Observational Study of Safety of Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine
A Prospective Observational Study of Safety and Occurrence of Influenza-like Illness Following Administration of Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine Celtura
1 other identifier
observational
4,028
4 countries
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2009
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 20, 2009
CompletedFirst Posted
Study publicly available on registry
December 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedMarch 14, 2017
March 1, 2017
6 months
December 20, 2009
March 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To quantify the safety of Flu Cell Culture Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects
6 months
To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects
6 months
Secondary Outcomes (1)
To assess the occurrence of laboratory confirmed H1N1sw and influenza-like illness following vaccination
6 Months
Study Arms (6)
Group 1: 6-23 months
Group 2: 2-8 years
Group 3: 9-17 years
Group 4: 18-44 years
Group 5: 45-60 years
Group: >60 years
Interventions
Non-intervention observational study
Eligibility Criteria
population of children, adolescents, adults and elderly
You may qualify if:
- 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
You may not qualify if:
- Received any prior H1N1 vaccination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Clinica Indisa
Av. Santa Maria, Santiago Metropolitan, 1810, Chile
Fundación Universitaria de Ciencias de Salud- Hospital San José Calle
Bogotá, Colombia
Nueva EPS: Centro de Especialistas Barrios Unidos - MEDERI
Calle 66 # 40-07 - Bogotá, Colombia
Hospital local de Yopal E.S.E
Calle 9 No. 24-37 - Yopal, Casanare, Colombia
Clinica del Country
Carrera 16 No. 82-57 Bogotá, Colombia
Hospital Universitario Infantil San José
Carrera 52 No. 67a-71 - Barrios Unidos - Bogotá, Colombia
CAIMED - Centro de Atencion e Investigación Medica
Cra. 42 A No. 17-50, Colombia
Unknown Facility
Augustenburger Platz 1, State of Berlin, Germany
Policlinique Médicale Universitaire
Rue Du Bugnon 44, Ch-1011 Lausanne, Switzerland
Institute of Social and Preventive Medicine, Division of Communicable Diseases
Hirschengraben 84, Ch-8001 Zürich, Switzerland
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2009
First Posted
December 23, 2009
Study Start
December 1, 2009
Primary Completion
June 1, 2010
Study Completion
January 1, 2011
Last Updated
March 14, 2017
Record last verified: 2017-03