3-dose primary vaccination against Streptococcus pneumoniae and Haemophilus influenzae in healthy infants between 6-12 weeks of age at the time of the first vaccination and booster vaccination at 12-15 months of age. MedDRA version: 14.1 Level: LLT Classification code 10042196 Term: Streptococcus pneumoniae secondary bacterial infection of acute bronchitis System Organ Class: 100000004862 MedDRA version: 14.1 Level: LLT Classification code 10042197 Term: Streptococcus pneumoniae septicaemia Sy
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol. • A male or female between, and including 6 to 12 weeks (42-90 days) of age at the time of the first vaccination. In addition, the first pneumococcal and DTPa.HBV-IPV-Hib vaccination should be given in accordance with the official national recommendations for the immunisation schedule of infants. • Written informed consent obtained from the parents/LAR(s) of the subject. • Healthy subjects as established by medical history and clinical examination before entering into the study. • Born after a gestation period of at least 36 weeks. Are the trial subjects under 18? yes Number of subjects for this age range: 940 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 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 of immunosuppressants or other immune-modifying drugs since birth. • Planned administration/administration of a vaccine containing diphtheria toxoid, tetanus toxoid (except MenC-TT in Spain) or CRM197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the following exceptions: - Licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines. - Licensed rotavirus vaccines are allowed if administered at least 7 days before or after each dose of study of vaccines. - Licensed MenC-TT vaccine is allowed in Spain and should be concomitantly administered with the study vaccine at around 2, 4 and 12-15 months of age. - In case an emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is organised by the public health authorities, outside the routine immunization program, that vaccine can be administered at any time during the study period provided it is licensed and used according to its Summary of Product Characteristics or Prescribing Information and according to the local governmental recommendations. • 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 • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination • Family history of congenital or hereditary immunodeficiency. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). • Major congenital defects or serious chronic illness, including Kawasaki’s syndrome. • History of any neurological disorders or seizures, including conditions such as hypotensive-hyporesponsive episodes, encephalopathy and any convulsions (afebrile and febrile). • Acute disease and/or fever at the time of enrolment. • Administration of immunoglobulins and/or any blood products since birth or planned administration during study period. • Previous vaccination against diphtheria, tetanus, pertussis, polio, H. influenzae type b. • Previous vaccination against S. pneumoniae. • History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b disease. • 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 that 2830929A vaccine co-administered with DTPa-HBV-IPV/Hib as a three-dose primary vaccination course at approximately 2, 3, 4 months of age is non-inferior to Prevenar 13 or Synflorix in terms of percentage of subjects with antibody concentrations greater or equal to the seropositivity threshold AND in terms of ELISA Geometric Mean Concentrations (GMCs). • To demonstrate that 2830930A vaccine co-administered with DTPa-HBV-IPV/Hib at approximately 2, 3, 4 months of age is non-inferior to Prevenar 13 or Synflorix in terms of percentage of subjects with antibody concentrations greater or equal to the seropositivity threshold AND in terms of ELISA GMCs. ;Secondary Objective: • To assess the immune responses to components of the 2830929A and 2830930A vaccine co-administered with DTPa-HBV-IPV/Hib vaccine after 3-dose primary vaccination course in infants at 2, 3, 4 months of age and after a booster vaccination at 12-15 months of age. • To assess the antibody persistence induced by 2830929A and 2830930A vaccines, 8-11 months after completion of the 3-dose primary vaccination course. • To assess the safety and reactogenicity of 2830929A and 2830930A vaccines after administration of any primary and booster vaccine dose when co-administered with DTPa-HBV-IPV/Hib.;Primary end point(s): Evaluation of immune responses to components of the 2830929A and 2830930A vaccines ;Timepoint(s) of evaluation of this end point: One month post-dose 3 (Month 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of the immune responses to components of the 2830929A and 2830930A vaccines, for additional parameters. - Concentrations of antibodies and opsonophagocityc activity against all components of the investigational pneumococcal vaccines. Evaluation of the immune responses to components of the 2830929A and 2830930A vaccines. - Concentrations of antibodies against all components of the investigational pneumococcal vaccines. Occurrence of each solicited adverse event - Solicited local adverse events (any and grade 3) - Solicited general adverse events (any, grade 3 and related) Occurrence of each unsolicited adverse event Occurrence of serious adverse event ;Timepoint(s) of evaluation of this end point: - One month post-dose 3 (Month 3) and one month post-booster vaccination (Month 11) - Prior to booster vaccination (Month 10) - Within 4 days (Day 0-Day 3) after each - Within 31 days (Day 0-Day 30) after each vaccination - During the entire study (from Month 0 up to Month 11) | — |
Countries
Czech Republic, Germany, Poland, Spain
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed