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| Name | Class |
|---|---|
| Henan Center for Disease Control and Prevention | OTHER_GOV |
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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 12-60 years, for a randomized, blind, placebo-controlled, age-stratified clinical study. The investigators designed three dosage groups: 7.5 μg,15 μg and 30 μg of hemagglutinin antigen. According to the age of the subjects, Each group was divided into different age subgroups. Phosphate buffer solution and Aluminum hydroxide adjuvant as placebo controls were both set up in the subgroups.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 were determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7.5μg H7N9 Vaccine | Experimental | Participants will receive 2 doses of 7.5μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals. |
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| 15μg H7N9 Vaccine | Experimental | Participants will receive 2 doses of 15μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals. |
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| 30μg H7N9 vaccine | Experimental | Participants will receive 2 doses of 30μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals. |
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| Aluminum hydroxide adjuvant | Placebo Comparator | Participants will receive 2 doses of aluminum hydroxide adjuvant at 21-day intervals. |
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| Phosphate buffer solution | Placebo Comparator | Participants will receive 2 doses of phosphate buffer solution at 21-day intervals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7.5μg 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 |
|---|---|---|
| Reactogenicity Events |
| 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 |
|---|---|---|
| Ze Chen, PhD | Shanghai Institute Of Biological Products | 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 17, 2017 | Nov 27, 2017 | Prot_SAP_000.pdf |
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| Phosphate Buffer Solution | Biological | 0.5ml phosphate buffer solution |
|
| Aluminum Hydroxide Adjuvant | Biological | 0.5ml aluminum hydroxide adjuvant |
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| 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. |
|
| 30μg 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. |
|
| 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 |