A single dose of Aventis Pasteur’s 23-valent pneumococcal polysaccharide vaccine (Pneumo 23) to healthy children who were either primed with the 3-dose primary vaccination followed by the booster dose with GSK Biologicals’ 11 valent conjugate pneumococcal vaccine or received control vaccine Havrix in the Undeca-Pn-010 (347414-010) POET study & who belonged to the 'blood subset'.
Conditions
Interventions
Trade Name: Pneumo-23
Product Name: 23-valent pneumococcal polysaccharide vaccine, Pneumo 23
Pharmaceutical Form: Suspension for injection
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Male and female subjects who participated in study Undeca-Pn-010 (347414/010) and received the full vaccination course (4 doses) of GSK Biologicals’ 11Pn-PD vaccine vaccine or were part of the control group who received Havrix™ vaccine. All should be part of the ‘blood’ subset for Undeca-Pn-010 study. ? Subjects 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) should be enrolled in the study. ? Written informed consent obtained from the parents or guardians 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: The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study: ? Participation in another clinical trial at the time of this trial and during the study period ? Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the single 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 single dose of study vaccine. (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 one month before the administration of the study vaccine and during the study period ? Administration of any additional pneumococcal vaccine since study end of Undeca-Pn-010 (347414/010) ? Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection ? 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 diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature <37.5°C / axillary temperature <37.5°C / rectal temperature <38°C.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immune memory induced by the full four dose vaccination schedule with GSK Biologicals’ 11-valent pneumococcal vaccine compared to unprimed subjects by giving a single dose of Aventis Pasteur’s 23-valent pneumococcal polysaccharide vaccine (Pneumo 23).;Secondary Objective: To assess the antibody persistence of the immune response induced by the full four-dose vaccination course of GSK Biologicals’ 11-valent pneumococcal conjugate vaccine in healthy children prior to the administration of a single dose of Aventis Pasteur’s 23-valent pneumococcal polysaccharide vaccine (Pneumo 23).;Primary end point(s): Antibody concentrations (ELISA) to pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F 10-15 days after the single dose of Aventis Pasteur’s 23-valent pneumococcal polysaccharide vaccine (Pneumo 23). | — |
Countries
Slovakia
Outcome results
None listed