Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™
Trial overview
Concentrations of antibodies against vaccine pneumococcal serotypes
Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Antibody concentrations against protein D (anti-PD antibodies)
Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A and -19A)
Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Titers for opsonophagocytic activity (OPA) against vaccine pneumococcal serotypes
Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Titers for opsonophagocytic activity (OPA) against cross-reactive pneumococcal serotypes
Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of subjects seropositive for antibodies against vaccine pneumococcal serotypes
Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of subjects seroprotected as regards antibodies against vaccine pneumococcal serotypes
Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of subjects seropositive as regards antibodies against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A and -19A)
Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of subjects seroprotected as regards antibodies against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A and -19A)
Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of subjects seropositive as regards antibodies against protein D (Anti-PD antibodies)
Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of subjects seropositive as regards opsonophagocytic activity against vaccine pneumococcal serotypes
Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of subjects seropositive as regards opsonophagocytic activity against cross-reactive pneumococcal serotypes
Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Anti-Bordetella pertussis (anti-BPT) antibody concentrations
Timeframe: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of subjects seropositive as regards anti-Bordetella pertussis (anti-BPT) antibodies
Timeframe: At Month 3, one month after the administration of the third dose of DTPw-HBV/Hib vaccine
Anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-TT) antibody concentrations
Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
Number of subjects seroprotected as regards anti-diphtheria (Anti D) and anti-tetanus toxoids (Anti TT) antibodies
Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations
Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
Number of subjects seroprotected as regards anti-polyribosyl-ribitol phosphate (anti-PRP) antibodies ≥ the cut-off.
Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
Number of subjects seroprotected as regards anti-polyribosyl-ribitol phosphate (anti-PRP) antibodies ≥ the cut-off
Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
Anti-hepatitis B surface antigen (HBs) antibody concentrations
Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix -HepB /Hiberix vaccine
Number of subjects seroprotected as regards anti-Hepatitis B surface antigen (HBs) antibodies.
Timeframe: At Month 3, one month after the administration of the third dose of Tritanrix HepB/ Hiberix vaccine
Number of subjects with any and any Grade 3 solicited local symptoms
Timeframe: Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines
Number of subjects with any and any Grade 3 and related solicited general symptoms
Timeframe: Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines
Number of subjects with fever (temperature measured rectally) > the cut-off
Timeframe: Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines
Number of subjects with unsolicited adverse events (AEs)
Timeframe: Within the 31-day (Days 0-30) follow-up periods post vaccination, across doses and across vaccines
Number of subjects with serious adverse events (SAEs)
Timeframe: Throughout the entire study period, from Month 0 to Month 3
Participation criteria
- Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, 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 (pharmaceutical product or device).
- Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
- Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, 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 (pharmaceutical product or device).
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- A family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed).
- Previous vaccination against, diphtheria, tetanus, pertussis, Haemophilus influenzae type b and/or Streptococcus pneumoniae.
- History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of any neurological disorders or seizures.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment. Study entry should be delayed until the illness has improved.
- Babies for which birth weight is < 2 kilogram (if known) at Visit 1
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.