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To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in healthy population aged 3-8 years following different immunization procedures.
To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in healthy population aged 3-8 years following different immunization procedures, and the participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at day 0 and 28.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outcome | Experimental | Quadrivalent influenza vaccine Participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at Day 0 and 28. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Influenza Virus Split Vaccine | Biological | 0.5ml Quadrivalent influenza vaccine 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 hemagglutination inhibition (HI) antibodies | 28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. Seroconversion rate of HI antibodies against any subtype of influenza virus in each group. | up to 56 days |
| seroprotection rate of HI antibodies | 28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. Seroprotection rate of HI antibodies against any subtype of influenza virus in each group. | up to 56 days |
| geometric mean increase (GMI) of HI antibodies | 28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. GMI of HI antibodies against any subtype of influenza virus in each group. | up to 56 days |
| The proportion of all adverse reactions/events | The proportion of all adverse reactions/events in subjects through 28 days after the second dose. | up to 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| p value of difference of seroconversion rate in subjects with different immunization procedures | p value of the difference of seroconversion rate of HI antibodies at 28 days between subjects receiving one dose of vaccine and subjects receiving two. | up to 56 days |
| p value of difference of seroprotection rate in subjects with different immunization procedures |
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Inclusion Criteria:
Exclusion Criteria:
Receiving the second dose of vaccine
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| Name | Affiliation | Role |
|---|---|---|
| Li Zhang | Shandong Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tingting and Yu | Tai’an | Shandong | China |
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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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Subjects in one group received a first and a second dose of the vaccine at different time points.
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Open Label
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p value of the difference of seroprotection rate of HI antibodies at 28 days between subjects receiving one dose of vaccine and subjects receiving two. |
| up to 56 days |
| p value of difference of GMI in subjects with different immunization procedures | p value of the difference of GMI of HI antibodies at 28 days between subjects receiving one dose of vaccine and subjects receiving two. | up to 56 days |
| Reactogenicity Events | The proportion of all adverse reactions/events in subjects from the day subjects receiving the first dose of vaccine to 180 days after subjects receiving the second dose. | 208 days |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |