Last updated: 10/03/2020 12:10:36
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 GSK’s Clinical Study Register is no longer maintained for this study.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

Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects

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GSK study ID
109495
See study documents
Clinicaltrials.gov ID
NCT00514904
See results summary
EudraCT ID
2012-000283-23
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Non-inferiority of GSK Biologicals' Meningococcal vaccine GSK134612 versus Mencevax™ in healthy subjects aged 2 through 10 years of age
Trial description: The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of subjects with vaccine response to N. meningitidis serogroups A (MenA), MenC, MenY and MenW-135

Timeframe: One month after vaccination (Post-vaccination, study Month 1)

Number of subjects with grade 3 general symptoms (solicited and unsolicited)

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Secondary outcomes:

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) titers greater than or equal (≥) to the cut-off values

Timeframe: Pre vaccination (Month 0) and post vaccination (Month 1)

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

Timeframe: Pre vaccination (Month 0) and post vaccination (Month 1)

Number of subjects with anti-tetanus toxoid (anti-TT) concentrations greater than or equal to (≥) the cut-off values

Timeframe: Pre vaccination (Month 0) and post vaccination (Month 1)

Anti-tetanus toxoid (anti-TT) antibody concentrations

Timeframe: Pre vaccination (Month 0) and post vaccination (Month 1)

Number of subjects with anti-polysaccharide (anti-PS) concentrations greater than or equal to (≥) the cut-off values

Timeframe: Pre vaccination (Month 0) and post vaccination, (Month 1)

Anti-polysaccharide (anti-PS) antibody concentrations

Timeframe: Pre vaccination (Month 0) and post vaccination (Month 1)

Number of subjects less than (<) 6 years of age with solicited local symptoms

Timeframe: During the 4-day (Days 0-3) follow-up period after vaccination

Number of subjects ≥ 6 years of age with solicited local symptoms

Timeframe: During the 4-day (Days 0-3) follow-up period after vaccination

Number of subjects < 6 years of age with solicited general symptoms

Timeframe: During the 4-day (Days 0-3) follow-up period after vaccination

Number of subjects ≥ 6 years of age with solicited general symptoms

Timeframe: During the 4-day (Days 0-3) follow-up period after vaccination

Number of subjects reporting specific adverse events (AEs)

Timeframe: From Day 0 up to 6 months after vaccination

Number of subjects reporting any unsolicited symptoms

Timeframe: Up to one month (Day 0-Day 30) after vaccination

Number of subjects reporting any serious adverse events (SAEs)

Timeframe: From Day 0 up to 6 months after vaccination

Interventions:
Biological/vaccine: Nimenrix
Biological/vaccine: Mencevax
Enrollment:
1504
Observational study model:
Not applicable
Primary completion date:
2008-03-09
Time perspective:
Not applicable
Clinical publications:
Memish ZA et al. (2011) Immunogenicity of a single dose of tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine administered to 2-10 year olds is non-inferior to a licensed ACWY polysaccharide vaccine, with an acceptable safety profile. Pediatr Infect Dis J. 30(4):56-62.
Medical condition
Infections, Meningococcal
Product
GSK134612A, SB208144
Collaborators
Not applicable
Study date(s)
September 2007 to January 2009
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
2 - 10 years
Accepts healthy volunteers
Yes
  • Subjects who the investigator believes that their parents or guardians 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 vaccination.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Inclusion and exclusion criteria
Inclusion criteria:

    Subjects who the investigator believes that their parents or guardians 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 vaccination.
    • Written informed consent obtained from the parent 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 vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

    • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
    • Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
    • 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 previous years (for subjects 6 years old or above).
    • Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y.
    • Previous vaccination with tetanus toxoid within the last month.
    • History of meningococcal disease.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination..
    • History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
    • Major congenital defects or serious chronic illness.
    • 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 study period.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Beirut, Lebanon, 1107-2020
Status
Study Complete
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Location
GSK Investigational Site
Goa, India, 403202
Status
Study Complete
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Location
GSK Investigational Site
Indore, India, 452001
Status
Study Complete
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Location
GSK Investigational Site
New Delhi, India, 110002
Status
Study Complete
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Location
GSK Investigational Site
Riyadh, Saudi Arabia
Status
Study Complete
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Location
GSK Investigational Site
Sampaloc, Manila, Philippines, 1008
Status
Study Complete
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Location
GSK Investigational Site
Vellore, India, 632004
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2008-03-09
Actual study completion date
2009-06-01

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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