A 2-4-11 month vaccination schedule of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, co-administered with DTPa combined vaccines in healthy infants between 8-16 weeks of age at the time of first vaccination.
Conditions
Interventions
PS-TT for for 18C
PS-DT for 19F
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: PS:32
-PD:24
DT:9
Trade Name: Infanrix Hexa
Product Name: Infanrix Hexa
Product Code: DTPa-HBV-IPV/Hib
Pharmaceutical Form: Powder and solvent for suspension for injection
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy the following criteria at study entry: •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, 8 and 16 weeks (56-120 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: The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study: •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 30 days before the first dose of vaccine(s) and ending 30 days after the last dose, with exception of BCG vaccination which can be given after visit 4 and a minimum of 30 days before visit 5. •Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae. •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 /= 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 assess the post-dose 2 immune response elicited by GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered according to a 2-4-11 months vaccination schedule with co-administration of DTPa combined vaccine.;Secondary Objective: Assess post-dose 3 immune response elicited by GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered at 2, 3, 4, 11 months of age with co-administration of DTPa combined vaccine at 2, 4, 11 months of age. Assess persistence of pneumococcal antibodies elicited by GSK Biologicals’ 10-valent pneumococcal conjugate vaccine prior to booster vaccination at 11 months of age. Assess immune response elicited by a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine following 2 doses at 2, 4 months of age or 3 doses at 2, 3, 4 months of age when co-administered with DTPa combined vaccine at 11 months of age. Assess safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered according to a 2-4-11 or 2-3-4-11 months vaccination schedule with co-administration of DTPa combined vaccine. Assess safety, reactogenicity and immune response of DTPa combined vaccine at 2, 4, 11 months of age. ;Primary end point(s): Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >/= 0.20 µg/mL, one month after the administration of the second dose (in a 2-4-11 months of age vaccination schedule) with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine. | — |
Countries
Denmark, Slovakia, Sweden
Outcome results
None listed