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Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand

NCT00255021 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2012-04-16

No results posted yet for this study

Summary

The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTacP-IPV// PRP\~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.

Conditions

  • Diphtheria
  • Tetanus
  • Poliomyelitis
  • Haemophilus Infections
  • Pertussis

Interventions

BIOLOGICAL

Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac

0.5 mL, IM

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Months
Max Age
2 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-09-30
Completion
2009-01-31

Countries

  • Thailand

Study Locations

More Related Trials

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 NCT00255021 on ClinicalTrials.gov