E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Children of both sex between 2-5 years old, already socialized or to be socialized (nursery school or preschool) in the following three months after been included in the study. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057868 |
E.1.2 | Term | Upper respiratory tract infection bacterial |
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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 |
Evaluation after 6 months of the effects, vs placebo, of the treatment with Biomunil / Immucytal administrated at the dosage described in the SPC, on the overall duration of the infective episodes. |
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E.2.2 | Secondary objectives of the trial |
Evaluation, vs placebo, of the effects of the treatment of Biomunil/Immucytal on: 1. Number of IRR episodes (at 6 and at12 months); 2. Overall duration, of infective episodes vs. placebo (at 12 months); 3. Frequency and severity of the episodes, aggregated into clusters of frequency and diagnosis (at 6 and at 12 months); 4. Overall duration of the episodes (at 6 and at 12 months); 5. Onset time of first episode after the end of the treatment; 6. Use of drugs and of other assistance services (at 6 and at 12 months); 7. Absence from the community (at 6 and at 12 months); 8. Time off work for parents and/or need to contact a babysitter (at 6 and at 12 months); 9. Safety and tolerability; 10. Evaluation by parents (health) and by physicians (efficacy, safety). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Children of both sex between 2-5 years old, already socialized or to be socialized (nursery school or preschool) in the following three months after been included in the study. 2. Absence of malformations and/or clinically significant pathologies in progress. 3. Parents (o legal guardians) and/or children who are able to understand and follow what the study protocol demands |
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E.4 | Principal exclusion criteria |
1. Any RRI episode in the 7 days prior randomization 2. Infective and non infective acute episodes in progress during randomization in any body system which require hospital recovery and/or intensive therapy 3. Gastroesophageal reflux 4. Cistic Fibrosis, deficit of α 1-antitrypsin, ciliary dyskinesia 5. Severe and chronic pathologies in any body system. 6. Corporal mass less than 3rd percentile of the respective age. 7. Autoimmune disease carrier. 8. Any product belonging to the groups ATC J06 (immune serum and immunoglobulins) or J07AX (immunostimulants) two weeks before the recruitment. 9. Treated two weeks prior the recruitment or presumed necessity of treatment for the entire period of study (including the follow up period) with: Immunostimulants belonging to the group J07AX ATC; Antineoplastic drugs belonging to the group L01 ATC; Drugs belonging to the groups L03 and L04 ATC like cytokines, interleukins, interferon, immunosoppressors; systemic corticosteroids; pharmaceutical products or food supplies whos ingredients contain zinc; any ethical, over the counter, herboristic (eg. echinacea) or homeopathic product that have immunonostimulant properties as one of their indications. 10. History of allergy or intolerance to the studied products and/or one of the excipients 11. Parents (or legal guardians) and/or patients that cant understand the information given in order to obtain informed consent or that refuse to give a written informed consent due to linguistic or psychological factors. 12. Parents (or legal guardians) that have lost the guardianship. 13. Parents (or legal guardians) and/or patients that cant be contacted during the study. 14. Participation to other clinical studies within a month prior or during the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of efficacy will be the overall duration of infective episodes, expressed in days, observed 6 months after the start of the treatment with Biomunil/Immucytal adminsitrated at the doses described in the SPC. |
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
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 | Yes |
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 | 4 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
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 | 2 |