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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01101074
First received: April 1, 2010
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Influenza A (H1N1)
Other: This is non-intervention observational study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Safety and Effectiveness Following Administration of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 135469
Study Start Date: October 2009
Study Completion Date: September 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Population of children, adolescents, adults and elderly

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101074

Locations
Italy
Emilia Romagna, Italy
Sponsors and Collaborators
Novartis Vaccines
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01101074     History of Changes
Other Study ID Numbers: V111_05
Study First Received: April 1, 2010
Last Updated: October 7, 2011
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Novartis:
Swine Flu A (H1N1) vaccine
Adjuvanted flu egg derived
Novel influenza A (H1N1): a new flu virus of swine origin

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014