E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
no medical, condition: unprimed, healthy, |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059429 |
E.1.2 | Term | Influenza immunisation |
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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 |
Safety: To demonstrate the safety and tolerability of one or two 0.25mL IM doses of FLUAD in unprimed children aged 6 to <36 months, compared with Agrippal S1 and/or with Influsplit SSW (flu vaccine control) in terms of any solicited local and systemic reactions (combined) reported within 7 days after any vaccination.
Absolute efficacy: To demonstrate protection provided by two 0.25mL intramuscular (IM) doses of FLUAD in unprimed children aged 6 to <36 months, compared with Menjugate/Encepur Children (non-flu vaccine control), against influenza illness caused by virus-confirmed community-acquired influenza wild type strains matching with those contained in the vaccine
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E.2.2 | Secondary objectives of the trial |
Safety: To demonstrate the safety and tolerability of one or two 0.25mL or 0.5mL IM doses of FLUAD in unprimed children aged 6 to <72 months, compared to flu vaccine control, in terms of any solicited local and systemic reactions (combined) reported within 7 days after any vaccination.
Absolute efficacy: To demonstrate protection provided by two 0.25mL or 0.5mL IM doses of FLUAD compared to non-flu vaccine control, against influenza illness caused by virus-confirmed community-acquired influenza wild type strains matching with those contained in the vaccine, in children aged 6 to <72 months. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Children whose parents/legal guardians have given written informed consent prior to study entry:
a. aged 6 to <72 months (Part I and II of the study; influenza seasons 2007/2008 and 2008/2009), b. aged 6 to <36 months (Part III of the study; influenza season 2009/2010).
2. In good health as determined by: a. medical history, b. physical examination, c. clinical judgment of the investigator.
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E.4 | Principal exclusion criteria |
1. Administration of licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study. Routine vaccines, according to local recommendations, or any other vaccines not foreseen in the protocol can be given after the active trial phase (i.e., 21 days after last vaccination) has been concluded. 2. Receipt of another investigational vaccine or any investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and participation in another clinical trial during the present study. 3. Experience of a severe acute infectious disease in the month prior to study start or experience of a mild acute infection disease in the week prior the study start, (untreated common cold is acceptable). The severity of the infectious disease occurred will be based on the investigator’s judgment. 4. Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 2 days prior to study start. 5. Experience an axillary temperature >=37.8°C (rectal temperature >=38.3°C) within the 2 days before enrollment. 6. Any serious disease in the opinion of the investigator including, for example: a. cancer, b. autoimmune disease (including rheumatoid arthritis under immunosuppressive therapy), c. insulin dependent diabetes mellitus, d. chronic pulmonary disease, asthma under inhalative therapy only is acceptable, e. acute or progressive hepatic disease, f. acute or progressive renal disease. 7. Known or suspected impairment/alteration of immune function, for example, resulting from: a. receipt of immunosuppressive therapy (corticosteroid -except topical or inhaled steroids- or cancer chemotherapy), b. receipt of immunostimulants, c. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 90 days and for the full length of the study, d. high risk for developing an immunocompromising disease (suspected or known HIV infection or HIV-related disease). 8. Bleeding diathesis. 9. History of hypersensitivity to any component of the study medication or chemically related substances. 10. History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products or any other vaccine component. 11. Laboratory confirmed influenza disease. 12. History of neurological disorder or seizures (febrile seizures allowed). 13. Ever received any influenza vaccine. 14. Major surgery planned during the study period. 15. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, e.g., planned travel or relocation of residence that would interfere with completion of study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Serum samples will be assessed by means of strain-specific HI tests. The HI tests against A/H1N1, A/H3N2 and B will be performed by Clinical Serology, Novartis Vaccines, Marburg, Germany. The primary measure of immunogenicity is the geometric mean titer (GMT) at study day 50 (3 weeks after the second vaccination), as measured by Hemagglutination Inhibition (HI) test, and possibly by other functional assays. The immunogenicity will also be assessed by the measurement of strain-specific HI tests in terms of: - GMTs at study day 1, study day 29, and study day 181 - Study day 29/study day 1, study day 50/study day 1, and study day 181/study day 1 geometric mean titer ratios (GMRs) - Percentage of subjects achieving seroprotection (i.e., with HI titer ≥40) at study day 1, study day 29, study day 50, and study day 181 - Percentage of subjects achieving seroconversion or significant increase in antibody titer at study day 29, study day 50, and study day 181 |
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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 | Yes |
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 | Yes |
E.8.1.2 | Open | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 140 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |