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Immunogenicity and Safety of Pentaxim in South African Infants

NCT00254969 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2012-04-17

No results posted yet for this study

Summary

The present clinical study will assess the immunogenicity and reactogenicity 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 in order to meet the requirements for application for the use of the product in the Expanded Program on Immunization (EPI) in South Africa.

Conditions

  • Diphtheria
  • Tetanus
  • Haemophilus Infections
  • Pertussis
  • Poliomyelitis

Interventions

BIOLOGICAL

Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib

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
24 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-05-31
Completion
2010-01-31

Countries

  • South Africa

Study Locations

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Entities

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 NCT00254969 on ClinicalTrials.gov