Last updated: 11/07/2018 02:30:49
A Phase IV, single centre, open-label study, to investigate the persistence of antibody 6 years after priming immunization with meningococcal conjugate vaccine and indiction of long term immunological memory by assessing persistence of memory B cells and response to the Hib-MenC (Menitorix) vaccine in healthy children 6 to 12 years 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 IV, single centre, open-label study, to investigate the persistence of antibody 6 years after priming immunization with meningococcal conjugate vaccine and indiction of long term immunological memory by assessing persistence of memory B cells and response to the Hib-MenC (Menitorix) vaccine in healthy children 6 to 12 years of age.
Trial description: A Phase IV, single centre, open-label study, to investigate the persistence of antibody 6 years after priming immunization with meningococcal conjugate vaccine and indiction of long term immunological memory by assessing persistence of memory B cells and response to the Hib-MenC (Menitorix) vaccine in healthy children 6 to 12 years 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:
O’Connor D et al. Functional SNPS within TLR3 involve response to serogroup C meningococcal conjugate vaccine. Abstract presented at the 30th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Thessaloniki, Greece, 8-12 May 2012.
Perrett KP et. (2010) Antibody persistence after serogroup C meningococcal conjugate immunization of United Kingdom primary-school children in 1999–2000 and response to a booster: a phase 4 clinical trial. Clin Infect Dis. 50(12):1601–1610.
Pollard AJ et al. (2009) Maintaining protection against invasive bacteria with protein-polysaccharide conjugate vaccines. Nature reviews immunology. 9(3):213-220.
Medical condition
Neisseria Meningitidis-Haemophilus influenzae type b Vaccine
Product
SB811936
Collaborators
Not applicable
Study date(s)
September 2006 to August 2008
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
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
2008-06-08
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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