Last updated: 11/03/2018 09:36:55
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 GSK’s Clinical Study Register is no longer maintained for this study.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
Comparison of GSK134612 in subjects previously vaccinated against meningococcal disease versus non-vaccinated subjects
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: Immunogenicity & safety study of GSK Biologicals’ meningococcal vaccine GSK134612 administered in healthy subjects either previously primed with Mencevax™ ACWY or naïve to meningococcal vaccination.
Trial description: In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a previous study (whose objectives & outcome measures are presented in a separate protocol posting with NCT number = 00227422) will be vaccinated with a new vaccine using conjugation technology.These subjects will be compared to subjects vaccinated with the new vaccine, but who were not previously vaccinated with a meningococcal polysaccharide vaccine.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Meningococcal Serum Bactericidal Antibodies/assay (rSBA) titers
Timeframe: One month post-vaccination (Month 1)
Secondary outcomes:
Meningococcal rSBA titers
Timeframe: Prior to vaccination (Day 0)
Anti-meningococcal polysaccharide (PS) antibody concentrations
Timeframe: Prior to (Day 0) and one month post-vaccination (Month 1)
Anti-tetanus toxoid antibody concentrations
Timeframe: Prior to (Day 0) and one month post-vaccination (Month 1)
Number of subjects with a vaccine response to meningococcal antigens A, C, W and Y
Timeframe: One month post-vaccination (Month 1)
Number of subjects with any and grade 3 solicited local symptoms
Timeframe: During the 4-day (Day 0 to Day 3) period after vaccination
Number of subjects with any, grade 3 and related solicited general symptoms
Timeframe: During the 4-day (Day 0 to Day 3) period after vaccination
Number of subjects with unsolicited symptoms
Timeframe: Up to one month post-vaccination (Month 1)
Number of subjects reporting any Serious Adverse Events
Timeframe: Day 0 to study month 6
Number of subjects with any specific adverse events
Timeframe: Day 0 to study month 6
Interventions:
Biological/vaccine: Meningococcal vaccine GSK134612 (Nimenrix)
Enrollment:
271
Observational study model:
Not applicable
Primary completion date:
2008-19-12
Time perspective:
Not applicable
Clinical publications:
Dbaibo G et al. (2012) The tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic with a clinically acceptable safety profile in subjects previously vaccinated with a tetravalent polysaccharide vaccine. Int J Infect Dis. 16(8):608-615.
Dbaibo G et al. One dose of the meningococcal tetravalent tetanus toxoid conjugated vaccine (MenACWY-TT) is immunogenic with an acceptable safety profile in unvaccinated subjects and those previously vaccinated with a MenACWY polysaccharide vaccine. Abstract presented at the 3rd Northern European Conference on Travel Medicine (NECTM). Hamburg, Germany, 26-29 May 2010.
Medical condition
Infections, Meningococcal
Product
GSK134612A, SB208144
Collaborators
Not applicable
Study date(s)
May 2008 to December 2008
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
4 - 34 years
Accepts healthy volunteers
Yes
- Only subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- For the MPS group, a male or female between, and including, 4.5 and 34 years of age at the time of the study vaccination, who has been vaccinated in GSK Biologicals' study 102394.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding administration of the study vaccine, or planned use during the complete study period (active phase and extended safety follow-up).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccine dose.
Inclusion and exclusion criteria
Inclusion criteria:
- Only subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- For the MPS group, a male or female between, and including, 4.5 and 34 years of age at the time of the study vaccination, who has been vaccinated in GSK Biologicals' study 102394.
- For the noMPS group, a male or female between, and including, 4.5 and 34 years of age at the time of the study vaccination.
- Written informed consent obtained from the subject/ from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her knowledge.
- If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding administration of the study vaccine, or planned use during the complete study period (active phase and extended safety follow-up).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of the study vaccine and up to 30 days after the study vaccine.
- Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- For the MPS Group, vaccination against meningococcal disease after completion of study 102394
- For the noMPS group, previous vaccination, or vaccination within the last 10 years, against meningococcal disease (of any serogroup).
- Previous vaccination against tetanus within 30 days.
- History of meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical.
- A family history of congenital or hereditary immunodeficiency, unless the child has previously been documented, through laboratory testing, to have normal immune function.
- History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
- Know hypersensitivity to any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
- Acute disease at the time of enrolment
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the active stage of the study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
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
2008-19-12
Actual study completion date
2008-19-12
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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