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This is a randomized, blinded, controlled phase I clinical trial with a total of 120 participants aged ≥ 60 years. Experimental group: Influenza virus split vaccine (0.7mL/vial), control group 1: Influenza virus split vaccine, control group 2: placebo group. The three groups were recruited at a ratio of 1:1:1, and 40 individuals were randomly vaccinated in each group. Each person was injected with one dose of the vaccine into the deltoid muscle of the upper arm. Participants in each study group are required to undergo laboratory indicator tests before and on the 4th day after vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Influenza virus split vaccine, with a specification of 0.7mL/bottle |
|
| Control group 1 | Active Comparator | Influenza virus split vaccine, with a specification of 0.5mL/bottle |
|
| Control group 2 | Placebo Comparator | Phosphate buffer solution |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Unsolicited Adverse Events | Other adverse events that occurred among participants within 0-30 days after vaccination, in addition to the solicited adverse events. | 30 days after vaccination |
| 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 |
| Serious Adverse Events (SAE) | That is serious adverse events, any serious adverse events that occurred to the participant during the study period. | 6 months after vaccination |
| 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 |
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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 |
| Name | Affiliation | Role |
|---|---|---|
| Yeqing Tong | Hubei Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danjiangkou Disease Prevention and Control Center | Recruiting | 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 |
|
| Phosphate buffer solution (PBS) | Biological | PBS, with a specification of 0.5mL/bottle. |
|
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 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |