Clinical trial NCT02710409: A Phase III Clinical Trial of An Inactivated Quadrivalent Influenza Vaccine in Healthy Subjects Aged 3 Years and Older
Official title: A Double-blind,Randomized,Positive-controlled, Non-inferiority Phase III Clinical Trial of An Inactivated Quadrivalent Influenza Vaccine (Split Virion) in Healthy Chinese Subjects Aged 3 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: safety, immunogenicity , quadrivalent influenza vaccine
Lead sponsor: Jiangsu Province Centers for Disease Control and Prevention
Sponsor class: NETWORK
Collaborators: name: Jiangsu Jindike Biotechnology Co., Ltd.
First posted: 2016-03-16
Enrollment: 3664
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Subjects will be randomized into three arms- Experimental Group, Active Comparator A and Active Comparator B by the ratio of 2:1:1.

Eligibility criteria: Inclusion Criteria:

* Aged 3 years and older
* Healthy subjects judged from medical history and clinical examination
* Subjects themselves or their guardians able to understand and sign the informed consent
* Subjects themselves or their guardians can and will comply with the requirements of the protocol
* Subjects with temperature \<=37.0°C on axillary setting

Exclusion Criteria:

* Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
* Any prior administration of influenza vaccine in last 6 month
* Subject who is allergic to any ingredient of the vaccine
* Female subject aged ≥18 years with a positive result after urine pregnancy test or during pregnancy or baby nursing period
* Subject with damaged or low immune function which has already been known
* Subject who had a seasonal influenza medical history in last 6 months
* Subject with acute febrile illness or infectious disease
* Major congenital defects or serious chronic illness, including perinatal brain damage
* Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection
* Subject who has serious allergic history
* Subject with other medical history not suitable for vaccination such as fainting during injection
* Any prior administration of immunodepressant or corticosteroids in last 6 months
* Any prior administration of blood products in last 3 months
* Any prior administration of other research medicine/vaccine in last 30 days
* Any prior administration of any attenuated live vaccine in last 30 days
* Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
* Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent

Primary outcomes:
measure: 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
timeFrame: 28 days after vaccination
measure: incidence of solicited adverse reactions after vaccination
timeFrame: 0-7 days after vaccination
Secondary outcomes:
measure: the 95% CI lower limit for the post-vaccination seroprotection rates against each corresponding flu strain is ≥70%
timeFrame: 28 days after vaccination
measure: 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
timeFrame: 28 days after vaccination
measure: incidence of unsolicited adverse reactions after vaccination
timeFrame: 0-28 days after vaccination
measure: incidence of serious adverse event (SAE) after vaccination
timeFrame: 0-28 days after vaccination
measure: incidence of serious adverse event (SAE) after vaccination
timeFrame: 29 days to 6 month after vaccination
Other outcomes:
Locations:
city: Lianyungang
country: China
facility: Guanyun County Center for Disease Control and Prevention
state: Jiangsu
Study officials:
References: