This protocol is to compare the immune response of different influenza vaccines given by two different routes of administration in healthy adults ages 18 to 64 years.
This is a multi-center, randomized, partially blinded trial to compare the safety and immunogenicity of intramuscularly versus intradermally administered influenza vaccine in healthy 18-64 year old adults. Subjects will have blood drawn immediately prior to and approximately three to four weeks after vaccination. After the completion of the trial, all subjects will be offered influenza vaccine of the 2005-2006 formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,597
A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain.. Group 4: 382 subjects receive Fluzone 15 mcg IM on day 0
A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain. Group 1: 382 subjects receive 6 mcg ID with BD system. Group 2: 382 subjects receive 9 mcg ID with BD system, all doses on day 0.
A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain..Group 3: 382 subjects receive 3 mcg Fluzone ID using Mantoux technique on day 0.
Stanford University School of Medicine
Stanford, California, United States
UCLA Center For Vaccine Research
Torrance, California, United States
University of Iowa - Vaccine Research & Education Unit
Iowa City, Iowa, United States
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University of Maryland Baltimore
Baltimore, Maryland, United States
Saint Louis University
St Louis, Missouri, United States
University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
Rochester, New York, United States
Duke Health Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Vanderbilt University
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States