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.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513740-28-00

Acronym

D8610C00001

Enrollment

3714

Registered

2024-11-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus and Human Metapneumovirus

Brief summary

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

Detailed description

Occurrence of the first RSV-confirmed LRTD (confirmed RSV A and/or B associated LRTD) starting on Day 15 over two seasons, Occurrence of the first hMPV-confirmed LRTD (confirmed hMPV A and/or B associated LRTD) starting on Day 15 over two seasons, Occurrence of the first RSV-confirmed severe LRTD (confirmed RSV A and/or B associated LRTD) starting on Day 15 over two seasons, Occurrence of the first hMPV-confirmed severe LRTD (confirmed hMPV A and/or B associated LRTD) starting on Day 15 over two seasons

Interventions

DRUGPlacebo is 0.9% (w/v) NaCl for injection and is to be provided by sites.

DRUGIVX-A12

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
Occurrence of the first RSV-confirmed LRTD (confirmed RSV A and/or B associated LRTD) starting on Day 15 over two seasons, Occurrence of the first hMPV-confirmed LRTD (confirmed hMPV A and/or B associated LRTD) starting on Day 15 over two seasons, Occurrence of the first RSV-confirmed severe LRTD (confirmed RSV A and/or B associated LRTD) starting on Day 15 over two seasons, Occurrence of the first hMPV-confirmed severe LRTD (confirmed hMPV A and/or B associated LRTD) starting on Day 15 over two seasons	—

Measure

Time frame

—

Countries

Belgium, Bulgaria, Estonia, Finland, Germany, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026