Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines
Trial overview
Number of subjects reporting fever above 39.0 degree Celsius (°C)
Timeframe: During the 4-day (Day 0-3) period after the booster vaccination
Number of subjects reporting solicited local symptoms
Timeframe: During the 4-day (Day 0-3) period after the booster vaccination
Number of subjects reporting solicited general symptoms
Timeframe: During the 4-day (Day 0-3) period after the booster vaccination
Number of subjects reporting unsolicited adverse events (AE)
Timeframe: During the 31-day (Day 0-30) period after the booster vaccination
Number of subjects reporting serious adverse events (SAE)
Timeframe: During the 31-day (Day 0-30) period after the booster vaccination
Number of subjects reporting serious adverse events (SAE)
Timeframe: From the beginning of the study up to the end of the extended 6-month safety follow-up period
Number of subjects with vaccine pneumococcal serotype antibody concentrations above the cut-off value
Timeframe: Before (pre) and one month after (post) the booster administration
Number of subjects with opsonophagocytic activity against vaccine pneumococcal serotypes above the cut-off value
Timeframe: Before (pre) and one month after (post) the booster administration
Number of subjects with cross-reactive pneumococcal serotype antibody concentrations above the cut-off value
Timeframe: Before (pre) and one month after (post) the booster administration
Number of subjects with opsonophagocytic activity against cross-reactive pneumococcal serotypes above the cut-off value
Timeframe: Before (pre) and one month after (post) the booster administration
Number of subjects with anti-protein D antibody concentrations above the cut-off value
Timeframe: Before (pre) and one month after (post) the booster administration
Number of subjects with meningococcal serogroup C serum bactericidal assay titer above the cut-off value
Timeframe: Before (pre) and one month after (post) the booster administration
Number of subjects with anti-meningococcal polysaccharide C antibody concentrations above the cut-off value
Timeframe: Before (pre) and one month after (post) the booster administration
Number of subjects with anti-polyribosyl-ribitol phosphate antibody concentrations above the cut-off value
Timeframe: Before (pre) and one month after (post) the booster administration
- 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, 11-18 months of age at the time of the booster vaccination.
- Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period
•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, 11-18 months of age at the time of the booster vaccination. •A male or female who previously participated in study 107005 and received three doses of pneumococcal conjugate vaccine. •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.
•Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product. •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines. •Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the booster dose of study vaccines and up to the follow-up visit (one month after the booster dose of study vaccines). •Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, MenC and/or Hib-MenC vaccines other than the study vaccines from study 107005. •History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C disease. •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. •History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease. •Acute disease at the time of enrolment. •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. •A family history of congenital or hereditary immunodeficiency. •Major congenital defects or serious chronic illness. •Administration of immunoglobulins and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study (starting with the administration of the booster dose of study vaccines up to the follow-up visit one month after).
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.