Clinical trial NCT01040741: Observational Safety Study of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pandemic Influenza A (H1N1)
A New Flu Virus of Swine Origin
Keywords: Pandemic influenza A (H1N1) vaccine
Adjuvanted
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-12-30
Enrollment: 7284
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population of children, adolescents, adults and elderly

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 Months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Combate de Los Pozos 1881
country: Argentina
facility: Hospital Garrahan
state: Ciudad Autónoma de Buenos Aires
city: Gallo 1330
country: Argentina
facility: Hospital de Ninos "Dr. Ricardo Gutierrez"
state: Ciudad Autónoma de Buenos Aires
city: Belgrano 1500
country: Argentina
facility: Hospital Nuestra Señora de la Misericordia
state: Córdoba
city: Castro Barros 650 - San Martín
country: Argentina
facility: Hospital Pediatrico del Niño Jesus
state: Córdoba
city: Humberto Primo 520
country: Argentina
facility: Sanatorio Mayo Privado S.A.
state: Córdoba
city: Bandera de los Andes 2603 Villa nueva
country: Argentina
facility: Hospital Pediatrico "Dr. Humberto Notti"
state: Guaymallen Mendoza
city: Kanaalweg West 61
country: Netherlands
facility: Huisartsenpraktijk Bergentheim
state: Bergentheim
city: Brederostraat 2/A
country: Netherlands
facility: Huisartsenpraktijk Bredero
state: Breda
city: M.v.d. Thijnensingel 1
country: Netherlands
facility: Saxenburg Groep, Zorgcentrum Aleida Kramer
state: Coevorden
city: Dennenlaan 56
country: Netherlands
facility: Huisartsenpraktijk Dennenlaan
state: Emmen
city: Prinses Julianastraat 25
country: Netherlands
facility: Huisartsenpraktijk de Steenpoort
state: Genemuiden
city: Voorstraat 3
country: Netherlands
facility: Huisartsenpraktijk Gramsbergen
state: Gramsbergen
city: Edveensweg 13
country: Netherlands
facility: Huisartsenpraktijk Oosterhesselen
state: Oosterhesselen
city: Groot Wezenland 20
country: Netherlands
facility: Isala Klinieken Zwolle
state: Zwolle
Study officials:
References: