- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01037855
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
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
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Santiago
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Av. Santa Maria, Santiago, Chile, 1810
- Clinica Indisa
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Bogota, Colombia
- Fundación Universitaria de Ciencias de Salud- Hospital San José Calle
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Calle 66 # 40-07 - Bogotá, Colombia
- Nueva EPS: Centro de Especialistas Barrios Unidos - MEDERI
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Calle 9 No. 24-37 - Yopal, Casanare, Colombia
- Hospital local de Yopal E.S.E
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Carrera 16 No. 82-57 Bogotá, Colombia
- Clinica del Country
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Carrera 52 No. 67A-71 - Barrios Unidos - Bogotá, Colombia
- Hospital Universitario Infantil San José
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Cra. 42 A No. 17-50, Colombia
- CAIMED - Centro de Atencion e Investigación Medica
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Berlin
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Augustenburger Platz 1, Berlin, Germany
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CH-1011 Lausanne
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Rue du Bugnon 44, CH-1011 Lausanne, Switzerland
- Policlinique Medicale Universitaire
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CH-8001 Zürich
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Hirschengraben 84, CH-8001 Zürich, Switzerland
- Institute of Social and Preventive Medicine, Division of Communicable Diseases
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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 |
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Group 1: 6-23 months
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Non-intervention observational study
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Group 2: 2-8 years
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Non-intervention observational study
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Group 3: 9-17 years
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Non-intervention observational study
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Group 4: 18-44 years
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Non-intervention observational study
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Group 5: 45-60 years
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Non-intervention observational study
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Group: >60 years
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Non-intervention observational study
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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
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6 months
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To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects
Time Frame: 6 months
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6 months
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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
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6 Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
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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