Status:
COMPLETED
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Meningococcal
Eligibility:
All Genders
10-25 years
Phase:
PHASE2
Brief Summary
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 ag...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 19 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2011
Estimated Enrollment :
1013 Patients enrolled
Trial Details
Trial ID
NCT01165242
Start Date
August 19 2010
End Date
July 29 2011
Last Update
June 26 2018
Active Locations (32)
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1
GSK Investigational Site
Chandler, Arizona, United States, 85224
2
GSK Investigational Site
Paramount, California, United States, 90723
3
GSK Investigational Site
Sacramento, California, United States, 95816
4
GSK Investigational Site
Sacramento, California, United States, 95823