Immunological persistence after priming with GSK1024850A vaccine and safety& immunogenicity after booster dose
Trial overview
Concentrations of antibodies against vaccine pneumococcal serotypes.
Timeframe: Before booster vaccination at Month 0
Concentrations of antibodies against protein D (PD).
Timeframe: Before booster vaccination at Month 0
Number of subjects reporting any and grade 3 solicited local adverse events (AEs).
Timeframe: Within 4 days (Days 0-3) after booster vaccination.
Number of subjects reporting any, grade 3 and related solicited general adverse events (AEs).
Timeframe: Within 4 days (Days 0-3) after booster vaccination.
Number of subjects reporting unsolicited adverse events (AEs).
Timeframe: Within 31 days (Days 0-30) after booster vaccination
Number of subjects reporting serious adverse events (SAEs).
Timeframe: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1
Opsonophagocytic activity against vaccine pneumococcal serotypes.
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)
Opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A.
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of antibodies against cross-reactive pneumococcal serotypes.
Timeframe: Before booster vaccination at Month 0
Concentrations of antibodies against diphtheria and tetanus.
Timeframe: Before booster vaccination at Month 0
Concentrations of antibodies against pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN).
Timeframe: Before booster vaccination at Month 0
Concentrations of antibodies against polyribosyl-ribitol phosphate (PRP).
Timeframe: Before booster vaccination at Month 0
Titers of antibodies against poliovirus types 1, 2 and 3.
Timeframe: Before booster vaccination at Month 0
Concentrations of antibodies against vaccine pneumococcal serotypes.
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of antibodies against cross-reactive pneumococcal serotypes.
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of antibodies against protein D (PD).
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of antibodies against diphtheria and tetanus.
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of antibodies against pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN).
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of antibodies against polyribosyl-ribitol phosphate (PRP).
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)
Titers of antibodies against poliovirus types 1, 2 and 3.
Timeframe: Before and one month after booster vaccination (at Month 0 and Month 1)
- 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, 18 and 21 months of age at the time of booster vaccination.
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding vaccination, or planned use during the study period.
- 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.
- Male or female between, and including, 18 and 21 months of age at the time of booster vaccination.
- Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00808444
- 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
- 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.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- A family history of congenital or hereditary immunodeficiency.
- Administration of immunoglobulins and/ or any blood products within the 3 months preceding vaccination or planned use during the study period.
- Administration of any pneumococcal and/or vaccine containing diphtheria, tetanus, pertussis, poliomyelitis or Haemophilus influenzae type b antigens since the end of study NCT00808444.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before vaccination and ending 30 days after vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of any reaction or allergic disease likely to be exacerbated by any component of the study vaccines.
- Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures. (Subjects who have had a single uncomplicated febrile convulsion in the past can be included)
- Fever at the time of vaccination. -Fever is defined as rectal temperature >= 38.0°C or tympanic/axillary/ oral temperature >= 37.5°C.
- Acute disease at the time of enrolment.
- Child in care.
Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding vaccination, or planned use during the study period.
Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
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.