Status:
COMPLETED
Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Meningococcal
Eligibility:
All Genders
11-55 years
Phase:
PHASE2
Brief Summary
Meningococcal disease is mostly caused by N. meningitidis of serogroups A, B, C, W-135, Y. Meningococcal polysaccharide-conjugate vaccines have the advantage to induce a T-cell dependant immune respon...
Detailed Description
All subjects will have 7 blood samples taken: prior to and one month after vaccination and one, two, three, four and five years after vaccination. No new subjects will be enrolled in the extension pha...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that they and/or their parents/ legally acceptable representative can and will comply with the requirements of the protocol.
- A male or female between, and including, 11 and 55 years of age at the time of vaccination.
- Written informed consent obtained from the subject/ from the parent or legally acceptable representative of the subject.
- Free of obvious health problems 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 and/or his/her parents/legally acceptable representative's knowledge.
- If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, and must agree to continue such precautions for two months after completion of the vaccination series. Female subjects in childbearing potential who are not abstinent must have a negative pregnancy test.
Exclusion
- 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.
- History of meningococcal disease due to serogroup A, C, W or Y.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- History of Guillain-Barré syndrome.
- 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.
- Specific criteria to be checked at each study visit for the long term follow-up:
- History of meningococcal serogroup A,C, W and Y disease.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol.
Key Trial Info
Start Date :
December 23 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2008
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00356369
Start Date
December 23 2006
End Date
February 28 2008
Last Update
July 3 2018
Active Locations (3)
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1
GSK Investigational Site
City of Muntinlupa, Philippines, 1781
2
GSK Investigational Site
Manila, Philippines, 1000
3
GSK Investigational Site
Riyadh, Saudi Arabia