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Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

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

NCT05512494•Sinovac Biotech Co., Ltd

View on ClinicalTrials.gov

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), inactivated in health subjects aged 9-59 years old.

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.

Eligibility

Age

9 - 59 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.

Exclusion Criteria

•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.
•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;
+9 more criteria

Locations (1)

Yuping Dong Autonomous County Center for Disease Control and Prevention

Zhumadian, Guizhou, China

Key Dates

Start Date

November 27, 2022

Primary Completion Date

January 24, 2023

Completion Date

January 24, 2023

Last Updated

September 18, 2023

Enrollment

1,260

ACTUAL participants

Conditions

Seasonal Influenza

Interventions

Quadrivalent Influenza Vaccine (Split Virion), inactivated

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age

Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults

A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults

Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010

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