Immunogenicity and safety study of GlaxoSmithKline Biologicals’ GSK2202083A vaccine administered as a booster dose
Trial overview
Number of seroprotected subjects against Polyribosyl-Ribitol-Phosphate (PRP)
Timeframe: At Month 1, post-booster dose
Number of seroprotected subjects against Neisseria meningitidis serogroup C using baby rabbit completent (rSBA-MenC)
Timeframe: At Month 1, post-booster dose
Number of seropositive subjects for anti-PRP
Timeframe: At Month 0, before the booster dose
Number of subjects with anti-PRP antibody concentrations ≥ the cut-off
Timeframe: At Month 0 and Month 1, before and one month after booster dose
Anti-PRP antibody concentrations
Timeframe: At Month 0 and Month 1, before and one month after booster dose
Number of seroprotected subjects against rSBA-MenC
Timeframe: At Month 0, before the booster dose
Number of seropositive subjects for anti-rSBA-MenC
Timeframe: At Month 0 and Month 1, before and one month after booster dose
Anti-rSBA-MenC antibody titres
Timeframe: At Month 0 and Month 1, before and one month after booster dose
Number of subjects with polysaccharide N. meningitidis serogroup C (PSC) antibody concentrations ≥ cut-off values
Timeframe: At Month 0 and Month 1, before and one month after booster dose
Anti-PSC antibody concentrations
Timeframe: At Month 0 and Month 1, before and one month after booster dose
Number of seropositive subjects for anti-diphteria (anti-D) and anti-tetanus (anti-T)
Timeframe: At Month 0 and Month 1, before and one month after booster dose
Anti-D and anti-T antibody concentrations
Timeframe: At Month 0 and Month 1, before and one month after booster dose
Number of subjects with anti-hepatitis B (Anti-HBs) antibody concentrations ≥ cut-off values
Timeframe: At Month 0 and Month 1, before and one month after booster dose
Anti-HBs antibody concentrations
Timeframe: At Month 0 and Month 1, before and after booster dose
Number of seropositive subjects for anti-poliovirus types 1, 2 and 3
Timeframe: At Month 0 and Month 1, before and one month after booster dose
Anti-poliovirus types 1, 2 and 3 antibody titres
Timeframe: At Month 0 and Month 1, before and one month after booster dose
Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)
Timeframe: At Month 0 and Month 1, before and one month after booster dose
Anti-PT, anti-FHA and anti-PRN antibody concentrations
Timeframe: At Month 0 and Month 1, before and one month after booster dose
Number of subjects with any solicited local symptoms
Timeframe: During the 8-day (Days 0-7) post-booster period
Number of subjects with any solicited general symptoms
Timeframe: During the 8-day (Days 0-7) post-booster period
Number of subjects with unsolicited adverse events (AEs)
Timeframe: During the 31-day (Days 0-30) post-booster period
Number of subjects with serious adverse events (SAEs)
Timeframe: After the booster dose of the study vaccine up to the study end (from Month 0 to Month 1)
Participation criteria
- Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol.
- Subjects who have completed the full three-dose primary vaccination course according to their group allocation in the primary study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157).
- Child in care.
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Subjects who have completed the full three-dose primary vaccination course according to their group allocation in the primary study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157).
- A male or female between, and including, 12 and 18 months of age at the time of booster vaccination.
- Written informed consent obtained from the parent(s)/ legally acceptable representative(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol.
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination.
- Planned administration/administration of immunoglobulins and/or any blood products within three months before the booster dose, or during the study period.
- Planned administration/administration of any vaccine not foreseen by the study protocol during the period starting 30 days before and ending 30 days after the booster dose.
- Participation in another clinical study since the primary study DTPa-HBV-IPV/Hib-MenC-TT-002 in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal and MenC vaccination or disease since the conclusion visit of study DTPa-HBV-IPV/Hib-MenC-TT-002.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- The following adverse event having occurred after previous administration of DTP vaccine:
- Encephalopathy.
- Temperature of >= 40.5°C (rectal temperature) within 48 hours of vaccination, not due to another identifiable cause.
- Collapse or shock-like state within 48 hours of vaccination.
- Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting >= 3 hours.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator. -
Child in care.
Seizures with or without fever occurring within 3 days of vaccination. The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
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.