Status:
COMPLETED
Clinical Trial of Quadrivalent Influenza Virus Split Vaccine
Lead Sponsor:
Shanghai Institute Of Biological Products
Conditions:
Influenza
Eligibility:
All Genders
6-35 years
Phase:
PHASE2
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
- 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
- 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.
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2021
Estimated Enrollment :
1980 Patients enrolled
Trial Details
Trial ID
NCT04363359
Start Date
January 15 2020
End Date
September 14 2021
Last Update
December 26 2023
Active Locations (1)
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1
Henan Provincial Center for Disease Control and Prevention
Shangqiu, Henan, China, 450016