Status:
COMPLETED
Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m
Lead Sponsor:
GlaxoSmithKline
Conditions:
Whole Cell Pertussis
Haemophilus Influenzae Type b
Eligibility:
All Genders
427-730 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of a...
Detailed Description
This study will be conducted in two stages. In the DTP booster phase subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hib (active control) at 15 to 24 months in a sin...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy male or female between and including 15 and 24 months of age
- Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480)
- Exclusion criteria:
- Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not foreseen in the protocol, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480).
- History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy.
Exclusion
Key Trial Info
Start Date :
January 22 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2006
Estimated Enrollment :
617 Patients enrolled
Trial Details
Trial ID
NCT00136604
Start Date
January 22 2006
End Date
April 23 2006
Last Update
February 20 2020
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