Last updated: 11/06/2018 23:35:37
Phase III, partially blinded, randomized, controlled, primary vaccination study to demonstrate the non-inferiority of GlaxoSmithKline (GSK) Biologicals’ DTPw-HBV/Hib Kft. compared to GSK Biologicals’ Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants at 6, 10 and 14 weeks of age. The immunogenicity of GSK Biologicals’ DTPw-HBV/Hib Kft. administered after a birth dose of Hepatitis B vaccine will also be assessed.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Phase III, partially blinded, randomized, controlled, primary vaccination study to demonstrate the non-inferiority of GlaxoSmithKline (GSK) Biologicals’ DTPw-HBV/Hib Kft. compared to GSK Biologicals’ Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants at 6, 10 and 14 weeks of age. The immunogenicity of GSK Biologicals’ DTPw-HBV/Hib Kft. administered after a birth dose of Hepatitis B vaccine will also be assessed.
Trial description: Phase III, partially blinded, randomized, controlled, primary vaccination study to demonstrate the non-inferiority of GlaxoSmithKline (GSK) Biologicals’ DTPw-HBV/Hib Kft. compared to GSK Biologicals’ Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants at 6, 10 and 14 weeks of age. The immunogenicity of GSK Biologicals’ DTPw-HBV/Hib Kft. administered after a birth dose of Hepatitis B vaccine will also be assessed.
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:
Gatchalian S et al. (2005) A new DTPw-HBV/Hib vaccine is immunogenic and safe when administered according to the EPI (Expanded Programme for Immunization) schedule and following hepatitis B vaccination at birth. Human Vaccines. 1(5): 198-203.
Medical condition
Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus influenzae type b Vaccines
Product
GSK323527A
Collaborators
Not applicable
Study date(s)
March 2004 to October 2004
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
2004-25-10
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
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Access to clinical trial data by researchers
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