 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2012-04-16

No results posted yet for this study

Summary

The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP\~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life.

Safety:

This study will describe the safety after each dose of the primary series of the study's combined vaccine (Pentaxim™).

Conditions

  • Diphtheria
  • Tetanus
  • Polio
  • Pertussis
  • Haemophilus Infections

Interventions

BIOLOGICAL

Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine

0.5 mL, IM

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-04-30
Completion
2008-12-31

Countries

  • India

Study Locations

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Entities

Diseases
Companies

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 NCT00259337 on ClinicalTrials.gov