Primary Vaccination Study with a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age
Trial overview
Concentrations of antibodies against vaccine components of the pneumococcal vaccine
Timeframe: One month after primary immunization (month 4)
Concentration of antibody against protein D (PD)
Timeframe: One month after primary immunization (month 4)
Number of subjects with anti-pneumococcal vaccine serotype antibody concentrations equal to or above 0.20 µg/mL
Timeframe: One month after primary immunization (month 4)
Number of subjects with anti-pneumococcal cross-reactive serotype concentrations equal to or above 0.20 µg/mL
Timeframe: One month after primary immunization (month 4)
Number of subjects with opsonophagocytic activity against vaccine pneumococcal serotypes
Timeframe: One month after primary immunization (month 4)
Number of subjects with opsonophagocytic activity against cross-reactive pneumococcal serotypes
Timeframe: One month after primary immunization (month 4)
Opsonophagocytic titers of cross-reactive pneumococcal serotypes
Timeframe: One month after primary immunization (month 4)
Poliovirus types 1, 2 and 3 titers
Timeframe: One month after primary immunization (month 4)
Concentrations of antibodies against diphteria toxoid (DT) and tetanus toxoid (TT)
Timeframe: One month after primary immunization (month 4)
Concentration of antibody against hepatitis B surface antigen (HBs) by Enzyme Linked ImmunoSorbent Assay (ELISA).
Timeframe: One month after primary immunization (month 4)
Concentration of antibody against rotavirus immunoglobulin A (IgA)
Timeframe: 3 months after primary immunization (month 4)
Occurrence of serious adverse events
Timeframe: Following vaccination and throughout the entire study period (Month 0 to Month 4)
Opsonophagocytic titers of vaccine pneumococcal serotypes
Timeframe: One month after primary immunization (month 4)
Number of subjects with solicited local and general symptoms.
Timeframe: Within 4 days (day 0-3) after vaccination
Concentrations of antibodies against pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN)
Timeframe: One month after primary immunization (month 4)
Concentration of antibody against polyribosyl-ribitol phosphate (PRP)
Timeframe: One month after primary immunization (month 4)
Occurrence of unsolicited adverse events
Timeframe: Within 31 days (day 0-30) after vaccination
- Male or female subjects between, and including 6-12 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.
- 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.
- Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
- Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward.
- Free of any known or suspected 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.
Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
- Concurrently participating in another clinical study, at any time during the study period.
- Chronic administration (defined as more than 14 days) 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 (with the exception of hepatitis B immunoglobulins at birth).
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of vaccines where the first dose can be given within the first two weeks of life).
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 7 days after Dose 1 and Dose 2 and 30 days after Dose 3.
- History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, H. influenzae type b and rotavirus 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.
- Gastroenteritis within 7 days preceding the study vaccine administration.
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.
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.
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.