Study to evaluate persistence of antibodies after vaccination with meningococcal vaccine GSK134612
Trial overview
Number of subjects with serum bactericidal assay /activity (rSBA) against Neisseria meningitidis serogroup A, C, W-135 and Y (using baby rabbit complement) titres ≥ the cut-off
Timeframe: At Month 24 post Nimenrix vaccine
Number of subjects with rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off
Timeframe: At Month 36 post Nimenrix vaccine
Number of subjects with rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off
Timeframe: At Month 48 post Nimenrix vaccine
Number of subjects with rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY titres
Timeframe: At Month 36 post-primary vaccination.
Number of subjects with rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY titres
Timeframe: At Month 48 post-primary vaccination
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY titres ≥ the cut-off
Timeframe: At Month 24 post primary dose
Number of subjects with rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off
Timeframe: At Month 36 post primary dose
Number of subjects with rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off
Timeframe: At Month 48 post primary dose
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres
Timeframe: At Months 24 post primary dose.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres
Timeframe: At Month 36 post primary dose
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres
Timeframe: At Month 48 post primary dose
Number of subjects with rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off
Timeframe: At Month 36 post-primary vaccination
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off
Timeframe: At Month 48 post-primary vaccination
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres
Timeframe: At Month 36 post-primary vaccination
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres
Timeframe: At Month 48 post-primary vaccination
Number of subjects with serum bactericidal assay/activity against Neisseria meningitidis serogroup A, C, W-135 and Y (using human complement) titres ≥ the cut-off
Timeframe: At Month 24 post primary dose
Number of subjects with serum bactericidal assay/activity against Neisseria meningitidis serogroup A, C, W-135 and Y (using human complement) titres ≥ the cut-off
Timeframe: At Month 36 post primary dose.
Number of subjects with serum bactericidal assay/activity against Neisseria meningitidis serogroup A, C, W-135 and Y (using human complement) titres ≥ the cut-off
Timeframe: At Month 48 post primary dose
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres
Timeframe: At Month 24 post primary dose
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres
Timeframe: At Month 36 post primary dose
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres
Timeframe: At Month 48 post primary dose
Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values
Timeframe: At Month 24 post primary dose
Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values
Timeframe: At Month 36 post primary dose
Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values
Timeframe: At Month 48 post primary dose
Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations
Timeframe: At Month 24 post primary dose
Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations
Timeframe: At Month 36 post primary dose
Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations
Timeframe: At Month 48 post primary dose
Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values
Timeframe: At Month 36 post-primary vaccination
Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values
Timeframe: At Month 48 post-primary vaccination
Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY antibody concentrations
Timeframe: At Month 36 post-primary vaccination
Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY antibody concentrations
Timeframe: At Month 48 post-primary vaccination.
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off
Timeframe: At Month 60 pre-primary vaccination and post-primary vaccination
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres
Timeframe: At Month 60 pre-primary vaccination and post-primary vaccination
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ the cut-off
Timeframe: At one month (Month 49) post booster dose
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres above the cut-off values
Timeframe: At 12 months (Month 60) post booster dose
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres
Timeframe: At one month (Month 49) post booster dose
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres
Timeframe: At 12 months (Month 60) post booster dose
Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres above the cut-off values
Timeframe: At one month (Month 49) post booster dose
Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres above the cut-off values
Timeframe: At 12 months (Month 60) post booster dose.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres
Timeframe: At one month (Month 49) post booster dose
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres
Timeframe: At 12 months (Month 60) post booster dose
Number of subjects with anti-PSA, anti-PSC, anti-PSW, and anti-PSY above the cut-off values
Timeframe: At one month (Month 49) post booster dose
Number of subjects with anti-PSA, anti-PSC, anti-PSW, and anti-PSY ≥ the cut-off values
Timeframe: At 12 months (Month 60) post booster dose
Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations
Timeframe: At one month (Month 49) post booster dose
Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations
Timeframe: At 12 months (Month 60) post booster dose
Number of subjects reporting any solicited local symptoms
Timeframe: During the 8-day period (Days 0-7) after booster vaccination
Number of subjects reporting any solicited general symptoms
Timeframe: During the 8-day period (Days 0-7) after the booster vaccination
Number of subjects reporting any adverse events (AEs)
Timeframe: During the 31-day period (Days 0-30) after booster vaccination
Number of subjects reporting any serious adverse events (SAEs)
Timeframe: At Month 24 post primary dose
Number of subjects reporting any serious adverse events (SAEs)
Timeframe: At Month 36
Number of subjects reporting any serious adverse events (SAEs)
Timeframe: At Month 48
Number of subjects reporting any serious adverse events (SAEs)
Timeframe: At one month (Month 49) post booster dose.
Number of subjects reporting any serious adverse events (SAEs)
Timeframe: At 12 months (Month 60) post booster dose
- Subjects who the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the parent(s) or guardian(s) of the subject.
- Exclusion criteria for persistence study entry (i.e. Month 24, 36 or 48):
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the subject’s first visit.
- Written informed consent obtained from the parent(s) or guardian(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- A male or female having completed the primary study 109670 and who was primed with the investigational or Meningitec™ vaccines.
Subjects who the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the subject’s first visit.
- History of meningococcal disease.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of study 109670.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- Administration of immunoglobulins and/or blood products within the three months preceding the subjects first visit.
- Concurrently participating in another clinical study, within 30 days of study entry, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy. Additional exclusion criteria for booster vaccination (to be checked at Month 48):
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Hypersensitivity to any vaccine containing diphtheria toxoid or non-toxic diphtheria toxin protein and/or tetanus toxoid.
- History of hypersensitivity after previous administration of Meningitec or the investigational vaccines in study 109670.
- Hypersensitivity to latex.
- Planned administration/ administration of a vaccine not foreseen by the protocol within one month before and 30 days after the booster dose.
- Previous vaccination with any component of the vaccines within the last month.
- History of any neurological disorder or seizures (one episode of febrile convulsion does not constitute an exclusion criteria).
- Major congenital defects or serious chronic illness.
- Acute disease at the time of vaccination.
Exclusion criteria for persistence study entry (i.e. Month 24, 36 or 48):
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.