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| Name | Class |
|---|---|
| Jiangsu Jindike Biotechnology Co., Ltd. | INDUSTRY |
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Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. For those aged 6 months through 8 years who have previously received ≥2 total doses of trivalent or quadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose of influenza vaccine. For those who have not previously received ≥2 doses of trivalent or quadrivalent influenza vaccine, they require 2 dose of influenza vaccine. but the evidence on how to select vaccine doses for quadrivalent influenza vaccine is limited in China. The study is a prospective, open-label comparison of the immunogenicity and reactogenicity of 1 versus 2 doses of an inactivated quadrivalent influenza vaccine in subjects of 3-8 years old with different history of influenza vaccination.
Subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart.
Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeks after dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2, A/H1N1, and B antigens included in the vaccine were measured at each time point
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadrivalent influenza vaccine | Experimental | Subjects received 2 doses of 0.5 mL of quadrivalent influenza vaccine, 4 weeks apart. Each 0.5-ml dose contained 15 μg of hemagglutinin per strain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent influenza vaccine | Biological | Subjects receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI) antibodies against each virus strain after 2nd vaccination ≥40% | The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer. | day 28 after dose 2 |
| Number of participants with Adverse Reactions (ARs) | Frequency and severity of ARs for 28 days after each vaccination | 28 days after each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| the 95% CI lower limit for seroprotection rates of HAI antibodies against each virus strain after 2nd vaccination≥70% | A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40. | day 28 after dose 2 |
| Geometric Mean Fold Increase (GMFI) of HAI titer against each virus strain after 2nd vaccination>2.5 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparision between Seroconversion Rate (SCR) of HAI antibodies against each virus strain post dose 1 and dose 2 | The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer. | day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fangyue Meng, Master | Jiangsu Province Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pizhou City Center for Disease Control and Prevention | Xuzhou | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39993940 | Derived | Wen F, Liu S, Zhou L, Zhu Y, Wang W, Wei M, Xu X, Liu Y, Shuai Q, Yu J, Jing P, Li J, Zhu F. Immunogenicity and safety of 1 versus 2 doses of quadrivalent-inactivated influenza vaccine in children aged 3-8 years with or without previous influenza vaccination histories. Hum Vaccin Immunother. 2025 Dec;21(1):2468074. doi: 10.1080/21645515.2025.2468074. Epub 2025 Feb 24. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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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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Subjects received 2 doses of an inactivated quadrivalent influenza vaccine, 4 weeks apart. Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeks after dose 2.
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Hemagglutination inhibition (HAI) titers were used to calculate post-vaccination geometric mean fold increase (GMFI) against each virus strain |
| day 28 after dose 2 |
| Number of participants with Adverse Events (AEs) | Frequency and severity of AEs for 28 days after each vaccination | 28 days after each vaccination |
| Number of participants with Serious Adverse Events (SAE) | Frequency of SAEs for 6 months after the last vaccination | 6 months after the last vaccination |
| Comparision between Geometric Mean Titre (GMT) of HAI antibodies against each virus strain post dose 1 and dose 2 | day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2. |
| Comparision between seroprotection rates of HAI antibodies against each virus strain post dose 1 and dose 2 | A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40. | day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2. |
| Comparision between Geometric Mean Fold Increase (GMFI) of HAI antibodies against each virus strain post dose 1 and dose 2 | Hemagglutination inhibition (HAI) titers were used to calculate post-vaccination geometric mean fold increase (GMFI) against each virus strain | day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2. |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |