E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2010/2011 season for yearly licensing application |
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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 assess the immunogenicity to each of the three antigens contained in a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2010/2011 season in an adult and elderly population |
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E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2010/2011 season in an adult and elderly population |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-) Subject is 18 to 59 years of age , inclusive, at the time of screening (for Stratum A only). -) Subject is 60 years of age or older , inclusive, at the time of screening (for Stratum B only). -) Subject has given written informed consent prior to study entry. Subject is generally healthy , as determined by the investigator’s clinical judgment through collection of medical history and performance of a physical examination, such that the investigator would not hesitate to provide routine influenza immunization to the subject in the course of routine medical practice. -) Subject agrees to keep a daily record of symptoms for the duration of the study. -) If subject is of childbearing potential, subject presents with a negative urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study. -) Subject is willing and able to comply with the requirements of the protocol.
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E.4 | Principal exclusion criteria |
-) Subject has a history of severe allergic reaction or anaphylaxis. -) Subject has an oral temperature of ≥37.5°C on the day of vaccination in this study. -) Subject has a rash or dermatologic condition or tattoos, which may interfere with injection site reaction rating. -) Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of study entry. -) Subject has received a seasonal influenza vaccine within 6 months of study entry. -) Subject currently has or had a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder ; -) Subject has any inherited or acquired immunodeficiency. Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800 µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs. -) Subject has a functional or surgical asplenia. -) Subject has a known or suspected problem with alcohol or drug abuse. -) Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study. -) Subject is pregnant or lactating at the time of enrollment. -) Subject has participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Immongenicity: Number of subjects demonstrating seroconversion (defined as either an HIA titer of ≥1:40 in case of a negative pre-vaccination sample (HIA titer <1:10) or a minimum fourfold HIA titer increase if the pre-vaccination sample is ≥1:10) to each of the three antigens contained in the vaccine 21 days after 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 |
Immunogenicity and tolerability |
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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 | No |
E.8.1.1 | Randomised | No |
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 | 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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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 visit of last subject
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |