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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00514904
First Posted: August 10, 2007
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose

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.


Condition Intervention Phase
Infections, Meningococcal Biological: Meningococcal vaccine GSK134612 Biological: Mencevax™ Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Versus Mencevax™ in Healthy Subjects Aged 2 Through 10 Years of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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) ]
    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).

  • Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited) [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]
    Grade 3 symptom was defined as symptom that prevented normal, everyday activities.


Secondary Outcome Measures:
  • 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) ]
    The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively.

  • rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers [ Time Frame: Pre vaccination (Month 0) and post vaccination (Month 1) ]
    Antibody titers were expressed as geometric mean titers (GMTs).

  • 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) ]
    The cut-off values for anti-TT concentrations were ≥ 0.1 international units per milliliter (IU/mL) and ≥ 1.0 IU/mL respectively.

  • Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations [ Time Frame: Pre vaccination (Month 0) and post vaccination (Month 1) ]
    Antibody concentrations were expressed as geometric mean concentrations (GMCs)

  • 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) ]
    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.

  • Anti-polysaccharide (Anti-PS) Antibody Concentrations [ Time Frame: Pre vaccination (Month 0) and post vaccination (Month 1) ]
    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.

  • 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 ]
    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.

  • 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 ]
    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.

  • 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 ]
    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.

  • 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 ]
    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.

  • Number of Subjects Reporting Specific Adverse Events (AEs) [ Time Frame: From Day 0 up to 6 months after vaccination ]
    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.

  • Number of Subjects Reporting Any Unsolicited Symptoms [ Time Frame: 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. ]
    Up to one month (Day 0-Day 30) after vaccination

  • Number of Subjects Reporting Any Serious Adverse Events (SAEs) [ Time Frame: From Day 0 up to 6 months after vaccination ]
    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.


Enrollment: 1505
Study Start Date: September 18, 2007
Study Completion Date: January 6, 2009
Primary Completion Date: September 3, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: Meningococcal vaccine GSK134612
Single dose, intramuscular injection
Active Comparator: Group B Biological: Mencevax™
Single dose, subcutaneous injection

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514904


Locations
India
GSK Investigational Site
Goa, India, 403202
GSK Investigational Site
Indore, India, 452001
GSK Investigational Site
New Delhi, India, 110002
GSK Investigational Site
Vellore, India, 632004
Lebanon
GSK Investigational Site
Beirut, Lebanon, 1107-2020
Philippines
GSK Investigational Site
Sampaloc, Manila, Philippines, 1008
Saudi Arabia
GSK Investigational Site
Riyadh, Saudi Arabia
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 109495
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 109495
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 109495
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 109495
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 109495
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 109495
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 109495
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00514904     History of Changes
Other Study ID Numbers: 109495
First Submitted: August 9, 2007
First Posted: August 10, 2007
Results First Submitted: May 11, 2017
Results First Posted: October 6, 2017
Last Update Posted: October 6, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by GlaxoSmithKline:
safety
meningococcal vaccine
immunogenicity

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs