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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 3 | Experimental | 382 subjects will receive one 3 mcg dose of Fluzone intradermally using the Mantoux technique on Day 0, |
|
| Group 4 | Experimental | 382 subjects will receive one 15 mcg dose Fluzone vaccine intramuscularly (IM) on Day 0, |
|
| Group 1 | Experimental | 382 subjects will receive one 6 mcg dose of Trivalent inactivated influenza vaccine (TIV) intradermally (ID) with the BD ID System on Day 0, |
|
| Group 2 | Experimental | 382 subjects will receive one 9 mcg dose of TIV intradermally (ID) with the BD ID System on Day 0, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trivalent inactivated influenza vaccine | Biological | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305-2200 | United States | ||
| UCLA Center For Vaccine Research |
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| Trivalent inactivated influenza vaccine | Biological | 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. |
|
| Trivalent inactivated influenza vaccine | Biological | 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. |
|
| Torrance |
| California |
| 90509 |
| United States |
| University of Iowa - Vaccine Research & Education Unit | Iowa City | Iowa | 52242-2600 | United States |
| University of Maryland Baltimore | Baltimore | Maryland | 21201 | United States |
| Saint Louis University | St Louis | Missouri | 63110 | United States |
| University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases | Rochester | New York | 14642-0001 | United States |
| Duke Health Center | Durham | North Carolina | 27704 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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