Clinical Trial of Quadrivalent Influenza Virus Split Vaccine

Immunogenicity and Safety of Quadrivalent Influenza Vaccine In 6 to 35 Months Population: a Randomized, Double-blind, Parallel-group Ⅱ Phase of Clinical Trials

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: 0.5ml Quadrivalent influenza vaccine; Biological: 0.25ml Quadrivalent influenza vaccine; Biological: 0.25ml Trivalent influenza vaccine(B/V); Biological: 0.25ml Trivalent influenza vaccine(B/Y)

• Study Type: Interventional
• Enrollment (Actual): 1980
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Henan
    • Shangqiu, Henan, China, 450016
      • Henan Provincial Center for Disease Control and Prevention
      • Contact: Xia Sheng-Li, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quadrivalent influenza vaccine HD; Participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at Day 0 and 28.	Biological: 0.5ml Quadrivalent influenza vaccine; The inactivated split virion vaccines contained 15 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains
Experimental: Quadrivalent influenza vaccine LD; Participants randomized to receive two injections of 0.25 mL quadrivalent influenza vaccine at Day 0 and 28.	Biological: 0.25ml Quadrivalent influenza vaccine; The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains
Active Comparator: Trivalent influenza vaccine Victoria; Participants randomized to receive two injections of 0.25 mL trivalent influenza vaccine containing B/Victoria strain at Day 0 and 28.	Biological: 0.25ml Trivalent influenza vaccine(B/V); The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Victoria strains
Active Comparator: Trivalent influenza vaccine Yamagata; Participants randomized to receive two injections of 0.25 mL trivalent influenza vaccine containing B/Yamagata strain at Day 0 and 28.	Biological: 0.25ml Trivalent influenza vaccine(B/Y); The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Yamagata strains

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
seroconversion rate of HI antibodies	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.	56 days
seroprotection rate of HI antibodies	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.	56 days
GMT and GMI of HI antibodies	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.	56 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Institute Of Biological Products
• Investigators: Principal Investigator: Shilei Wang, PhD, Shanghai Institute Of Biological Products

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): September 14, 2021
• Study Completion (Actual): September 14, 2021

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: CXSL1900048-Ⅰ+Ⅱ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No