Safety & Immunogenicity study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule
Trial overview
Number of seroprotected subjects against pneumococcal serotypes
Timeframe: One month post-dose 2 (Month 3) administration of Synflorix™ vaccine
Number of seroprotected subjects against pneumococcal serotypes
Timeframe: One month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine
Antibody concentrations against pneumococcal serotypes
Timeframe: One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine
Opsonophagocytic activity against vaccine pneumococcal serotypes
Timeframe: One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine
Antibody concentrations against protein D (Anti-PD)
Timeframe: One month post-dose 2 or post-dose 3 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine
Antibody concentrations against diphteria (Anti-D) and tetanus (Anti-T) toxoids
Timeframe: One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine
Antibody concentrations against polyribosyl ribitol phosphate (Anti-PRP)
Timeframe: One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) booster dose of Synflorix™ vaccine
Antibody concentrations against pertussis toxoid (Anti-PT), filamentous haemagglutinin (Anti-FHA) and pertactin (Anti-PRN)
Timeframe: One month post-dose 2 (Month 3) administration, one month before (Month 9) and after (Month 10) the booster dose of Synflorix™ vaccine
Antibody concentrations against hepatitis B surface antigen (Anti-HBs)
Timeframe: One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine
Antibody titers against polio type 1, 2 and 3 (Anti-polio 1, 2 and 3)
Timeframe: One month post-dose 2 (Month 3) administration, one month before (Month 9) and one month after (Month 10) the booster dose of Synflorix™ vaccine
Number of subjects with booster vaccine response to Anti-PT, Anti-FHA and Anti-PRN antibodies
Timeframe: One month after (Month 9) the administration of the booster dose of Synflorix™ vaccine
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Booster) with the Synflorix™ vaccine
Number of subjects with solicited general symptoms
Timeframe: During the 4-day (Days 0-3) period following the primary vaccination (across doses) and during the 4-day (Days 0-3) period following the booster vaccination (post Booster) with the Synflorix™ vaccine
Number of subjects with unsolicited adverse events
Timeframe: Within the 31-day (Days 0-30) post-primary vaccination period, across doses
Number of subjects with unsolicited adverse events
Timeframe: Within the 31-day (Days 0-30) post booster vaccination period
Number of subjects with serious adverse events
Timeframe: During the primary vaccination period
Number of subjects with serious adverse events
Timeframe: During the booster vaccination period
Participation criteria
- Inclusion criteria:
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 8 and 16 weeks (56-120 days) of age at the time of the first vaccination.
- 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.
- Born after a gestation period of 36 to 42 weeks. Exclusion criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the first dose of vaccine(s) and ending 30 days after the last dose, with exception of BCG vaccination which can be given after the 1 month post-dose 2 or 3 (2-4-11 or 2-3-4-11 months of age schedule) blood sampling and a minimum of 30 days before the pre-booster dose blood sampling.
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae.
- History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, and/or invasive pneumococcal diseases.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- 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 since birth or planned administration during the study period.
Inclusion criteria:
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.