Respiratory Syncytial Virus InfectionPhase 2NCT06251024
Study of a Respiratory Syncytial Virus Candidate Formulation in Adults Aged 60 Years and Older
A Phase 2 study testing RSV vaccine candidate in people with Respiratory Syncytial Virus Infection and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 25 sites in 6 countries.
Trial summary
The purpose of this Phase IIb study is to evaluate the efficacy of the RSV vaccine candidate for the prevention of lower respiratory tract disease (LRTD) due to RSV. The study will enroll approximately 4500 adults aged 60 years and older in a 1:1 ratio to receive a single intra-muscular (IM) administration of either a… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infection, Healthy Volunteers
- What is being tested?
- RSV vaccine candidate
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,541 participants
- Where
- 25 sitesin 6 countries
- Study dates
- 2 Apr 2024to 11 Mar 2025
- Phase
- Phase 2
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 60 years or older on the day of inclusion
- A female participant is eligible to participate if she is not pregnant or breastfeeding and:
- 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.
- Participants with high-risk medical conditions who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion.
- Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Show all 18Show fewer
- Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances ;any allergic reaction (eg, anaphylaxis) after administration of an mRNA vaccine
- History of RSV-associated illness, diagnosed clinically, serologically, or microbiologically in the last 12 months
- Previous history of myocarditis, pericarditis, and/or myopericarditis
- Thrombocytopenia, contraindicating IM injection based on investigator's judgment
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
- Receipt of any vaccine in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine in the 4 weeks following any study intervention administration
- Receipt of any mRNA vaccine in the 60 days preceding any study intervention administration or planned receipt of any mRNA vaccine in the 60 days following any study intervention administration
- Previous vaccination against RSV with a licensed or investigational vaccine or planned receipt during study participation, of vaccination against RSV with a licensed or investigational vaccine other than the study vaccine
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months
- Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Who cannot join
None listed.
Trial locations and contacts
25 sites in 6 countries.
25 sites in 6 countries
Colombia7 sites
Investigational Site Number : 1700004
Aguazul, 856010
Investigational Site Number : 1700002
Barranquilla, 080020
Investigational Site Number : 1700006
Bogotá, 110111
Investigational Site Number : 1700007
Cali, 76001
Investigational Site Number : 1700003
Girardot, 252431
Investigational Site Number : 1700005
Ibague, 730001
Investigational Site Number : 1700001
Quindío, 630001
Chile6 sites
Investigational Site Number : 1520006
Concepción, Biobio, 4070094
Investigational Site Number : 1520005
Santiago, Reg Metropolitana de Santiago, 7580206
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 8380453
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, 8420383
Investigational Site Number : 1520002
Santiago, 7500657
Investigational Site Number : 1520008
Santiago, 7510157
Australia5 sites
Investigational Site Number : 0360003
Botany, New South Wales, 2019
Investigational Site Number : 0360002
Camberwell, Victoria, 3124
Investigational Site Number : 0360005
Norwood, 5067
Investigational Site Number : 0360004
Sippy Downs, Queensland, 4556
Investigational Site Number : 0360001
Southport, Queensland, 4222
Honduras3 sites
Investigational Site Number : 3400001
San Pedro Sula, 21104
Investigational Site Number : 3400003
Tegucigalpa, 11101
Investigational Site Number : 3400002
Tegucugalpa, 11101
Dominican Republic2 sites
Investigational Site Number : 2140001
Santo Domingo, 10205
Investigational Site Number : 2140002
Santo Domingo, 10205
Mexico2 sites
Investigational Site Number : 4840002
León, Guanajuato, 37000
Investigational Site Number : 4840003
Querétaro, 76100
About this study
Official title: A Phase IIb, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of an RSV Vaccine Candidate in Adult Participants 60 Years and Older
The purpose of this Phase IIb study is to evaluate the efficacy of the RSV vaccine candidate for the prevention of lower respiratory tract disease (LRTD) due to RSV.
The study will enroll approximately 4500 adults aged 60 years and older in a 1:1 ratio to receive a single intra-muscular (IM) administration of either a pre-determined dose of the RSV vaccine candidate or placebo.
Read the detailed description
Study duration per participant:
6 months.
