Status:
COMPLETED
Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Meningococcal
Eligibility:
All Genders
18-25 years
Phase:
PHASE3
Brief Summary
The purpose of the observer-blinded study is to determine the immunogenicity and safety of one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK 134612 compared to one dose of Mence...
Eligibility Criteria
Inclusion
- All subjects must satisfy all of the following criteria at study entry:
- Subjects whom the investigator believes they can and will comply with the requirements of the protocol will be enrolled in the study.
- A male or female between, and including, 18 and 25 years of age the time of the vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after vaccination.
Exclusion
- The following criteria should be checked at the time of study entry. If any exclusion criterion applies, the subject must not be included in the study:
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. (For corticosteroids, this will mean prednisone \<10 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed).
- Planned administration/administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine, with the exception of any licensed inactivated influenza vaccine, including H1N1 vaccine.
- Previous vaccination with meningococcal polysaccharide vaccine within the last five years.
- Previous vaccination with meningococcal conjugate vaccine.
- Previous vaccination with tetanus-toxoid or tetanus-toxoid containing vaccine within the last month.
- History of meningococcal disease.
- Seropositive for HIV or HBsAg (for subjects in the Philippines only).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus 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 has been demonstrated.
- History of reactions or allergic disease likely to be exacerbated by any component of either vaccine.
- History of any neurologic disorders, including Guillain-Barré Syndrome.
- 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.
- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Key Trial Info
Start Date :
August 27 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2010
Estimated Enrollment :
1170 Patients enrolled
Trial Details
Trial ID
NCT01154088
Start Date
August 27 2010
End Date
December 30 2010
Last Update
November 26 2018
Active Locations (3)
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1
GSK Investigational Site
Panama City, Panama
2
GSK Investigational Site
City of Muntinlupa, Philippines
3
GSK Investigational Site
Bangkok, Thailand, 10400