Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-17

Study Completion Date

2026-03-25

Brief Summary

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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.

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Detailed Description

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The study duration will be up to approximately 12 months minus the screening period.

Conditions

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Respiratory Syncytial Virus Infection Metapneumovirus Infection Parainfluenzae Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Modified double-blind study

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

-Investigators, Sponsor and study site staff, laboratory personnel, and participants will be blinded. Study staff preparing/administering the study interventions will be unblinded. Specific Sponsor personnel will be unblinded for the assessment of safety in the sentinel cohorts

Study Groups

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