Study to evaluate the safety and immunogenicity of a 10-valent pneumococcal conjugate vaccine in preterm infants
Trial overview
Number of subjects with core fever (rectal temperature) greater than (>) the cut-off
Timeframe: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Number of subjects with any and Grade 3 solicited general symptoms
Timeframe: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Number of subjects with any unsolicited adverse events (AEs)
Timeframe: Within 31 days (Days 0-30) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Number of subjects with any serious adverse events (SAEs)
Timeframe: Throughout the active phase of the study (from the first vaccine administration (Month 0) up to 1 month after the third vaccine administration (Month5).
Number of subjects with any serious adverse events (SAEs)
Timeframe: Throughout the entire study period starting from the first vaccine dose administration (Month 0) up to the end of the 6-month safety follow-up (ESFU- Month 10).
Number of subjects with concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F greater than or equal to (≥) the cut-off
Timeframe: One month after the 3rd vaccine dose (Month 5)
Number of subjects with concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the cut-off
Timeframe: One month after the 3rd vaccine dose (Month 5)
Concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Timeframe: One month after the 3rd vaccine dose (Month 5)
Number of subjects with opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the cut-off
Timeframe: One month after the 3rd vaccine dose (Month 5)
Opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Timeframe: One month after the 3rd vaccine dose (Month 5)
Number of subjects with concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A ≥ the cut-off
Timeframe: One month after the 3rd vaccine dose (Month 5)
Concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A
Timeframe: One month after the 3rd vaccine dose (Month 5)
Number of subjects with opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A ≥ the cut-off
Timeframe: One month after the 3rd vaccine dose (Month 5)
Opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A
Timeframe: One month after the 3rd vaccine dose (Month 5)
Number of subjects with concentrations of antibodies against protein D (Anti-PD) ≥ the cut-off
Timeframe: One month after the 3rd vaccine dose (Month 5)
Concentrations of antibodies against protein D (Anti-PD)
Timeframe: One month after the 3rd vaccine dose (Month 5)
Number of subjects with anti-diphtheria (Anti DT) and anti-tetanus toxoids (Anti TT) antibody concentrations ≥ the cut-off
Timeframe: One month after the 3rd vaccine dose (Month 5)
Antibody concentrations for anti-diphtheria and tetanus toxoids ≥ the cut-off
Timeframe: One month after the 3rd vaccine dose (Month 5)
Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration ≥ the cut-off
Timeframe: One month after the 3rd vaccine dose (Month 5)
Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration ≥ the cut-off
Timeframe: One month after the 3rd vaccine dose (Month 5)
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations ≥ th cut-off
Timeframe: One month after the 3rd vaccine dose (Month 5)
Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations ≥ the cut-off
Timeframe: One month after the 3rd vaccine dose (Month 5)
Antibody concentration for anti-pertussis toxoid (anti-PT) , anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)
Timeframe: One month after the 3rd vaccine dose (Month 5)
Number of subjects with anti-Hepatitis B surface antigen (HBs) antibody concentrations ≥ the cut-off.
Timeframe: One month after the 3rd vaccine dose (Month 5)
Anti-hepatitis B surface antigen (HBs) antibody concentrations
Timeframe: One month after the 3rd vaccine dose (Month 5)
Number of subjects with anti-polio type 1, 2 and 3 antibody titres
Timeframe: One month after the 3rd vaccine dose (Month 5)
Antibody titers for polio type 1, 2 and 3 ≥ the cut-off
Timeframe: One month after the 3rd vaccine dose (Month 5)
Number of subjects with vaccine response to anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN)
Timeframe: One month after the 3rd vaccine dose (Month 5)
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- A male or female between, and including, 8-16 weeks (56-118 days) of age at the time of the first vaccination.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth to the first vaccine dose.
•Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol •A male or female between, and including, 8-16 weeks (56-118 days) of age at the time of the first vaccination. •Written informed consent obtained from the parent or guardian of the subject. •Born after a gestation period of >27 weeks (at least 189 days). •If full term born, healthy subjects as established by medical history and clinical examination before entering into the study •If premature, medically stable condition (not requiring significant medical support or ongoing management for debilitating disease and having demonstrated a clinical course of sustained recovery).
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth to the first vaccine dose. •Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month before the first dose of vaccines and up to Visit 6. •Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis and/or Streptococcus 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, Haemophilus influenzae type b disease, Neisseria meningitidis. •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. •History of any neurologic disorders or seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past). •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, with the exception of monoclonal antibodies against RSV, and/or any blood products within one month preceding the first dose of study vaccines or planned administration during the active phase of the study.
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.