A Phase I Study In Healthy Adults To Assess The Safety And Immunogenicity Of Priming With Live Attenuated A/H7N9 Influenza Virus Vaccine Followed By Inactivated A/H7N9 Influenza Virus Vaccine With AS03 Adjuvant
Sponsor study identifier
interventional
53
1 country
1
Study Start
December 2016
Actual (reported)Primary Completion
June 2018
Actual (reported)Study Completion
Not reported
Date not reportedThe purpose of this study is to evaluate the safety and immunogenicity of one dose of H7N9 pandemic live attenuated influenza vaccine (H7N9 pLAIV) followed by AS03-adjuvanted H7N9 pandemic inactivated influenza vaccine (H7N9 pIIV).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick 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.
November 2, 2016
Actual (reported)November 8, 2016
Actual (reported)December 2016
Actual (reported)June 2018
Actual (reported)Rates of local and systemic reactogenicity events
Measured through Day 264
Development of adverse events at any time point during the study
Measured through Day 264
Geometric mean titer (GMT) of H7N9-specific serum hemagglutination inhibition (HAI) and/or microneutralization (MN) antibody responses
Measured through Day 264
Rates of H7N9-specific serum HAI and/or MN antibody responses
Measured through Day 264
Participants will receive one dose of approximately 10\^7.0 FFU of H7N9 pLAIV at study entry (Day 0). They will receive one dose of 15 µg of AS03-adjuvanted H7N9 pIIV at Day 84.
Participants will receive one dose of 15 µg of AS03-adjuvanted H7N9 pIIV at study entry (Day 0) and one dose of 15 µg of AS03-adjuvanted H7N9 pIIV at Day 84.
10\^7.0 fluorescent focus units (FFU); delivered by an Accuspray device
University of Rochester Medical Center
Rochester, New York, 14642, United States
Angela Branche
University of Rochester
53 participants (actual enrollment reported by the registry).
First Submitted
November 2, 2016
First Posted
November 8, 2016
Study Start
December 2016
Actual (reported)Participants will receive one dose of 15 µg of AS03-adjuvanted H7N9 pIIV at study entry (Day 0).
Participants received one dose of 10\^7 FFU of H7N9 pLAIV at study entry (Day 0), one dose of 10\^7 FFU of H7N9 pLAIV at Day 28, and one dose of 30 µg of unadjuvanted H7N9 pIIV at Day 84.
Participants received one dose of 10\^7 FFU of H7N9 pLAIV at study entry (Day 0), one dose of 10\^7 FFU of H7N9 pLAIV at Day 28, and one dose of 30 µg of unadjuvanted H7N9 pIIV at Day 84.
Administered by intramuscular injection in the deltoid.
Mixed with H7N9 pIIV vaccine; administered by intramuscular injection in the deltoid
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
June 2018
Actual (reported)Last Updated
October 2, 2018
Record last verified: 2018-10
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Source: ClinicalTrials.gov.
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