Study to evaluate persistence of antibodies after vaccination with meningococcal vaccine GSK 134612
- Registration Number
- CTRI/2009/091/000585
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 697
Subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female having been vaccinated with a meningococcal vaccine in the primary study 109069.
Written informed consent obtained from parent(s)/guardian(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject?s first visit.
History of meningococcal disease; such cases will be documented.
Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study 109069.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
Administration of immunoglobulins and/or any blood products within the three months preceding the subjects first visit.
Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy
Subjects who withdrew consent to be contacted for follow-up studies.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Persistence of immunogenicity with respect to components of the investigational vaccineTimepoint: 24, 36, 48 and 60 months post primary dose
- Secondary Outcome Measures
Name Time Method Persistence of immunogenicity with respect to components of the investigational vaccine (on secondary readouts)Timepoint: 24, 36, 48 and 60 months post primary dose