A Phase 1, Dose-Escalation, Randomized, Active-Controlled, Modified Double-Blind, Parallel-Group, Multi-Arm Study to Investigate the Safety and Immunogenicity of a Combined Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adult Participants Aged 60 Years and Older

Status: Active_not_recruiting

Location: See all (8) locations...

Intervention Type: Biological

Study Type: Interventional

Study Phase: Phase 1

SUMMARY

The purpose of this phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called antibodies (immunogenicity) against the respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The study will use different doses of PIV3 only and different combinations of RSV/hMPV/PIV3 or RSV/hMPV or only RSV vaccine in adults aged 60 years and older.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 60

Healthy Volunteers: t

View:

• Aged 60 years or older on the day of inclusion (means from the means from the day of the 60th birthday).

• Informed consent form (ICF) has been signed and dated

• A female participant is eligible to participate if she is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.

Locations

Other Locations

Australia

Investigational Site Number : 0360003

Bayswater

Investigational Site Number : 0360006

Blacktown

Investigational Site Number : 0360001

Botany

Investigational Site Number : 0360009

Brookvale

Investigational Site Number : 0360002

Camberwell

Investigational Site Number : 0360008

Herston

Investigational Site Number : 0360005

Kanwal

Investigational Site Number : 0360004

Miranda

Time Frame

Start Date: 2024-09-17

Completion Date: 2026-03-05

Participants

Target number of participants: 390

Treatments

Experimental: PIV3 Dose 1