Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612
- Conditions
- Infections, Meningococcal
- Interventions
- Procedure: Blood Sampling
- Registration Number
- NCT00974363
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled.
- Detailed Description
Subjects were previously vaccinated at 11 to 17 months of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new studies will be enrolled. The subjects will have 4 blood samples taken: at 24, 36, 48 and 60 months after vaccination.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- 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 subject's 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
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A Blood Sampling Subjects who received GSK Biologicals' meningococcal vaccine 134612 in the primary vaccination study 109069. Group B Blood Sampling Subjects who received MencevaxTM ACWY in the primary vaccination study 109069.
- Primary Outcome Measures
Name Time Method Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups At Month 60 post primary dose A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
- Secondary Outcome Measures
Name Time Method Antibody Concentrations Against the Vaccine Polysaccharides At Month 24 post primary dose Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups At Months 24, 36, 48 and 60 post primary dose A seropositive subject was defined as a subject who had the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:128. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides At Month 24 post primary dose Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
Antibody Titers Against the Vaccine Meningococcal Serogroups At Months 24, 36, 48 and 60 post primary dose Seropositivity status was defined as the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) titers equal to or above the cut-off value of 1:128. Antibody titers were presented as geometric mean titers (GMTs). The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
Trial Locations
- Locations (1)
GSK Investigational Site
🇵🇭Muntinlupa, Philippines