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

Completed

• Conditions: Novel Influenza A (H1N1); A New Flu Virus of Swine Origin
• Interventions: Other: Non-intervention observational study

• Registration Number: NCT01037855
• Lead Sponsor: Novartis Vaccines

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-20
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-23
• Primary Completion: 2010-06
• Study Completion: 2011-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4028

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects	6 months
To quantify the safety of Flu Cell Culture Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects	6 months

Secondary Outcome Measures

Name	Time	Method
To assess the occurrence of laboratory confirmed H1N1sw and influenza-like illness following vaccination	6 Months

Trial Locations

Locations (9)

Policlinique Médicale Universitaire; 🇨🇭 Rue du Bugnon 44, CH-1011 Lausanne, Switzerland

Hospital local de Yopal E.S.E; 🇨🇴 Calle 9 No. 24-37 - Yopal, Casanare, Colombia

Clinica Indisa; 🇨🇱 Av. Santa Maria, Santiago, Chile

Hospital Universitario Infantil San José; 🇨🇴 Carrera 52 No. 67A-71 - Barrios Unidos - Bogotá, Colombia

Institute of Social and Preventive Medicine, Division of Communicable Diseases; 🇨🇭 Hirschengraben 84, CH-8001 Zürich, Switzerland

CAIMED - Centro de Atencion e Investigación Medica; 🇨🇴 Cra. 42 A No. 17-50, Colombia

Fundación Universitaria de Ciencias de Salud- Hospital San José Calle; 🇨🇴 Bogota, Colombia

Nueva EPS: Centro de Especialistas Barrios Unidos - MEDERI; 🇨🇴 Calle 66 # 40-07 - Bogotá, Colombia

Clinica del Country; 🇨🇴 Carrera 16 No. 82-57 Bogotá, Colombia