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Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory Adults

NCT00133471 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2010-08-27

No results posted yet for this study

Summary

The purpose of this study is to compare the body's reactions and immune responses after receiving different strengths of a H9N2 influenza virus vaccine with and without an adjuvant given into the arm muscle. Study participants will include up to 96 healthy adults, ages 18-34. The 4 dosages of the experimental H9N2 vaccine to be tested in this study are the following: 3.75, 7.5, 15, and 30-mcg (with and without MF59 adjuvant). Participants will be vaccinated on Days 0 and 28. Participants will record any vaccine side effects in a diary for 7 days following each vaccination. Participants will return to the clinic on days 2 and 7 after vaccination. Blood samples will be collected 7 days following each vaccination. Serum and nasal wash specimens will be collected before each vaccination and 4 weeks after injections (0, 4, and 8 weeks). Participants will be involved in study related procedures for up to 8 months.

Conditions

Interventions

BIOLOGICAL

Influenza A/H9N2 vaccine

A single lot of monovalent inactivated SA influenza A/H9N2 vaccine. All injections will be administered in a 0.5-mL volume into the deltoid muscle. Dosage levels are: 3.75-, 7.5-, 15-, and 30-mcg of HA of the vaccine strain with and without MF59 adjuvant.

DRUG

MF59 adjuvant

MF59 adjuvant is an oil-in-water emulsion.

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
18 Years
Max Age
34 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2005-12-31
Completion
2005-12-31

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 NCT00133471 on ClinicalTrials.gov