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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Influenza Vaccine (Split Virion), inactivated | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity index of GMT | GMT of HI antibodies of each influenza strain at 28 days after vaccination. | 28 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity index of seroconversion rate | Seroconversion rate of HI antibodies of each influenza strain at 28 days after vaccination. | 28 days after vaccination |
| Immunogenicity index of protection rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qinghu Guan | Guizhou Provincial Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuping Dong Autonomous County Center for Disease Control and Prevention | Zhumadian | Guizhou | 554099 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39116486 | Derived | 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. |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Protection rate of HI antibodies of each influenza strain at 28 days after vaccination (HI antibody titer ≥1:40).
| 28 days after vaccination |
| Immunogenicity index of GMI | GMI of HI antibodies of each influenza strain at 28 days after vaccination. | 28 days after vaccination |
| Safety index of the incidence of adverse reactions | Incidence of adverse reactions from 0 to 28 days after vaccination. | 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. | 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. | 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. | From 0 to 28 days after vaccination |