Treatment Duration:
1 IM injection. Participants will be followed for approximately 6 months post- vaccination.
- Being tested
- RSV vaccine candidate, Placebo
- 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 candidateBiological
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
PlaceboBiological
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1: RSV vaccine candidate | Experimental | Participants will be enrolled in a 1:1 ratio to receive a single IM administration of the RSV vaccine candidate. Receives: Biological: RSV vaccine candidate |
| Group 2: placebo | Placebo comparator | Participants will be enrolled in a 1:1 ratio to receive a single IM administration of the placebo. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of the first episode of RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination
Number of participants experiencing RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination
Measured: ≥ 14 days after vaccination
Secondary outcomes (23)
Presence of the first episode of RSV-ARD (RSV A and/or RSV B) ≥ 14 days after vaccination
Number of participants experiencing RSV-ARD (RSV A and/or RSV B) ≥ 14 days after vaccination
Measured: ≥ 14 days after vaccination
Presence of the first episode of RSV MAARD (RSV A and/or RSV B) ≥ 14 days after vaccination
Number of participants experiencing RSV-MAARD (RSV A and/or RSV B) ≥ 14 days after vaccination
Measured: ≥ 14 days after vaccination
Presence of the first episode of RSV LRTD (RSV A) occurring ≥ 14 days after vaccination)
Number of participants experiencing RSV-LRTD (RSV A) ≥ 14 days after vaccination
Measured: ≥ 14 days after vaccination
Presence of the first episode of RSV LRTD (RSV B) occurring ≥ 14 days after vaccination
Number of participants experiencing RSV-LRTD (RSV B) ≥ 14 days after vaccination
Measured: ≥ 14 days after vaccination
Presence of the first episode of RSV-LRTD (RSV A and/or RSV B and by each one) by age group
Number of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by age group
Measured: ≥ 14 days after vaccination
Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline comorbidities
Number of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by baseline comorbidities
Measured: ≥ 14 days after vaccination
Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline frailty status
Number of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by baseline frailty status
Measured: ≥ 14 days after vaccination
Presence of hospitalization due to RSV-ARD and/or RSV-LRTD
Number of participants hospitalized due to RSV-ARD and/or RSV-LRTD
Measured: ≥ 14 days after vaccination
Duration (number of days) of RSV LRTD episodes (RSV A and/or RSV B)
Duration (number of days) of RSV LRTD episodes (RSV A and/or RSV B)
Measured: ≥ 14 days after vaccination
Duration (number of days) of RSV ARD episodes (RSV A and/or RSV B)
Duration (number of days) of RSV ARD episodes (RSV A and/or RSV B)
Measured: ≥ 14 days after vaccination
Presence of the first episode of severe RSV LRTD (RSV A and/or RSV B and by each one) occurring ≥ 14 days after vaccination
Number of participants experiencing severe RSV-LRTD (RSV A and/or B and by each one)
Measured: ≥ 14 days after vaccination
RSV A serum neutralizing antibodies (nAb) titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
RSV A serum neutralizing antibodies (nAb) titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
Measured: Day 1 and Day 29
RSV B serum nAb titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
RSV B serum nAb titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
Measured: Day 1 and Day 29
Serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
Serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
Measured: Day 1 and Day 29
RSV A serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset
RSV A serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset
Measured: Month 6
RSV B serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset
RSV B serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset
Measured: Month 6
Serum anti-F IgG Ab titers at 6 months post-vaccination in the Immunogenicity Subset
Serum anti-F IgG Ab titers at 6 months post-vaccination in the Immunogenicity Subset
Measured: Month 6
Presence of solicited injection site or systemic reactions
Number of participants reporting:
- injection site reactions: pain, erythema and swelling
- systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills
Measured: Within 7 days after primary vaccination
Presence of unsolicited immediate systemic adverse events (AEs)
Number of participants experiencing an unsolicited immediate systemic adverse event
Measured: Within 30 minutes after primary vaccination
Presence of unsolicited AEs
Number of participants experiencing unsolicited AEs
Measured: Within 28 days after primary vaccination
Presence of serious adverse events (SAEs)
Number of participants experiencing SAEs
Measured: Throughout study (approximately 6 months)
Presence of medically attended adverse events (MAAEs)
Number of participants experiencing MAAEs
Measured: Throughout study (approximately 6 months)
Presence of adverse events of special interest (AESIs)
Number of participants experiencing AESIs
Measured: Throughout study (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start2 Apr 2024
- Primary completion11 Mar 2025
- Study completion11 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel, multi-center, case driven
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251024
- Sponsor's protocol ID
- VAE00017
- Other IDs
- U1111-1271-1514, VAE00017
- Status last verified
- Mar 2026
- First submitted
- 1 Feb 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of an RSV Vaccine Candidate in Adult Participants 60 Years and Older
- ClinicalTrials.gov ID
- NCT06251024
- Acronym / sponsor ID
- VAE00017
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,541 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 9 Feb 2024 (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 Phase IIb study is to evaluate the efficacy of the RSV vaccine candidate for the prevention of lower respiratory tract disease (LRTD) due to RSV.
