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Trials / Completed

CompletedNCT01040741

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
7,284 (actual)
Sponsor
Novartis Vaccines · Industry
Sex
All
Age
6 Months
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERNon-intervention observational studyNon-intervention observational study

Timeline

Start date
2009-12-01
Primary completion
2011-03-01
Completion
2011-03-01
First posted
2009-12-30
Last updated
2011-10-05

Locations

14 sites across 2 countries: Argentina, Netherlands

Source: ClinicalTrials.gov record NCT01040741. Inclusion in this directory is not an endorsement.

Observational Safety Study of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine (NCT01040741) · Clinical Trials Directory