Last updated: 11/03/2018 07:03:44
A phase III, multicenter booster vaccination study to assess the immunogenicity, safety and reactogenicity of a fourth dose of GSK Biologicals' Tritanrix TM-HepB/HibMenAC vaccine at 15 to 24 months of age and to assess the immunogenicity, safety and reactogenicity of a dose of Menecvax TM ACWY at 24 to 30 months of age in subjects primed with 3 doses of Tritanrix TM-HepB/HibMenAC in study 100480 (DTPW-HBV=HIB-MENAC-TT-003)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A phase III, multicenter booster vaccination study to assess the immunogenicity, safety and reactogenicity of a fourth dose of GSK Biologicals' Tritanrix TM-HepB/HibMenAC vaccine at 15 to 24 months of age and to assess the immunogenicity, safety and reactogenicity of a dose of Menecvax TM ACWY at 24 to 30 months of age in subjects primed with 3 doses of Tritanrix TM-HepB/HibMenAC in study 100480 (DTPW-HBV=HIB-MENAC-TT-003)
Trial description: A phase III, multicenter booster vaccination study to assess the immunogenicity, safety and reactogenicity of a fourth dose of GSK Biologicals' Tritanrix TM-HepB/HibMenAC vaccine at 15 to 24 months of age and to assess the immunogenicity, safety and reactogenicity of a dose of Menecvax TM ACWY at 24 to 30 months of age in subjects primed with 3 doses of Tritanrix TM-HepB/HibMenAC in study 100480 (DTPW-HBV=HIB-MENAC-TT-003)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus influenzae type b-Neisseria Meningitidis Vaccines
Product
SB759346
Collaborators
Not applicable
Study date(s)
August 2006 to November 2006
Type
Not applicable
Phase
2/3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2006-10-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website