Dose ranging study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) vaccine
Trial overview
Number of subjects with anti-polyribosyl ribitol phosphate (anti-PRP) antibody concentrations greater than or equal to 1 milligram per milliliter
Timeframe: One month after primary vaccination (Month 5)
Number of subjects with serum bactericidal activity using baby rabbit complement (rSBA)- Neisseria meningitidis serogroup C (MenC) titers greater than or equal to 1:8
Timeframe: One month after primary vaccination (Month 5)
Number of subjects with serum bactericidal activity using baby rabbit complement (rSBA)- Neisseria meningitidis serogroup Y (MenY) titers greater than or equal to 1:8
Timeframe: One month after primary vaccination (Month 5)
Number of subjects with serum bactericidal activity using baby rabbit complement (rSBA)- Neisseria meningitidis serogroup C (MenC) titers greater than or equal to 1:8
Timeframe: Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Serum bactericidal activity using baby rabbit complement (rSBA)- Neisseria meningitidis serogroup C (MenC) titers
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Number of subjects with rSBA-MenY titers greater than or equal to 1:8
Timeframe: Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Serum bactericidal activity using baby rabbit complement (rSBA)- Neisseria meningitidis serogroup Y (MenY) titers
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Number of subjects with anti-polysaccharide C (PSC) antibody concentration greater than or equal to 30 micrograms per milliliter (µg/mL)
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Anti-polysaccharide C (PSC) antibody concentration
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Number of subjects with anti-polysaccharide Y (PSY) antibody concentration greater than or equal to 30 micrograms per milliliter (µg/mL)
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Anti-polysaccharide Y (PSY) antibody concentration
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Number of subjects with anti-PRP antibody concentration greater than or equal to pre-defined cut-off values
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Anti-PRP antibody concentration
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
Number of subjects seroprotected for anti-diphtheria antibodies
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Anti-diphtheria antibody concentrations
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Number of subjects seroprotected for anti-tetanus antibodies
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Anti-tetanus antibody concentrations
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Number of subjects seroseropositive for anti-filamentus haemagglutinin (FHA) antibodies
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Anti- FHA antibody concentrations
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Number of subjects seroseropositive for anti-pertactin (PRN) antibodies
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Anti-PRN antibody concentrations
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Number of subjects seroseropositive for anti-pertussis toxoid (PT) antibodies
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Anti- PT antibody concentrations
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Number of subjects seroprotected for anti-hepatitis B (HBs) antibodies
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Anti- HBs antibody concentrations
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Number of subjects seroprotected for anti-poliovirus types 1, 2 and 3 antibodies
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Anti-poliovirus types 1, 2 and 3 antibody titers
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Number of subjects with anti-pneumococcal antibody concentrations greater than or equal to pre-defined cut-off values
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Anti-pneumococcal antibody concentrations
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
Number of subjects reporting solicited local and general symptoms during the primary vaccination course
Timeframe: During the 8-Day (Day 0-7) follow-up period after any vaccine dose during the primary vaccination course
Number of subjects reporting solicited local and general symptoms after administration of the polysaccharide challenge dose
Timeframe: During the 8-Day (Day 0-7) follow-up period after the polysaccharide challenge dose
Number of subjects reporting unsolicited adverse events during the primary vaccination course
Timeframe: During the 31-Day (Day 0-30) follow-up period after any vaccine dose during the primary vaccination course
Number of subjects reporting unsolicited adverse events after administration of the polysaccharide challenge dose
Timeframe: During the 31-Day (Day 0-30) follow-up period after administration of the polysaccharide challenge dose
Number of subjects reporting serious adverse events during the primary vaccination course
Timeframe: Up to one month after the 3-dose primary vaccination course (Month 5)
Number of subjects reporting serious adverse events after administration of the polysaccharide challenge dose
Timeframe: Up to one month following administration of the polysaccharide challenge dose (Month 11)
Participation criteria
- Inclusion criteria:
- A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
- Inclusion criteria:
- 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 or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Vaccinated against hepatitis B at birth.
- Born after a gestation period of 36 – 42 weeks. Exclusion criteria:
- Use of any investigational or non-registered 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 of immunosuppressants or other immune-modifying drugs since birth
- Any chronic drug therapy to be continued during the study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine(s).
- Previous vaccination against diphtheria, tetanus, pertussis, polio, N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.
- History of or known exposure to diphtheria, tetanus, pertussis, polio, or invasive diseases due to N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.
- 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 vaccines.
- 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 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.