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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadrivalent influenza vaccine HD | Experimental | Participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at Day 0 and 28. |
|
| Quadrivalent influenza vaccine LD | Experimental | Participants randomized to receive two injections of 0.25 mL quadrivalent influenza vaccine at Day 0 and 28. |
|
| Trivalent influenza vaccine Victoria | Active Comparator | Participants randomized to receive two injections of 0.25 mL trivalent influenza vaccine containing B/Victoria strain at Day 0 and 28. |
|
| Trivalent influenza vaccine Yamagata | Active Comparator | Participants randomized to receive two injections of 0.25 mL trivalent influenza vaccine containing B/Yamagata strain at Day 0 and 28. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5ml Quadrivalent influenza vaccine | Biological | The inactivated split virion vaccines contained 15 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reactogenicity Events |
| 30 days and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shilei Wang, PhD | Shanghai Institute Of Biological Products | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial Center for Disease Control and Prevention | Shangqiu | Henan | 450016 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2020 | Apr 22, 2020 | Prot_SAP_000.pdf |
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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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| 0.25ml Quadrivalent influenza vaccine | Biological | 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 |
|
| 0.25ml Trivalent influenza vaccine(B/V) | Biological | The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Victoria strains |
|
| 0.25ml Trivalent influenza vaccine(B/Y) | Biological | The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Yamagata strains |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |