NCT03369808

A Clinical Trail Of An Adjuvanted Inactivated H7N9 Influenza Vaccine

Immunogenicity And Safety Of An Alum-Adjuvanted Inactivated H7N9 Influenza Vaccine

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• H7N9 Influenza

Interventions

Type	Name	Description
BIOLOGICAL	7.5μg H7N9 Vaccine	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.
BIOLOGICAL	Phosphate Buffer Solution	0.5ml phosphate buffer solution
BIOLOGICAL	Aluminum Hydroxide Adjuvant	0.5ml aluminum hydroxide adjuvant
BIOLOGICAL	15μg H7N9 Vaccine	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.
BIOLOGICAL	30μg H7N9 Vaccine	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.

Timeline

• Start date: 2017-12-29
• Primary completion: 2018-08-29
• Completion: 2019-11-15
• First posted: 2017-12-12
• Last updated: 2024-10-15

Locations

1 site across 1 country: China