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

GlaxoSmithKline (GSK) logo

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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