Last updated: 11/07/2018 02:19:42
Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results
Study in adolescents/adults to evaluate the persistence up to 3.5 yrs of GSK Biologicals meningococcal vaccine 134612
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: Assess long term persistence of a primary dose of GSK Biologicals' meningococcal vaccine 134612 versus one dose of Mencevax™ ACWY in healthy adolescents/young adults (15 to 19 years at vaccination)
Trial description: This study will investigate the long-term protection offered by GSK Biologicals' meningococcal vaccine 134612 up to 3.5 years after vaccination. Subjects were vaccinated at 15 to 19 years of age. This extension phase starts 18 months after vaccination and part of the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled. This protocol posting deals with objectives & outcome measures of the extension phase 18, 30 and 42 months after vaccination. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00126945). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Meningococcal rSBA titres.
Timeframe: At the start of this persistence study and 12 and 24 months later.
Anti-meningococcal polysaccharide concentrations
Timeframe: At the start of this persistence study and 12 and 24 months later.
Occurrence of serious adverse events related to vaccination, adverse events related to lack of vaccine efficacy or study participation.
Timeframe: From the last study contact of the primary vaccination study to the end of this persistence study.
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Meningococcal vaccine 134612
Biological/vaccine: Mencevax™ ACWY
Enrollment:
46
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Østergaard L et al. (2012) Persistence of antibodies for 42 months following vaccination of adolescents with a meningococcal serogroups A, C, W-135 and Y tetanus toxoid-conjugate vaccine (MenACWY-TT). Int J Infect Dis. pii: S1201-9712(12)01269-6. doi: 10.1016/j.ijid.2012.10.001. [Epub ahead of print]
Medical condition
Infections, Meningococcal
Product
GSK134612A, SB208144
Collaborators
Not applicable
Study date(s)
February 2007 to May 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
15 - 19 years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
- A male or female, who was primed with meningococcal vaccine 134612 or Mencevax™ ACWY in the primary vaccination study 18 months before the first persistence assessment and who completed that study.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since the last visit of the primary vaccination study.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female, who was primed with meningococcal vaccine 134612 or Mencevax™ ACWY in the primary vaccination study 18 months before the first persistence assessment and who completed that study.
- Written informed consent obtained from the subject/ from the parent or guardians of the subject.
- Written informed assent obtained from the subject, as applicable, at the time of study entry.
Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
Exclusion criteria:
Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since the last visit of the primary vaccination study.
Trial location(s)
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
Refer to study documents
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
2007-14-05
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.
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