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A Dose Finding Study of VN-0200 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Dose Finding Study of VN-0200

A Phase 2, Randomized, Double-Blind, Dose Finding Study to Describe the Immunogenicity, Safety and Tolerability of VN-0200 in Japanese Adults Aged 60-80 Years

NCT05547087•Daiichi Sankyo

View on ClinicalTrials.gov

Summary

This study will assess the immunogenicity, safety and tolerability of VN-0200 after intramuscular injections in Japanese healthy elderly subjects.

Eligibility

Age

60 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Japanese healthy elderly aged \>=60 and =\<80 years (at the time of informed consent).
•Subjects who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc.

Exclusion Criteria

•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.
•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.

Locations (3)

SOUSEIKAI PS Clinic

Hakata, Fukuoka, Japan

SOUSEIKAI Sumida Hopital

Sumida City, Tokyo, Japan

SOUSEIKAI Nishi-Kumamoto Hospital

Kumamoto, Japan

Key Dates

Start Date

October 13, 2022

Primary Completion Date

April 11, 2023

Completion Date

February 15, 2024

Last Updated

February 29, 2024

Enrollment

342

ACTUAL participants

Conditions

Respiratory Syncytial Virus Infections

Interventions

VN-0200

BIOLOGICAL

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Respiratory Syncytial Virus Infections

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RECRUITINGPHASE2

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

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Respiratory Syncytial Virus Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 29, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Dose Finding Study of VN-0200

Inclusion Criteria

Exclusion Criteria

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

Genotype and Disease Burden of RSV in Older Vietnamese Adults (RSV: Respiratory Syncytial Virus )

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children

Evaluating the Benefits of RSV Maternal Vaccination Using a Scottish National Dataset