Last updated: 11/07/2018 00:21:53
A phase II, double blind, randomized, controlled study to evaluate the immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Hib-MenAC vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix™-HepB, as compared to GSK Biologicals’ Hiberix™ vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix™-HepB, when administered intramuscularly in infants at 6, 10 and 14 weeks 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: A phase II, double blind, randomized, controlled study to evaluate the immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Hib-MenAC vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix™-HepB, as compared to GSK Biologicals’ Hiberix™ vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix™-HepB, when administered intramuscularly in infants at 6, 10 and 14 weeks of age.
Trial description: A phase II, double blind, randomized, controlled study to evaluate the immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Hib-MenAC vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix™-HepB, as compared to GSK Biologicals’ Hiberix™ vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix™-HepB, when administered intramuscularly in infants at 6, 10 and 14 weeks 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:
Hodgson A et al. (2008) A Phase II, Randomized Study on an Investigational DTPw-HBV/Hib-MenAC Conjugate Vaccine Administered to Infants in Northern Ghana. PLoS ONE 3(5): e2159.
Medical condition
Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus influenzae type b-Neisseria Meningitidis Vaccines
Product
SB759346
Collaborators
Not applicable
Study date(s)
January 2005 to October 2005
Type
Not applicable
Phase
1/2
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
2005-07-10
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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