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

NCT ID: NCT01101074

Last Updated: 2011-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

135469 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Influenza A (H1N1)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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6-23 months

This is non-intervention observational study

Intervention Type OTHER

This is non-intervention observational study

2-8 years

This is non-intervention observational study

Intervention Type OTHER

This is non-intervention observational study

9-17 years

This is non-intervention observational study

Intervention Type OTHER

This is non-intervention observational study

18-44 years

This is non-intervention observational study

Intervention Type OTHER

This is non-intervention observational study

45-60 years

This is non-intervention observational study

Intervention Type OTHER

This is non-intervention observational study

>60 years

This is non-intervention observational study

Intervention Type OTHER

This is non-intervention observational study

Interventions

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This is non-intervention observational study

This is non-intervention observational study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Emilia Romagna, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 22885015 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22766247 (View on PubMed)

Other Identifiers

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V111_05

Identifier Type: -

Identifier Source: org_study_id