A booster vaccination study against Streptococcus pneumoniae in subjects aged 36-46 months and a two-dose vaccination against Streptococcus pneumoniae of age-matched unprimed children.
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female between, and including, approximately 36-46 months of age at the time of vaccination. For primed subjects: having completed the full vaccination course with the 10Pn-PD-DiT vaccine in study 10PN-PD-DIT-002 (105539). Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). Written informed consent obtained from the parent(s)/guardian(s) 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) within 30 days preceding the vaccination or planned use during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the vaccination. (For corticosteroids, this will mean prednisone, or equivalent, equal or above 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) For primed subjects: administration of any pneumococcal vaccine since the end of study 10PN-PD-DIT-002 (105539). For unprimed subjects: previous vaccination with any pneumococcal vaccine. Administration of immunoglobulins and/or any blood products less than 6 months prior to the vaccination or planned use during the study period. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). History of reactions or allergic disease likely to be exacerbated by any component of the study vaccine. Acute disease at the time of vaccination (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 infection, provided the body temperature is <38°C (rectal measurement) or <37.5°C (for oral/axillary/tympanic measurements). Study entry should be delayed until the illness has improved).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Concentrations of antibodies against vaccine pneumococcal serotypes, 7-10 days after immunization or dose 1.;Main Objective: To assess the immune responses following vaccination with a booster dose of the 10Pn-PD-DiT vaccine administered at 36-46 months of age in children previously vaccinated with the 10Pn-PD-DiT vaccine in study 10PN-PD-DIT-002 (105539) according to either a 3-dose or 2-dose primary vaccination within the first 6 months of age and booster vaccination at 11 months of age and to assess the immune responses following vaccination with a single dose of the 10Pn-PD-DiT vaccine in age-matched unprimed children.;Secondary Objective: To assess the antibody persistence 24-34 months following vaccination in study 10PN-PD-DIT-002 (105539) with the 10Pn-PD-DiT vaccine according to either a 3-dose or 2-dose primary vaccination within the first 6 months of age and booster vaccination at 11 months of age. To evaluate the safety, reactogenicity and immunogenicity of the 10Pn-PD-DiT vaccine when given as a 2-dose vaccination course to unprimed children in their fourth year of life. To assess the safety and reactogenicity of a booster dose of the 10Pn-PD-DiT vaccine administered at 36-46 months of age in children previously vaccinated with the 10Pn-PD-DiT vaccine in study 10PN-PD-DIT-002 (105539) according to either a 3-dose or 2-dose primary vaccination within the first 6 months of age and booster vaccination at 11 months of age. | — |
Countries
Sweden
Outcome results
None listed