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

Novartis Vaccines7,284 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

7,284

Conditions

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

Interventions

Non-intervention observational studyOTHER

Non-intervention observational study

Eligibility

Sex: ALLMin age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (14)

Hospital Garrahan

Combate de Los Pozos 1881, Buenos Aires F.D., Argentina

Hospital de Ninos "Dr. Ricardo Gutierrez"

Gallo 1330, Buenos Aires F.D., Argentina

Outcomes

Primary Outcomes

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.

Time frame: 6 Months

Secondary Outcomes

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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