H7N9 avian influenza (AI) viruses have caused a recent outbreak of severe respiratory disease in humans in China. The purpose of this study is to evaluate the safety and immunogenicity of a live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine in healthy adults. A single dose of inactivated subvirion H7N9 influenza vaccine will be administered 3 months later.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Frequency of vaccine-related reactogenicity events that occur during the acute monitoring (inpatient) phase of the study
Timeframe: Measured through Day 9 (Group 1) or Day 37 (Group 2)
Area under the curve (AUC) of nasal virus shedding after each dose of vaccine, as assessed by liquid titration of nasal secretions on Madin Darby canine kidney (MDCK) cells at 33°C
Timeframe: Measured through Day 180
Vaccine virus shedding on one or more days on Days 2 through 9 as assessed by culture or real-time reverse transcriptase polymerase chain reaction (rRT-PCR)
Timeframe: Measured through Day 9
Evidence of a 4-fold or greater increase in either hemagglutination inhibition (HAI) or microneutralization (MN) antibody comparing pre-vaccination to either Day 29 or Day 56 post-dose two samples
Timeframe: Measured through Day 56
Development of serum antibody assessed by either HAI or MN assays
Timeframe: Measured through Day 180