臨床研究等提出・公開システム
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Jan. 20, 2020 |
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Dec. 21, 2022 |
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jRCT2080225026 |
A Phase 3, Randomized, Observer-blinded Study of JVC-001 Compared to Active-controlled in Healthy Japanese Children 1 Year of Age |
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A Phase 3, Randomized, Observer-blinded Study of JVC-001 Compared to Active-controlled in Healthy Japanese Children 1 Year of Age |
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Nov. 25, 2020 |
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862 |
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The mean (standard deviation [SD]) age was 12.9 (1.90) months in the JVC-001 group and 12.9 (1.63) months in the control group. The proportion of male were 52.0% (223/429) and 50.0% (216/432), mean (SD) body weights were 9.40 (1.100) kg and 9.23 (1.069) kg. The number of participants with a history of prior medical history was 38.0% (163/429) and 39.1% (169/432), and the number of participants with complications was 60.6% (260/429) and 56.0% (242/432). There were no significant differences in baseline characteristics between the groups. |
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In total, 862 participants were enrolled and randomized, and 861 (JVC-001: n=429, control: n=432) received the study vaccine and completed the study. One participant in the control group did not receive vaccine and the study was discontinued. |
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The incidence of adverse events was 85.8% (368/429) in the JVC-001 group and 86.6% (374/432) in the control group. No adverse events resulting in death or discontinuation due to adverse events were observed. There were 5 serious adverse events in 5 participates (JVC-001 group: 1 participate、control group: 4 participates). The incidence of injection site solicited adverse events was erythema 19.8% (85/429) and 18.3% (79/432), swelling 6.3% (27/429) and 7.2% (31/432), pain 3.0% (13/429) and 3.9% (17/432). Most injection site solicited adverse events were judged to be related to the vaccination, most were mild or moderate, and severe events were observed in one participate in each vaccination group (JVC-001 group: erythema; control group: swelling). The incidence of systemic solicited adverse events was 64.6% (277/429) and 70.8% (306/432) for fever, of which 38.7% (166/429) and 43.3% (187/432) were determined to be related to the vaccination. Measles-like rash was 0.2% (1/429) and 0.5% (2/432), both of which were judged to be related to the vaccination. Parotid swelling was observed in one patient in the control group and was judged to be related to the vaccination. Rubella-like rash, salivary gland swelling, and meningitis were not observed in either group. The incidence of unsolicited adverse events was 66.7% (286/429) and 69.7% (301/432), and common events were inflammation of the upper respiratory tract (JVC-001 group: 21.7%, Control group: 19.9%), nasopharyngitis (10.5%, 12.7%), exanthema subitum (5.4%, 9.0%), eczema (5.8%, 6.3%), and gastroenteritis (3.7%, 4.6%). |
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The seropositve rate of antibody titers in the JVC-001 and control groups was 99.8% (95% CI: 98.7 to 100.0) and 100.0% (99.1 to 100.0) against measles virus (between group difference: -0.2% [-1.3 to 0.7]); 99.5% (98.3 to 99.9), and 99.5% (98.3 to 99.9) against rubella virus (between-group difference: 0.0% [-1.3 to 1.3]). As for the immune response against mumps virus genotype D, the seropositive rate in the JVC-001 and control groups was 80.6% (76.5 to 84.4) and 88.1% (84.6 to 91.0) (between-group difference: -7.5% [-12.5 to -1.9]). The lower 95% CI limit of the between-group difference did not fall below the non-inferiority margin of -10% for the measles and rubella virus antibody titers but did for mumps virus genotype D antibody titers; thus, the non-inferiority of JVC-001 to the control vaccine was not confirmed. |
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The seroconversion rate of antibody titers against measles virus and rubella virus on Day 43 was 100.0% (95% CI: 99.1 to 100.0), 99.5% (98.3 to 99.9) for the JVC-001 group and 100.0% (99.1 to 100.0), 99.5% (98.3 to 99.9) for the control group. The seroresponse rate of antibody titers against mumps virus genotype D virus on Day 43 was 75.9% (75.8 to 84.3) for the JVC-001 and 87.1% (83.1 to 90.4) for control groups. The seroconversion rate of mumps virus genotype G was 75.9% (71.5 to 79.9) for the JVC-001 group and 82.0% (78.0 to 85.5) for the control group. The GMT against measles virus on Day 43 was 35.1-fold (95% CI: 32.6 to 37.7) in the JVC-001 group and 36.2-fold (33.7 to 38.9) in the control group (GMT ratio: 1.0 [0.9 to 1.1]). The GMT against rubella virus on Day 43 was 71.1-fold (66.5 to 76.0) in the JVC-001 group and 77.8-fold (73.1 to 82.9) in the control group (GMT ratio: 0.9 [0.8 to 1.0]). The GMT against mumps virus genotype D on Day 43 was 15.1 ED50 (13.3 to 17.1) in the JVC-001 group and 29.8 ED50 (25.8 to 34.6) in the control group (GMT ratio, 0.5 [0.4 to 0.6]). The GMT against mumps virus genotype G was 9.0-fold (8.1 to 10.0) in the JVC-001 group and 10.8-fold (9.8 to 12.0) in the control group (GMT ratio: 0.8 [0.7 to 1.0]). |
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The seropositive rates for measles and rubella virus after JVC-001 vaccination met the non-inferiority criteria compared to the control group, the seropositive rate for mumps virus genotype D did not meet the non-inferiority criteria, and the non-inferiority of JVC-001 compared to the control group could not be established. However, seropositive rate for mumps virus genotype D at Day 43 in JVC-001 group was approximately 80%. The safety of JVC-001 after vaccination was considered tolerable. |
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Feb. 06, 2025 |
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https://www.sciencedirect.com/science/article/pii/S0264410X2401380X |
Yes |
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De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/ Supporting Information: -Study Protocol -Statistical Analysis Plan (SAP) -Informed Consent Form (ICF) Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication. Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent. URL: https://vivli.org/ourmember/daiichi-sankyo/ |
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| version:VERSION 1.1 date:April. 28, 2020 |
Inoguchi Akihiro |
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DAIICHI SANKYO Co.,Ltd. |
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1-2-58, Hiromachi, Shinagawa-ku, Tokyo |
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+81-3-6225-1111 |
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dsclinicaltrial_jp@daiichisankyo.com |
Contact for Clinical Trial Information |
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DAIICHI SANKYO Co.,Ltd. |
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dsclinicaltrial_jp@daiichisankyo.com |
completed |
Feb. 01, 2020 |
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| 840 | ||
Interventional |
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multicenter, randomized, active-controlled, observer-blinded, parallel-group comparative study |
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prevention purpose |
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3 |
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Japanese healthy children of 12 months and older and younger than 24 months |
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- Subjects with history of measles, mumps, or rubella infection |
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| 12month old over | ||
| 23month old under | ||
Both |
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Prophylaxis of measles, mumps, and rubella |
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investigational material(s) |
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confirmatory |
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efficacy |
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| DAIICHI SANKYO Co.,Ltd. | |
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| - | |
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| Kitamachi ethic committee | |
| 1-1-3, Kichijoji Kitamachi, Musashino city, Tokyo | |
| approved | |
Jan. 15, 2020 |
| JapicCTI-205118 | |
| Japan |