Influenza is an acute respiratory disease caused by influenza viruses. There are three types of the virus including A, B and C. Both type A and type B viruses can cause acute febrile respiratory tract infection, characterized by sudden fever, headache, muscle pain, cough, sore throat, nasal congestion and general malaise. The main transmission of influenza is through those highly contagious aerosol droplets containing influenza virus passed from infected people to susceptible population. Each year in the fall and winter infection of influenza is widespread in various age groups, with high incidence rate. Although influenza is generally a self-limiting disease, but in children, the elderly (especially those above 65 years old and those with chronic heart, lung, kidney, liver, blood or metabolic diseases such as diabetes or other certain diseases) and those with poor immunity function, influenza can easily lead to serious flu complications such as pneumonia, resulting in severe increase of morbidity and mortality. In order to evaluate safety and immunogenicity of a quadrivalent influenza vaccine produced by Jiangsu Jindike Biotechnology Co., Ltd. a phase III clinical trial is planned to conduct in healthy Chinese subjects aged 3 years and older.
Subjects will be randomized into three arms- Experimental Group, Active Comparator A and Active Comparator B by the ratio of 2:1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
3,664
0.5 ml/vial, one dose, intramuscular injection on day 0
0.5 ml/vial, one dose, intramuscular injection on day 0
0.5 ml/vial, one dose, intramuscular injection on day 0
Guanyun County Center for Disease Control and Prevention
Lianyungang, Jiangsu, China
the 95% confidence interval (CI) lower limit for the seroconversion against each corresponding flu strain after vaccination is≥40% in subjects aged 3-59 years and≥30% in subjects aged ≥60 years separately
Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
Time frame: 28 days after vaccination
incidence of solicited adverse reactions after vaccination
incidence of solicited adverse reactions (including systemic and local adverse reactions) after vaccination
Time frame: 0-7 days after vaccination
the 95% CI lower limit for the post-vaccination seroprotection rates against each corresponding flu strain is ≥70%
A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.
Time frame: 28 days after vaccination
the post-vaccination mean geometric increases (GMIs) of HAI titer against each corresponding flu strain is≥2.5 in subjects aged 3-59 years and≥2.0 in subjects aged ≥60 years separately
Hemagglutination inhibition (HI) titers were used to calculate post-vaccination mean geometric increases (GMIs) of each of the influenza vaccines.
Time frame: 28 days after vaccination
incidence of unsolicited adverse reactions after vaccination
incidence of unsolicited adverse reactions (including systemic and local adverse reactions) after vaccination
Time frame: 0-28 days after vaccination
incidence of serious adverse event (SAE) after vaccination
Time frame: 0-28 days after vaccination
incidence of serious adverse event (SAE) after vaccination
Time frame: 29 days to 6 month after vaccination
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