Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years
A Phase 1, Randomized, Modified Double-blind, Multi-center, Parallel Group, Multi-arm Study to Investigate the Safety and Immunogenicity of an RSV/hMPV Vaccine Candidate in Adult Participants Aged 60 to 75 Years
2 other identifiers
interventional
385
1 country
6
Brief Summary
VAV00039 is a first-in-human (FiH) study to assess the safety and immunogenicity (in adult participants aged 60-75 years) after a single injection of different dose formulations of an RSV/hMPV vaccine candidate and RSV vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2024
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2024
CompletedFirst Posted
Study publicly available on registry
September 3, 2024
CompletedStudy Start
First participant enrolled
October 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2025
CompletedNovember 20, 2025
October 1, 2025
1 year
August 30, 2024
November 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
On Day 1
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination
Day 1 through day 8
Presence of unsolicited AEs reported through 28 days after vaccination
Day 1 through day 29
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study (ie, through 6 months after vaccination
SAE: Screening through day 181; AESI: Day 1 through day 181
Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination
Screening through day 8
Secondary Outcomes (6)
RSV A and RSV B serum nAb (neutralizing antibodies) titers at pre-vaccination and 28 days post-vaccination in all participants
At day 1 and day 29
hMPV A serum nAb titers at pre-vaccination and 28 days post-vaccination in all participants, except in those receiving the MV RSV vaccine
At day 1 and day 28
RSV A and RSV B nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants
At day 1, day 29, day 91, and day 181
RSV A serum anti-F IgG (immunoglobulin type G) Ab (Antibody) titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants
At day 1, day 29, day 91, and day 181
hMPV A nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants, except in those receiving the MV RSV vaccine
At day 1, day 29, day 91, and day 181
- +1 more secondary outcomes
Study Arms (13)
Group 1 RSV/hMPV dose A1
EXPERIMENTALParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 2 RSV/hMPV dose A2
EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 3 RSV/hMPV dose A3
EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 4 RSV/hMPV dose B1
EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 5 RSV/hMPV dose B2
EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 6 RSV/hMPV dose B3
EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 7 RSV/hMPV dose C1
EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 8 RSV/hMPV dose C2
EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 9 RSV/hMPV dose C3
EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 10 RSV/hMPV dose 1
EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 11 RSV/hMPV dose 2
EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 12 RSV/hMPV dose 3
EXPERIMENTALParticipants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Group 13 Monovalent RSV Vaccine
EXPERIMENTALParticipants will receive a single IM injection on day 1 of a Monovalent (MV) RSV vaccine according to their randomization schedule.
Interventions
Suspension for injection. Route of administration: IM injection
Suspension for injection. Route of administration: IM injection
Suspension for injection. Route of administration: IM injection
Suspension for injection. Route of administration: IM injection
Suspension for injection. Route of administration: IM injection
Suspension for injection. Route of administration: IM injection
Suspension for injection. Route of administration: IM injection
Suspension for injection. Route of administration: IM injection
Suspension for injection. Route of administration: IM injection
Suspension for injection. Route of administration: IM injection
Suspension for injection. Route of administration: IM injection
Suspension for injection. Route of administration: IM injection
Suspension for injection. Route of administration: IM injection
Eligibility Criteria
You may qualify if:
- A female participant is eligible to participate if she is post-menopausal for at least 1 year, or surgically sterile
You may not qualify if:
- Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
- 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 (6)
Site # 0361004
Botany, New South Wales, 2019, Australia
Site # 031001
Brookvale, New South Wales, 2100, Australia
Site # 0361006
Miranda, New South Wales, 2228, Australia
Site # 0361002
Wollongong, New South Wales, 2500, Australia
Site # 0361003
Herston, Queensland, 4006, Australia
Site # 0361005
South Brisbane, Queensland, 4101, Australia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Modified double-blinded for the sentinel and main cohorts. * Blinding for vaccine group assignment: participants, outcome assessors, Investigators, laboratory personnel (for both sentinel and main cohort); Sponsor study staff (except biostatistician) and Sponsor SMT (Safety Management Team) for main cohort * No blinding for vaccine group assignment: those preparing and administering the study interventions; Sponsor study staff and Sponsor SMT for sentinel cohorts
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2024
First Posted
September 3, 2024
Study Start
October 9, 2024
Primary Completion
October 9, 2025
Study Completion
October 9, 2025
Last Updated
November 20, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
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