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The aim of this study is to investigate the immunogenicity and safety of the inactivated whole-virion vaccine for teenagers and adults.
The investigators will test the vaccine in participants aged above 12 years, for a randomized, blind, placebo-controlled, clinical study. The investigators designed one dosage groups: 15 μg of hemagglutinin antigen. Control group is designed to inoculate seasonal influence vaccine and aluminum hydroxide adjuvant. Participants will receive 2 doses of vaccine at 21-day intervals. Safety up to 6 months and changes in hemagglutinin inhibition (HI) titers at 21 days after each vaccination will be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15μg H7N9 Vaccine | Experimental | Participants will be inoculated with 2 doses of 15μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals. |
|
| Aluminum hydroxide adjuvant | Placebo Comparator | Participants will be first inoculated with one dose of seasonal influenza vaccine and followed with one dose of aluminum hydroxide adjuvant at 21-day intervals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 15μg H7N9 Vaccine | Biological | The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs,mixed with aluminum hydroxide adjuvant. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs) |
| Continuous observation for 30 days after two inoculations |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that presented seroconversion post injection |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xia Shengli, PhD | Henan Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suiping Center for Disease Control and Prevention | Zhumadian | Henan | 463100 | 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 | Oct 18, 2018 | Nov 25, 2018 | Prot_SAP_000.pdf |
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| Aluminum Hydroxide Adjuvant | Biological | The seasonal influenza vaccine was a inactivated, split virion preparation of the influenza virus, propagated in embryonated chicken eggs. The aluminum hydroxide adjuvant was 0.5ml aluminum hydroxide adjuvant. |
|
| 21 days after two inoculations |
| Number of participants that presented seroprotection post injection |
| 21 days after two inoculations |
| Geometric mean of Hemagglutination-inhibition titre post first study injection |
| 21 days after two inoculations |