E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Two doses vaccination in adults subjects aged between 18 and 40 years old, in good general health and not previously immunized with the 23-valent pneumococcal polysaccharide vaccine. |
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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 in healthy adult subjects the safety and reactogenicity of the 11PCV adjuvanted with AS02V, given as a 2-dose vaccination 3 months apart. • To evaluate the B-cell memory response to 11 polysaccharides in all subjects, before vaccination 1, 1 month post vaccination 1, 2 weeks and 1 month post vaccination 2.
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
The cohort to be enrolled is 23-valent pneumococcal polysaccharide vaccine naïve adults aged between 18 and 40 years old, in good general health at the time of the first vaccine dose. All subjects must satisfy to the following criteria at study entry: • Subjects who the investigator believes that they 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 18 and 40 years of age at the time of the first vaccination. • Written informed consent obtained from the subject
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E.4 | Principal 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: • Previous vaccination against Streptococcus pneumoniae. • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests, at the discretion of the investigator. • 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 or Axillary temperature <37.5°C. • History of documented radiologically confirmed pneumonia within 3 years prior to first vaccination. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. • All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years. • Subjects with documented anaemia or iron-deficiency (Hemoglobin level more than 10% below lower limit of normal) • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 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 within 2 weeks of the first dose of vaccine. • 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 study period. • Administration of immunoglobulins and/or any blood products within three months preceding the first dose of study vaccine or planned administration during the study period. • History of administration of an experimental/licensed vaccine containing MPL or QS21. • History of chronic alcohol consumption and/or drug abuse. • Pregnant or lactating female. • Female planning to become pregnant or planning to discontinue contraceptive precautions.
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety and Reactogenicity • Occurrence, intensity and relationship to vaccination of any solicited local and general signs and symptoms during a 7-day follow up period (i.e. day of vaccination and 6 subsequent days) after each vaccine dose. • Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during a 31-day follow up period (i.e. day of vaccination and 30 subsequent days) after each vaccine dose. • Occurrence and relationship to vaccination of all serious adverse events (SAEs) occurring throughout the study period. Immunogenicity • Frequencies of IgG PS-specific plasma cells generated by in vitro cultivated memory B-cells (measured by B-cell ELISPOT) for 11 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) in all subjects, before vaccination 1, 1 month post vaccination 1, 2 weeks and 1 month post vaccination 2.
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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) | Yes |
E.7.1.1 | First administration to humans | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 4 |