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

A New Flu Virus of Swine Origin Clinical Trial

Official title:

A Prospective Observational Study of Safety and Occurrence of Influenza-like Illness Following Administration of Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine Focetria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040741
• Other study ID #: V111_09OB
• Status: Completed
• Phase: N/A
• First received: December 29, 2009
• Last updated: October 4, 2011
• Start date: December 2009
• Est. completion date: March 2011

Study information

• Verified date: October 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: WGBO
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7284
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• A New Flu Virus of Swine Origin
• Influenza, Human
• Pandemic Influenza A (H1N1)

Intervention

Other:
• Non-intervention observational study
Non-intervention observational study

Locations

Country	Name	City	State
Argentina	Hospital Pediatrico "Dr. Humberto Notti"	Bandera de los Andes 2603 Villa nueva	Guaymallen Mendoza
Argentina	Hospital Nuestra Señora de la Misericordia	Belgrano 1500	Córdoba
Argentina	Hospital Pediatrico del Niño Jesus	Castro Barros 650 - San Martín	Córdoba
Argentina	Hospital Garrahan	Combate de Los Pozos 1881	Ciudad Autónoma de Buenos Aires
Argentina	Hospital de Ninos "Dr. Ricardo Gutierrez"	Gallo 1330	Ciudad Autónoma de Buenos Aires
Argentina	Sanatorio Mayo Privado S.A.	Humberto Primo 520	Córdoba
Netherlands	Huisartsenpraktijk Bredero	Brederostraat 2/A	Breda
Netherlands	Huisartsenpraktijk Dennenlaan	Dennenlaan 56	Emmen
Netherlands	Huisartsenpraktijk Oosterhesselen	Edveensweg 13	Oosterhesselen
Netherlands	Isala Klinieken Zwolle	Groot Wezenland 20	Zwolle
Netherlands	Huisartsenpraktijk Bergentheim	Kanaalweg West 61	Bergentheim
Netherlands	Saxenburg Groep, Zorgcentrum Aleida Kramer	M.v.d. Thijnensingel 1	Coevorden
Netherlands	Huisartsenpraktijk de Steenpoort	Prinses Julianastraat 25	Genemuiden
Netherlands	Huisartsenpraktijk Gramsbergen	Voorstraat 3	Gramsbergen

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

Argentina,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes