NCT06604767

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

September 17, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2026

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

September 17, 2024

Last Update Submit

April 22, 2026

Conditions

Respiratory Syncytial Virus InfectionMetapneumovirus InfectionParainfluenzae Virus Infection

Outcome Measures

Primary Outcomes (10)

  • Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination

    Number of participants experiencing immediate unsolicited systemic AEs

    Within 30 minutes after each vaccination

  • Presence of solicited administration site reactions within 7 days after vaccination

    Number of participants reporting: \- injection site reactions: pain, erythema and swelling

    Within 7 days after vaccination

  • Presence of solicited systemic reactions within 7 days after vaccination

    Number of participants reporting: * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills

    Within 7 days after vaccination

  • Presence of unsolicited AEs within 28 days after vaccination

    Number of participants experiencing unsolicited AEs

    Within 28 days after vaccination

  • Presence of serious adverse events (SAEs)

    Number of participants experiencing SAEs regardless of causality

    Within 6 months after vaccination

  • Presence of adverse events of special interest (AESIs)

    Number of participants experiencing AESIs regardless of causality

    Within 6 months after vaccination

  • Presence of related SAEs throughout the study

    Number of participants experiencing related SAEs regardless of causality

    Throughout the study, approximately 12 months

  • Presence of related AESIs throughout the study

    Number of participants experiencing related AESIs regardless of causality

    Throughout the study, approximately 12 months

  • Presence of related fatal SAEs throughout the study

    Number of participants experiencing related fatal SAEs regardless of causality

    Throughout the study, approximately 12 months

  • Presence of out-of-range biological test results (including shift from baseline values)

    Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)

    Within 7 days after vaccination

Secondary Outcomes (4)

  • RSV A serum neutralizing antibody (nAb) titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines

    At Day 01 and Day 29

  • RSV B serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines

    At Day 01 and Day 29

  • hMPV A serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 vaccines

    At Day 01 and Day 29

  • PIV3 serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV/PIV3 and PIV3 vaccines

    At Day 01 and Day 29

Study Arms (9)

PIV3 Dose 1

EXPERIMENTAL

Participants will receive a single intramuscular (IM) injection at Day 1

Biological: parainfluenza virus type 3 vaccine (PIV3)

PIV3 Dose 2

EXPERIMENTAL

Participants will receive a single intramuscular (IM) injection at Day 1

Biological: parainfluenza virus type 3 vaccine (PIV3)

PIV3 Dose 3

EXPERIMENTAL

Participants will receive a single intramuscular (IM) injection at Day 1

Biological: parainfluenza virus type 3 vaccine (PIV3)

PIV3 Dose 4

EXPERIMENTAL

Participants will receive a single intramuscular (IM) injection at Day 1

Biological: parainfluenza virus type 3 vaccine (PIV3)

RSV/hMPV /PIV3 Formulation 1

EXPERIMENTAL

Participants will receive a single intramuscular (IM) injection at Day 1

Biological: RSV/hMPV/PIV3 vaccine

RSV/hMPV Formulation 1

EXPERIMENTAL

Participants will receive a single intramuscular (IM) injection at Day 1

Biological: RSV/hMPV vaccine

RSV/hMPV Formulation 2

EXPERIMENTAL

Participants will receive a single intramuscular (IM) injection at Day 1

Biological: RSV/hMPV vaccine

RSV vaccine 1

EXPERIMENTAL

Participants will receive a single intramuscular (IM) injection at Day 1

Biological: RSV vaccine 1

RSV vaccine 2

EXPERIMENTAL

Participants will receive a single intramuscular (IM) injection at Day 1

Biological: RSV vaccine 2

Interventions

RSV vaccine 1BIOLOGICAL

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

RSV vaccine 1
RSV vaccine 2BIOLOGICAL

Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular

RSV vaccine 2
RSV/hMPV/PIV3 vaccineBIOLOGICAL

Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular

RSV/hMPV /PIV3 Formulation 1
RSV/hMPV vaccineBIOLOGICAL

Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular

RSV/hMPV Formulation 1RSV/hMPV Formulation 2
parainfluenza virus type 3 vaccine (PIV3)BIOLOGICAL

Pharmaceutical form:Frozen liquid solution -Route of administration:Intramuscular

PIV3 Dose 1PIV3 Dose 2PIV3 Dose 3PIV3 Dose 4

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants are excluded from the study if any of the following criteria apply:
  • Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
  • Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Investigational Site Number : 0360006

Blacktown, New South Wales, 2148, Australia

Location

Investigational Site Number : 0360001

Botany, New South Wales, 2019, Australia

Location

Investigational Site Number : 0360009

Brookvale, New South Wales, 2100, Australia

Location

Investigational Site Number : 0360005

Kanwal, New South Wales, 2259, Australia

Location

Investigational Site Number : 0360004

Miranda, New South Wales, 2228, Australia

Location

Investigational Site Number : 0360008

Herston, Queensland, 4006, Australia

Location

Investigational Site Number : 0360003

Bayswater, Victoria, 3153, Australia

Location

Investigational Site Number : 0360002

Camberwell, Victoria, 3124, Australia

Location

Related Links

MeSH Terms

Conditions

Respiratory Syncytial Virus InfectionsParamyxoviridae Infections

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
-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
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Modified double-blind study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 19, 2024

Study Start

September 17, 2024

Primary Completion

March 24, 2026

Study Completion

March 24, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Locations

AU(8)