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To evaluate the immunogenicity of administering one dose of influenza virus split vaccine (0.7mL/dose) to individuals aged 60 and above.
This is a randomized, blinded, parallel controlled trial design, a total of 1200 participants aged ≥ 60 years were enrolled in the study. Study participants were randomly vaccinated with either the experimental vaccine: influenza virus split vaccine (0.7mL/dose) or the control vaccine: influenza virus split vaccine, at a 1:1 ratio. One dose of the vaccine was administered on day 0 for immunogenicity and safety evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza virus split vaccine (0.7mL/vial) | Experimental | Influenza virus split vaccine (0.7mL/vial) |
|
| Influenza virus split vaccine | Active Comparator | Influenza virus split vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza virus split vaccine (0.7mL/vial) | Biological | Influenza virus split vaccine, with a specification of 0.7mL/bottle, containing 60 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each Control: Influenza virus split vaccine. |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate | 30 days after vaccination of all participants with the experimental vaccine or control vaccines, the HI antibody seroconversion rate against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups. | 30 days after vaccination |
| Ratio of ≥1:40 | 30 days after vaccination of all participants with the experimental vaccine or control vaccines, the ratio of HI antibody titers ≥ 1:40 against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups. | 30 days after vaccination |
| Geometric mean titer (GMT) | 30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMT of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups. | 30 days after vaccination |
| Geometric mean increase (GMI) | 30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMI of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups. | 30 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Solicited Adverse Events (AEs) | Adverse events defined by the protocol that occurred to the participant during 0-7 days after vaccination. | 7 days after vaccination |
| Unsolicited Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Liu | Contact | 86-010-65777702 | liuyang30@sinopharm.com | |
| Chaorong Xu | Contact | 86-021-62800991 | xuchaorong@sinopharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danjiangkou City Center for Disease Control and Prevention | Wuhan | Hubei | 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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| Influenza virus split vaccine | Biological | Influenza virus split vaccine, with a specification of 0.5mL/bottle, containing 15 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each. |
|
Other adverse events that occurred among participants within 0-30 days after vaccination, in addition to the solicited adverse events.
| 30 days after vaccination |
| Serious Adverse Events (SAEs) | That is serious adverse events, any serious adverse events that occurred to the participant during the study period. | 6 months after vaccination |
| Yunxi County Center for Disease Control and Prevention | Wuhan | Hubei | China |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |