Observational Safety and Effectiveness Study of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine

Novartis

Status: Completed

Conditions: Influenza A (H1N1)

Treatments: Other: This is non-intervention observational study

Study type: Observational

Funder types: Industry

Identifiers

NCT01101074

V111_05

Details and patient eligibility

About

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.

Enrollment: 135,469 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

135,469 participants in 6 patient groups

6-23 months

Treatment:

Other: This is non-intervention observational study

2-8 years

Treatment:

Other: This is non-intervention observational study

9-17 years

Treatment:

Other: This is non-intervention observational study

18-44 years

Treatment:

Other: This is non-intervention observational study

45-60 years

Treatment:

Other: This is non-intervention observational study

>60 years

Treatment:

Other: This is non-intervention observational study