Status:
COMPLETED
Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Tetanus
Diphtheria
Eligibility:
All Genders
90-120 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 3 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2007
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT00412854
Start Date
January 3 2007
End Date
June 25 2007
Last Update
June 6 2018
Active Locations (2)
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1
GSK Investigational Site
Mengshan, China
2
GSK Investigational Site
Wuzhou, China