E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Three dose primary vaccination of preterm infants between 8-16 weeks (56-118 days) of age at the time of first vaccination against Streptococcus pneumoniae. |
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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 evaluate the safety and reactogenicity of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine when administered as a 3-dose primary vaccination course and co-administered with DTPa-HBV-IPV/Hib vaccine in preterm infants. |
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E.2.2 | Secondary objectives of the trial |
To assess the immunogenicity of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with DTPa-HBV-IPV/Hib vaccine in preterm infants, one month post dose III vaccination. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All subjects: •Subjects who 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. •A male or female between, and including, 8-16 weeks (56-118 days) of age at the time of the first vaccination. •Written informed consent obtained from the parent or guardian of the subject. •Born after a gestation period of >27 weeks (at least 189 days). Subjects of the Preterm I and Preterm II group: •Medically stable* prematurely born infants, born after a gestation period of 27-36 weeks. *Medically stable refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery. Subjects of the Full term group: •Healthy subjects as established by medical history and clinical examination before entering into the study.
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E.4 | Principal exclusion criteria |
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period (active phase and 5 months extended safety follow-up) •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth 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 from one month (30 days) before the first dose of vaccines (Visit 1) and up to Visit 6. •Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations (for example hepatitis B vaccination, BGC vaccination) •History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, Neisseria meningitidis. •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 temperature increase, i.e. oral/axillary/tympanic temperature <37.5°C / rectal temperature <38°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, with the exception of monoclonal antibodies against RSV, and/or any blood products within one month (30 days) preceding the first dose of study vaccines or planned administration during the active phase of the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Occurrence of core fever >39°C (rectal temperature) or >38.5°C (oral, axillary or tympanic temperature) within 4 days (day 0-day 3) after at least one vaccination. |
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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 | 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 |
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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 | 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 | No |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
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
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Last subject/last visit (end of active phase) and last subject/last contact (end of safety follow-up) |
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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 | 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 |