Influenza caused by the new A(H1N1)v influenza virus ("swine influenza") MedDRA version: 12.0 Level: LLT Classification code 10022001 Term: Influenza (epidemic)
Conditions
Interventions
Product Name: Pandemrix
Product Code: A(H1N1)v influenza vaccine
Pharmaceutical Form: Concentrate and solvent for solution for injection
Current Sponsor code: A(H1N1)v influenza vaccine
Other descript
Sponsors
National Institute for Health and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Full legal competence; • Written informed consent obtained; • Assigned to use the services of Tampere health centre and community-dwelling; • At least 18 and no more than 75 years old, inclusive; • Belongs to the target group of A(H1N1)v vaccination in the region during the pandemic vaccination campaign; • Able to communicate fluently in Finnish or Swedish • 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: • For the total study cohort, no specific exclusion criteria will be applied; • For the subgroup for follow-up of immunogenicity of the vaccine (immunogenicity cohort), exclusion criteria comprise: o previous severe allergic reaction to influenza vaccines or known severe allergy to the ingredients of the vaccine o previous severe allergic reaction to eggs o significant immunological disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effectiveness of an A(H1N1)v influenza vaccination in preventing the first episode of laboratory-confirmed infection with the novel, pandemic influenza A(H1N1)v virus among community-dwelling and recently vaccinated adults as compared to unvaccinated adults from a cohort of at least 4,000 persons ;Secondary Objective: • To assess the safety for 6 months after vaccination with the A(H1N1)v vaccine during the follow up; • To determine humoral and cellular immune responses to one or two doses of the A(H1N1)v vaccine in 200 adults aged 18 to 75 years • To evaluate the incidence, severity and possible complications of laboratory-confirmed infection with the novel A(H1N1)v influenza virus; • To explore the effectiveness of the A(H1N1)v vaccine in subgroups stratified by age • To study the narcolepsy associated risk and protective HLA genotypes in the subgroup of the individuals in whom the immune responses to A(H1N1)v vaccine are studied (immunogenicity cohort) and to evaluate the effect of these genotypes on the characteristics of immune responses to to A(H1N1)v vaccine • To explore the systemic inflammatory responses induced by A(H1N1)v vaccine in the follow-up serum samples from the individuals of the immunogenicity cohort ;Primary end point(s): Effectiveness: occurrence of laboratory-confirmed infection with the novel, pandemic influenza A(H1N1)v virus in vaccinated and not vaccinated persons Case definition: A(H1N1)v influenza virus identified by reverse transcription polymerase chain reaction from a combined nasal and throat swab specimen obtained within five 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