Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children
Trial overview
Number of subjects with rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY titers greater than or equal to (≥) the cut-off values
Timeframe: 42 days after the first vaccine dose (Day 42)
Number of subjects with anti-measles antibody concentrations ≥ the cut-off values
Timeframe: 42 days after the first vaccine dose (Day 42)
Number of subjects with anti-mumps antibody concentrations ≥ the cut-off values
Timeframe: 42 days after the first vaccine dose (Day 42)
Number of subjects with anti-rubella antibody concentrations ≥ the cut-off values.
Timeframe: 42 days after the first vaccine dose (Day 42)
Number of subjects with anti-varicella antibody concentrations ≥ the cut-off values
Timeframe: 42 days after the first vaccine dose (Day 42)
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ the cut-off values
Timeframe: Prior to vaccination (Day 0) and after the first vaccination dose (Day 42)
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers
Timeframe: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Anti-PSA (anti-polysaccharide A), anti-PSC, anti-PSW-135 and anti-PSY antibodies concentrations ≥ the cut-off values
Timeframe: Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies concentrations ≥ the cut-off values
Timeframe: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Number of subjects with hSBA-MenA (meningococcal polysaccharide A serum bactericidal antibodies using human complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers ≥ the cut-off values
Timeframe: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers
Timeframe: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Anti-measles antibody concentrations
Timeframe: 42 days after the first vaccine dose (Day 42)
Anti-measles antibody concentrations
Timeframe: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
Anti-mumps antibody concentrations
Timeframe: 42 days after the first vaccine dose (Day 42)
Anti-mumps antibody concentrations
Timeframe: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
Anti-rubella antibody concentrations
Timeframe: 42 days after the first vaccine dose (Day 42)
Anti-rubella antibody concentrations
Timeframe: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
Anti-varicella antibody titers
Timeframe: 42 days after the first vaccine dose (Day 42)
Anti-varicella antibody titers
Timeframe: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
Number of subjects reporting solicited local symptoms specific for Priorix-Tetra vaccination
Timeframe: During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0
Number of subjects reporting solicited local symptoms after Nimenrix or Meningitec vaccination at Day 0
Timeframe: During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0
Number of subjects reporting solicited general symptoms
Timeframe: During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups
Number of subjects with Priorix-Tetra - specific solicited general symptoms
Timeframe: During the 43-day (Days 0-42) after first vaccination dose
Number of subjects reporting specific adverse events (AEs)
Timeframe: From Day 0 up to Month 6 after first vaccine dose
Number of subjects reporting unsolicited symptoms
Timeframe: During the 43-day (Days 0-42) post Dose 1 vaccination period
Number of subjects reporting unsolicited symptoms
Timeframe: During the 43-day (Days 0-42) follow-up period after each vaccination
Number of subjects reporting serious adverse events (SAEs)
Timeframe: From Day 0 up to Month 6 after vaccination
Participation criteria
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 12 and 23 months of age at the time of the vaccination.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first 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.
- A male or female between, and including, 12 and 23 months of age at the time of the vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of parents’ or legal guardians’ knowledge.
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- 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 before and 42 days after the first dose of vaccine(s).
- Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y.
- History of meningococcal disease.
- Previous vaccination against measles, mumps, rubella, and/or varicella.
- History of measles, mumps, rubella and/or varicella.
- Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including neomycin.
- 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.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
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.