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| Name | Class |
|---|---|
| Zhejiang Provincial Center for Disease Control and Prevention | OTHER_GOV |
| Henan Center for Disease Control and Prevention | OTHER_GOV |
| Guizhou Center for Disease Control and Prevention | OTHER |
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Subjects will be recruited and divided into 3 groups:
All blood samples will be collected before and one month after vaccinatioin. The immunogenicity and safety of both experimental and control groups will be compared and the data be analyzed.
To further evaluate the feasibility of simultaneously administration of EV71 vaccine and flu vaccine, we design this clinical trial to test its immunogenicity and safety. 1134 subjects aged from 6 to 11 months old are divided into one experimental group and two control groups (control group A and B).
378 subjects from the experimental group will be simultaneously administrated with one dose of EV71 vaccine (0.5 ml) and one dose of influenza vaccine (0.25 ml). One month later, they are going to receive a second dose of EV71 vaccine and influenza vaccine, simultaneously. Blood samples are collected before the first vaccination, and one month following the second vaccination.
378 subjects from the control group A will be only administrated with two doses of EV71 vaccine (0.5 ml) (1 month apart). Blood samples are collected before the first vaccination, and one month following the second vaccination.
378 subjects from the control group B will be only administrated with two doses of influenza vaccine (0.25 ml) (1 month apart). Blood samples are collected before the first vaccination, and one month following the second vaccination.
To evaluate the immunogenicity, we will detect and compare the neutralization antibody levels, the seroprotection rates, and antibody geometric mean concentrations. The safety of all groups will be monitored as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | 378 subjects from the experimental group will be simultaneously administrated with one dose of EV71 vaccine (0.5 ml) and one dose of influenza vaccine (0.25 ml). One month later, they are going to receive a second dose of EV71 vaccine and influenza vaccine, simultaneously. |
|
| control group A | Active Comparator | 378 subjects from the control group A will be only administrated with two doses of EV71 vaccine (0.5 ml) (1 month apart). |
|
| control group B | Active Comparator | 378 subjects from the control group B will be only administrated with two doses of influenza vaccine (0.25 ml) (1 month apart). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV71 vaccine and influenza vaccine | Biological | simultaneously administrated with EV71 vaccine and influenza vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate I | the rate of positive seroconversion against EV71 | Baseline (before vaccination) and 1 month after the last dose |
| Seroconversion rate II | the rate of positive seroconversion against Influenza A (H3N2, H1N1) and B Type viruses | Baseline (before vaccination ) and 1 month after the last dose |
| Geometric mean titer (GMT) I | Measure neutralizing antibody titers against EV71 | Baseline (before vaccination) and 1 month after the last dose |
| Geometric mean titer (GMT) II | Measure neutralizing antibody titers against Influenza A (H3N2, H1N1) and B Type viruses | Baseline (before vaccination) and 1 month after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events following vaccination | analyse the numbers and rates of participants who experience adverse events following immunization | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanqing He | Zhejiang Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang provincial center for disease control and prevention | Hangzhou | Zhejiang | 310051 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36569946 | Derived | Chen Y, Xiao Y, Ye Y, Jiang F, He H, Luo L, Chen H, Shi L, Mu Q, Chen W, Guo X, Zhang M, Li J, Guan Q, Chen Z, Yang X. Immunogenicity and safety of an inactivated enterovirus 71 vaccine coadministered with trivalent split-virion inactivated influenza vaccine: A phase 4, multicenter, randomized, controlled trial in China. Front Immunol. 2022 Dec 8;13:1080408. doi: 10.3389/fimmu.2022.1080408. eCollection 2022. |
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| Wuhan Institute of Biological Products Co., Ltd | INDUSTRY |
| Changchun Institute of Biological Products Co., Ltd. | INDUSTRY |
| Peking University | OTHER |
| National Institutes for Food and Drug Control, China | OTHER |
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| EV71 vaccine | Biological | administrated with EV71 vaccine only |
|
| influenza vaccine | Biological | administrated with influenza vaccine only |
|
| ID | Term |
|---|---|
| D004769 | Enterovirus Infections |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D009976 | Orthomyxoviridae Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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