Last updated: 11/29/2018 19:10:15
Single-blind, multicentre, phase IV clinical trial to assess and compare the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) and Aventis Pasteur’s DTPa-HBV-IPV-Hib vaccine (Hexavac™) given as a primary vaccination course at 2, 4 and 6 months of age.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Single-blind, multicentre, phase IV clinical trial to assess and compare the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) and Aventis Pasteur’s DTPa-HBV-IPV-Hib vaccine (Hexavac™) given as a primary vaccination course at 2, 4 and 6 months of age.
Trial description: Single-blind, multicentre, phase IV clinical trial to assess and compare the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) and Aventis Pasteur’s DTPa-HBV-IPV-Hib vaccine (Hexavac™) given as a primary vaccination course at 2, 4 and 6 months of age.
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:
Schuerman et al. Comparison of a Three-dose primary vaccination course with GlaxoSmithKline Biologicals DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) or Aventis Pasteur's DTPa-HBV-IPV-Hib vaccine (Hexavac) followed by a fourth (booster) dose of Infanrix hexa. Abstract presented at the 24th ICP, Cancun, Mexico, 15-20 Aug 2004.
Sänger R et al. Comparison of the Immunogenicity and Reactogenicity of Two Commercially Available Hexavalent Vaccines Administered as a Primary Vaccination Course at 2, 4 and 6 Months of Age. Abstract presented at the 21st Annual Meeting ESPID, Taormina, Sicily, 9-11 April 2003.
Tichmann I et al. (2005) Comparison of the immunogenicity and reactogenicity of two commercially available hexavalent vaccines administered as a primary vaccination course at 2, 4 and 6 months of age. Vaccine. 23: 3272–3279.
Medical condition
Diphtheria, Haemophilus influenzae type b, Hepatitis B, Poliomyelitis, Tetanus, acellular pertussis
Product
Combined Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B, Inactivated Polio, Haemophilus influenzae Type b Vaccine
Collaborators
Not applicable
Study date(s)
December 2001 to October 2002
Type
Not applicable
Phase
4
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
2002-21-10
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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