Immunogenicity and safety of meningococcal vaccine GSK 134612 co-administered with pneumococcal and DTPa-HBV-IPV/Hib vaccines
Trial overview
Number of subjects with serum bactericidal assay using baby rabbit complement against meningococcal serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) antibody titers greater than or equal to (≥) the cut-off value
Timeframe: One month after the final primary vaccination at Month 3
Number of subjects with rSBA-MenC antibody titers ≥ the cut-off value
Timeframe: One month after the final primary vaccination at Month 3
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers above cut-off values
Timeframe: Pre-primary vaccination at Month 0
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers
Timeframe: Pre-primary vaccination at Month 0
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titers above the cut-off values
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of subjects with serum bactericidal assay using human complement against meningococcal serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) antibody titers above the cut-off values
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers above the cut-off values
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of subjects with anti-pneumococcal serotypes (anti-P) antibody concentrations above the cut-off values
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-pneumococcal serotypes antibody concentrations
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of subjects with anti-pneumococcal serotypes antibody concentrations above the cut-off values
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-pneumococcal serotypes antibody concentrations
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of subjects with anti-diphtheria (anti-D) and anti-tetanus (anti-T) concentrations ≥ the cut-off value
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-D and anti-T antibody concentrations
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of subjects with anti-D and anti-T antibody concentrations ≥ the cut-off value
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-D and anti-T antibody concentrations
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) concentrations ≥ the cut-off value
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-PT, anti-FHA and anti-PRN antibody concentrations
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of subjects with anti-PT, anti-FHA and anti-PRN concentrations ≥ the cut-off value
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-PT, anti-FHA and anti-PRN antibody concentrations
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentrations above the cut-off values
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-HBs antibody concentrations
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of subjects with anti-HBs antibody concentrations above the cut-off values
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-HBs antibody concentrations
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of subjects with anti-polyribosyl ribitol phosphate (anti-PRP) concentrations ≥ the cut-off values
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-PRP antibody concentrations
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of subjects with anti-PRP antibody concentrations above the cut-off values
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-PRP antibody concentrations
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of subjects with anti-poliovirus type 1, 2 and 3 antibody concentrations ≥ the cut-off value
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-polio type 1, 2 and 3 antibody titers
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of subjects with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-polio type 1, 2 and 3 antibody titers
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of subjects with any and grade 3 solicited local symptoms
Timeframe: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of subjects with any and grade 3 solicited local symptoms post-meningococcal vaccination
Timeframe: During the 8-day (Days 0-7) post-meningococcal vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of subjects with any and grade 3 solicited local symptoms post-Infanrix™ hexa vaccination
Timeframe: During the 8-day (Days 0-7) post-Infanrix hexa vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of subjects with any and grade 3 solicited local symptoms post-Synflorix vaccination
Timeframe: During the 8-day (Days 0-7) post-Synflorix vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of subjects with any and grade 3 solicited local symptoms post-meningococcal vaccination
Timeframe: During the 8-day (Days 0-7) post-meningococcal booster vaccination period
Number of subjects with any and grade 3 solicited local symptoms post-Infanrix™ hexa vaccination
Timeframe: During the 8-day (Days 0-7) post-Infanrix™ hexa booster vaccination period
Number of subjects with any unsolicited adverse events (AEs)
Timeframe: Within 31-days (Days 0-30) post-each primary vaccination dose
Number of subjects with any and grade 3 solicited local symptoms post-Synflorix™ vaccination
Timeframe: During the 8-day (Days 0-7) post-Synflorix™ booster vaccination period
Number of subjects with any, grade 3 and related solicited general symptoms
Timeframe: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of subjects with any, grade 3 and related solicited general symptoms
Timeframe: During the 8-day (Days 0-7) post-booster vaccination period
Number of subjects with any unsolicited adverse events (AEs)
Timeframe: Within 31-days (Days 0-30) post-booster vaccination period
Number of subjects with serious adverse events (SAEs)
Timeframe: Throughout the entire study (from Day 0 to Month 16)
Number of subjects with serious adverse events (SAEs)
Timeframe: From Booster vaccination (Month 10) up to Extended Safety Follow-Up (ESFU) (Month 16)
Number of subjects with new onset of chronic illnesses (NOCIs)
Timeframe: During 31-days (Days 0-30) post-each primary vaccination dose (Day 0 to Month 3) and from primary vaccination up to ESFU (Month 16)
Number of subjects with new onset of chronic illnesses (NOCIs)
Timeframe: From Booster vaccination (Month 10 to Month 11) up to ESFU (Month 16)
Participation criteria
- All subjects must satisfy ALL the following criteria at study entry:
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
- Child in care.
- 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.
- All subjects must satisfy ALL the following criteria at study entry:
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
- A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s) or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of at least 36 weeks.
- Child in care.
- 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.
- Extended administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the first dose of vaccine(s) until 30 days after the last dose of vaccine(s) (i.e. booster dose), with the exception of rotavirus vaccine which can be administered at any time during the study, according to the national immunisation recommendations. MMR(V) vaccine, if recommended in national immunisation programs, can be given after the last blood sampling time point i.e. after Visit 6. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national recommendations.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Streptococcus pneumoniae, Neisseria meningitidis serogroups A, C, W-135 or Y with the exception of vaccines where the first dose may be given within the first two weeks of life according to the national recommendations (for example hepatitis B and BCG).
- History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease, pneumococcal and/or meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures (history of a single, simple febrile seizure is permitted).
- Acute disease and/or fever at the time of enrolment. (Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting, or ≥ 38.0°C (100.4°F) on rectal setting). (Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator).
- Administration of immunoglobulins and/ or any blood products since birth 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.