臨床研究等提出・公開システム

A Phase 3, Open-label Study of JVC-001 in Healthy Japanese Children 5 to 6 Years of Age

A Phase 3, Open-label Study of JVC-001 in Healthy Japanese Children 5 to 6 Years of Age

100

The mean (standard deviation [SD]) age was 5.2 (0.36) years. The proportion of male were 58.0% (58/100), mean (SD) body weights were 18.88 (2.019) kg. The number of participants with a history of prior medical history was 35.0% (35/100) and the number of participants with complications was 71.0% (71/100). The persistence effect of antibody titer for each type of vaccine in the past (seropositive rate about 4 years after the first vaccination) was as follows: measles virus antibody titer was 97.5% (78/80) for MR vaccine and 100.0% (20/20) for JVC-001, rubella virus antibody titer was 96.3% (77/80) for MR vaccine and 100.0% (20/20), and mumps virus genotype D antibody titer was 93.8% (75/80) for mumps vaccine (Torii and Hoshino strains) and 95.0% (19/20) for JVC-001.

In total, 100 participants were enrolled and received the vaccination. All participants were completed the study.

The incidence of adverse events was 70.0% (70/100). 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 (14.0% [14/100]), injection site swelling (14.0% [14/100]), and injection site erythema (24.0% [24/100]). 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 fever was 29.0% (29/100), of which the incidence of events judged to be related to the vaccination was 13.0% (13/100). Measles-like rash, rubella-like rash, parotid swelling, salivary gland swelling, and meningitis were not observed. The incidence of unsolicited adverse events was as followed; nasopharyngitis 8.0% (8/100), upper respiratory tract 7.0% (7/100), gastroenteritis 6.0% (6/100), conjunctivitis allergic 5.0% (5/100), and eczema 4.0% (4/100).

The seropositive rate against measles virus, rubella virus, and mumps virus (Genotype D) at Day 43 of the second vaccination with JVC-001 were 100.0% (95%CI: 96.4 to 100.0), 100.0% (96.4 to 100.0), and 100.0% (96.3 to100.0). The induction of sufficient antibodies was confirmed by JVC-001 second vaccination regardless of the type of measles and rubella virus vaccine or mumps virus vaccine in first vaccination.

The seroconversion rate against measles virus and rubella virus at Day 43 of the second vaccination with JVC-001 were 100.0% (95% CI: 15.8 to 100.0) and 100.0% (29.2 to 100.0), respectively. The seroresponse rate against mumps virus Genotype D at Day 43 of the second vaccination with JVC-001 were 100.0% (47.8 to 100.0). The GMT against measles virus, rubella virus, mumps virus Genotype D at Day 43 of the second vaccination with JVC-001 were 55.7-fold (95% CI: 49.1 to 63.2), 99.0-fold (87.7 to 111.8), 89.0 ED50 (71.5 to 112.2), respectively.

A second vaccination with JVC-001 demonstrated sufficient antibody against measles, rubella, and mumps viruses on Day43. Most children had antibody titers above the cut-off levels against measles and rubella virus at about 4 years after the first vaccination, but some children had a decrease in mumps virus antibody titers. A second vaccination of JVC-001 was considered useful for reducing the risk in these children. The safety profile of second vaccination with JVC-001 was tolerable.

July. 29, 2024

https://www.jiac-j.com/article/S1341-321X(24)00166-1/fulltext

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

dsclinicaltrial_jp@daiichisankyo.com

completed

Feb. 01, 2020

Interventional

multicenter, open-label study

prevention purpose

3

- Japanese healthy children of 5 years and older and younger than 6 years
- Subjects with history of measles, mumps, and rubella virus vaccination

Subjects with measles, mumps, or rubella infection

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