Study to asses DTPw-HBV/Hib at 15-18 months (m) and Mencevax™ ACW at 24 to 30 m in primed subjects
Trial overview
Number of subjects with serum bactericidal assay against N. meningitidis serogroups A, C using rabbit complement (rSBA-MenA,C) antibodies
Timeframe: At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)
Number of subjects with rSBA-MenA,C, W-135 antibody titers ≥ predefined cut-offs
Timeframe: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Anti-rSBA-MenA, C, W-135 antibody titers
Timeframe: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Number of subjects with Anti-polysaccharide A (anti-PSA) and C (anti-PSC) antibody concentrations above predefined cut-off values
Timeframe: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Anti-PSA and anti-PSC antibody concentrations
Timeframe: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31
Number of subjects with anti- polysaccharide W (anti-PSW) antibody concentrations ≥ predefined cut-off values
Timeframe: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Anti-PSW antibody concentrations
Timeframe: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Number of subjects with anti-hepatitis B (anti-HBs) antibody concentrations ≥ predefined cut-off values
Timeframe: Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
Anti-HBs antibody concentrations
Timeframe: Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
Number of subjects with vaccine response for rSBA-Men A, C and W-135
Timeframe: At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Number of subjects with fever
Timeframe: During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccine
Number of subjects with solicited local symtoms
Timeframe: During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
Number of subjects with solicited general symptoms
Timeframe: During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
Number of subjects with unsolicited adverse events (AEs)
Timeframe: During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccine
Number of subjects with serious adverse events (SAEs)
Timeframe: From Months 15-18 and up to Months 25-31 post 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, 15 and 18 months of age at the time of vaccination.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, 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 vaccination.
- 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, 15 and 18 months of age at the time of vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Having participated in the primary vaccination study (CPMS N° 759346/007).
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, 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 vaccination.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination.
- Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A, C or W disease, after the date of the study conclusion visit of the primary vaccination study (CPMS N° 759346/007).
- History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
- Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines administered in the study.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures including febrile seizures in infancy.
- Acute disease at the time of enrolment.
- Axillary temperature ≥ 37.5°C at the time of vaccination.
- Administration of immunoglobulins and/or any blood products within the three months preceding the vaccination or planned administration during the study period.
- Anaphylactic reaction following the administration of vaccine in the primary vaccination study.
- Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, Hib or meningococcal vaccines.
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.