Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate vaccine
Trial overview
Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 microgram per milliliter (µg/mL). (Primary/full vaccination)
Timeframe: At one month after primary (Synflorix <6M & Synflorix 7-11M Groups) or after the full (Synflorix 12-23M & Synflorix >=24M Groups) vaccination course with Synflorix™, that is Month (M)3 for Synflorix <6M & 12-23M groups, M2 for Synflorix 7-11M Group, & M1
Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/full vaccination)
Timeframe: At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.
Antibody concentrations against pneumococcal cross-reactive serotypes 6A and 19A. (Primary/full vaccination)
Timeframe: At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.
Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/full vaccination)
Timeframe: At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.
Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A. (Primary/full vaccination)
Timeframe: At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.
Antibody concentrations against protein D (anti-PD). (Primary/full vaccination)
Timeframe: At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.
Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL. (Booster vaccination)
Timeframe: Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups
Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations. (Booster vaccination)
Timeframe: Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups
Antibody concentrations against pneumococcal cross-reactive serotypes 6A and 19A.(Booster vaccination)
Timeframe: Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups
Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster vaccination)
Timeframe: Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups
Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A. (Booster vaccination)
Timeframe: Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups
Antibody concentrations against protein D. (Booster vaccination)
Timeframe: Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups
Anti-diphtheria (anti-D) and anti-tetanus toxoids (anti-T) antibody concentrations. (Primary vaccination)
Timeframe: At 1 month after the administration of the primary vaccination course (Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.
Anti-polyribosyl ribitol phosphate (PRP) antibody concentrations. (Primary vaccination)
Timeframe: At 1 month after the administration of the primary vaccination course (Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group
Anti-pertussis toxoid (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN) antibody concentrations. (Primary vaccination)
Timeframe: At 1 month after the administration of the primary vaccination course(Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group
Anti-polio type 1, 2 and 3 titers. (Primary vaccination)
Timeframe: At 1 month after the administration of the primary vaccination course (Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.
Booster vaccine response to PT, FHA and PRN
Timeframe: Before and one month after the booster dose with Synflorix™
Number of subjects solicited local symptoms (any and grade 3). (Primary vaccination)
Timeframe: Within 4-day (Days 0-3) following the primary vaccination
Number of subjects with solicited local symptoms (any and grade 3). (Booster vaccination)
Timeframe: Within 4-day (Days 0-3) following the booster vaccination
Number of subjects with solicited general symptoms (any and grade 3). (Booster vaccination)
Timeframe: Within 4 day (Days 0-3) following the booster vacination
Number of subjects with unsolicited adverse events (AEs). (Primary vaccination)
Timeframe: Within 31-day (Days 0-30) post primary vaccination
Number of subjects with unsolicited adverse events (AEs). (Booster vaccination)
Timeframe: Within 31 day (Days 0-30) following the booster vaccination
Number of subjects with serious adverse events (SAEs) (Primary vaccination)
Timeframe: During the Primary vaccination course up until start of Booster vaccination course
Number of subjects with serious adverse events (SAEs). (Booster vaccination)
Timeframe: During the booster vaccination course
Number of subjects with solicited general symptoms (Primary vaccination)
Timeframe: Within 4-day (Days 0-3) following the primary vaccination
Anti-diphtheria (anti-D) and anti-tetanus toxoids (anti-T) antibody concentrations.(Booster vaccination)
Timeframe: Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.
Anti-polyribosyl ribitol phosphate (PRP) antibody concentrations. (Booster vaccination)
Timeframe: Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.
Anti-pertussis toxoid (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN) antibody concentrations. (Booster vaccination)
Timeframe: Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.
Titers of antibodies against polio type 1, 2 and 3 (Anti-polio 1, 2 and 3). (Booster vaccination)
Timeframe: Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.
Participation criteria
- Male or female between, and including
- 9-12 weeks of age at the time of first vaccination for the <6 Mo group.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period for each age-group.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- 9-12 weeks of age at the time of first vaccination for the <6 Mo group.
- 7-11 months of age at the time of first vaccination for the 7-11 Mo group.
- 12-23 months of age at the time of first vaccination for the 12-23 Mo group.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- 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 between 36 and 42 weeks.
Male or female between, and including
24 months to 5 years at the time of first vaccination for the >= 24 Mo group.
- Chronic administration (defined as more than 14 days) 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 period starting one month before and ending one month after each dose of vaccine(s).
- Previous vaccination against S. pneumoniae.
- 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 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 since birth or planned administration during the entire study period.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period for each age-group.
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.