The study will enroll approximately 4500 adults aged 60 years and older in a 1:1 ratio to receive a single intra-muscular (IM) administration of either a pre-determined dose of the RSV vaccine candidate or placebo.
Detailed description
Study duration per participant:
6 months.
Treatment Duration:
1 IM injection. Participants will be followed for approximately 6 months post- vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel, multi-center, case driven
| Arm | Type | Receives |
|---|---|---|
| Group 1: RSV vaccine candidate | Experimental | Biological: RSV vaccine candidateParticipants will be enrolled in a 1:1 ratio to receive a single IM administration of the RSV vaccine candidate. |
| Group 2: placebo | Placebo comparator | Biological: PlaceboParticipants will be enrolled in a 1:1 ratio to receive a single IM administration of the placebo. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Aged 60 years or older on the day of inclusion
- A female participant is eligible to participate if she is not pregnant or breastfeeding and:
- Participants with high-risk medical conditions who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion.
- Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Key exclusion criteria (0 listed)
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 candidatePharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection | Biological | Group 1: RSV vaccine candidate |
| PlaceboPharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection | Biological | Group 2: placebo |
Primary outcome
Presence of the first episode of RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination
Time frame: ≥ 14 days after vaccination
Number of participants experiencing RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination
23 secondary outcomes
Presence of the first episode of RSV-ARD (RSV A and/or RSV B) ≥ 14 days after vaccination
Time frame: ≥ 14 days after vaccination
Presence of the first episode of RSV MAARD (RSV A and/or RSV B) ≥ 14 days after vaccination
Time frame: ≥ 14 days after vaccination
Presence of the first episode of RSV LRTD (RSV A) occurring ≥ 14 days after vaccination)
Time frame: ≥ 14 days after vaccination
Presence of the first episode of RSV LRTD (RSV B) occurring ≥ 14 days after vaccination
Time frame: ≥ 14 days after vaccination
Presence of the first episode of RSV-LRTD (RSV A and/or RSV B and by each one) by age group
Time frame: ≥ 14 days after vaccination
Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline comorbidities
Time frame: ≥ 14 days after vaccination
Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline frailty status
Time frame: ≥ 14 days after vaccination
Presence of hospitalization due to RSV-ARD and/or RSV-LRTD
Time frame: ≥ 14 days after vaccination
Duration (number of days) of RSV LRTD episodes (RSV A and/or RSV B)
Time frame: ≥ 14 days after vaccination
Duration (number of days) of RSV ARD episodes (RSV A and/or RSV B)
Time frame: ≥ 14 days after vaccination
Presence of the first episode of severe RSV LRTD (RSV A and/or RSV B and by each one) occurring ≥ 14 days after vaccination
Time frame: ≥ 14 days after vaccination
RSV A serum neutralizing antibodies (nAb) titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
Time frame: Day 1 and Day 29
RSV B serum nAb titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
Time frame: Day 1 and Day 29
Serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
Time frame: Day 1 and Day 29
RSV A serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset
Time frame: Month 6
RSV B serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset
Time frame: Month 6
Serum anti-F IgG Ab titers at 6 months post-vaccination in the Immunogenicity Subset
Time frame: Month 6
Presence of solicited injection site or systemic reactions
Time frame: Within 7 days after primary vaccination
Presence of unsolicited immediate systemic adverse events (AEs)
Time frame: Within 30 minutes after primary vaccination
Presence of unsolicited AEs
Time frame: Within 28 days after primary vaccination
Presence of serious adverse events (SAEs)
Time frame: Throughout study (approximately 6 months)
Presence of medically attended adverse events (MAAEs)
Time frame: Throughout study (approximately 6 months)
Presence of adverse events of special interest (AESIs)
Time frame: Throughout study (approximately 6 months)
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 10 Mar 2026.
- VAE00017 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.
25 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RSV vaccine candidate in people with Respiratory Syncytial Virus Infection and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 25 sites in 6 countries.
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 18 inclusion and 0 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 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Colombia, Chile, Australia, Honduras, Dominican Republic and 1 more country. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 the first episode of RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination (time frame: ≥ 14 days after vaccination). 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 10 Mar 2026.