E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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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 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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
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E.4 | Principal 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 <37.5°C / rectal temperature <38.0°C. Study entry should be delayed until the illness has improved. •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (For corticosteroids, this will mean prednisone, or equivalent, >/= 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.
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E.5 End points |
E.5.1 | 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. |
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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 | Information not present in EudraCT |
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 |
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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 | No |
E.8.1.1 | Randomised | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Same as test vaccine but administered in a different schedule |
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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 | No |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 13 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 13 |