E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Influenza caused by the 2009 H1N1 influenza virus ("swine influenza") |
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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 | 10022001 |
E.1.2 | Term | Influenza (epidemic) |
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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 determine the effectiveness of 2009 H1N1 influenza vaccination in preventing the first episode of laboratory-confirmed influenza caused by the 2009 H1N1 influenza virus or its variation during the influenza season 2010-11 among vaccinated adults as compared to unvaccinated adults participating in the study “Evaluation of a vaccination campaign with A(H1N1)v pandemic vaccines: a prospective cohort study” |
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E.2.2 | Secondary objectives of the trial |
• To explore the ability of different vaccination regimens to prevent 2009 H1N1 influenza; • To explore the effectiveness of the 2009 H1N1 vaccines in subgroups stratified by age; • To evaluate the incidence, severity and possible complications of laboratory-confirmed infection with the 2009 H1N1 influenza virus.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria for the interview follow-up • Participating in the study “Evaluation of a vaccination campaign with A(H1N1)v pandemic vaccines: a prospective cohort study” (AH1N1-483-09THL); • Assigned to use the services of Tampere health care centre; • Written consent for the interview follow-up phase obtained by mail; • Able to adhere to all protocol-required study procedures without any special burden or risk, as judged by the participant himself/herself
Inclusion criteria for the confirmation of 2009 H1N1 influenza cases • Participating in the study interview follow-up of the current study ‘Evaluation the effectiveness of vaccination with 2009 H1N1 vaccines during influenza season 2010-11 (H1N1-495-10THL) • Assigned to use the services of Tampere health care centre; • Written informed consent for the confirmation phase obtained at the first study visit; • Able to adhere to all protocol required study procedures without any special burden or risk, as judged by the investigator or designate.
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E.4 | Principal exclusion criteria |
• no specific exclusion criteria will be applied |
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E.5 End points |
E.5.1 | Primary end point(s) |
Occurrence of laboratory-confirmed infection with 2009 H1N1 influenza virus in vaccinated and not vaccinated persons
Case definition: 2009 H1N1 influenza virus identified by reverse transcription polymerase chain reaction from a combined nasal and throat swab specimen obtained within 7 days after onset of following self-reported clinical signs and symptoms: fever (=> 38 °C) and at least one sign or symptom of acute respiratory infection, or pneumonia diagnosed by a physician
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
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 | Yes |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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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Last visit of the last subject (LVLS) after the end of the epidemic in the region, presumably by 30.4.2011. |
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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 | 8 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |