Suiping Center for Disease Control and Prevention
Zhumadian, Henan, 463100, China
NCT Number: NCT03755427
The aim of this study is to investigate the immunogenicity and safety of the inactivated whole-virion vaccine for teenagers and adults.
The investigators will test the vaccine in participants aged above 12 years, for a randomized, blind, placebo-controlled, clinical study. The investigators designed one dosage groups: 15 μg of hemagglutinin antigen. Control group is designed to inoculate seasonal influence vaccine and aluminum hydroxide adjuvant. Participants will receive 2 doses of vaccine at 21-day intervals. Safety up to 6 months and changes in hemagglutinin inhibition (HI) titers at 21 days after each vaccination will be determined.
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Notify Me12 year and older
All sexes
Interventional
Phase 2
Zhumadian, Henan, 463100, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs,mixed with aluminum hydroxide adjuvant.
The seasonal influenza vaccine was a inactivated, split virion preparation of the influenza virus, propagated in embryonated chicken eggs. The aluminum hydroxide adjuvant was 0.5ml aluminum hydroxide adjuvant.
Time frame: Continuous observation for 30 days after two inoculations
Time frame: 21 days after two inoculations
Time frame: 21 days after two inoculations
Time frame: 21 days after two inoculations
Shanghai Institute Of Biological Products
Industry
Immunogenicity and Safety of an Alum-adjuvanted Inactivated H7N9 Influenza Vaccine: a Randomized, Blind, Placebo-controlled, a Phase II Clinical Trial
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