Infections, Pneumococcal
Conditions
Interventions
Trade Name: Synflorix
Product Name: Synflorix
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: -
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO PROTEIN
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects for whom, in the opinion of the investigator, the parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g., return for vaccination and follow-up visits). •A male or female between, and including 6-10 weeks (42-76 days) of age at the time of the first vaccination. •Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the subject. For all subjects, the consent form should be countersigned by a witness. •Healthy subjects as established by medical history and clinical examination before entering into the study. •Born full-term (i.e., after a gestation period from 37 to 42 weeks). Are the trial subjects under 18? yes Number of subjects for this age range: 320 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Child in care. •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 in total) of immunosuppressants or other immune-modifying drugs since birth. Inhaled and topical steroids are allowed. •Planned administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab). •Administration or planned administration of a vaccine not foreseen by the study protocol administered during the period starting from 30 days before each dose of study vaccines and ending 30 days after with the following exceptions: •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 vaccine/product •Previous vaccination against diphtheria, tetanus, pertussis, H. influenzae type b and/or S. pneumoniae. •History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, and H. influenzae type b disease. •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). •Family history of congenital or hereditary immunodeficiency. •Major congenital defects or serious chronic illness. •History of any neurological disorders or seizures. •Acute disease and/or fever at the time of enrolment. Fever is defined as temperature = 37.5°C for oral, axillary or tympanic route, or = 38.0°C on rectal route. The preferred route for recording temperature in this study will be axillary. Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator. •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed). •Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of GSK Biologicals’ 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of the immune response to the 10 vaccine pneumococcal serotypes one month after dose 3.;Secondary Objective: •To demonstrate the non-inferiority of GSK Biologicals’ 10Pn-PD-DiT vaccine (4-dose presentation) as compared to Synflorix (1-dose presentation) in terms of the immune response to the vaccine-related pneumococcal serotype 19A one month after dose 3. •To evaluate the immunogenicity of 10Pn-PD-DiT vaccine (4-dose presentation) one month after dose 3. •To evaluate the persistence of antibodies elicited by 10Pn-PD-DiT vaccine (4-dose presentation), approximately 5 months after completion of the 3-dose primary vaccination course. •To evaluate the immunogenicity of 10Pn-PD-DiT vaccine (4-dose presentation), one month after a booster dose. •To assess the reactogenicity and safety of 10Pn-PD-DiT vaccine (4-dose presentation), given as a primary vaccination course at approximately 6, 10 and 18 weeks of age, co-administered with DTPw-HBV/Hib vaccine (at 6 and 10 weeks of age), followed by a booster dose (without DTPw-HBV/Hib vaccine co-administration) at approximately 9 months of age.;Primary end point(s): Evaluation of the immune response to the investigational study vaccine. Concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.;Timepoint(s) of evaluation of this end point: One month post-dose 3 (Month 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.) Evaluation of the immune response to the investigational study vaccine. ?Concentrations of antibodies against vaccine-related pneumococcal serotype 19A. ?Concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. ?Opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. ?Concentrations of antibodies against vaccine-related pneumococcal serotype 6A. ?Opsonophagocytic activity against vaccine-related pneumococcal serotypes 6A and 19A. 2.) Evaluation of the immune response to the investigational study vaccine. ?Concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. ?Opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. ?Concentrations of antibodies against vaccine-related pneumococcal serotypes 6A and 19A. ?Opsonophagocytic activity against vaccine-related pneumococcal serotypes 6A and 19A. 3.) Evaluation of the immune response to the investigational study vaccine. ?Concentration of antibodies against protein D. 4.) Occurrence of solicited local and general adverse events. ?Occurrence of each solicited local adverse event (any and grade 3). ?Occurrence of each solicited general adverse event (any, grade 3, related). 5.) Occurrence of unsolicited adverse events (AEs). 6.) Occurrence of serious adverse events.;Timepoint(s) of evaluation of this end point: 1.) One month post-dose 3 (Month 3); 2.) Prior to (Month 8) and one month post-booster vaccination (Month 9); 3.) One month post-dose 3 (Month 3) and one month post-booster vaccination (Month 9); 4.) Within the 4 days (Days 0-3) after each dose of 10Pn-PD-DiT vaccine co-administered with DTPw-HBV/Hib vaccine at dose 1 and dose 2 of the 10Pn-PD-DiT; 5.) Within 31 days (Day 0 – Day 30) after dose of 10Pn-PD-DiT vaccine co-administered with DTPw-HBV/Hib vacci | — |
Countries
Bangladesh
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed