Safety & immunogenicity of 1 Dose of GSK134612 in Children 12-14 months and 3-5 years old
Trial overview
Number of subjects with an immune response to different meningococcal serogroups
Timeframe: One month after the first vaccine dose (Month 1)
Number of seroprotected subjects against different meningococcal serogroups
Timeframe: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of seropositive subjects for different anti-meningococcal serogroups
Timeframe: Prior to (Month 0) and one month after (Month 1) after the first vaccine dose
Antibody titers against different meningococcal serogroups
Timeframe: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of seropositive subjects for different anti-meningococcal polysaccharides
Timeframe: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of seroprotected subjects against different meningococcal polysaccharides
Timeframe: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Antibody concentrations against different meningococcal polysaccharides
Timeframe: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of seropositive subjects for anti-tetanus (anti-T)
Timeframe: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Antibody concentrations against tetanus (Anti-T)
Timeframe: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of toddlers with any solicited local symptoms
Timeframe: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Number of children with any solicited local symptoms
Timeframe: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Number of toddlers with any solicited general symptoms
Timeframe: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Number of children with any solicited general symptoms
Timeframe: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Number of seroprotected subjects against different meningococcal serogroups
Timeframe: At one month (M1) and 12 months (M12) post-primary vaccination
Number of seropositive subjects for different anti-meningococcal serogroups
Timeframe: At one month (M1) and 12 months (M12) post-primary vaccination
Antibody titers against different meningococcal serogroups
Timeframe: At one month (M1) and 12 months (M12) post-primary vaccination
Number of seropositive subjects for different anti-meningococcal polysaccharides
Timeframe: At one month (M1) and 12 months (M12) post-primary vaccination
Number of seroprotected subjects against different meningococcal polysaccharides
Timeframe: At one month (M1) and 12 months (M12) post primary vaccination
Antibody concentrations against different meningococcal polysaccharides
Timeframe: At one month (M1) and 12 months (M12) post-primary vaccination
Number of seropositive and seroprotected subjects against different meningococcal serogroups
Timeframe: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Antibody titers against different meningococcal serogroups
Timeframe: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Number of seropositive and seroprotected subjects against different meningococcal polysaccharides
Timeframe: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Antibody concentrations against different meningococcal polysaccharides
Timeframe: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Number of subjects with any solicited local symptoms
Timeframe: During the 8-day (Days 0-7) post-vaccination period following booster dose
Number of subjects with any solicited general symptoms
Timeframe: During the 8-day (Days 0-7) post-vaccination period following booster dose
Number of subjects with any unsolicited adverse events (AEs) after the primary vaccination
Timeframe: Within 31 days (Days 0-30) after the primary meningococcal vaccination
Number of subjects with any unsolicited AEs during the primary vaccination
Timeframe: Within 31 days (Days 0-30) post-vaccination with diphteria, tetanus and acellular pertusis-containing vaccine, during the primary vaccination
Number of subjects with any unsolicited AEs
Timeframe: Within 31 days (Days 0-30) after the booster vaccination
Number of subjects with serious adverse events (SAEs)
Timeframe: During the primary vaccination study (from Month 0 up to Month 2)
Number of subjects with SAEs
Timeframe: Since the last study contact in the primary study up to the end of the booster study (from Month 2 up to Month 13)
Participation criteria
- Inclusion criteria:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- Inclusion 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 14 months or 3 and 5 years of age at the time of the first 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 his/her parents’/guardians’ knowledge. For pertussis vaccination, the children aged 12-14 months should have been vaccinated with an acellular pertussis vaccine. Exclusion criteria:
- 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 first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine and up to one month after administration of each study vaccine dose with the exception of oral polio vaccine (OPV).
- Previous vaccination against meningococcal serogroup A, C, W-135 or Y disease.
- Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3 months before the first dose of vaccine.
- For subjects aged 12-14 months at enrolment: o For Austria: DTPa-HBV-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2. o For Greece: DTPa-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2.
- History of meningococcal serogroup A, C, W-135 or Y disease.
- Known exposure to meningococcal serogroup A, C, W-135 or Y disease within the previous year.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- 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.
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.