Booster vaccination against Streptococcus pneumoniae in healthy children having previously received vaccines as a primary 3-dose vaccination course in the study 11PN-PD-DIT-002.
Conditions
Interventions
PS-DT for 19F
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: PS:32-
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
Trade Name: Pneumovax 23 Durchstechflas
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Age at first vaccine dose in the study: children will be 11-14 months of age for the 23PS group and 12-23 months of age for the 10V group at the time of the first vaccination. Although the age interval, 12-23 months, for the administration of the fourth pneumococcal conjugate vaccine is quite large, every effort should be made to vaccinate the children as soon as possible. •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 who previously participated in the study 11PN-PD-DIT-002 and received at least one dose of pneumococcal conjugate vaccine during the primary study •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. 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 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) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, higher than or equal to 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 the first dose of vaccine(s) and during the entire study period. •Administration of any additional pneumococcal vaccine or DTPa combined vaccine since study end of 11PN-PD-DIT-002 study. •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. •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. •Major congenital defects or serious chronic illness. •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 diarrhea, 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). •History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, and/or invasive pneumococcal diseases. •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. •Anaphylactic reaction following the administration of vaccine(s). •Febrile illness defined as oral, axillary or tympanic temperature higher than or equal to 37.5°C, rectal temperature higher than or equal to 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immunological memory following primary vaccination with either GSK Biologicals’ selected 3µg 18C-TT containing 11Pn-PD-DiT vaccine formulation or the 11Pn-PD vaccine or Prevenar™, through the administration of a single dose of unconjugated 23-valent pneumococcal polysaccharide vaccine (Pneumovax™). To assess the immune response of a booster dose of GSK Biologicals’ 10Pn-PD-DiT vaccine administered to children 12-23 months of age following primary vaccination with one of the 8 other GSK Biologicals’ 11Pn-PD-DiT vaccine formulations.;Secondary Objective: To assess the safety and reactogenicity of GSK Biologicals’ 10Pn-PD-DiT vaccine when coadministered with Infanrix™ hexa as a booster dose during the second year of life. To assess 7 to 10 months after completion of the 3-dose primary immunization course in study 11PN-PD-DIT-002, the persistence of antibodies induced by the different pneumococcal conjugate vaccines and the coadministered Infanrix™ hexa. To assess the immunogenicity of a booster dose of Infanrix™ hexa when co-administered with GSK Biologicals’ 10Pn-PD-DiT vaccine at 12-23 months of age. ;Primary end point(s): One month after the administration of the booster dose with either GSK Biologicals’ 10Pn-PD-DiT vaccine or 1 month after the administration of the single dose of unconjugated 23- valent pneumococcal polysaccharide vaccine (Pneumovax™), anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations. | — |
Countries
Germany
Outcome results
None listed