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

NCT01101074 | Completed

• 1 other identifier: V111_05
• Study Type: observational
• Target: 135,469
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  Within 3 weeks and 6 weeks after vaccine administration

Secondary Outcomes (1)

• 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

  2 years

Study Arms (6)

6-23 months

Other: This is non-intervention observational study

2-8 years

Other: This is non-intervention observational study

9-17 years

Other: This is non-intervention observational study

18-44 years

Other: This is non-intervention observational study

45-60 years

Other: This is non-intervention observational study

>60 years

Other: This is non-intervention observational study

Interventions

This is non-intervention observational study OTHER

This is non-intervention observational study

18-44 years; 2-8 years; 45-60 years; 6-23 months; 9-17 years; >60 years

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population of children, adolescents, adults and elderly

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

Unknown Facility

Emilia Romagna, Italy

Location

Related Publications (2)

• 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.

  PMID: 22885015 DERIVED

• 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.

  PMID: 22766247 DERIVED

MeSH Terms

Conditions

Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 9, 2010
• Study Start: October 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

IT (1)