Three dose primary vaccination of healthy infants between 6 and 12 weeks of age at the time of the first vaccination against Streptococcus pneumaniae
Conditions
Interventions
PS-DT for 19F
PS-TT for 18C
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: PS:32
-PD:7
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). •A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination. •Written informed consent obtained from the parent or guardian of the subject. •Free of obvious 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. Are the trial subjects under 18? yes Number of subjects for this age range: 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: •Use of any investigational or non-registered 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. •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and during the entire study period. •Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae with the exception of Poland where the first dose of hepatitis B will be given at birth. •History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, and/or invasive pneumococcal diseases. •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. •History of any neurologic disorders or seizures. •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, mild upper respiratory infection with or without low-grade febrile illness, i.e oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C. Study entry should be delayed until the illness has improved. •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (For corticosteroids, this will mean prednisone, or equivalent, higher than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.). •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 study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the lot-to-lot consistency of three consecutive production lots of the GSK Biologicals’ 10-valent pneumococcal conjugate vaccine in terms of the immune response induced against each of the 10 pneumococcal serotypes and the carrier protein PD. To demonstrate that GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (pooled data of the three 10Pn-PD-DiT vaccine groups) administered as a three-dose primary vaccination course is non-inferior to Prevenar™ for the immune response against at least 7 of the pneumococcal serotypes. ;Secondary Objective: To demonstrate that GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (pooled data of the three 10Pn-PD-DiT vaccine groups), when administered as a 3-dose primary vaccination course, is non-inferior to Prevenar, both co-administered with DTPa-combined vaccines, in terms of post-immunization febrile reactions with rectal fever > 39.0° C. To evaluate the reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine when concomitantly administered with DTPa-combined vaccines, as three-dose primary vaccination course. To evaluate the reactogenicity and immunogenicity of DTPa-combined vaccines when concomitantly administered with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, as three-dose primary vaccination course. ;Primary end point(s): •To demonstrate the lot-to-lot consistency of three consecutive production lots of the GSK Biologicals’ 10-valent pneumococcal conjugate vaccine: antibody concentrations to pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and to carrier protein PD one month post dose 3. •To demonstrate that GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (pooled data of the three 10-Pn-PD-DiT vaccine groups) is non-inferior to Prevenar™: anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations equal or higher than 0.20 µg/mL one month post dose 3. | — |
Countries
Finland
Outcome results
None listed