Clinical Trial of Quadrivalent Influenza Virus Split Vaccine

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: 0.25ml Quadrivalent influenza vaccine; Biological: 0.5ml Quadrivalent influenza vaccine; Biological: 0.25ml Trivalent influenza vaccine(B/Y); Biological: 0.25ml Trivalent influenza vaccine(B/V)

• Registration Number: NCT04363359
• Lead Sponsor: Shanghai Institute Of Biological Products

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-15
• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-27
• Primary Completion: 2021-09-14
• Study Completion: 2021-09-14
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1980

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadrivalent influenza vaccine LD	0.25ml Quadrivalent influenza vaccine	Participants randomized to receive two injections of 0.25 mL quadrivalent influenza vaccine at Day 0 and 28.
Quadrivalent influenza vaccine HD	0.5ml Quadrivalent influenza vaccine	Participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at Day 0 and 28.
Trivalent influenza vaccine Yamagata	0.25ml Trivalent influenza vaccine(B/Y)	Participants randomized to receive two injections of 0.25 mL trivalent influenza vaccine containing B/Yamagata strain at Day 0 and 28.
Trivalent influenza vaccine Victoria	0.25ml Trivalent influenza vaccine(B/V)	Participants randomized to receive two injections of 0.25 mL trivalent influenza vaccine containing B/Victoria strain at Day 0 and 28.

Primary Outcome Measures

Name	Time	Method
seroconversion rate of HI antibodies	56 days	28 days after receiving two doses of vaccine in subjects aged 6-35 months, seroconversion rate of HI antibodies against any subtype of influenza virus in each group.
seroprotection rate of HI antibodies	56 days	28 days after receiving two doses of vaccine in subjects aged 6-35 months, seroprotection rate of HI antibodies against any subtype of influenza virus in each group.
GMT and GMI of HI antibodies	56 days	28 days after receiving two doses of vaccine in subjects aged 6-35 months, GMT and GMI of HI antibodies against any subtype of influenza virus in each group.

Secondary Outcome Measures

Name	Time	Method
Reactogenicity Events	30 days and 6 months	1. The proportion of all adverse reactions/events in each group through 30 days after the second dose.; 2. The proportion of serious adverse events (SAE) within 6 months after inoculation in each group.

Trial Locations

Locations (1)

Henan Provincial Center for Disease Control and Prevention; 🇨🇳 Shangqiu, Henan, China