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

October 4, 2011 updated by: Novartis Vaccines

A Prospective Observational Study of Safety and Occurrence of Influenza-like Illness Following Administration of Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine Focetria

This is an observational safety study of a prophylactic use of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Vaccine in subjects 6 months of age and older. Subjects may receive either 1 or 2 doses: children and elderly will receive 2 doses and adults will receive either 1 or 2 doses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7284

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

  • Argentina
    • Ciudad Autónoma de Buenos Aires
      • Combate de Los Pozos 1881, Ciudad Autónoma de Buenos Aires, Argentina
        • Hospital Garrahan
      • Gallo 1330, Ciudad Autónoma de Buenos Aires, Argentina
        • Hospital de Ninos "Dr. Ricardo Gutierrez"
    • Córdoba
      • Belgrano 1500, Córdoba, Argentina
        • Hospital Nuestra Senora de la Misericordia
      • Castro Barros 650 - San Martín, Córdoba, Argentina
        • Hospital Pediatrico del Niño Jesus
      • Humberto Primo 520, Córdoba, Argentina
        • Sanatorio Mayo Privado S.A.
    • Guaymallen Mendoza
      • Bandera de los Andes 2603 Villa nueva, Guaymallen Mendoza, Argentina
        • Hospital Pediatrico "Dr. Humberto Notti"
  • Netherlands
    • Bergentheim
      • Kanaalweg West 61, Bergentheim, Netherlands, 7691BV
        • Huisartsenpraktijk Bergentheim
    • Breda
      • Brederostraat 2/A, Breda, Netherlands, 4819HH
        • Huisartsenpraktijk Bredero
    • Coevorden
      • M.v.d. Thijnensingel 1, Coevorden, Netherlands, 7741GB
        • Saxenburg Groep, Zorgcentrum Aleida Kramer
    • Emmen
      • Dennenlaan 56, Emmen, Netherlands, 7822EL
        • Huisartsenpraktijk Dennenlaan
    • Genemuiden
      • Prinses Julianastraat 25, Genemuiden, Netherlands, 8281CK
        • Huisartsenpraktijk de Steenpoort
    • Gramsbergen
      • Voorstraat 3, Gramsbergen, Netherlands, 7783AL
        • Huisartsenpraktijk Gramsbergen
    • Oosterhesselen
      • Edveensweg 13, Oosterhesselen, Netherlands, 7861AM
        • Huisartsenpraktijk Oosterhesselen
    • Zwolle
      • Groot Wezenland 20, Zwolle, Netherlands, 8011JW
        • Isala Klinieken Zwolle

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 (Child, Adult, Older Adult)

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:

  • Subject's age in accordance with the approved product label of the country where the study is conducted
  • Subjects will be vaccinated with Focetria®, independently of this study.
  • Subjects or parent/guardian willing to provide informed consent prior to vaccination administration and complete all of the study, including follow-up contact

Exclusion Criteria:

• Received any prior H1N1 vaccination

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
Group 1: 6-23 months
Other: Non-intervention observational study
Non-intervention observational study
Group 2: 2-8 years
Other: Non-intervention observational study
Non-intervention observational study
Group 3: 9-17 years
Other: Non-intervention observational study
Non-intervention observational study
Group 4: 18-44 years
Other: Non-intervention observational study
Non-intervention observational study
Group 5: 45-60 years
Other: Non-intervention observational study
Non-intervention observational study
Group: >60 years
Other: Non-intervention observational study
Non-intervention observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To quantify the safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects; To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects.
Time Frame: 6 Months
6 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the occurrence of laboratory confirmed H1N1sw and influenza-like illness following vaccination with Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine.
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Novartis Vaccines

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

December 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

December 29, 2009

First Submitted That Met QC Criteria

December 29, 2009

First Posted (Estimate)

December 30, 2009

Study Record Updates

Last Update Posted (Estimate)

October 5, 2011

Last Update Submitted That Met QC Criteria

October 4, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V111_09OB

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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