Last updated: 11/07/2018 15:16:15
A phase II, open, randomised, controlled, multicentre, primary vaccination study to evaluate the immunogenicity (including immune memory), reactogenicity and safety of three different formulations of the GSK Biologicals’ combined Haemophilus influenzae type b-meningococcal serogroups CY conjugate vaccine given concomitantly with Infanrix® penta and Prevenar®, versus ActHIB® and Meningitec® given concomitantly with Infanrix® penta and versus ActHIB® given concomitantly with Infanrix® penta and Prevenar® in infants according to a 2-4-6 month schedule.
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, open, randomised, controlled, multicentre, primary vaccination study to evaluate the immunogenicity (including immune memory), reactogenicity and safety of three different formulations of the GSK Biologicals’ combined Haemophilus influenzae type b-meningococcal serogroups CY conjugate vaccine given concomitantly with Infanrix® penta and Prevenar®, versus ActHIB® and Meningitec® given concomitantly with Infanrix® penta and versus ActHIB® given concomitantly with Infanrix® penta and Prevenar® in infants according to a 2-4-6 month schedule.
Trial description: A phase II, open, randomised, controlled, multicentre, primary vaccination study to evaluate the immunogenicity (including immune memory), reactogenicity and safety of three different formulations of the GSK Biologicals’ combined Haemophilus influenzae type b-meningococcal serogroups CY conjugate vaccine given concomitantly with Infanrix® penta and Prevenar®, versus ActHIB® and Meningitec® given concomitantly with Infanrix® penta and versus ActHIB® given concomitantly with Infanrix® penta and Prevenar® in infants according to a 2-4-6 month schedule.
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:
Bryant KA et al. (2011) Haemophilus influenzae type b–Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines.10(7):941-950.
Nolan T et al. (2007) A novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus-toxoid conjugate vaccine is immunogenic and induces immune memory when co-administered with DTPa-HBV-IPV and conjugate pneumococcal vaccines in infants. Vaccine 25 (51) 8487–8499.
T Nolan et al. A novel Haemophilus influenzae type b – meningococcal serogroups C and Y conjugate (Hib-MenCY-TT) vaccine induces persistent immune responses and immune memory. Abstract presented at Pediatric Academic Societies’ (PAS) Annual meeting. San Francisco, California, US, 29 April to 2 May 2006.
Medical condition
Neisseria Meningitidis-Haemophilus influenzae type b Vaccine
Product
SB792014
Collaborators
Not applicable
Study date(s)
December 2003 to August 2004
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
2004-23-08
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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