Safety and immunogenicity study of GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate vaccine
Trial overview
Number of subjects reporting rectal temperature above (>) 39.0 degrees Celsius (°C)
Timeframe: Within 4 day (Days 0-3) after each dose and across doses
Number of subjects with any and any Grade 3 solicited local symptoms
Timeframe: Within 4 day (Days 0-3) after each dose and across doses
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: Within 4-day (Days 0-3) after each dose and across doses
Number of subjects with unsolicited adverse events (AEs)
Timeframe: Within 31 days (Days 0-30) after each vaccination
Number of subjects with serious adverse events (SAEs)
Timeframe: During the Active Phase: From Month 0 to Month 3 for Synflorix 1 Group and Prevenar 1 Group and from Month 0 to Month 5 for the Synflorix 2 Group and Prevenar 2 Group
Number of subjects with serious adverse (SAEs)
Timeframe: During the Extended Safety Follow-Up Phase: At Month 8 for Synflorix 1 Group and Prevenar 1 Group and at Month 10 for the Synflorix 2 Group and Prevenar 2 Group
Concentrations of antibodies against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations equal to or above (≥) 0.2 microgram per milliliter (µg/mL)
Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations equal to or above (≥) 0.05 microgram per liter (µg/mL)
Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Opsonophagocytic activity (OPA) against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of subjects with opsonophagocytic activity (OPA) against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F equal to or above (≥) 8
Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A
Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of subjects with concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A equal to or above (≥) 0.05 microgram per milliliter (μg/mL)
Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Opsonophagocytic activity (OPA) against cross-reactive pneumococcal serotypes 6A and 19A
Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of subjects with opsonophagocytic activity (OPA) against cross-reactive pneumococcal serotypes 6A and 19A equal to or above (≥) 8
Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Concentrations of antibodies against protein D (Anti-PD)
Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of subjects with concentrations of antibodies against protein D (Anti-PD) equal to or above (≥) 100 ELISA units per milliliter (EL.U/mL)
Timeframe: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration equal to or above 0.15 microgram per milliliter (µg/ mL)
Timeframe: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration equal to or above 1.0 microgram per milliliter (µg/mL)
Timeframe: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations
Timeframe: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of subjects with anti-diphtheria (Anti D) and anti-tetanus toxoids (Anti TT) antibody concentrations equal to or above 0.1 International Units per milliliter (IU/mL)
Timeframe: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-TT) antibody concentrations
Timeframe: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of subjects with anti-Hepatitis B surface antigen (HBs) antibody concentrations equal to or above 10 milli-International Units per milliliter (mIU/mL)
Timeframe: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Anti-hepatitis B surface antigen (HBs) antibody concentrations
Timeframe: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of subjects with anti-polio type 1, 2 and 3 antibody titers equal to or above (≥) 8
Timeframe: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Anti-polio type 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers
Timeframe: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of subjects with anti-Bordetella pertussis (anti-BPT) antibody concentrations equal to or above 15 ELISA unit per milli-liter (EL.U/mL) (seropositivity)
Timeframe: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Anti-Bordetella pertussis (anti-BPT) antibody concentrations
Timeframe: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of subjects with vaccine response to Bordetella pertussis
Timeframe: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Participation criteria
- Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- Use of any investigational or non-registered product (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
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- 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, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination.
- 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 each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations
- History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b diseases.
- 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
- 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 active phase of the study.
Use of any investigational or non-registered product (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
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.