Last updated: 06/13/2019 12:20:31
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 GSK’s Clinical Study Register is no longer maintained for this study.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 GSK Biologicals' meningococcal vaccine (GSK134612) and licensed MenC-CRM197 vaccine in healthy children
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: Non-inferiority of GSK Biologicals’ meningococcal vaccine (GSK134612) compared to licensed MenC-CRM197 conjugate vaccine in healthy children
Trial description: The purpose of the study is to investigate whether or not GSK Biologicals’ meningococcal vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine antibody response against meningococcal serogroup C disease.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of subjects with vaccine response to meningococcal serogroup C serum based on a bactericidal assay using baby rabbit complement (rSBA-MenC) antibody
Timeframe: One month after vaccination (Month 1)
Secondary outcomes:
Meningococcal serogroup A (rSBA) antibody titers
Timeframe: Prior to (Month 0) and one month after vaccination (Month 1)
Anti-meningococcal serogroup polysaccharides (anti-PS) antibody concentrations
Timeframe: Prior to (Month 0) and one month after vaccination (Month 1)
Number of subjects between 2 and 5 years of age with any and Grade 3 solicited local symptoms
Timeframe: During the 4-day (Days 0-3) post-vaccination period
Number of subjects between 6 and 10 years of age with any and Grade 3 solicited local symptoms
Timeframe: During the 4-day (Days 0-3) post-vaccination period
Number of subjects between 2 and 5 years of age with any, Grade 3 and related solicited general symptoms
Timeframe: During the 4-day (Days 0-3) post-vaccination period
Number of subjects between 6 and 10 years of age with any, Grade 3 and related solicited general symptoms
Timeframe: During the 4-day (Days 0-3) post-vaccination period
Number of subjects reporting specific adverse events
Timeframe: Up to 6 months after vaccination (Month 6)
Number of subjects with any unsolicited adverse events (AEs)
Timeframe: During the 31-day (Days 0-30) post-vaccination period
Number of subjects with any serious adverse events (SAEs)
Timeframe: Up to six months after vaccination (Month 6)
Interventions:
Biological/vaccine: GSK Biologicals' meningococcal vaccine GSK134612
Biological/vaccine: Menjugate
Enrollment:
414
Observational study model:
Not applicable
Primary completion date:
2008-02-09
Time perspective:
Not applicable
Clinical publications:
Knuf M et al. (2013) Immunogenicity and safety of the quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) in 2-10-year-old children: results of an open, randomised, controlled study. Eur J Pediatr. 172(5):601-612. DOI 10.1007/s00431-012-1924-0.
Medical condition
Infections, Meningococcal
Product
GSK134612A
Collaborators
Not applicable
Study date(s)
May 2008 to January 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
2 - 10 years
Accepts healthy volunteers
Yes
- Subjects whose parents/guardians, the investigator believes can and will comply with the requirements of the protocol.
- A male or female between, and including, 2 and 10 years of age at the time of the vaccination.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the study vaccine dose, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose..
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects whose parents/guardians, the investigator believes can and will comply with the requirements of the protocol.
- A male or female between, and including, 2 and 10 years of age at the time of the vaccination.
- Written informed consent obtained from the parent(s) or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her parents’/guardians’ knowledge.
Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the study vaccine dose, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose..
- Administration of a vaccine not foreseen by the study protocol during the period starting from one month before the dose of the study vaccine and ending 30 days after.
- Concurrently participating in another clinical study or planned participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C W-135 and/or Y (for subjects below 6 years) or within the last five years (for subjects 6 years old and above).
- Previous vaccination with meningococcal polysaccharide conjugate vaccine serogroups A, C, W-135 and/or Y.
- History of meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment
- Administration of immunoglobulins and/or any blood products within the three months preceding the study vaccine dose or planned administration during the study period. Exclusion criteria for specified regions in France
- Subjects in contact with somebody suffering from an invasive infection with meningococcal serogroups A, C, Y or W-135, or
- Subjects living in a geographic area in France where local outbreak with meningococcal serogroup C has occurred and would thus be likely to participate in a vaccination campaign against meningococcal serogroup C.
Trial location(s)
Location
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
Status
Study Complete
Location
GSK Investigational Site
Espelkamp, Nordrhein-Westfalen, Germany, 32339
Status
Study Complete
Location
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
Status
Study Complete
Location
GSK Investigational Site
Hille, Nordrhein-Westfalen, Germany, 32479
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
Status
Study Complete
Location
GSK Investigational Site
Solingen, Nordrhein-Westfalen, Germany, 42719
Status
Study Complete
Location
GSK Investigational Site
Tettnang, Baden-Wuerttemberg, Germany, 88069
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Status
Study Complete
Location
GSK Investigational Site
Velbert, Nordrhein-Westfalen, Germany, 42551
Status
Study Complete
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
2008-02-09
Actual study completion date
2009-08-01
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
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