Status:
COMPLETED
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Meningococcal
Eligibility:
All Genders
11-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
Detailed Description
Multicentre study with 2 treatment groups. Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later. The Protocol Posting has bee...
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 vaccination.
- Written informed assent/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 the subject's/the subject's parent's/guardian's 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 two months after vaccination.
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.
- 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(s).
- 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 :
May 2 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2008
Estimated Enrollment :
1025 Patients enrolled
Trial Details
Trial ID
NCT00464815
Start Date
May 2 2007
End Date
September 10 2008
Last Update
June 8 2018
Active Locations (7)
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1
GSK Investigational Site
Goa, India, 403202
2
GSK Investigational Site
Indore, India, 452001
3
GSK Investigational Site
New Delhi, India, 110002
4
GSK Investigational Site
Pune, India, 411 011