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| Name | Class |
|---|---|
| Zhejiang Provincial Center for Disease Control and Prevention | OTHER_GOV |
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The main objective of this study is to evaluate the persistence of Japanese encephalitis antibodies in participants at the age of 6, after they have followed different Japanese encephalitis vaccination schedules. Furthermore, the study will assess the immunogenicity and antibody persistence of primary immunization across different Japanese encephalitis vaccination schedules, as well as the immunogenicity following booster immunizations within these schedules. The safety of each vaccine dose will also be evaluated.
This is a randomized, controlled, open-label, non-inferiority study. Healthy children aged 8 months will be invited to participate and randomly allocated to six groups (Group 1 to Group 6) in a 1:1:1:1:1:1 ratio. They will be administered the inactivated Japanese encephalitis vaccine (JEV-I) and/or the live attenuated Japanese encephalitis vaccine (JEV-L) based on the six schedules delineated in the protocol. The primary immunization will be administered to participants at 8 months of age, and a booster dose will be given at 24 months of age. Additionally, participants in Groups 1, 2, and 5 will receive an additional booster dose at the age of 6.
Blood samples (3 mL) will be collected from participants at 8 months, 24 months, and 6 years of age. Samples will be taken before vaccination and 30 days after it for detecting Japanese encephalitis neutralizing antibodies. The titers of these antibodies will be assayed via the 50% plaque reduction neutralization test. Those in groups 3, 4, and 6 who've completed all immunization procedures by 24 months old will have a blood sample taken at 6 years old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (4 doses of JEV-I) | Experimental | Participants will receive 2 doses of JEV-I (7-10 days apart) at 8 months of age, 1 dose of JEV-I at 24 months of age, and 1 dose of JEV-I at 6 years of age. |
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| Group 2 (4 doses of JEV-I) | Experimental | Participants will receive 2 doses of JEV-I (28-35 days apart) at 8 months of age, 1 dose of JEV-I at 24 months of age, and 1 dose of JEV-I at 6 years of age. |
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| Group 3 (2 doses of JEV-I and 1 dose of JEV-L) | Experimental | Participants will receive 2 doses of JEV-I (7-10 days apart) at 8 months of age and 1 dose of JEV-L at 24 months of age. |
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| Group 4 (1 dose of JEV-L and 2 doses of JEV-I) | Experimental | Participants will receive 1 dose of JEV-L at 8 months of age and 2 doses of JEV-I (7-10 days apart) at 24 months of age. |
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| Group 5 (1 dose of JEV-L and 2 doses of JEV-I) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Japanese Encephalitis Vaccine (Vero Cell), Inactivated | Biological | 0.5ml for each dose, manufactured by Liaoning Chengda Biotechnology Co., Ltd., administered in the deltoid area of lateral arm by intramuscular injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Testing Seropositive for Japanese Encephalitis Neutralizing Antibodies | The persistence of immunity following various Japanese encephalitis (JE) vaccination schedules is evaluated based on the proportion of participants exhibiting seropositivity for JE neutralizing antibodies at 6 years of age. Seropositivity is defined as a JE neutralizing antibody titer of at least 1:10, as ascertained by the 50% plaque reduction neutralization test. | 4 years after the booster vaccination at 24 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion Rates of Japanese Encephalitis Neutralizing Antibodies after Primary vaccination | The seroconversion rate is defined as the percentage of participants with a change in Japanese Encephalitis neutralizing antibody titer from <1:10 at baseline (pre-vaccination) to a titer of ≥1:10 30 days post-vaccination, or a 4-fold or greater rise from the baseline, as measured by the 50% plaque reduction neutralization test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huanyu Wang | Liaoning Chengda Biotechnology CO., LTD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiashan County Center for Disease Control and Prevention | Jiaxing | Zhejiang | China | |||
| Pinghu Center For Disease Control and Prevention |
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Participants will receive 1 dose of JEV-L at 8 months of age, 1 dose of JEV-I at 24 months of age, and 1 dose of JEV-I at 6 years of age. |
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| Group 6 (2 doses of JEV-L) | Active Comparator | Participants will receive 2 doses of JEV-L at 8 months of age, and 1 dose of JEV-L at 24 months of age. |
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| Japanese Encephalitis Vaccine, Live | Biological | 0.5ml for each dose, manufactured by Chengdu Institute of Biological Products Co., Ltd., administered subcutaneously in the lower part of the deltoid area of lateral arm. |
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| 30 days post-primary immunization |
| Geometric Mean Titer of Japanese Encephalitis Neutralizing Antibodies before and after Primary Immunization | pre-primary immunization (Day 0) and 30 days post-primary immunization |
| Percentage of Participants Testing Seropositive for Japanese Encephalitis Neutralizing Antibodies before and after Primary Immunization | Seropositivity is defined as a Japanese Encephalitis neutralizing antibody titer of at least 1:10, as ascertained by the 50% plaque reduction neutralization test. | pre-primary immunization (Day 0) and 30 days post-primary immunization |
| Seroconversion Rates of Japanese Encephalitis Neutralizing Antibodies after Booster vaccination | The seroconversion rate is defined as the percentage of participants with a change in Japanese Encephalitis neutralizing antibody titer from <1:10 at baseline (pre-vaccination) to a titer of ≥1:10 30 days post-vaccination, or a 4-fold or greater rise from the baseline, as measured by the 50% plaque reduction neutralization test | 30 days post-booster immunization |
| Geometric Mean Titer of Japanese Encephalitis Neutralizing Antibodies before and after booster Immunization | pre-booster immunization (Day 0) and 30 days post-booster immunization |
| Percentage of Participants Testing Seropositive for Japanese Encephalitis Neutralizing Antibodies before and after booster Immunization | Seropositivity is defined as a Japanese Encephalitis neutralizing antibody titer of at least 1:10, as ascertained by the 50% plaque reduction neutralization test. | pre-booster immunization (Day 0) and 30 days post-booster immunization |
| Incidence of any Local and Systemic Adverse Events Within 30 Days of Each Vaccination | Adverse events will be collected through a combination of proactive visits by researchers and participant reports | within 30 days of each vaccination |
| Jiaxing |
| Zhejiang |
| China |
| Dongyang Center for Disease Control and Prevention | Jinhua | Zhejiang | China |
| Yongkang Center for Disease Control and Prevention | Jinhua | Zhejiang | China |
| Yuyao Center for Disease Control and Prevention | Ningbo | Zhejiang | China |
| Jiangshan Center For Disease Control and Prevention | Quzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D022321 | Japanese Encephalitis Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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