臨床研究等提出・公開システム

A Phase 3, Global, Randomized, Modified Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of IVX-A12, a Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (hMPV) Virus-Like Particle (VLP) Vaccine, in Adults 60 Years of Age and Older

A Phase 3 study of IVX-A12 in Adults 60 Years of Age and Older

Falsey Ann

University of Rochester School of Medicine

-

ann.falsey@rochesterregional.org

jRCT Inquiry Contact IQVIA Services Japan G.K.

IQVIA Services Japan G.K.

Keikyu Dai-1 Building 4-10-18 Takanawa, Minato-ku, Tokyo

+81-3-6859-9500

JP-Gemini-CL@iqvia.com

Complete

Aug. 01, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

- Participant >= 60 years of age at the time of signing the informed consent.
- Participants who are medically stable in the opinion of the Investigator at the time of study intervention. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension, or cardiac disease, are allowed to participate in this study if considered by the Investigator as medically stable.
- Able to understand and comply with study requirements/procedures including attending all scheduled study visits (if applicable, with assistance by caregiver, surrogate, or legally authorized representative or equivalent representative as locally defined) based on the assessment of the Investigator.
- Participants who are capable of giving signed informed consent as described in Appendix A 3, which includes compliance with the requirements and restrictions listed in the ICF and this protocol, and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the US) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.

- Acute (time-limited) or febrile (temperature >= 38.0 degrees C [100.4 F]) illness/infection within 3 days prior to or on day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves and may be rescreened once.
- History of a clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder) contraindicating IM injections or venipuncture based on Investigator judgement.
- History of Guillain-Barre syndrome or any other demyelinating condition.
- Receipt of any licensed or investigational RSV and/or hMPV vaccine within the past 6 months prior to administration of study intervention, or planned receipt during the study.
- Receipt of any licensed vaccine (other than licensed influenza or COVID-19 vaccines) within 28 days prior to Visit 1, or expected receipt prior to the end of Visit 2 assessments. Licensed influenza or COVID-19 vaccines are permitted beginning > 14 days before and > 14 days after administration of study intervention.
- Receipt of immunoglobulin or blood products within 3 months prior to administration of study intervention, or planned receipt during the study.
- Receipt of immune-modifying drugs or immunosuppressive therapy (eg, anti-cancer chemotherapy, anti-cytokine therapy, or radiation therapy) within 6 months prior to Visit 1 (or planned receipt during study).
- Long-term systemic corticosteroid therapy (prednisone or equivalent at a dose of >= 20 mg daily or every other day for more than 2 consecutive weeks) within 6 months prior to Visit 1. Topical/inhaled steroids or short-term oral steroids are permitted.

Both

RSV and hMPV associated lower respiratory tract disease

IVX-A12 300ug or Placebo are intramuscularly dosed at Visit1 (Season1) and Visit4 (Season4). Participants are supposed to be randomized in either IVX-A12 or Placebo in Season1.
Those who were randomized in IVX-A12 in Season1 will be randomized in either IVX-A12 or Placebo in Season2, whereas those who were randomized in placebo in season1 will be assigned a Placebo again in season2.

- Occurrence of the first RSV-confirmed LRTD (confirmed RSV A and/or B associated LRTD) starting on Day 15 during the first season
- Occurrence of the first hMPV-confirmed LRTD (confirmed hMPV A and/or B associated LRTD) starting on Day 15 during the first season

+81-3-5213-0028

Aug. 16, 2024

No

France/UK/Canada/USA/South Korea/Taiwan