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

October 7, 2011 updated by: Novartis Vaccines

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

135469

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Emilia Romagna, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population of children, adolescents, adults and elderly

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
6-23 months
Other: This is non-intervention observational study
This is non-intervention observational study
2-8 years
Other: This is non-intervention observational study
This is non-intervention observational study
9-17 years
Other: This is non-intervention observational study
This is non-intervention observational study
18-44 years
Other: This is non-intervention observational study
This is non-intervention observational study
45-60 years
Other: This is non-intervention observational study
This is non-intervention observational study
>60 years
Other: This is non-intervention observational study
This is non-intervention observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Within 3 weeks and 6 weeks after vaccine administration
Within 3 weeks and 6 weeks after vaccine administration

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Vaccines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

April 1, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (ESTIMATE)

April 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 7, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V111_05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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