Safety & immunogenicity of pneumococcal vaccine 2189242A in children aged 12-23 months at the time of first vaccination
Trial overview
Number of subjects with fever > 40.0°C (rectal temperature)
Timeframe: Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination
Number of subjects with fever > 40.0°C (rectal temperature)
Timeframe: Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination
Number of subjects reporting any and grade 3 solicited local symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose)
Number of subjects reporting any, grade 3 and related solicited general symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose)
Number of subjects with unsolicited adverse events (AEs)
Timeframe: During the 31-day (Days 0-30) follow-up period after each primary dose
Number of subjects with unsolicited adverse events (AEs)
Timeframe: During the 31-day (Days 0-30) follow-up period after the booster dose
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period starting at the administration of the first vaccine dose up to study end (from Day 0 up to Month 7)
Anti-pneumococcal dPly and PhtD proteins antibody concentrations
Timeframe: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Anti-pneumococcal serotypes and cross-reactive serotypes antibody concentrations
Timeframe: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Opsonophagocytic activity (OPA) titers against pneumococcal serotypes and cross-reactive serotypes
Timeframe: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Antibody concentrations to protein D (Anti-PD)
Timeframe: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Level of anti-dPly antibodies inhibiting Ply haemolysis activity
Timeframe: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Participation criteria
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
- Male or female between, and including, 12 and 23 months of age at the time of the first vaccination.
- Use of any investigational or non-registered product 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 within six months prior to the first vaccine dose.
- Male or female between, and including, 12 and 23 months of age at the time of the first vaccination.
- Written informed consent obtained from the parents/LAR(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 their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
- Chronic administration 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 during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s).
- Previous vaccination against S. pneumoniae since birth.
- History of any hypersensitivity reaction following any previous vaccination.
- Eczema and any history of allergy
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus infection.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or any chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature >= 37.5°C on oral or axillary setting, or >= 38.0°C on rectal setting.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned use during the study period.
- Child in care.
Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use 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.