Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Meningococcal

Treatments: Biological: Twinrix; Biological: Nimenrix (Meningococcal vaccine 134612)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00465816

109063

Details and patient eligibility

About

This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. There will be 3 groups in this study.

Full description

All subjects of groups A and B will have 4 blood samples taken, all subjects of group C will have 3 blood samples taken.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Enrollment: 611 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: Accepts Healthy Volunteers

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 first dose of vaccine.
• Written informed 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 his/her/the parents'/guardians' knowledge.
• If the subject is female and 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 completion of the vaccination series.

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.
• Previous vaccination with hepatitis A and/or hepatitis B vaccine.
• Seropositivity for hepatitis A IgG, hepatitis B surface antigen, hepatitis B core antibody and/or hepatitis B surface antigen at screening.
• History of hepatitis A, hepatitis B and/or Neisseria meningitidis infection.
• Known exposure to hepatitis A and/or hepatitis B virus within three months preceding the first dose of study vaccine.
• 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 either 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 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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611 participants in 3 patient groups

Nimenrix + Twinrix Group

Experimental group

Description:

Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.

Treatment:

Biological: Nimenrix (Meningococcal vaccine 134612)

Biological: Twinrix

Nimenrix Group

Active Comparator group

Description:

Subjects received 1 dose of Nimenrix™ vaccine at Month 0.

Treatment:

Biological: Nimenrix (Meningococcal vaccine 134612)

Twinrix Group

Active Comparator group

Description:

Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.

Treatment:

Biological: Twinrix