Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults

GlaxoSmithKline1,352 enrolled

Overview

The purpose of this study is to demonstrate, in 18-55 year old adults, the consistency of different manufactured lots of meningococcal vaccine GSK134612, the non-inferiority of GSK134612 compared to licensed meningococcal vaccine Mencevax™, the non-inferiority of GSK134612 when given in an experimental co-administration with Fluarix™ compared to GSK134612 given alone and the immunogenicity of GSK134612 given with Fluarix™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Multicentre study with 5 treatment groups. Three groups will receive three different manufactured lots of GSK134612, one group will receive one lot of GSK134612 given in an experimental co-administration with Fluarix™, the control group will receive Mencevax™. The study will be conducted in a double-blind manner with respect to the 3 lots of GSK134612 vaccine. The study will be 'open' between the groups receiving GSK134612 and the group receiving GSK134612 + Fluarix™ and the Mencevax™ group. Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

1,352

Conditions

Infections, Meningococcal

Interventions

Meningococcal vaccine GSK134612BIOLOGICAL

One intramuscular dose

Mencevax™ACWYBIOLOGICAL

One subcutaneous dose

Fluarix™BIOLOGICAL

One intramuscular dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: For all subjects: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * A male or female between, and including, 18 and 55 years of age at the time of the vaccination. * Written informed consent obtained from 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 his/her 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 2 months after completion of the vaccination series. Exclusion Criteria: For all subjects: * 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 vaccine of serogroup A, C, W, and/or Y within the last five previous years. * Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W, 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. * 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. * 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 criteria for subjects receiving Fluarix™ co-administration: * History of hypersensitivity to a previous dose of influenza vaccine. * History of reactions or allergy likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate, or sodium deoxycholate. * History of administration of an influenza vaccine outside of this study, during current flu season.

Locations (4)

GSK Investigational Site

Beirut, Lebanon

GSK Investigational Site

Cavite, Philippines

GSK Investigational Site

City of Muntinlupa, Philippines

GSK Investigational Site

Manila, Philippines

Outcomes

Primary Outcomes

Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups.

Titers were expressed as geometric mean antibody titers and were calculated on all subjects from both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.

Time frame: One month after vaccination (at Month 1)

Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.

Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (\<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥1:8). A seronegative subject had antibody titer below 1:8 prior to vaccination and a seropositive subject had antibody titer equal to or above 1:8 prior to vaccination. Vaccine response was assessed for subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.

Time frame: One month after vaccination (at Month 1)

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort)

Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine and on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort).

Time frame: One month after vaccination (at Month 1)

Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.

Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.

Data from ClinicalTrials.gov

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Secondary Outcomes

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.

Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.