Observational Study of Safety of Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine

March 13, 2017 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 Celtura

This is an observational study of safety and occurrence of influenza-like illness following administration of flu cell culture derived adjuvanted swine origin A (H1N1) pandemic subunit vaccine in subjects 6 months of age and older.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4028

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

  • Chile
    • Santiago
      • Av. Santa Maria, Santiago, Chile, 1810
        • Clínica INDISA
  • Colombia
      • Bogota, Colombia
        • Fundación Universitaria de Ciencias de Salud- Hospital San José Calle
      • Calle 66 # 40-07 - Bogotá, Colombia
        • Nueva EPS: Centro de Especialistas Barrios Unidos - MEDERI
      • Calle 9 No. 24-37 - Yopal, Casanare, Colombia
        • Hospital local de Yopal E.S.E
      • Carrera 16 No. 82-57 Bogotá, Colombia
        • Clinica del Country
      • Carrera 52 No. 67A-71 - Barrios Unidos - Bogotá, Colombia
        • Hospital Universitario Infantil San José
      • Cra. 42 A No. 17-50, Colombia
        • CAIMED - Centro de Atencion e Investigación Medica
  • Germany
    • Berlin
      • Augustenburger Platz 1, Berlin, Germany
  • Switzerland
    • CH-1011 Lausanne
      • Rue du Bugnon 44, CH-1011 Lausanne, Switzerland
        • Policlinique Medicale Universitaire
    • CH-8001 Zürich
      • Hirschengraben 84, CH-8001 Zürich, Switzerland
        • Institute of Social and Preventive Medicine, Division of Communicable Diseases

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:

  • Age ≥ 6 months
  • Subjects will be vaccinated with Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine, 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 Cell Culture Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects
Time Frame: 6 months
6 months
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
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)

June 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

December 20, 2009

First Submitted That Met QC Criteria

December 22, 2009

First Posted (Estimate)

December 23, 2009

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V110_07OB

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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