Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects

GlaxoSmithKline86 enrolled

Overview

The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new meningococcal vaccine 134612 in subjects with increased risk of meningococcal disease and compare it to its activity in healthy subjects.

For each at risk subject enrolled, an age-matched healthy subject will be enrolled. Age matching will be performed according to the following age strata: 1-5 years, 6-10 years, 11-17 years.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Infections, Meningococcal

Interventions

Meningococcal vaccine GSK134612BIOLOGICAL

2 doses of the vaccine administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.

Eligibility

Sex: ALLMin age: 1 YearMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol. * A male or female 1 to 17 years of age at the time of the first vaccination. * Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment. * Female subjects of non-childbearing potential may be enrolled in the study. * Female subjects of childbearing potential may be enrolled in the study, if * the subject has practiced adequate contraception for one month (30 days) prior to the first vaccine dose, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception from administration of the first vaccine dose until 2 months after administration of the second vaccine dose. Additional inclusion criterion for At-risk group • Subjects with an increased risk for meningococcal disease, such as anatomic asplenia or some degree of functional asplenia or complement deficiencies. Additional inclusion criteria for Healthy group * Healthy subject as established by medical history and clinical examination before entering into the study. * Age-matched to a subject from the At-risk group according to age strata 1-5 years, 6-10 years and 11 to 17 years. Exclusion Criteria: * Child in care. * Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (until the phone contact at Month 8). * Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before administration of each study vaccine dose until 30 days after administration of each study vaccine dose. Administration of licensed inactivated influenza vaccines is allowed as per local recommendations. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * History of meningococcal disease. * Any confirmed or suspected Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine until one month after the second dose of study vaccine. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine including latex. * Major congenital defects. * History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted. * Acute disease and/or fever at the time of enrolment. * Pregnant or lactating female. * History of chronic alcohol consumption and/or drug abuse. * Female planning to become pregnant or planning to discontinue contraceptive precautions. Additional exclusion criteria for the At-risk group • Vaccination against meningococcal disease of any serogroup * within the last 3 years for subjects younger than 7 years. * within the last 5 years for subjects 7 years and older. Additional exclusion criteria for the Healthy group * Vaccination against meningococcal disease of any serogroup with polysaccharide or conjugate vaccine within the last 5 years. * Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. * Family history of congenital or hereditary immunodeficiency. * Any confirmed or suspected immunosuppressive or immunodeficient condition. * Serious chronic illness. * History of asplenia or hyposplenia or complement deficiencies.

Locations (16)

GSK Investigational Site

Antioch, California, United States

GSK Investigational Site

Daly City, California, United States

Outcomes

Primary Outcomes

Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies

Vaccine response was defined as: rSBA antibody titers greater than or equal to (≥) 1:32, for initially seronegative subjects \[i.e. pre-vaccination rSBA antibody titers below (\<) 1:8\] and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).

Time frame: One month after the first vaccine dose (at Month 1)

Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies

Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers \< 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).

Time frame: One month after the first vaccine dose (at Month 1)

Secondary Outcomes

Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies

Vaccine response was defined as: rSBA antibody titers ≥ 1:32, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers \< 1:8) and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).

Time frame: One month after the second vaccine dose (At Month 3)

Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies

Data from ClinicalTrials.gov

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GSK Investigational Site

Fremont, California, United States

GSK Investigational Site

Hayward, California, United States

GSK Investigational Site

Oakland, California, United States

GSK Investigational Site

Redwood City, California, United States

GSK Investigational Site

Roseville, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

Santa Clara, California, United States

...and 6 more locations

Time frame: One month after the second vaccine dose (At Month 3)

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values

The cut-off value for the assay was ≥ 1:8.

Time frame: At pre-primary vaccination (Month 0), at post first vaccine dose (Month 1) and post second vaccine dose (Month 3)

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values

The cut-off value for the assay was ≥ 1:128.

Time frame: Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3

Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens

Antibody titers were measured in geometric mean titers (GMTs), calculated on all subjects.

Time frame: At pre-primary vaccination (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)

Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values

The cut-off value for the assay was ≥ 1:4.