Status:
COMPLETED
Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Meningococcal
Eligibility:
All Genders
11-17 years
Phase:
PHASE3
Brief Summary
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...
Detailed 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 Amendmen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 11 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2008
Estimated Enrollment :
611 Patients enrolled
Trial Details
Trial ID
NCT00465816
Start Date
April 11 2007
End Date
April 28 2008
Last Update
June 8 2018
Active Locations (6)
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1
GSK Investigational Site
Aarhus N, Denmark, 8200
2
GSK Investigational Site
Karlskrona, Sweden, SE-371 41
3
GSK Investigational Site
Linköping, Sweden, SE-581 85
4
GSK Investigational Site
Malmo, Sweden, SE-205 02