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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: | NCT00310206 |
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 may be involved in the study for 13 months or less. Study procedures include blood samples.
Condition | Intervention | Phase |
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Influenza |
Biological: Inactivated Influenza A Vaccine A/H5N1 (sanofi pasteur) |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study |
Official Title: | A Randomized, Open-Label, Phase I Clinical Trial Comparing the Safety, Reactogenicity, and Immunogenicity of Immunization With Inactivated Influenza A/H5N1 Vaccine Administered by the Intradermal or the Intramuscular Route Among Healthy Adults |
Enrollment: | 100 |
Study Start Date: | July 2005 |
Study Completion Date: | October 2006 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
25 subjects to receive 2 doses 1 month apart of 15 mcg of H5 HA by the intramuscular route.
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Biological: Inactivated Influenza A Vaccine A/H5N1 (sanofi pasteur)
Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intramuscularly (IM); doses: 15 or 45 micrograms.
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2: Experimental
25 subjects to receive 2 doses 1 month apart of 45 mcg of H5 HA by the intramuscular route.
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Biological: Inactivated Influenza A Vaccine A/H5N1 (sanofi pasteur)
Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intramuscularly (IM); doses: 15 or 45 micrograms.
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3: Experimental
25 subjects to receive 2 doses 1 month apart of 3 mcg of H5 HA by the intradermal route.
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Biological: Inactivated Influenza A Vaccine A/H5N1 (sanofi pasteur)
Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intradermally (ID); doses: 3 or 9 micrograms.
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4: Experimental
25 subjects to receive 2 doses 1 month apart of 9 mcg of H5 HA by the intradermal route.
|
Biological: Inactivated Influenza A Vaccine A/H5N1 (sanofi pasteur)
Monovalent subvirion H5 vaccine (HA of A/Vietnam/1203/04), inactivated A/H5N1 vaccine administered intradermally (ID); doses: 3 or 9 micrograms.
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This is a single-center, randomized, open-labeled, dose-ranging, phase I comparative trial of intradermal (ID) and intramuscular (IM) injection with subvirion inactivated influenza A/H5N1 vaccine in healthy adults, 18 to 40 years old, inclusive. This study is designed to investigate the safety, reactogenicity, and dose-related immunogenicity of an investigational inactivated influenza A/H5N1 virus vaccine given by ID injection compared to IM injection. This study is linked to DMID protocol 07-0022.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to participate in this study:
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria at baseline will be excluded from study participation:
Responsible Party: | HHS/NIAID/DMID ( Robert Johnson ) |
Study ID Numbers: | 05-0015 |
Study First Received: | March 30, 2006 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00310206 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Federal Government; United States: Institutional Review Board |
Influenza, pandemic, H5N1 |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human |
Influenza in Birds Healthy Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |