Status:
COMPLETED
Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Whole Cell Pertussis
Tetanus
Eligibility:
All Genders
427-577 years
Phase:
PHASE3
Brief Summary
This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP) booster phase, subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix (activ...
Detailed Description
Subjects previously primed with Tritanrix-HepB/Hib-MenAC will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m), respectively, without or with Mencevax ACWY vaccine at...
Eligibility Criteria
Inclusion
- Written informed consent obtained from the parent or guardian of a healthy male or female child between, and including 15 and 18 months age (Philippines)/ 15 and 24 months age (Thailand) at the time of vaccination and who have previously received a 3-dose primary vaccination in the studies DTPwHB/HibMenAC-TT-004 (CPMS No. 759346/004) or DTPW-HBV=HIB-MENAC-TT-013 (eTrack No. 100791).
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
- Chronic administration (\> than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of vaccination. Note: Oral poliovirus vaccine can be given concomitantly.
- Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and C disease, after the date of the study conclusion visit of the primary vaccination study.
Key Trial Info
Start Date :
June 16 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2006
Estimated Enrollment :
798 Patients enrolled
Trial Details
Trial ID
NCT00228917
Start Date
June 16 2005
End Date
January 20 2006
Last Update
February 20 2020
Active Locations (2)
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1
GSK Investigational Site
City of Muntinlupa, Philippines, 1781
2
GSK Investigational Site
Bangkok, Thailand, 10400