NCT00950456

Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine

A Prospective Non-Interventional Observational Study to Assess the Safety of Two Vaccinations of a Vero Cell-Derived, Whole Virus H1N1 Pandemic Influenza Vaccine in Subjects Exposed to the Vaccine Through Policies by Governments or Health Authorities

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,216 (actual)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 2 Months
• Healthy volunteers: Accepted

Summary

The purpose of this observational study, which will be initiated as soon as the licensed H1N1 Pandemic Influenza Vaccine is used in a mass vaccination campaign, is to estimate the incidence of any medically-attended adverse events in all vaccinated subjects.

Conditions

• Influenza
• Pandemic Influenza

Interventions

Type	Name	Description
BIOLOGICAL	H1N1 Pandemic Influenza Vaccine (whole virion, Vero Cell-derived, inactivated)	It is anticipated that subjects will receive two intramuscular injections approximately 3 weeks apart. The vaccine will be provided in two doses, one for adults, the other for children.

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-12-01
• Completion: 2011-02-01
• First posted: 2009-07-31
• Last updated: 2015-10-09

Locations

17 sites across 1 country: Austria