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

Novartis Vaccines4,028 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

4,028

Conditions

Novel 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: * 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

Locations (10)

Clinica Indisa

Av. Santa Maria, Santiago Metropolitan, Chile

Fundación Universitaria de Ciencias de Salud- Hospital San José Calle

Bogotá, Colombia

Nueva EPS: Centro de Especialistas Barrios Unidos - MEDERI

Calle 66 # 40-07 - Bogotá, Colombia

Outcomes

Primary Outcomes

To quantify the safety of Flu Cell Culture Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects

Time frame: 6 months

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

Time frame: 6 Months

Data from ClinicalTrials.gov

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