Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.

Study Overview
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Brief Summary
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The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults 11-25 years of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment.

Detailed Description
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Subjects 11-25 years of age will be randomized to receive either the meningococcal vaccine GSK134612 or Menactra®. An additional non-randomized group of subjects aged 10 years (< 11 years of age) will be enrolled to receive meningococcal vaccine GSK134612 only (At the time the study begun, Menactra® was only licensed in the United States for individuals above 11 years of age and therefore could not be used as a control vaccine in subjects less than 11 years old). This study will be single-blind for the subjects 11 to 25 years of age and open for the subjects 10 to < 11 years of age.

Official Title
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Study to Assess Immunogenicity, Reactogenicity and Safety of 1 Dose of GSK Biologicals' Meningococcal Vaccine GSK134612 vs. 1 Dose of Sanofi-Pasteur's Menactra® in Healthy Subjects 10-25 Years.

Conditions
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Infections, Meningococcal

Intervention / Treatment
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* Biological: Meningococcal vaccine 134612
* Biological: Menactra®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects whom the investigator believes can and will comply with the requirements of the protocol. A male or female between, and including, 10 and 25 years of age (has not attained his/her 26th birthday) at the time of the vaccination. Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday. Healthy subjects as established by medical history and clinical examination before entering into the study. If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception (including abstinence) for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after vaccination. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the 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 vaccine dose. Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s). Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W-135, and/or Y. Previous vaccination with tetanus and diphtheria toxoids within the last month (i.e., Tdap, Td, and TT-containing vaccine within the last month). History of meningococcal disease due to serogroup A, C, W-135, or Y. Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required). 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. Hypersensitivity to latex. Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures. Previous history of Guillain-Barré Syndrome. Bleeding disorders, such as hemophilia or thrombocytopenia, or subjects on anti-coagulant therapy. Acute disease at the time of enrollment. 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. Pregnant or lactating female. History of chronic alcohol consumption and/or drug abuse. Female planning to become pregnant or planning to discontinue contraceptive precautions.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Subjects aged 10 years (< 11 years) vaccinated with meningococcal vaccine GSK134612. | Biological: Meningococcal vaccine 134612<br>* Single dose intramuscular injection.<br>|
| Experimental: Group B<br>Subjects aged 11 to 25 years vaccinated with meningococcal vaccine GSK134612. | Biological: Meningococcal vaccine 134612<br>* Single dose intramuscular injection.<br>|
| Active Comparator: Group C<br>Subjects aged 11 to 25 years vaccinated with Menactra®. | Biological: Menactra®<br>* Single dose intramuscular injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8. | At Day 0 (PRE) | 
| Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8. | At Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4. | At Day 0 (PRE) and Month 1 | 
| hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | Antibody titers are presented as geometric mean titers (GMTs). | At Day 0 (PRE) and Month 1 | 
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period | 
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, fever [defined as orally temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. | During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period | 
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | During the 31-day (Days 0-30) follow-up period after vaccination | 
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | From Day 0 to Month 6 | 
| Number of Subjects With New Onset Chronic Illness(es) (NOCI) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | From Day 0 to Month 6 | 
| Number of Subjects Reporting Rash | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae. | From Day 0 to Month 6 | 
| Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits |  | From Day 0 to Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningococcal Serogroups A, C, W-135 and/or Y Disease