E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022000 |
E.1.2 | Term | Influenza |
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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 |
To explore the cell mediated immune (CMI) responses to two 0.25 mL IM injections of Fluad or to two 0.25 mL IM injections of Agrippal as determined by the quality and quantity of the antigen-specific T- cells responses after in-vitro restimulation of peripheral blood mononuclear cells in previously unvaccinated healthy children aged 6 to <36 months.
To evaluate the safety and tolerability of two 0.25 mL IM injections of Fluad or Agrippal in previously unvaccinated healthy children aged 6 to <36 months. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the immune responses to two 0.25 mL IM injections of Fluad or Agrippal according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to <36 months for all three strains. Exploratory Objective If enough plasma is available, evaluation of the immune responses to two 0.25 mL IM injections of Fluad or Agrippal according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test from previously unvaccinated healthy children aged 6 to <36 months for heterologous strains. To evaluate descriptively and quantitatively the relationship and correlation between cell mediated and humoral immunity against influenza viruses, as determined from the primary and secondary objectives.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Children of 6 to <36 months of age, whose parent(s) or legal guardian(s) have given written informed consent prior to study entry; 2. Children good health as determined by the outcome of medical history; physical examination and clinical judgment of the investigator; 3. Children and children’s parent(s) or legal guardian(s) that are able to comply with all study procedures and are available for all clinic visits scheduled in the study. 4. Willingness to allow for samples to be stored beyond the study period, for potential additional future testing to better characterize immune responses.
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E.4 | Principal exclusion criteria |
1. Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment 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 (3 weeks 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 unwilling to refuse participation in another clinical study through the end of the 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); 4. Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 6 days prior to study start; 5. Experience a body temperature 38.0°C within the 3 days before enrollment. 6. Children with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study 7. Children with known or suspected impairment/alteration of immune function, for example resulting from: a. receipt of immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis (15 mg/day of prednisone or its equivalent) or chronic use of inhaled high-potency corticosteroids (e.g. budesonide 800µg/day or fluticasone 750µg/day) within 60 days prior to Visit 1, b. receipt of immunostimulants within 60 days prior to Visit 1, c. receipt of parenteral immunoglobulin preparartion, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study, d. known HIV infection or HIV-related disease; 8. Children with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time 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. Individuals who have had influenza vaccine or documented suspected influenza disease prior to day 1; 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. Children hospitalized 16. Children with any fatal prognosis of an underlying medical condition (<12 month life expectancy
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E.5 End points |
E.5.1 | Primary end point(s) |
The measures of CMI for the primary objective are collected for all evaluable subjects and are determined by Intracellular staining/FACS (ICS/FACS) after in vitro restimulation of PBMC with vaccine antigens More precisely, ICS/FACS will determine: - Frequency of CD4 T cells specific for the antigen/s present in the vaccine. - Qualitative cytokine profile of the antigen specific CD4 T cells.
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 |
to explore cell mediated immune responses and evaluate hemagglutination inhibition |
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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) | 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 | 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
| 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 | 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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |