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Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00412854
First received: December 18, 2006
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 & 5 months of age, in terms of safety and immunogenicity.


Condition Intervention Phase
Haemophilus Influenzae Type b Disease
Diphtheria
Pertussis
Tetanus
 Biological: Infanrix™/Hib
Biological: Infanrix
Biological: Hiberix
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase IIIb, Multicentre Study to Assess Safety & Immunogenicity of GSK Biologicals' Combined DTPa/Hib (Infanrix/Hib) Vaccine vs Separate Administration of DTPa (Infanrix) & Hib (Hiberix) Vaccines in Healthy Infants 3,4,&5 Months of Age

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN, anti-FHA & anti-PRP antibody concentration. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Solicited symptoms (Day 0-3), unsolicited adverse events (Day 0-30) & serious adverse events [ Designated as safety issue: No ]

Enrollment: 660
Study Start Date: January 2007
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   90 Days to 120 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female between, and including, 90 and 120 days of age at the time of the first vaccination,
  • written informed consent obtained from the parent or guardian of the subject

Exclusion Criteria:

  • Subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate,
  • Subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b diseases can not participate.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412854

Locations
China
GSK Investigational Site
Mengshan, China
GSK Investigational Site
Wuzhou, China
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00412854     History of Changes
Other Study ID Numbers: 104567
Study First Received: December 18, 2006
Last Updated: November 21, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diphtheria
Influenza, Human
Whooping Cough
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Infection
Clostridium Infections

ClinicalTrials.gov processed this record on May 21, 2013