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Higher Dose Intradermal H5 Vaccine

NCT00439335 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2013-04-09

Study results available
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Summary

This study will compare the influenza A/H5N1 virus vaccine given by injection in the muscle versus injection in the skin in healthy adults. The study will look at the safety of the injections, how the body reacts, and what the body's immune response does when the vaccine is given in the muscle versus in the skin. The study will look at 226 healthy volunteers, ages 18-49 years old. Study procedures will include getting 2 doses of vaccine 28 days apart, physical exams, follow-up clinic visits to check the places on the body where each vaccine was given, and blood sample collections. Volunteers will complete a memory aid by writing down temperatures and health changes for 7 days after each vaccination. Volunteers will be involved in the study for up to 241 days.

Conditions

Interventions

BIOLOGICAL

Inactivated Influenza A Vaccine A/H5N1

Inactivated influenza A/H5N1 vaccine formulated to a concentration of HA greater than or equal to 300 mcg/mL administered via intramuscular (IM) injection. Vaccine will be administered to each subject at Days 0 and 28.

BIOLOGICAL

Inactivated Influenza A Vaccine A/H5N1

Inactivated influenza A/H5N1 vaccine formulated to a concentration of HA greater than or equal to 300 mcg/mL administered via intradermal (ID) injection. Vaccine will be administered to each subject at Days 0 and 28.

DRUG

Placebo (IM)

The placebo will be 0.1 mL of saline administered by the IM route.

DRUG

Placebo (ID)

The placebo will be 0.1 mL of saline administered by the ID route.

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
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-02-29
Completion
2008-02-29

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 NCT00439335 on ClinicalTrials.gov