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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00253734 |
The purpose of this research study is to find out if giving the smaller dose of flu vaccine under the skin generates antibodies against flu compared to giving the vaccine the usual way, as a shot in the arm. If using smaller doses in this manner is effective, the current supply of vaccine could be used to make more doses to give to more people. About 217 healthy adults, 18 to 49 years of age, will participate. The study will be conducted at one site in the United States and subjects are expected to participate for about 6 months. Blood samples will be taken to assess the immune system response. Local and systemic safety will be evaluated in the 28 days following vaccination.
Condition | Intervention | Phase |
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Influenza |
Biological: Fluzone® Biological: Fluzone® (IM) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route Compared to an Intramuscular Vaccination With Fluzone® in Healthy Adults |
Enrollment: | 217 |
Study Start Date: | November 2005 |
Study Completion Date: | November 2006 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
31 subjects to receive 9 mcg of TIV administered intradermally.
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Biological: Fluzone®
9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by intradermal route (Mantoux technique).
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2: Experimental
31 subjects to receive 6 mcg of TIV administered intradermally.
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Biological: Fluzone®
9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by intradermal route (Mantoux technique).
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4: Active Comparator
31 subjects to receive 15 mcg of TIV administered intramuscularly.
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Biological: Fluzone® (IM)
15, 9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by the standard intramuscular route.
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6: Active Comparator
31 subjects to receive 6 mcg of TIV administered intramuscularly.
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Biological: Fluzone® (IM)
15, 9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by the standard intramuscular route.
|
7: Active Comparator
31 subjects to receive 3 mcg of TIV administered intramuscularly.
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Biological: Fluzone® (IM)
15, 9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by the standard intramuscular route.
|
5: Active Comparator
31 subjects to receive 9 mcg of TIV administered intramuscularly.
|
Biological: Fluzone® (IM)
15, 9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by the standard intramuscular route.
|
3: Experimental
31 subjects to receive 3 mcg of TIV administered intradermally.
|
Biological: Fluzone®
9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by intradermal route (Mantoux technique).
|
This study is a randomized, prospective, active-controlled, single-center, open label, dose-ranging clinical trial of TIV (Fluzone®) administered to healthy 18-to-49 year old adults who did not receive 2003-2004, 2004-2005 and 2005-2006 influenza vaccine. Subjects will be randomized to one of 7 groups (4 intramuscular and 3 intradermal) to compare the immunogenicity and safety of different concentrations of the standard Fluzone® administered intradermally using the Mantoux technique to that of standard Fluzone® administered intramuscularly. The primary objective of the study is to compare the immunogenicity of injected Fluzone® across different dose levels and different routes of administration. The secondary objectives are to describe the number and proportions of subjects in each group experiencing any injection site or systemic symptoms and the proportion of subjects who experience moderate-to-severe symptoms post vaccination. Approximately 31 subjects per group (217 in total) will be enrolled with each group determined by dose and route of administration of vaccines. Subjects will be observed in the clinic for at least 30 minutes after immunization and will maintain a memory aid to record daily oral temperature and any systemic and local reactions for 7 days after the day of immunization. Subjects will be contacted by phone between 8 to 12 days after immunization to review their 7-day memory aid, including the assessment of their recorded daily oral temperature, any local or systemic reactions, and the occurrence of any other AEs and SAEs. Subjects will return at 28 (+/- 3) days after immunization to assess the occurrence of unsolicited AEs and SAEs and complete an acceptability and functional skill questionnaire. Serum for immunogenicity evaluations will be obtained prior to the first vaccination and approximately 28 (+/- 3) days post vaccination. The 2005-2006 formulation will be used for all seven groups.
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Use of experimental devices or participation in a medical procedure trial within the month prior to study entry, or expected use of experimental devices or participation in a medical procedure trial during the entire study period.
13. Receipt of immunoglobulin or other blood product within 3 months prior to enrollment.
Responsible Party: | HHS/NIAID/DMID ( Robert Johnson ) |
Study ID Numbers: | 05-0109 |
Study First Received: | November 11, 2005 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00253734 |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board |
Influenza |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Healthy Orthomyxoviridae Infections |
RNA Virus Infections |