Clinical Trial of Quadrivalent Influenza Virus Split Vaccine

Shanghai Institute Of Biological Products

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: 0.25ml Quadrivalent influenza vaccine; Biological: 0.25ml Trivalent influenza vaccine(B/V); Biological: 0.5ml Quadrivalent influenza vaccine; Biological: 0.25ml Trivalent influenza vaccine(B/Y)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04363359

CXSL1900048-Ⅰ+Ⅱ

Details and patient eligibility

About

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.

Enrollment: 1,980 patients

Sex: All

Ages: 6 to 35 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,980 participants in 4 patient groups

Quadrivalent influenza vaccine HD

Experimental group

Description:

Participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at Day 0 and 28.

Treatment:

Biological: 0.5ml Quadrivalent influenza vaccine

Quadrivalent influenza vaccine LD

Experimental group

Description:

Participants randomized to receive two injections of 0.25 mL quadrivalent influenza vaccine at Day 0 and 28.

Treatment:

Biological: 0.25ml Quadrivalent influenza vaccine

Trivalent influenza vaccine Victoria

Active Comparator group

Description:

Participants randomized to receive two injections of 0.25 mL trivalent influenza vaccine containing B/Victoria strain at Day 0 and 28.

Treatment:

Biological: 0.25ml Trivalent influenza vaccine(B/V)

Trivalent influenza vaccine Yamagata

Active Comparator group

Description:

Participants randomized to receive two injections of 0.25 mL trivalent influenza vaccine containing B/Yamagata strain at Day 0 and 28.

Treatment:

Biological: 0.25ml Trivalent influenza vaccine(B/Y)