Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults
Status: | Completed |
---|---|
Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 10 - 25 |
Updated: | 6/28/2018 |
Start Date: | August 19, 2010 |
End Date: | July 29, 2011 |
Immunogenicity and Safety Study of One Dose of GSK Biologicals' Meningococcal Vaccine GSK 134612 (Blinded Lots) Versus One Dose of Menactra® in Healthy Subjects Aged 10-25 Years
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.
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.
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.
We found this trial at
23
sites
Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials
