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Safety, Reactogenicity, and Immunogenicity of Inactivated Influenza A/H7/N7 Vaccine in Healthy Adults

NCT00546585 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2013-08-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, any adverse events or side effects, and the body's immune response to an experimental flu vaccine \[Inactivated Influenza A/H7N7 Vaccine\] being given in increasing doses. Researchers will try to find the smallest dose of flu vaccine needed to cause antibody responses against the flu virus in both single and repeat doses. The study will enroll 125 healthy adults ranging in age from 18 to 40 years old. Subjects will be given 2 doses of the vaccine 28 days apart. Study procedures will include obtaining a medical history, physical exam, blood sample collections, and use of patient memory aids. The volunteers will be in the study for about 7 months.

Conditions

Interventions

BIOLOGICAL

Influenza A/H7N7 Vaccine

Monovalent subvirion H7N7 vaccine, 4 dose levels of vaccine, each subject will receive 2 doses (7.5, 15, 45, or 90 micrograms); the same dose will be given at Day 0 and Day 28.

DRUG

Placebo

Sterile normal saline for injection (0.9%); 0.5 ml volume sodium chloride injection. Subjects will receive 2 doses on Day 0 and Day 28.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00546585 on ClinicalTrials.gov