Status:
COMPLETED
Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diphtheria
Hepatitis B
Eligibility:
All Genders
56-83 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to demonstrate consistent results in 3 production lots of Hib-MenAC vaccine when extemporaneously mixed with Tritanrix™-HepB and administered as a single injection, with re...
Detailed Description
Randomized study with five groups to receive one of the following vaccination regimens after a birth dose of hepatitis B vaccine: One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- • Healthy infants 56-83 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks and received a birth dose of hepatitis B vaccine within the first 72 hours of life.
- Exclusion criteria:
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history \& physical examination.
- 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 with the exception of oral polio vaccine (OPV).
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (\>14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and/or meningococcal disease.
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00317161
Start Date
August 1 2004
End Date
April 1 2005
Last Update
September 20 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