Inactivated Influenza A/H5N1 Vaccine in Adult Subjects at Risk of Occupational Exposure to Live H5N1 Viruses

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00417560
• Date of registration: 28/12/2006
• Primary sponsor: Centers for Disease Control and Prevention
• Public title: Inactivated Influenza A/H5N1 Vaccine in Adult Subjects at Risk of Occupational Exposure to Live H5N1 Viruses
• Scientific title: A Single Center, Open-label, Phase I/II Study of Two 90 Microgram Doses of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Adult Subjects at Risk of Occupational Exposure to Live H5N1 Viruses
• Date of first enrolment: January 2007
• Target sample size: 55
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00417560
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Carolyn Bridges, MD
• Affiliation: Centers for Disease Control and Prevention

Key inclusion & exclusion criteria

Inclusion Criteria:

- Non-pregnant

- Non-immune compromised adults 18 years and older

- At occupational risk of exposure to live H5N1 viruses

- Must be eligible for care by the CDC occupational health clinic



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Biological: inactivated influenza A/H5N1 vaccine

Primary Outcome(s)

The primary outcome measures will be the frequencies and severities of AEs and the GMTS and proportions of subjects who achieve 4-fold rises in serum neutralizing and HAI titers against the influenza A/H5N1 virus. [Time Frame: 28 days, 56 days, 180 days]

Secondary ID(s)

CDC-NCIRD-5000

Source(s) of Monetary Support

Please refer to primary and secondary sponsors