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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07071558
Registration number
NCT07071558
Ethics application status
Date submitted
8/07/2025
Date registered
17/07/2025
Date last updated
17/08/2025
Titles & IDs
Public title
Study to Evaluate the Safety and Immunogenicity of Investigational Vaccines Using the RSV (Respiratory Syncytial Virus) Monovalent Antigen in Healthy Participants 18 to 49 Years of Age
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Scientific title
A Phase 1, Parallel, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Different LNP Formulations of mRNA Vaccines Using the RSV Monovalent Antigen in Healthy Participants 18 to 49 Years of Age
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Secondary ID [1]
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WHO UTN
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Secondary ID [2]
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VAV00026
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Immunization
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - RSV vaccine formulation 1 dose
Treatment: Other - RSV vaccine formulation 2 dose
Treatment: Other - RSV vaccine formulation 3 dose
Treatment: Other - RSV vaccine formulation 4 dose
Treatment: Other - RSV vaccine formulation 5 dose
Treatment: Other - RSV vaccine formulation 6 dose
Treatment: Other - RSV vaccine formulation 7 dose
Treatment: Other - RSV vaccine formulation 8 dose
Experimental: RSV Formulation 1 - Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
Experimental: RSV Formulation 2 - Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
Experimental: RSV Formulation 3 - Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
Experimental: RSV Formulation 4 - Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
Experimental: RSV Formulation 5 - Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
Experimental: RSV Formulation 6 - Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
Experimental: Control group 1 dose 1 - Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
Experimental: Control group 2 dose 2 - Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
Treatment: Other: RSV vaccine formulation 1 dose
Suspension for injection. Route of administration: IM injection
Treatment: Other: RSV vaccine formulation 2 dose
Suspension for injection. Route of administration: IM injection
Treatment: Other: RSV vaccine formulation 3 dose
Suspension for injection. Route of administration: IM injection
Treatment: Other: RSV vaccine formulation 4 dose
Suspension for injection. Route of administration: IM injection
Treatment: Other: RSV vaccine formulation 5 dose
Suspension for injection. Route of administration: IM injection
Treatment: Other: RSV vaccine formulation 6 dose
Suspension for injection. Route of administration: IM injection
Treatment: Other: RSV vaccine formulation 7 dose
Suspension for injection. Route of administration: IM injection
Treatment: Other: RSV vaccine formulation 8 dose
Suspension for injection. Route of administration: IM injection
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Presence of any unsolicited systemic adverse events (aes)
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Assessment method [1]
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Number of participants experiencing immediate AEs
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Timepoint [1]
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Within 30 minutes after each vaccine injection
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Primary outcome [2]
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Presence of solicited injection site reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form)
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Assessment method [2]
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Number of participants experiencing solicited injection site reactions
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Timepoint [2]
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Through 7 days after each vaccine injection
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Primary outcome [3]
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Presence of solicited systemic reactions (ie, pre-listed in the participant diary and in the CRF)
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Assessment method [3]
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Number of participants experiencing solicited systemic reactions
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Timepoint [3]
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Through 7 days after each vaccine injection
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Primary outcome [4]
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Presence of unsolicited AEs
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Assessment method [4]
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Number of participants experiencing unsolicited AEs
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Timepoint [4]
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Day 1 through day 29
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Primary outcome [5]
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Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest)
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Assessment method [5]
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Number of participants experiencing SAEs and AESIs
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Timepoint [5]
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Throughout study, approximately 6 months
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Primary outcome [6]
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Presence of out-of-range biological test results (including shift from baseline values)
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Assessment method [6]
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number of participants with out-of-range biological tests
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Timepoint [6]
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Through 7 days after each vaccine injection
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Primary outcome [7]
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RSV A nAb (Neutralizing Antibodies) titers
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Assessment method [7]
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Timepoint [7]
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At day 1 and day 29
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Eligibility
Key inclusion criteria
* Aged 18 to 49 years on the day of inclusion
* A female participant is eligible to participate if she is not pregnant or breastfeeding and of the following conditions applies:
* Is of NCBP (Non-Child-Bearing Potential). To be considered of NCBP, a female must be post-menopausal for at least 1 year, or surgically sterile. OR
* Is of CBP (Child-Bearing Potential) and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.
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Minimum age
18
Years
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Maximum age
49
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/07/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
26/02/2026
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Actual
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Sample size
Target
240
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Site # 0361003 - Wollongong
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Recruitment hospital [2]
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Site # 0361006 - Brisbane
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Recruitment hospital [3]
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Site # 0361005 - Morayfield
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Recruitment hospital [4]
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Site # 0361004 - Southport
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Recruitment hospital [5]
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Site # 0361002 - Bayswater
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Recruitment hospital [6]
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Site # 0361001 - Camberwell
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Recruitment postcode(s) [1]
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2500 - Wollongong
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Recruitment postcode(s) [2]
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4006 - Brisbane
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Recruitment postcode(s) [3]
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4506 - Morayfield
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Recruitment postcode(s) [4]
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4215 - Southport
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Recruitment postcode(s) [5]
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3153 - Bayswater
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Recruitment postcode(s) [6]
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3124 - Camberwell
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of different liponanaoparticle (LNP) formulations of modified ribonucleic acid (mRNA) vaccines using the RSV pre-F antigen in healthy participants 18 to 49 years of age. -Each participant will remain in the study for approximately 6 months. * The study intervention will be administered as a single intramuscular (IM) dose in the upper arm on Day 1 (D01). * The visit frequency will include 1 Screening Visit, 4 planned site visits to occur on D01, D03, D08, and D29, and 2 telephone calls to occur at Month (M)3 and M6.
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Trial website
https://clinicaltrials.gov/study/NCT07071558
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Sanofi Trial Transparency Email Recommended (Toll free for US and Canada)
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Address
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Country
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Phone
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800-633-1610
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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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/NCT07071558
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