Status:
COMPLETED
Lot-to-lot Consistency of Tritanrix™-HepB/Hib-MenAC & Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Tetanus
Hepatitis B
Eligibility:
All Genders
56-83 years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of GSK Biologicals' Hib-MenAC (Haemophilus influenzae type b and meningococcal serogroups A and C) v...
Detailed Description
The study is double blind. However the active control vaccine Tritanrix™-HepB/Hiberix™ will be administered in a single-blind manner. Blood samples will be collected for immunogenicity analyses. GSK B...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- healthy male or female, between, and including, 56 and 83 days of age.
- Born after a gestation period between 36 and 42 weeks
- Birth dose of hepatitis B vaccine within the first 72 hours of life
- Exclusion criteria:
- planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period.
- Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- History of OR previous vaccination against OR known exposure since birth to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- A family history of congenital or hereditary immunodeficiency
- History of any neurologic disorders or seizures
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00197275
Start Date
February 1 2006
End Date
November 1 2006
Last Update
October 7 2016
Active Locations (3)
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1
GSK Investigational Site
Bangkok, Thailand, 10400
2
GSK Investigational Site
Khon Kaen, Thailand, 40002
3
GSK Investigational Site
Songkhla, Thailand, 90110