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H5 Vaccine Alone or With Aluminum Hydroxide in Elderly Adults

NCT00294099 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2013-06-03

No results posted yet for this study

Summary

The purpose of this study is to compare how the body reacts to different strengths of the new A/H5N1 flu vaccine when given with the addition of aluminum hydroxide adjuvant and provide dosing information. How the body's immune system responds to the new H5N1vaccine with aluminum hydroxide approximately 1 month following receipt of 2 doses of vaccine will also be evaluated. The vaccine is given as an injection or shot in the arm. Volunteer participants in this study will be 600 healthy elderly adults, aged 65 years and older. Participants will be randomly assigned to 4 different dosage groups of vaccine, either with or without adjuvant, for a total of 8 different groups. Volunteers will participate in the study for 7 months. Each individual will receive two vaccinations, the second 28 days after the first. In addition to visits for these vaccinations, subjects will return to the clinic for physical evaluations and blood sample collection 6 times during the course of this study.

Conditions

Interventions

BIOLOGICAL

Aluminum hydroxide

Aluminum hydroxide adjuvant.

BIOLOGICAL

Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)

Inactivated monovalent subvirion influenza H5N1 vaccine. Supplied in 0.5 mL unit dose vials as a sterile solution for IM injection. Dosages: 45 mcg, 15 mcg, 7.5, mcg, or 3.75 mcg administered with or without aluminum hydroxide adjuvant on Days 0 and 28.

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
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-03-31
Completion
2007-03-31

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 NCT00294099 on ClinicalTrials.gov