Last updated: 11/07/2018 04:26:51
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 GSK’s Clinical Study Register is no longer maintained for this study.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 to evaluate persistence of antibodies after vaccination with meningococcal vaccine GSK 134612
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: Persistence of antibodies after vaccination with GSK Biologicals’ meningococcal vaccine GSK134612 in adolescents and young adults
Trial description: Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of seroprotected subjects against the vaccine meningococcal serogroups
Timeframe: At Month 24 post primary dose
Number of seroprotected subjects against the vaccine meningococcal serogroups
Timeframe: At Month 36 post primary dose
Number of seroprotected subjects against the vaccine meningococcal serogroups
Timeframe: At Month 48 post primary dose
Number of seroprotected subjects against the vaccine meningococcal serogroups
Timeframe: At Month 60 post primary dose
Secondary outcomes:
Number of seropositive subjects against the vaccine meningococcal serogroups
Timeframe: At Months 24, 36, 48 and 60 post primary dose
Antibody titers against the vaccine meningococcal serogroups
Timeframe: At Months 24, 36, 48 and 60 post primary dose
Number of subjects with antibody concentrations against the vaccine polysaccharides
Timeframe: At Month 24 post primary dose
Antibody concentrations against the vaccine polysaccharides
Timeframe: At Month 24 post primary dose
Interventions:
Enrollment:
697
Primary completion date:
2013-17-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Quiambao BP et al. (2016) Persistence of the immune response 2 years after vaccination with quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine (MenACWY-TT) in Asian adolescents. Hum Vaccin Immunother. 12(8): 2162-2168.
Quiambao BP et al. (2017) Antibody persistence up to 5 years after vaccination with a quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine in adolescents. Hum Vaccin Immunother. 2:1-9. doi: 10.1080/21645515.2016.1248009. [Epub ahead of print].
Medical condition
Infections, Meningococcal
Product
GSK134612A, SB208144
Collaborators
Not applicable
Study date(s)
September 2009 to May 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
11 - 17 years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female having been vaccinated with a meningococcal vaccine in the primary study 109069.
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject’s first visit.
- History of meningococcal disease; such cases will be documented.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female having been vaccinated with a meningococcal vaccine in the primary study 109069.
- Written informed consent obtained from parent(s)/guardian(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion criteria:
- History of meningococcal disease; such cases will be documented.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study 109069.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- Administration of immunoglobulins and/or any blood products within the three months preceding the subject’s first visit.
- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy
- Subjects who withdrew consent to be contacted for follow-up studies.
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject’s first visit.
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
Results posted on ClinicalTrials.gov
Recruitment status
No longer a GSK study
Actual primary completion date
2013-17-05
Actual study completion date
2013-17-05
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.
Additional information about the trial
Additional information
Not applicable
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