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A Phase 3, Randomized, Observer-blinded Study of Low and High titer JVC-001 in Healthy Japanese Children 1 Year of Age

A Phase 3, Randomized, Observer-blinded Study of Low and High titer JVC-001 in Healthy Japanese Children 1 Year of Age

102

The mean (standard deviation [SD]) age was 12.6 (0.99) months in the Low-titer JVC-001 group and 13.0 (1.74) months in the High-titer JVC-001 group. The proportion of male were 64.6% (31/48) and 38.5% (20/52), mean (SD) body weights were 9.36 (0.984) kg and 8.91 (0.969) kg. The number of participants with a history of prior medical history was 47.9% (23/48) and 32.7% (17/52), and the number of participants with complications was 56.3% (27/48) and 51.9% (27/52). Aside from a higher population of male participants in the Low- versus High-titer JVC-001 group, there were no significant differences in baseline characteristics between the groups.

In total, 102 participants were enrolled and randomized, and 100 (Low-titer JVC-001 group: n=48, High-titer JVC-001 group: n=52) received the vaccination and completed the study. Two participants who did not receive the vaccination after randomization were discontinued because blood could not be collected due to thin veins.

The incidence of adverse events was 89.6% (43/48) in the Low-titer JVC-001 group and 90.4% (47/52) in the High-titer JVC-001 group. No adverse events resulting in death or discontinuation due to adverse events were observed. The incidence of injection site solicited adverse events was as follows: injection site pain (Low-titer JVC-001 group: 2.1%, High-titer JVC-001 group: 9.6%), injection site swelling (2.1%, 5.8%), and injection site erythema (12.5%, 25.0%). All events were judged to be related to the vaccination, were mild or moderate in severity, and no severe events were observed. The incidence of severe fever was 12.5% in the Low-titer JVC-001 group and 9.6% in the High-titer JVC-001 group. Measles-like rash, rubella-like rash, salivary gland swelling, and meningitis were not observed in either group. The incidence of unsolicited adverse events was as followed; upper respiratory tract (Low-titer JVC-001 group: 10.4%, High-titer JVC-001 group: 13.5%), bronchitis (10.4%, 7.7%), pharyngitis (8.3%, 7.7%), fever (6.3%, 7.7%), and sudden rash (6.3%, 3.8%).

The seropositve rate of antibody titers in the Low-titer JVC-001 group and High-titer JVC-001 group was 97.9% (95% CI: 88.9 to 99.9) and 100.0% (93.2 to 100.0) against measles virus; 100.0% (92.6 to 100.0) and 100.0% (93.2 to 100.0) against rubella virus; 95.7% (85.5 to 99.5) and 94.2% (84.1 to 98.8) against mumps virus genotype D.

The seroconversion rate of antibody titers against measles virus on Day 43 was 97.9% (95% CI: 88.9 to 99.9) in the Low-titer JVC-001 group and 100.0% (93.2 to 100.0) in the High-titer JVC-001 group. The seroconversion rate of antibody titers against rubella virus on Day 43 was 100.0% (92.6 to 100.0) in the Low-titer JVC-001 group and 100.0% (93.2 to 100.0) in the High-titer JVC-001 group. The seroresponse rate of antibody titers against mumps virus genotype D on Day 43 was 91.3% (72.0 to 98.9) in the Low-titer JVC-001 group and 93.1% (77.2 to 99.2) in the High-titer JVC-001 group. The GMT against measles virus on Day 43 was 37.0-fold (28.8 to 47.4) in the Low-titer JVC-001 group and 38.1-fold (30.9 to 46.9) in the High-titer JVC-001 group. The GMT against rubella virus on Day 43 was 77.2-fold (63.6 to 93.7) in the Low-titer JVC-001 group and 63.2-fold (51.0 to 78.3) in the High-titer JVC-001 group. The GMT against mumps virus genotype D on Day 43 was 42.2ED50 (29.8 to 59.7) in the Low-titer JVC-001 group and 38.7 ED50 (28.4 to 52.8) 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]).

The immunogenicity and safety of the Low-titer and High-titer JVC-001 against measles, rubella, and mumps virus Genotype D were investigated in healthy Japanese children. Both the Low-titer JVC-001 group and High-titer JVC-001 groups showed sufficient antibody levels against measles, rubella, and mumps virus Genotype D on Day 43, and the safety of these groups after vaccination was considered tolerable.

Feb. 06, 2025

https://www.sciencedirect.com/science/article/pii/S0264410X2401380X

Yes

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/

Inoguchi Akihiro

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

dsclinicaltrial_jp@daiichisankyo.com

Contact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial_jp@daiichisankyo.com

completed

Feb. 01, 2020

Interventional

multicenter, randomized, observer-blinded

prevention purpose

3

Japanese healthy children of 12 months and older and younger than 24 months

- Subjects with history of measles, mumps, or rubella infection
- Subjects with measles, mumps, or rubella infection
- Subjects with history of measles, mumps, or rubella virus vaccination

Both

Prophylaxis of measles, mumps, and rubella

investigational material(s)
Generic name etc : freeze-dried live attenuated measles, mumps, rubella combined vaccine
INN of investigational material : -
Therapeutic category code : 631 Vaccines
Dosage and Administration for Investigational material : subcutaneous injection

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

efficacy
- Seroprotection rate of anti-measles virus antibody
- Seroprotection rate of anti-rubella virus antibody
- Seroprotection rate of anti-mumps virus antibody

efficacy
- Seroconversion rate and GMT of anti-measles virus antibody
- Seroconversion rate and GMT of anti-rubella virus antibody
- Seroconversion rate, seroresponse rate, and GMT of anti-mumps virus antibody

Dec. 20, 2019