Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06237296




Registration number
NCT06237296
Ethics application status
Date submitted
23/01/2024
Date registered
1/02/2024

Titles & IDs
Public title
Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older
Scientific title
A Phase I, Dose-escalation, Parallel-group, Randomized, Multi-center Study to Assess Safety and Immunogenicity of an RSV/hMPV mRNA Vaccine Candidate in Healthy Participants Aged 18 to 49 Years and 60 Years and Older.
Secondary ID [1] 0 0
VAV00027
Secondary ID [2] 0 0
VAV00027
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infection 0 0
Healthy Volunteers 0 0
Metapneumovirus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - RSV/hMPV mRNA LNP 1
Treatment: Other - RSV/hMPV mRNA LNP 2
Treatment: Other - RSV mRNA LNP 1
Treatment: Other - hMPV mRNA LNP 1

Experimental: RSV/hMPV mRNA / LNP 1 Group 1 - Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 1.

Experimental: RSV/hMPV mRNA / LNP 1 Group 2 - Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 2.

Experimental: RSV/hMPV mRNA / LNP 1 Group 3 - Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 3.

Experimental: RSV/hMPV mRNA / LNP 2 Group 4 - Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 2 dose 1.

Experimental: RSV mRNA / LNP 1 Group 5 - Participants will be randomized to receive a single IM injection of RSV mRNA / LNP vaccine 1 dose 1.

Experimental: hMPV mRNA / LNP 1 Group 6 - Participants will be randomized to receive a single IM injection of hMPV mRNA / LNP vaccine 1 dose 1.

Experimental: RSV/hMPV mRNA / LNP 1 Group 7 - Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 4.


Treatment: Other: RSV/hMPV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Treatment: Other: RSV/hMPV mRNA LNP 2
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Treatment: Other: RSV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Treatment: Other: hMPV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of unsolicited systemic immediate adverse events (AEs)
Timepoint [1] 0 0
Within 30 minutes after vaccination
Primary outcome [2] 0 0
Presence of solicited injection site or systemic reactions
Timepoint [2] 0 0
Within 7 days after vaccination
Primary outcome [3] 0 0
Presence of unsolicited AEs
Timepoint [3] 0 0
Within 28 days after vaccination
Primary outcome [4] 0 0
Presence of medically attended adverse events (MAAEs)
Timepoint [4] 0 0
Throughout study (up to approximately 6 months)
Primary outcome [5] 0 0
Presence of serious adverse events (SAEs)
Timepoint [5] 0 0
Throughout study (up to approximately 6 months)
Primary outcome [6] 0 0
Presence of adverse events of special interest (AESIs)
Timepoint [6] 0 0
Throughout study (up to approximately 6 months)
Primary outcome [7] 0 0
Presence of out-of-range biological test results
Timepoint [7] 0 0
Within 7 days after vaccination
Primary outcome [8] 0 0
RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations
Timepoint [8] 0 0
Day 1 and Day 29
Primary outcome [9] 0 0
RSV-B serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations
Timepoint [9] 0 0
Day 1 and Day 29
Primary outcome [10] 0 0
hMPV- A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent hMPV formulations
Timepoint [10] 0 0
Day 1 and Day 29
Secondary outcome [1] 0 0
RSV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation
Timepoint [1] 0 0
Day 1, Day 29, Day 91 and Day 181
Secondary outcome [2] 0 0
RSV B serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation
Timepoint [2] 0 0
Day 1, Day 29, Day 91 and Day 181
Secondary outcome [3] 0 0
RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation
Timepoint [3] 0 0
Day 1, Day 29, Day 91 and Day 181
Secondary outcome [4] 0 0
hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations
Timepoint [4] 0 0
Day 1, Day 29, Day 91 and Day 181
Secondary outcome [5] 0 0
hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations
Timepoint [5] 0 0
Day 1, Day 29, Day 91 and Day 181

Eligibility
Key inclusion criteria
-Informed consent form (ICF) has been signed and dated
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

--The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/02/2025
Actual
Sample size
Target
Accrual to date
Final
558
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360006 - Blacktown
Recruitment hospital [2] 0 0
Investigational Site Number : 0360002 - Botany
Recruitment hospital [3] 0 0
Investigational Site Number : 0360003 - Kanwal
Recruitment hospital [4] 0 0
Investigational Site Number : 0360004 - Sydney
Recruitment hospital [5] 0 0
Investigational Site Number : 0360008 - Herston
Recruitment hospital [6] 0 0
Investigational Site Number : 0360005 - Morayfield
Recruitment hospital [7] 0 0
Investigational Site Number : 0360001 - Camberwell
Recruitment hospital [8] 0 0
Investigational Site Number : 0360007 - Canberra
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2019 - Botany
Recruitment postcode(s) [3] 0 0
2259 - Kanwal
Recruitment postcode(s) [4] 0 0
2035 - Sydney
Recruitment postcode(s) [5] 0 0
4006 - Herston
Recruitment postcode(s) [6] 0 0
4506 - Morayfield
Recruitment postcode(s) [7] 0 0
3124 - Camberwell
Recruitment postcode(s) [8] 0 0
2617 - Canberra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi Pasteur, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06237296