Clinical trial NCT01101074: Observational Safety and Effectiveness Study of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine
Official title: A Prospective Observational Study of Safety and Effectiveness Following Administration of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza A (H1N1)
Keywords: Swine Flu A (H1N1) vaccine
Adjuvanted flu egg derived
Novel influenza A (H1N1): a new flu virus of swine origin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-04-09
Enrollment: 135469
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population of children, adolescents, adults and elderly

Brief summary: This observational study will evaluate the safety and effectiveness following administration of adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine through both an ad hoc active monitoring system and a passive surveillance of hospitalization in a large cohort.


Eligibility criteria: Inclusion Criteria:

* Subjects resident in Emilia-Romagna and either registered with the AUSL of Reggio Emilia, Bologna, Modena and Parma or working in the province of Reggio Emilia, Bologna, Modena and Parma included in the target groups described in the Study Protocol vaccination with H1N1sw vaccine Focetria is recommended - according to the national pandemic plan adopted at the local level - will be eligible for enrolment.

Exclusion Criteria:

* Subjects already vaccinated with another pandemic vaccine or with known contraindications to Focetria, will be excluded from this study.
* Patients institutionalized in Hospital, Nursing Homes, Rehabilitation Centers, as well as home-cared patients, will also be excluded.

Primary outcomes:
measure: Safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine by estimating the incidence of reported Adverse Events, Serious Adverse Events or Adverse Events of Special Interest in a cohort of actively monitored vaccinated subjects
timeFrame: Within 3 weeks and 6 weeks after vaccine administration
Secondary outcomes:
measure: The occurrence of hospitalization within 6 weeks and 2 years after vaccination in a cohort of subjects vaccinated sw unvaccinated subjects, with Flu Egg Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine
timeFrame: 2 years
Other outcomes:
Locations:
city: Emilia Romagna
country: Italy
Study officials:
References:
citation: Moro ML, Nobilio L, Voci C, Di Mario S, Candela S, Magrini N; SaFoH1N1 working group. A population based cohort study to assess the safety of pandemic influenza vaccine Focetria in Emilia-Romagna region, Italy - part two. Vaccine. 2013 Feb 27;31(10):1438-46. doi: 10.1016/j.vaccine.2012.07.090. Epub 2012 Aug 10.
citation: Candela S, Pergolizzi S, Ragni P, Cavuto S, Nobilio L, Di Mario S, Dragosevic V, Groth N, Magrini N; SaFoH1N1 working group. An early (3-6 weeks) active surveillance study to assess the safety of pandemic influenza vaccine Focetria in a province of Emilia-Romagna region, Italy - part one. Vaccine. 2013 Feb 27;31(10):1431-7. doi: 10.1016/j.vaccine.2012.06.030. Epub 2012 Jul 2.