Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to demonstrate, in 18-55 year old adults, the consistency of different manufactured lots of meningococcal vaccine GSK134612, the non-inferiority of GSK134612 compared to licensed meningococcal vaccine Mencevax™, the non-inferiority of GSK134612 when given in an experimental co-administration with Fluarix™ compared to GSK134612 given alone and the immunogenicity of GSK134612 given with Fluarix™.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Full description
Multicentre study with 5 treatment groups. Three groups will receive three different manufactured lots of GSK134612, one group will receive one lot of GSK134612 given in an experimental co-administration with Fluarix™, the control group will receive Mencevax™. The study will be conducted in a double-blind manner with respect to the 3 lots of GSK134612 vaccine. The study will be 'open' between the groups receiving GSK134612 and the group receiving GSK134612 + Fluarix™ and the Mencevax™ group.
Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
For all subjects:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- A male or female between, and including, 18 and 55 years of age at 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.
- Previously completed routine childhood vaccinations to the best of his/her knowledge.
- If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test, and continue such precautions for 2 months after completion of the vaccination series.
Exclusion criteria
For all subjects:
- Use of any investigational or non-registered product (drug or vaccine) 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 the vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).
- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W, and/or Y within the last five previous years.
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W, and/or Y.
- Previous vaccination with tetanus toxoid within the last month.
- History of meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) 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 reactions or allergic disease likely to be exacerbated by any component of the vaccine.
- 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 first 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.
Additional criteria for subjects receiving Fluarix™ co-administration:
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of reactions or allergy likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate, or sodium deoxycholate.
- History of administration of an influenza vaccine outside of this study, during current flu season.
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,352 participants in 5 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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