Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Infections, Meningococcal

Treatments

Biological: Mencevax ACWY

Biological: GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01154088

114248

Details and patient eligibility

About

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 Mencevax™ ACWY in healthy subjects 18-25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK's 134612 vaccine.

Enrollment

1,170 patients

Sex

All

Ages

18 to 25 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.