- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00514904
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
October 2, 2020 updated by: GlaxoSmithKline
Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Versus Mencevax™ in Healthy Subjects Aged 2 Through 10 Years of Age
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Multicentre study with 2 treatment groups.
Two blood samples will be taken, prior to and one month after vaccination, from the first 75% enrolled subjects per country independent of the treatment group.
Study Type
Interventional
Enrollment (Actual)
1504
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Goa, India, 403202
- GSK Investigational Site
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Indore, India, 452001
- GSK Investigational Site
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New Delhi, India, 110002
- GSK Investigational Site
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Vellore, India, 632004
- GSK Investigational Site
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Beirut, Lebanon, 1107-2020
- GSK Investigational Site
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Sampaloc, Manila, Philippines, 1008
- GSK Investigational Site
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Riyadh, Saudi Arabia
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Nimenrix Group
Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
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Single dose, intramuscular injection
Other Names:
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Active Comparator: Mencevax ACWY Group
Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
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Single dose, subcutaneous injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135
Time Frame: One month after vaccination (Post-vaccination, study Month 1)
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Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8).
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One month after vaccination (Post-vaccination, study Month 1)
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Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited)
Time Frame: During the 4-day (Days 0-3) post-vaccination period
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Grade 3 symptom was defined as symptom that prevented normal, everyday activities.
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During the 4-day (Days 0-3) post-vaccination period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
Time Frame: Pre vaccination (Month 0) and post vaccination (Month 1)
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The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively.
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Pre vaccination (Month 0) and post vaccination (Month 1)
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rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Time Frame: Pre vaccination (Month 0) and post vaccination (Month 1)
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Antibody titers were expressed as geometric mean titers (GMTs).
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Pre vaccination (Month 0) and post vaccination (Month 1)
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Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Time Frame: Pre vaccination (Month 0) and post vaccination (Month 1)
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The cut-off values for anti-TT concentrations were ≥ 0.1 international units per milliliter (IU/mL) and ≥ 1.0 IU/mL respectively.
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Pre vaccination (Month 0) and post vaccination (Month 1)
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Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations
Time Frame: Pre vaccination (Month 0) and post vaccination (Month 1)
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Antibody concentrations were expressed as geometric mean concentrations (GMCs)
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Pre vaccination (Month 0) and post vaccination (Month 1)
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Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
Time Frame: Pre vaccination (Month 0) and post vaccination, (Month 1)
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The cut-off values for anti-PS concentrations were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL respectively for the anti- PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies respectively.
One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.
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Pre vaccination (Month 0) and post vaccination, (Month 1)
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Anti-polysaccharide (Anti-PS) Antibody Concentrations
Time Frame: Pre vaccination (Month 0) and post vaccination (Month 1)
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Anti-PS concentrations were expressed as geometric mean concentrations (GMCs) and expressed in μg/mL.
One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.
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Pre vaccination (Month 0) and post vaccination (Month 1)
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Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms
Time Frame: During the 4-day (Days 0-3) follow-up period after vaccination
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Solicited local symptoms assessed were pain, redness and swelling.
Any was defined as occurrence of any local symptom regardless of intensity grade.
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During the 4-day (Days 0-3) follow-up period after vaccination
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Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms
Time Frame: During the 4-day (Days 0-3) follow-up period after vaccination
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Solicited local symptoms assessed were pain, redness and swelling.
Any was defined as occurrence of any local symptom regardless of intensity grade.
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During the 4-day (Days 0-3) follow-up period after vaccination
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Number of Subjects < 6 Years of Age With Solicited General Symptoms
Time Frame: During the 4-day (Days 0-3) follow-up period after vaccination
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Solicited general symptoms assessed were drowsiness, fever (measured orally and temperature ≥ 37.5°C ), irritability and loss of appetite.
Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.
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During the 4-day (Days 0-3) follow-up period after vaccination
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Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms
Time Frame: During the 4-day (Days 0-3) follow-up period after vaccination
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Solicited general symptoms assessed were fatigue, fever (measured orally and temperature ≥ 37.5°C ), gastrointestinal and headache.
Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.
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During the 4-day (Days 0-3) follow-up period after vaccination
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Number of Subjects Reporting Specific Adverse Events (AEs)
Time Frame: From Day 0 up to 6 months after vaccination
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Specific AEs include: rash; new onset of chronic illness(es) (NOCI) and/ or conditions prompting emergency room (ER) visits or non-routine physician office visits.
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From Day 0 up to 6 months after vaccination
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Number of Subjects Reporting Any Unsolicited Symptoms
Time Frame: Up to one month (Day 0-Day 30) after vaccination
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Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
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Up to one month (Day 0-Day 30) after vaccination
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Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Time Frame: From Day 0 up to 6 months after vaccination
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SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability /incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.
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From Day 0 up to 6 months after vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 18, 2007
Primary Completion (Actual)
September 3, 2008
Study Completion (Actual)
January 6, 2009
Study Registration Dates
First Submitted
August 9, 2007
First Submitted That Met QC Criteria
August 9, 2007
First Posted (Estimate)
August 10, 2007
Study Record Updates
Last Update Posted (Actual)
October 27, 2020
Last Update Submitted That Met QC Criteria
October 2, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 109495
- 2012-000283-23 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Individual Participant Data Set
Information identifier: 109495Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 109495Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 109495Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 109495Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 109495Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 109495Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 109495Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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