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A Ph2, randomized, double-blind, dose finding study to describe the immunogenicity, safety and tolerability of VN-0200 in Japanese adults aged 60-80 years

A Ph2, randomized, double-blind, dose finding study to describe the immunogenicity, safety and tolerability of VN-0200 in Japanese adults aged 60-80 years

Inoguchi Akihiro

DAIICHI SANKYO Co.,Ltd.

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

dsclinicaltrial@daiichisankyo.co.jp

Contact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

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

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

Complete

Oct. 12, 2022

Interventional

randomized controlled trial

double blind

dose comparison control

parallel assignment

prevention purpose

1) Healthy Japanese subjects aged 60 to 80 years of age at the time of informed consent.
2) Subjects who complied with the compliance instructions in the study, underwent physical examination and examinations specified in the protocol, and were able to report symptoms, etc.

-Serious cardiovascular, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disorders.
-Serious acute illness.
-Has been diagnosed with congenital or acquired immunodeficiency.
-Previous vaccination with an RSV vaccine (including the investigational drugs)
-Having a history of anaphylaxis or severe allergies due to medicines, or vaccination, etc.
-Administration of gamma globulins, systemic immunosuppressants (including drugs for the treatment of autoimmune diseases), hematopoietics (excluding iron and vitamins), and corticosteroids (excluding topical preparations, inhalants, and small-dose short-term oral administration*) or planned administration of them in the period starting 28 days prior to informed consent and ending 28 days after the second vaccination. * <14 days, <=20 mg/day on a prednisolone basis.
-Planned or actual administration of other vaccine in the period starting 14 days prior to informed consent and ending 14 days after the second vaccination., etc.

Both

Prevention of respiratory syncytial viral infection

VN-0200 0.5 mL is intramuscularly administered twice at upper arm on Day 1 and Day 29.

Geometric mean titer (GMT) and geometric mean fold rise (GMFR) of anti-RSV/A (RSV subgroup A) neutralizing activity on 28 days after the second administration of the study drug (Day 57)

Efficacy
- GMT and GMFR of anti-RSV/A neutralizing activity on 28 days after the first administration of the Study Drug (Day 29)
- GMT and GMFR of anti-RSV/B (RSV subgroup B) neutralizing activity on Day 29 and Day 57
- GMT and GMFR of anti-VAGA-9001a antibody on Day 29 and Day 57
- Summary statistics of VAGA-9001a-specific IFN-r production responses on Day 29 and Day 57

Safety
- Solicited adverse events (injection site and systemic), Non-solicited adverse events, Serious adverse events, Laboratory test values, Potential immune-mediated disease (pIMD)

+81-92-283-7701

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/

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