Clinical trial NCT04363359: Clinical Trial of Quadrivalent Influenza Virus Split Vaccine
Official title: Immunogenicity and Safety of Quadrivalent Influenza Vaccine In 6 to 35 Months Population: a Randomized, Double-blind, Parallel-group Ⅱ Phase of Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Lead sponsor: Shanghai Institute Of Biological Products
Sponsor class: INDUSTRY
First posted: 2020-04-27
Enrollment: 1980
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the immunogenicity and safety of 2 doses of quadrivalent influenza virus split vaccine in healthy population aged 6-35 month., so as to provide a data support for phase III clinical trials.


Eligibility criteria: Inclusion Criteria:

* Healthy infants aged 6-35 months.
* Volunteer legal guardian or client informed consent, voluntarily participate in and sign informed consent.
* The volunteer legal guardian or client has the ability (non-illiterate) to understand the study procedures, to use a thermometer, scale, and fill in a diary card as required, and be able to complete the clinical study in compliance with the clinical trial protocol.

Exclusion Criteria:

* The underarm body temperature on the day of enrollment was \> 37.0℃.
* Have been suffering from influenza within the previous 3 months (confirmed by either clinical, serological or microbiological methods).
* Any previous influenza vaccination (registered or experimental) within 6 months or any planned influenza vaccination during the study period.
* Allergic to any component of the vaccine, a history of allergic reactions to eggs or gentamicin sulfate.
* A history of severe allergy to any vaccine or drug.
* Preterm birth (delivered before 37 weeks of gestation), low birth weight baby (birth weight \< 2300g for girls, \<2500g for boys).
* Dystocia, asphyxia rescue, nervous system damage history;
* Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
* Acute illness, severe chronic illness or acute attack of chronic disease on the day of vaccination;
* A history of live attenuated vaccination within 14 days prior to vaccination and a history of other vaccinations within 7 days prior to vaccination;
* Patients who received immunoenhancement or inhibitor therapy within 3 months (continued oral or intravenous administration for more than 14 days);
* Congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
* History of asthma, past two years of instability requiring emergency treatment, hospitalization, intubation, oral or intravenous administration of corticosteroids;
* Have received blood or blood-related products;
* A history of convulsion, epilepsy, encephalopathy, guillain-barre syndrome, a history of mental illness or a family history;
* A history of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease);
* Planning to relocate before the end of the study or to leave for an extended -period during the scheduled study visit;
* Participating in or planning to participate in other clinical trials in the near future;
* The investigators determined that any conditions were inappropriate to participate in the clinical trial.

Primary outcomes:
measure: seroconversion rate of HI antibodies
timeFrame: 56 days
measure: seroprotection rate of HI antibodies
timeFrame: 56 days
measure: GMT and GMI of HI antibodies
timeFrame: 56 days
Secondary outcomes:
measure: Reactogenicity Events
timeFrame: 30 days and 6 months
Other outcomes:
Locations:
city: Shangqiu
country: China
facility: Henan Provincial Center for Disease Control and Prevention
state: Henan
Study officials:
affiliation: Shanghai Institute Of Biological Products
name: Shilei Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: