A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults over 60 Years of Age

JRCT ID: jRCT2031220274

Registered date:15/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prevention of infections caused by Respiratory Syncytial virus
• Date of first enrollment: 01/09/2022
• Target sample size: 700
• Countries of recruitment: Argentina,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,Colombia,Japan,Costa Rica,Japan,Finland,Japan,Germany,Japan,Mexico,Japan,Netherlands,Japan,New Zealand,Japan,Panama,Japan,Poland,Japan,Puerto Rico,Japan,Singapore,Japan,South Africa,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,UK,Japan,USA,Japan
• Study type: Interventional
• Intervention(s): Participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio. Investigational product will be administered as a single IM injection on Day 1. The injection will have a volume of 0.5 mL and contains mRNA-1345 or saline placebo.

Outcome(s)

Primary Outcome

Safety Endpoint:
Numbers and percentages of participants with solicited local and systemic adverse reactions (ARs) up to 7 days postinjection.

Number of participants with unsolicited adverse events (AEs) up to 28 days postinjection.

Number of participants with medically attended adverse events (MAAEs), adverse events of special interest (AESIs), serious adverse events (SAEs), and AEs leading to withdrawal up to 24 months postinjection.

Efficacy Endpoint:
Vaccine efficacy of mRNA-1345 to prevent a first episode of RSV-LRTD within the period of 14 days postinjection up to 12 months postinjection.

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Adults over 60 years of age who are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medical diagnoses (specifically chronic heart failure [CHF] and chronic obstructive pulmonary disease [COPD]), but should be medically stable as assessed by the following criteria: absence of changes in medical therapy within 1 month due to treatment failure or toxicity; absence of medical events qualifying as SAEs within 1 month of the planned study injection on Day 1; and absence of known, current, and life-limiting diagnoses, which could continue for the duration of the primary efficacy period (12 months from study injection on Day 1) and which, in the opinion of the investigator, would make completion of the protocol unlikely.

Body mass index from over18 kilograms(kg)/square meter (m2) to under 35 kg/m2.

Exclude criteria

Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 45 days before the planned date of the Day 1 vaccination.

Prior participation in research involving receipt of any investigational RSV product (drug/biologic/device).

History of a serious reaction to any prior vaccination or Guillain-Barre syndrome within 6 weeks of any prior influenza immunization.

Received or plans to receive any nonstudy vaccine (including authorized or approved vaccines for the prevention of COVID-19 regardless of type of vaccine) within 28 days before or after the Day 1 study injection. Nonstudy vaccination(s) should not be delayed.

Related Information

• Primary Sponsor: Azuma Yuki
• Secondary ID(s): NCT05127434,2021-005026-20