Catch-up immunization against Streptococcus pneumoniae in children older than 7 months at the time of the first vaccination and subdivided according to the age: • 7 to 11 months of age. • 12 to 23 months of age. • 24 months to 5 years of age.
Conditions
Interventions
Product Name: 10-valent streptococcus pneumoniae conjugate vaccine
Product Code: 10Pn-PD-DiT
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: PS-PD for serotypes 1,4,5,6B,7F,9V14,23F
PS-TT for 18C,PS-DT for 19F
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: PS:32
DT:9
Trade Name: Infanrix-Polio+Hib
Product Name: DTPa-IPV+Hib
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Diphtheria Toxoid
Concentration unit: IU/ml in
3:64DU/ml
INN or Proposed INN: Haemophilus type b polysaccharide conjugated to tetanus toxoid (TT)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: Hib
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female between, and including - 9-12 weeks (63 to 90 days) of age at the time of first vaccination for the =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period for each age-group. • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, = 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending one month after each dose of vaccine(s). • Previous vaccination against S. pneumoniae. • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including diphtheria toxoid. • History of seizures or neurological disease. • Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infections with or without low-grade fever, i.e oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C). • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). • A family history of congenital or hereditary immunodeficiency. • Major congenital defects or serious chronic illness. • Administration of immunoglobulins and/or any blood products since birth or planned administration during the entire study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when given as a catch-up immunization in children older than 7 months of age (three age-groups with different schedules).;Secondary Objective: • To assess the safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine when given as a catch-up immunization in children older than 7 months (three age-groups with different schedules). • To evaluate the immunogenicity of GSK Biologicals’ DTPa-IPV/Hib vaccine when co-administered with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine as a 3-dose primary immunization course in children before 6 months of age and as a booster dose in children 12-15 months of age. • To evaluate the safety and reactogenicity of GSK Biologicals’ DTPa-IPV/Hib vaccine when co-administered with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine as a 3-dose primary immunization course in children before 6 months of age and as a booster dose in children 12-15 months of age. ;Primary end point(s): 1 month after the administration of the primary (< 6 Mo and 7-11 Mo groups) or the full (12-23 Mo and = 24 Mo groups) vaccination course with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine: • Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations = 0.20 µg/mL. | — |
Countries
Finland
Outcome results
None listed