CompletedNot Applicable

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

Chile, Colombia4,028 participantsStarted 2009-12

Plain-language summary

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.

Who can participate

Age range6 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 6 months

To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects

Timeframe: 6 months

Trial details

NCT IDNCT01037855

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-06

View on ClinicalTrials.gov More Novel Influenza A (H1N1) trials