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

NCT00417560 | Withdrawn

• 1 other identifier: CDC-NCIRD-5000
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single center, open-label, Phase I/II study in up to 100 adult subjects, aged 18 years and older who are at occupational risk of exposure to live H5N1 viruses. This study is designed to investigate the safety, reactogenicity, and immunogenicity of two 90 µg doses of an investigational inactivated influenza A/H5N1 virus vaccine given approximately 28 days apart. A blood sample will be collected for immunogenicity evaluation prior to each vaccination. Subjects will maintain a memory aid (appendix C4 and C13) to record oral temperature and systemic and local AEs for 7 days after immunization. Subjects will be encouraged to take their temperature around the same time each day. All subjects will receive a safety follow-up telephone call at 1 to 3 days after each vaccination (approximately Day 2) to elicit any AE and concomitant medication information. Subjects will return to the clinic 7 days after each vaccination for assessment of AEs and concomitant medications, a targeted physical examination (if indicated), and review of the memory aid. At approximately Day 28 after the first vaccination, subjects will return to the clinic for evaluation of vital signs, blood sample collection and safety follow-up, confirmation of eligibility criteria and a second vaccination. Safety follow-up will be identical to that performed after the first vaccination. At approximately Day 56 (or about 28 days after the second vaccination), subjects will return to the clinic for immunogenicity blood sample collection, AE and concomitant medication assessment, and targeted physical examination and vital sign assessment (if indicated). At approximately Day 180 (6 months after the first vaccination), subjects will return to the clinic for a final immunogenicity blood sample collection and safety assessment.

Conditions

Influenza

Keywords

Influenza A/H5N1 vaccine avian influenza H5N1 H5N1

Study Arms (1)

Experimental: Influenza A/H5N1 Vaccine

EXPERIMENTAL

Two 90ug Doses of Intramuscular Inactivated Influenza A/H5N1 Vaccine

Biological: inactivated influenza A/H5N1 vaccine

Interventions

inactivated influenza A/H5N1 vaccine BIOLOGICAL

Experimental: Influenza A/H5N1 Vaccine

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Carolyn Bridges, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2006
• First Posted: January 1, 2007
• Study Start: January 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 17, 2025

Record last verified: 2025-04