E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Catch-up immunization against Streptococcus pneumoniae in children older than 7 months at the time of the first vaccination and subdivided according to the age: • 7 to 11 months of age. • 12 to 23 months of age. • 24 months to 5 years of age.
|
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when given as a catch-up immunization in children older than 7 months of age (three age-groups with different schedules). |
|
E.2.2 | Secondary objectives of the trial |
• To assess the safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine when given as a catch-up immunization in children older than 7 months (three age-groups with different schedules). • To evaluate the immunogenicity of GSK Biologicals’ DTPa-IPV/Hib vaccine when co-administered with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine as a 3-dose primary immunization course in children before 6 months of age and as a booster dose in children 12-15 months of age. • To evaluate the safety and reactogenicity of GSK Biologicals’ DTPa-IPV/Hib vaccine when co-administered with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine as a 3-dose primary immunization course in children before 6 months of age and as a booster dose in children 12-15 months of age.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female between, and including - 9-12 weeks (63 to 90 days) of age at the time of first vaccination for the <6 Mo group. - 7-11 months of age at the time of first vaccination for the 7-11 Mo group. - 12-23 months of age at the time of first vaccination for the 12-23 Mo group. - 24 months to 5 years at the time of first vaccination for the ≥24 Mo group. • 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). • 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 between 36 and 42 weeks.
|
|
E.4 | Principal exclusion criteria |
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period for each age-group. • 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, ≥ 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 and ending one month after each dose of vaccine(s). • Previous vaccination against S. pneumoniae. • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including diphtheria toxoid. • History of seizures or neurological disease. • 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 or mild upper respiratory infections with or without low-grade fever, i.e oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C). • 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 entire study period.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
1 month after the administration of the primary (< 6 Mo and 7-11 Mo groups) or the full (12-23 Mo and ≥ 24 Mo groups) vaccination course with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine:
• Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.20 µg/mL.
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |