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H5N1 (Clade 2) Vaccination of Adults and Elderly

NCT00680069 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 517

Last updated 2016-12-30

No results posted yet for this study

Summary

The purpose of this research study is to study the safety and effectiveness of vaccinating individuals who have previously received an avian influenza vaccine derived from one type of H5N1 virus with a vaccine derived from a different type of avian influenza virus. A second reason for this study is to compare responses in people who have received two different but similar types of H5N1 vaccine to the responses in subjects who receive 2 doses of only the H5N1 vaccine used in this study. The information obtained may provide important information into the usefulness of a pre-pandemic vaccination. Participants will include 600 healthy adult volunteers, ages 19 and older, in the United States. Study procedures include: physical exams, vaccination with either a low dose (15 micrograms) or high dose (90 micrograms) of vaccine, blood samples, and maintaining a memory aid to record oral temperatures and side effects. Study participation will be approximately 7 months.

Conditions

Interventions

BIOLOGICAL

Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005

Inactivated monovalent subvirion influenza A/H5N1/Indonesia/05/05 (clade 2) vaccine administered via intramuscular injection. Low Dose Group will receive 15 mcg intramuscularly (IM), High Dose Group will receive 90 mcg IM. Subjects who received previous clade 1 vaccine will receive 1 dose, clade 1 vaccine-naive subjects will receive 2 doses 28 days apart.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-05-31
Completion
2009-11-30

Countries

  • United States

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 NCT00680069 on ClinicalTrials.gov