NCT03369808|CompletedPhase 1/2
A Clinical Trail Of An Adjuvanted Inactivated H7N9 Influenza Vaccine
Immunogenicity And Safety Of An Alum-Adjuvanted Inactivated H7N9 Influenza Vaccine
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Immunogenicity And Safety Of An Alum-Adjuvanted Inactivated H7N9 Influenza Vaccine
Sponsor study identifier
interventional
360
1 country
1
Study Start
December 29, 2017
Actual (reported)Primary Completion
August 29, 2018
Actual (reported)Study Completion
November 15, 2019
Actual (reported)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 12-60 years, for a randomized, blind, placebo-controlled, age-stratified clinical study. The investigators designed three dosage groups: 7.5 μg,15 μg and 30 μg of hemagglutinin antigen. According to the age of the subjects, Each group was divided into different age subgroups. Phosphate buffer solution and Aluminum hydroxide adjuvant as placebo controls were both set up in the subgroups.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 were determined.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 15, 2019
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.
November 22, 2017
Actual (reported)December 12, 2017
Actual (reported)December 29, 2017
Actual (reported)August 29, 2018
Actual (reported)November 15, 2019
Actual (reported)Reactogenicity Events
* For each group the incidence rate of subjects with solicited AE(s) with 95% confidence interval * For each group the incidence rate of subjects with solicited SAE(s) with 95% confidence interval
Continuous observation for 30 days after two inoculations
Number of participants that presented seroconversion post injection
21 days after two inoculations
Number of participants that presented seroprotection post injection
21 days after two inoculations
Geometric mean of Hemagglutination-inhibition titre post first study injection
21 days after two inoculations
Participants will receive 2 doses of 7.5μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.
Participants will receive 2 doses of 15μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.
Participants will receive 2 doses of 30μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.
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.
0.5ml phosphate buffer solution
Suiping Center for Disease Control and Prevention
Zhumadian, Henan, 463100, China
Ze Chen, PhD
Shanghai Institute Of Biological Products
360 participants (actual enrollment reported by the registry).
First Submitted
November 22, 2017
First Posted
December 12, 2017
Study Start
December 29, 2017
Actual (reported)H5 Vaccine Alone or With Aluminum Hydroxide in Elderly Adults
Participants will receive 2 doses of aluminum hydroxide adjuvant at 21-day intervals.
Participants will receive 2 doses of phosphate buffer solution at 21-day intervals.
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 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.
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
August 29, 2018
Actual (reported)Study Completion
November 15, 2019
Actual (reported)Last Updated
October 15, 2024
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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