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Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine

NCT00950456 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3216

Last updated 2015-10-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Alachua Government Services, Inc.

    lead INDUSTRY

Principal Investigators

  • Baxter BioScience Medical Director · Baxter Healthcare Corporation

Eligibility

Min Age
2 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-12-31
Completion
2011-02-28

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00950456 on ClinicalTrials.gov