Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Infections, Meningococcal

Treatments: Biological: Meningococcal vaccine GSK 134612; Biological: Menactra®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01165242

114249

Details and patient eligibility

About

The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in subjects 10 through 25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK 134612 vaccine.

Enrollment: 1,013 patients

Sex: All

Ages: 10 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 that they and/or their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.

• A male or female between, and including, 10 and 25 years of age at the time of the vaccination.

• Written informed consent obtained from the subject/from the parent or Legally Acceptable Representative(s) of the subject. Assent will be obtained from subjects who are still legally minors in line with local rules and regulations.

• Healthy subjects as established by medical history and clinical examination before entering into the study.

• Previously completed routine childhood vaccinations to the best of subject's/Legally Acceptable Representative(s)'s knowledge.

• 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 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 (defined as more than 14 days) 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.
• Previous vaccination with meningococcal polysaccharide or conjugate vaccine.
• Previous vaccination with vaccine components within the last month.
• History of meningococcal disease.
• 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 is demonstrated.
• History of allergic reactions or disease likely to be exacerbated by any component of either vaccine, or by dry natural rubber latex.
• History of any neurologic disorders, including Guillain-Barré Syndrome.
• Major congenital defects or serious chronic illness.
• Acute disease at the time of enrollment.
• 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.
• Child in care.
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,013 participants in 3 patient groups

Group A

Experimental group

Description:

Subjects were vaccinated with vaccine GSK134612 Lot A

Treatment:

Biological: Meningococcal vaccine GSK 134612

Group B

Experimental group

Description:

Subjects were vaccinated with vaccine GSK134612 Lot B

Treatment:

Biological: Meningococcal vaccine GSK 134612

Group C

Active Comparator group

Description:

Subjects were vaccinated with Menactra®

Treatment:

Biological: Menactra®