Seasonal InfluenzaPhase 4NCT05512494

Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated

A Phase 4 study testing Quadrivalent Influenza Vaccine (Split Virion), inactivated in people with Seasonal Influenza, run by Sinovac Biotech Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a randomized, double-blind phase Ⅳ clinical trial of quadrivalent influenza vaccine (Split Virion), inactivated manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the lot-to-lot consistency, immunogenicity and safety of quadrivalent influenza vaccine (Split Virion)… Read more about this study

Who is it for?: Ages 9 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Seasonal Influenza
What is being tested?: Quadrivalent Influenza Vaccine (Split Virion), inactivated
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,260 participants
Where: 1 siteChina
Study dates: 27 Nov 2022to 24 Jan 2023
Phase: Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 59 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Healthy subjects aged 9-59 years;
The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 9-17 years, both subjects and guardians need to sign the informed consent form).
Proven legal identity.

Who cannot join

Received seasonal influenza vaccine for 2022-2023 influenza season, or had an influenza vaccine schedule during the study;
Suffering from seasonal influenza in the past 6 moths;
Women of childbearing age (menarche to premenopause) are pregnant(including positive urine pregnancy test), breastfeeding or planning pregnancy within 1 month;
Patients with fever on the day of vaccination,underarm body temperature>37.2 ℃;
History of asthma, allergy to vaccines or vaccine components, and serious adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;
Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.

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Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.;
Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
Autoimmune disease or immune deficiency/immunosuppression;
Thyroid disease or history of thyroidectomy,absence of spleen, functional functional asplenia,and absence of spleen or splenectomy as a result of any condition;
Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
A long history of alcohol or drug abuse;
Onset of various acute or chronic diseases within 7 days prior to the study;
Receipt of blood products within in the past 3 months;
Receipt of other investigational drugs within 30 days prior to receiving the investigational vaccine;
Receipt of attenuated live vaccines or COVID-19 vaccines in the past 14 days,receipt of inactivated or subunit vaccines in the past 7 days;
The subjects participated in other clinical trials during the follow-up period or will be planned to participate other clinical trials during the follow-up period;
According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Yuping Dong Autonomous County Center for Disease Control and Prevention
Zhumadian, Guizhou, 554099

Other trials in China

About this study

Official title: A Randomized, Double-blind Clinical Trial to Evaluate Lot-to-lot Consistency , Immunogenicity and Safety of Quadrivalent Influenza Vaccine (Split Virion), Inactivated in Health Populations Aged 9~59 Years Old

Read the detailed description

This study is a randomized, double-blind phase Ⅳ clinical trial in health subjects aged 9-59 years old to evaluate the lot-to-lot consistency,immunogenicity and safety of quadrivalent influenza vaccine (Split Virion), inactivated.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 1260 subjects,including 360 subjects aged 9-17 years and 900 subjects aged 18-59 years will be enrolled.The subjects in each age group will be randomly divided into three groups in a ratio of 1:1:1 to receive one dose of three lots of quadrivalent influenza vaccine (Split Virion), inactivated produced on a commercial scale,respectively.

Conditions: Seasonal Influenza
Being tested: Quadrivalent Influenza Vaccine (Split Virion), inactivated

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quadrivalent Influenza Vaccine (Split Virion), inactivatedBiological
The Quadrivalent Influenza Vaccine manufactured by Sinovac Biotech Co.,Ltd. The four influenza strains（including 4 antigens H1N1, H3N2, BV and BY, 15μg for each) in 0.5 mL of sodium chloride,disodium hydrogen phosphate,sodium dihydrogen phosphate water for per injection.The routine of administration is intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0.

Study groups in NCT05512494
Study group	Role	What they receive
Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 1	Experimental	420 participants including 120 subjects aged 9-17 years and 300 subjects aged 18-59 years will receive one dose of quadrivalent influenza vaccine of commercial scale production lot 1. Receives: Biological: Quadrivalent Influenza Vaccine (Split Virion), inactivated
Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 2	Experimental	420 participants including 120 subjects aged 9-17 years and 300 subjects aged 18-59 years will receive one dose of quadrivalent influenza vaccine of commercial scale production lot 2. Receives: Biological: Quadrivalent Influenza Vaccine (Split Virion), inactivated
Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 3	Experimental	420 participants including 120 subjects aged 9-17 years and 300 subjects aged 18-59 years will receive one dose of quadrivalent influenza vaccine of commercial scale production lot 3. Receives: Biological: Quadrivalent Influenza Vaccine (Split Virion), inactivated

What is being measured

The primary outcome is the main question the study is designed to answer.

Immunogenicity index of GMT
GMT of HI antibodies of each influenza strain at 28 days after vaccination.
Measured: 28 days after vaccination

Secondary outcomes (7)

Immunogenicity index of seroconversion rate
Seroconversion rate of HI antibodies of each influenza strain at 28 days after vaccination.
Measured: 28 days after vaccination
Immunogenicity index of protection rate
Protection rate of HI antibodies of each influenza strain at 28 days after vaccination (HI antibody titer ≥1:40).
Measured: 28 days after vaccination
Immunogenicity index of GMI
GMI of HI antibodies of each influenza strain at 28 days after vaccination.
Measured: 28 days after vaccination
Safety index of the incidence of adverse reactions
Incidence of adverse reactions from 0 to 28 days after vaccination.
Measured: From 0 to 28 days after vaccination.
Safety index -The incidence of adverse reactions
Incidence of adverse reactions from 0 to 7 days after vaccination.
Measured: From 0 to 7 days after vaccination.
Safety index of the incidence of serious adverse events
Incidence of serious adverse events from 0 to 28 days after vaccination.
Measured: From 0 to 28 days after vaccination
Safety index of incidence of adverse events
Incidence of adverse events of special concern from 0 to 28 days after vaccination.
Measured: From 0 to 28 days after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Nov 202224 Jan 2023

First posted23 Aug 2022
Study start27 Nov 2022
Primary completion24 Jan 2023
Study completion24 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Seasonal InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 1,260 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05512494
Sponsor's protocol ID: PRO-QINF-4003
Status last verified: Jul 2022
First submitted: 21 Aug 2022
Last updated: 18 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Gao Y, Yang X, Li X, Chen H, Li Y, Tan X, Yu D, Feng T, Zhou S, Lei S, Zhao C, Wang J, Guan Q. Lot-to-lot consistency, immunogenicity and safety of a quadrivalent split virion inactivated influenza vaccine in healthy population aged 9-59 years: A randomized, double-blind, controlled, phase IV clinical trial. Vaccine. 2024 Aug 30;42(21):126182. doi: 10.1016/j.vaccine.2024.126182. Epub 2024 Aug 6.
PubMed 39116486

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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