Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects

GlaxoSmithKline1,025 enrolled

Overview

The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.

Multicentre study with 2 treatment groups. Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,025

Conditions

Infections, Meningococcal

Interventions

Meningococcal vaccine GSK134612BIOLOGICAL

One intramuscular dose

Mencevax™ ACWYBIOLOGICAL

One subcutaneous dose

Eligibility

Sex: ALLMin age: 11 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 11 and 17 years of age at the time of the vaccination. * Written informed assent/consent obtained from the subject/ from the parent or guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Previously completed routine childhood vaccinations to the best of the subject's/the subject's parent's/guardian's knowledge. * If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two 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 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 within the last five years. * Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup 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. * A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. * 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 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.

Locations (7)

GSK Investigational Site

Goa, India

GSK Investigational Site

Indore, India

GSK Investigational Site

New Delhi, India

GSK Investigational Site

Pune, India

Outcomes

Primary Outcomes

Number of Subjects With Vaccine Response to Meningococcal Antigens

Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative \[rSBA titer below (\<) 1:8\] and as a 4-fold increase in titer in subjects initially seropositive \[rSBA titer greater than or equal to (≥) 1:8\].

Time frame: One month post-vaccination (At Month 1)

Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms

General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache. Grade 3 symptom= event that prevented normal activities. Grade 3 fever= temperature above (\>) 39.5 degrees Celsius (°C).

Time frame: During the 4-day (Days 0-3) period after vaccination

Secondary Outcomes

Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values

Neisseria meningitidis serogroups A, C, W-135 and Y were measured by serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). The cut-off values for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.

Time frame: Prior to (Month 0) and one month after vaccination (Month 1)

Meningococcal rSBA Antibody Titers

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented as geometric mean titers (GMTs).

Time frame: Prior to (Month 0) and one month after vaccination (Month 1)

Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value

The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (\>) 0.1 international units per milliliter (IU/mL).

Data from ClinicalTrials.gov

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