drugset / Trial / NCT00310206

H5N1 Vaccine Intramuscular Versus Intradermal in Healthy Adults

NCT00310206 ↗

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this research study is to compare how the body reacts to different strengths of an H5N1 flu vaccine when given by different routes of injection (injection into the skin or into the muscle). It will also compare how antibodies (proteins produced by the body's immune system that recognize and help fight infections and other foreign substances in the body) are made after receiving the H5N1 flu vaccine. Participants will include 100 healthy adults, ages 18-40 years. Study procedures include blood samples and completing a memory aid documenting daily oral temperature and side effects for 7 days following each vaccination. Participants may be involved in the study for up to 13 months.

Timeline

Start
2005-07
Primary completion
2006-10
Completion
2006-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Inactivated Influenza A Vaccine A/H5N1 Vaccine 3 ug Intramuscular
Subject Inactivated Influenza A Vaccine A/H5N1 Vaccine 9 ug Intramuscular
Subject Inactivated Influenza A Vaccine A/H5N1 Vaccine 15 ug Intramuscular
Subject Inactivated Influenza A Vaccine A/H5N1 Vaccine 45 ug Intramuscular

Indications