Influenza caused by the 2009 H1N1 influenza virus ("swine influenza") MedDRA version: 12.1 Level: LLT Classification code 10022001 Term: Influenza (epidemic)
Conditions
Interventions
Trade Name: Pandemrix, Influvac, Fluarix and other seasonal influenza vaccines used commercially in Finland
Product Name: Pandemrix, Influvac, Fluarix, others
Pharmaceutical Form: Injection*
INN or Pr
Sponsors
National Institute for Health and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • no specific exclusion criteria will be applied
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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” ;Secondary Objective: • 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. ;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 | — |
Countries
Finland
Outcome results
None listed