Respiratory Syncytial Virus ImmunizationPhase 1NCT07071558
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
A Phase 1 study testing RSV vaccine formulation 1 dose, RSV vaccine formulation 2 dose and RSV vaccine formulation 3 dose in people with Respiratory Syncytial Virus Immunization, run by Sanofi at 6 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Immunization
- What is being tested?
- RSV vaccine formulation 1 dose, RSV vaccine formulation 2 dose and RSV vaccine formulation 3 dose
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 6 sitesAustralia
- Study dates
- 14 Jul 2025to 17 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
Site # 0361002
Bayswater, Victoria, 3153
Site # 0361006
Brisbane, Queensland, 4006
Site # 0361001
Camberwell, Victoria, 3124
Site # 0361005
Morayfield, Queensland, 4506
Site # 0361004
Southport, Queensland, 4215
Site # 0361003
Wollongong, New South Wales, 2500
About this study
Official 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
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.
- Conditions
- Respiratory Syncytial Virus Immunization
- Being tested
- RSV vaccine formulation 1 dose, RSV vaccine formulation 2 dose, RSV vaccine formulation 3 dose, RSV vaccine formulation 4 dose, RSV vaccine formulation 5 dose
- Keywords
- RSV, RSV Infection, RSV Vaccine
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV vaccine formulation 1 doseBiological
Suspension for injection. Route of administration: IM injection
RSV vaccine formulation 2 doseBiological
Suspension for injection. Route of administration: IM injection
RSV vaccine formulation 3 doseBiological
Suspension for injection. Route of administration: IM injection
RSV vaccine formulation 4 doseBiological
Suspension for injection. Route of administration: IM injection
RSV vaccine formulation 5 doseBiological
Suspension for injection. Route of administration: IM injection
RSV vaccine formulation 6 doseBiological
Suspension for injection. Route of administration: IM injection
RSV vaccine formulation 7 doseBiological
Suspension for injection. Route of administration: IM injection
RSV vaccine formulation 8 doseBiological
Suspension for injection. Route of administration: IM injection
| Study group | Role | What they receive |
|---|---|---|
| RSV Formulation 1 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. Receives: Biological: RSV vaccine formulation 1 dose |
| RSV Formulation 2 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. Receives: Biological: RSV vaccine formulation 2 dose |
| RSV Formulation 3 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. Receives: Biological: RSV vaccine formulation 3 dose |
| RSV Formulation 4 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. Receives: Biological: RSV vaccine formulation 4 dose |
| RSV Formulation 5 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. Receives: Biological: RSV vaccine formulation 5 dose |
| RSV Formulation 6 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. Receives: Biological: RSV vaccine formulation 6 dose |
| Control group 1 dose 1 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. Receives: Biological: RSV vaccine formulation 7 dose |
| Control group 2 dose 2 | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. Receives: Biological: RSV vaccine formulation 8 dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of any unsolicited systemic adverse events (aes)
Number of participants experiencing immediate AEs
Measured: Within 30 minutes after each vaccine injection
Presence of solicited injection site reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form)
Number of participants experiencing solicited injection site reactions
Measured: Through 7 days after each vaccine injection
Presence of solicited systemic reactions (ie, pre-listed in the participant diary and in the CRF)
Number of participants experiencing solicited systemic reactions
Measured: Through 7 days after each vaccine injection
Presence of unsolicited AEs
Number of participants experiencing unsolicited AEs
Measured: Day 1 through day 29
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest)
Number of participants experiencing SAEs and AESIs
Measured: Throughout study, approximately 6 months
Presence of out-of-range biological test results (including shift from baseline values)
number of participants with out-of-range biological tests
Measured: Through 7 days after each vaccine injection
RSV A nAb (Neutralizing Antibodies) titers
Measured: At day 1 and day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start14 Jul 2025
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus ImmunizationStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071558
- Sponsor's protocol ID
- VAV00026
- Other IDs
- WHO UTN
- Status last verified
- Apr 2026
- First submitted
- 8 Jul 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07071558
- Acronym / sponsor ID
- VAV00026
- Conditions
- Respiratory Syncytial Virus Immunization
- Keywords
- RSV, RSV Infection, RSV Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| RSV Formulation 1 | Experimental | Biological: RSV vaccine formulation 1 doseParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| RSV Formulation 2 | Experimental | Biological: RSV vaccine formulation 2 doseParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| RSV Formulation 3 | Experimental | Biological: RSV vaccine formulation 3 doseParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| RSV Formulation 4 | Experimental | Biological: RSV vaccine formulation 4 doseParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| RSV Formulation 5 | Experimental | Biological: RSV vaccine formulation 5 doseParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| RSV Formulation 6 | Experimental | Biological: RSV vaccine formulation 6 doseParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| Control group 1 dose 1 | Experimental | Biological: RSV vaccine formulation 7 doseParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| Control group 2 dose 2 | Experimental | Biological: RSV vaccine formulation 8 doseParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSV vaccine formulation 1 doseSuspension for injection. Route of administration: IM injection | Biological | RSV Formulation 1 |
| RSV vaccine formulation 2 doseSuspension for injection. Route of administration: IM injection | Biological | RSV Formulation 2 |
| RSV vaccine formulation 3 doseSuspension for injection. Route of administration: IM injection | Biological | RSV Formulation 3 |
| RSV vaccine formulation 4 doseSuspension for injection. Route of administration: IM injection | Biological | RSV Formulation 4 |
| RSV vaccine formulation 5 doseSuspension for injection. Route of administration: IM injection | Biological | RSV Formulation 5 |
| RSV vaccine formulation 6 doseSuspension for injection. Route of administration: IM injection | Biological | RSV Formulation 6 |
| RSV vaccine formulation 7 doseSuspension for injection. Route of administration: IM injection | Biological | Control group 1 dose 1 |
| RSV vaccine formulation 8 doseSuspension for injection. Route of administration: IM injection | Biological | Control group 2 dose 2 |
Primary outcome
Presence of any unsolicited systemic adverse events (aes)
Time frame: Within 30 minutes after each vaccine injection
Number of participants experiencing immediate AEs
Presence of solicited injection site reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form)
Time frame: Through 7 days after each vaccine injection
Number of participants experiencing solicited injection site reactions
Presence of solicited systemic reactions (ie, pre-listed in the participant diary and in the CRF)
Time frame: Through 7 days after each vaccine injection
Number of participants experiencing solicited systemic reactions
Presence of unsolicited AEs
Time frame: Day 1 through day 29
Number of participants experiencing unsolicited AEs
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest)
Time frame: Throughout study, approximately 6 months
Number of participants experiencing SAEs and AESIs
Presence of out-of-range biological test results (including shift from baseline values)
Time frame: Through 7 days after each vaccine injection
number of participants with out-of-range biological tests
RSV A nAb (Neutralizing Antibodies) titers
Time frame: At day 1 and day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RSV vaccine formulation 1 dose, RSV vaccine formulation 2 dose and RSV vaccine formulation 3 dose in people with Respiratory Syncytial Virus Immunization, run by Sanofi at 6 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of any unsolicited systemic adverse events (aes) (time frame: Within 30 minutes after each vaccine injection). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.