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

Completed

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

• Registration Number: NCT01040741
• Lead Sponsor: Novartis Vaccines

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-29
• Study First Submitted QC: 2009-12-29
• Study First Posted: 2009-12-30
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7284

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.	6 Months

Secondary Outcome Measures

Name	Time	Method
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.	6 months

Trial Locations

Locations (14)

Huisartsenpraktijk Oosterhesselen; 🇳🇱 Edveensweg 13, Oosterhesselen, Netherlands

Hospital Pediatrico del Niño Jesus; 🇦🇷 Castro Barros 650 - San Martín, Córdoba, Argentina

Huisartsenpraktijk Dennenlaan; 🇳🇱 Dennenlaan 56, Emmen, Netherlands

Huisartsenpraktijk de Steenpoort; 🇳🇱 Prinses Julianastraat 25, Genemuiden, Netherlands

Isala Klinieken Zwolle; 🇳🇱 Groot Wezenland 20, Zwolle, Netherlands

Hospital de Ninos "Dr. Ricardo Gutierrez"; 🇦🇷 Gallo 1330, Ciudad Autónoma de Buenos Aires, Argentina

Sanatorio Mayo Privado S.A.; 🇦🇷 Humberto Primo 520, Córdoba, Argentina

Hospital Garrahan; 🇦🇷 Combate de Los Pozos 1881, Ciudad Autónoma de Buenos Aires, Argentina

Hospital Nuestra Señora de la Misericordia; 🇦🇷 Belgrano 1500, Córdoba, Argentina

Huisartsenpraktijk Bergentheim; 🇳🇱 Kanaalweg West 61, Bergentheim, Netherlands

Hospital Pediatrico "Dr. Humberto Notti"; 🇦🇷 Bandera de los Andes 2603 Villa nueva, Guaymallen Mendoza, Argentina

Huisartsenpraktijk Bredero; 🇳🇱 Brederostraat 2/A, Breda, Netherlands

Saxenburg Groep, Zorgcentrum Aleida Kramer; 🇳🇱 M.v.d. Thijnensingel 1, Coevorden, Netherlands

Huisartsenpraktijk Gramsbergen; 🇳🇱 Voorstraat 3, Gramsbergen, Netherlands