Sponsor study identifier
Secondary identifiers
interventional
500
1 country
6
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2010
Actual (reported)Study Completion
July 2011
Actual (reported)This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high dose) on Day 0 with or without a patch (low or high dose).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
May 22, 2009
Actual (reported)May 27, 2009
Actual (reported)January 2010
Actual (reported)July 2011
Actual (reported)March 13, 2014
Actual (reported)Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28.
Seroconversion is defined as either 1) baseline HI titer \< 1:10 and a post-vaccination HI titer ≥ 1:40, or 2) baseline HI titer ≥ 1:10 and a minimum four-fold rise. Seroprotection is defined as a post-vaccination HI antibody titer ≥ 1:40. FDA/EMEA criterion for seroconversion was to meet or exceed 40%. FDA/EMEA criterion for seroprotection was to meet or exceed 70%.
Day 28
Safety of A/H5N1 Vaccine IM Injection With and Without an LT Adjuvant Patch
6 months
Evaluate Treatment Group HI Responses Against US FDA Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (May 2007) and EMA CPMP/BWP/214/96 Criteria for Immunogenicity
Day 28
A/H5N1 Vaccine 30 µg HA i.m. on Day 0
A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
A/H5N1 Low Dose
A/H5N1 High Dose
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Solano Clinical Research
Vallejo, California, 94589, United States
Miami Research Associates
Miami, Florida, 33143, United States
Accelovance
South Bend, Indiana, 46601, United States
Johnson County Clinical Trials
Lenexa, Kansas, 66219, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Eric Sheldon, MD
Miami Research Associates
500 participants (actual enrollment reported by the registry).
First Submitted
May 22, 2009
First Posted
May 27, 2009
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age
A/H5N1 Vaccine 45 µg HA i.m. on Day 0
A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
LT Adjuvant Patch Low Dose
LT Adjuvant Patch High Dose
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 2010
Actual (reported)Study Completion
July 2011
Actual (reported)Last Updated
December 10, 2021
Results First Posted
March 13, 2014
Record last verified: 2021-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: