Respiratory Syncytial Virus InfectionPhase 1NCT06604767
Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older
A Phase 1 study testing parainfluenza virus type 3 vaccine (PIV3), RSV/hMPV/PIV3 vaccine and RSV/hMPV vaccine in people with Respiratory Syncytial Virus Infection and Metapneumovirus Infection, run by Sanofi Pasteur, a Sanofi Company at 8 sites in Australia.
Trial summary
The purpose of this phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). 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, Metapneumovirus Infection, Parainfluenzae Virus Infection
- What is being tested?
- parainfluenza virus type 3 vaccine (PIV3), RSV/hMPV/PIV3 vaccine and RSV/hMPV vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 8 sitesAustralia
- Study dates
- 17 Sep 2024to 24 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 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 (means from the means from the day of the 60th birthday).
- Informed consent form (ICF) has been signed and dated
- A female participant is eligible to participate if she 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.
Who cannot join
- 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.
- Note: 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
8 sites in 1 country.
8 sites in 1 country
Australia8 sites
Investigational Site Number : 0360003
Bayswater, Victoria, 3153
Investigational Site Number : 0360006
Blacktown, New South Wales, 2148
Investigational Site Number : 0360001
Botany, New South Wales, 2019
Investigational Site Number : 0360009
Brookvale, New South Wales, 2100
Investigational Site Number : 0360002
Camberwell, Victoria, 3124
Investigational Site Number : 0360008
Herston, Queensland, 4006
Investigational Site Number : 0360005
Kanwal, New South Wales, 2259
Investigational Site Number : 0360004
Miranda, New South Wales, 2228
About this study
Official title: A Phase 1, Dose-Escalation, Randomized, Active-Controlled, Modified Double-Blind, Parallel-Group, Multi-Arm Study to Investigate the Safety and Immunogenicity of a Combined Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adult Participants Aged 60 Years and Older
The purpose of this phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The study will use different doses of PIV3 only and different combinations of RSV/hMPV/PIV3 or RSV/hMPV or only RSV vaccine in adults aged 60 years and older.
Read the detailed description
The study duration will be up to approximately 12 months minus the screening period.
- Conditions
- Respiratory Syncytial Virus Infection, Metapneumovirus Infection, Parainfluenzae Virus Infection
- Being tested
- parainfluenza virus type 3 vaccine (PIV3), RSV/hMPV/PIV3 vaccine, RSV/hMPV vaccine, RSV vaccine 1, RSV vaccine 2
- Medical subject headings
- Respiratory Syncytial Virus Infections, Paramyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parainfluenza virus type 3 vaccine (PIV3)Biological
Pharmaceutical form:Frozen liquid solution -Route of administration:Intramuscular
RSV/hMPV/PIV3 vaccineBiological
Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
RSV/hMPV vaccineBiological
Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
RSV vaccine 1Biological
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
RSV vaccine 2Biological
Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| PIV3 Dose 1 | Experimental | Participants will receive a single intramuscular (IM) injection at Day 1 Receives: Biological: parainfluenza virus type 3 vaccine (PIV3) |
| PIV3 Dose 2 | Experimental | Participants will receive a single intramuscular (IM) injection at Day 1 Receives: Biological: parainfluenza virus type 3 vaccine (PIV3) |
| PIV3 Dose 3 | Experimental | Participants will receive a single intramuscular (IM) injection at Day 1 Receives: Biological: parainfluenza virus type 3 vaccine (PIV3) |
| PIV3 Dose 4 | Experimental | Participants will receive a single intramuscular (IM) injection at Day 1 Receives: Biological: parainfluenza virus type 3 vaccine (PIV3) |
| RSV/hMPV /PIV3 Formulation 1 | Experimental | Participants will receive a single intramuscular (IM) injection at Day 1 Receives: Biological: RSV/hMPV/PIV3 vaccine |
| RSV/hMPV Formulation 1 | Experimental | Participants will receive a single intramuscular (IM) injection at Day 1 Receives: Biological: RSV/hMPV vaccine |
| RSV/hMPV Formulation 2 | Experimental | Participants will receive a single intramuscular (IM) injection at Day 1 Receives: Biological: RSV/hMPV vaccine |
| RSV vaccine 1 | Experimental | Participants will receive a single intramuscular (IM) injection at Day 1 Receives: Biological: RSV vaccine 1 |
| RSV vaccine 2 | Experimental | Participants will receive a single intramuscular (IM) injection at Day 1 Receives: Biological: RSV vaccine 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination
Number of participants experiencing immediate unsolicited systemic AEs
Measured: Within 30 minutes after each vaccination
Presence of solicited administration site reactions within 7 days after vaccination
Number of participants reporting:
- injection site reactions: pain, erythema and swelling
Measured: Within 7 days after vaccination
Presence of solicited systemic reactions within 7 days after vaccination
Number of participants reporting:
- systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills
Measured: Within 7 days after vaccination
Presence of unsolicited AEs within 28 days after vaccination
Number of participants experiencing unsolicited AEs
Measured: Within 28 days after vaccination
Presence of serious adverse events (SAEs)
Number of participants experiencing SAEs regardless of causality
Measured: Within 6 months after vaccination
Presence of adverse events of special interest (AESIs)
Number of participants experiencing AESIs regardless of causality
Measured: Within 6 months after vaccination
Presence of related SAEs throughout the study
Number of participants experiencing related SAEs regardless of causality
Measured: Throughout the study, approximately 12 months
Presence of related AESIs throughout the study
Number of participants experiencing related AESIs regardless of causality
Measured: Throughout the study, approximately 12 months
Presence of related fatal SAEs throughout the study
Number of participants experiencing related fatal SAEs regardless of causality
Measured: Throughout the study, approximately 12 months
Presence of out-of-range biological test results (including shift from baseline values)
Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)
Measured: Within 7 days after vaccination
Secondary outcomes (4)
RSV A serum neutralizing antibody (nAb) titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines
Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
Measured: At Day 01 and Day 29
RSV B serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines
Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
Measured: At Day 01 and Day 29
hMPV A serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 vaccines
Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
Measured: At Day 01 and Day 29
PIV3 serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV/PIV3 and PIV3 vaccines
Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
Measured: At Day 01 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 posted19 Sep 2024
- Study start17 Sep 2024
- Primary completion24 Mar 2026
- Study completion24 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 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Modified double-blind study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 390 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
- NCT06604767
- Sponsor's protocol ID
- VBD00006
- Other IDs
- U1111-1304-9362
- Status last verified
- Apr 2026
- First submitted
- 17 Sep 2024
- Last updated
- 23 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Dose-Escalation, Randomized, Active-Controlled, Modified Double-Blind, Parallel-Group, Multi-Arm Study to Investigate the Safety and Immunogenicity of a Combined Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adult Participants Aged 60 Years and Older
- ClinicalTrials.gov ID
- NCT06604767
- Acronym / sponsor ID
- VBD00006
- Conditions
- Respiratory Syncytial Virus Infection, Metapneumovirus Infection, Parainfluenzae Virus Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 24 Mar 2026 (actual)
- First posted
- 19 Sep 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 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The study will use different doses of PIV3 only and different combinations of RSV/hMPV/PIV3 or RSV/hMPV or only RSV vaccine in adults aged 60 years and older.
Detailed description
The study duration will be up to approximately 12 months minus the screening period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 9
- Model description
- Modified double-blind study
| Arm | Type | Receives |
|---|---|---|
| PIV3 Dose 1 | Experimental | Biological: parainfluenza virus type 3 vaccine (PIV3)Participants will receive a single intramuscular (IM) injection at Day 1 |
| PIV3 Dose 2 | Experimental | Biological: parainfluenza virus type 3 vaccine (PIV3)Participants will receive a single intramuscular (IM) injection at Day 1 |
| PIV3 Dose 3 | Experimental | Biological: parainfluenza virus type 3 vaccine (PIV3)Participants will receive a single intramuscular (IM) injection at Day 1 |
| PIV3 Dose 4 | Experimental | Biological: parainfluenza virus type 3 vaccine (PIV3)Participants will receive a single intramuscular (IM) injection at Day 1 |
| RSV/hMPV /PIV3 Formulation 1 | Experimental | Biological: RSV/hMPV/PIV3 vaccineParticipants will receive a single intramuscular (IM) injection at Day 1 |
| RSV/hMPV Formulation 1 | Experimental | Biological: RSV/hMPV vaccineParticipants will receive a single intramuscular (IM) injection at Day 1 |
| RSV/hMPV Formulation 2 | Experimental | Biological: RSV/hMPV vaccineParticipants will receive a single intramuscular (IM) injection at Day 1 |
| RSV vaccine 1 | Experimental | Biological: RSV vaccine 1Participants will receive a single intramuscular (IM) injection at Day 1 |
| RSV vaccine 2 | Experimental | Biological: RSV vaccine 2Participants will receive a single intramuscular (IM) injection at Day 1 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 60 years or older on the day of inclusion (means from the means from the day of the 60th birthday).
- Informed consent form (ICF) has been signed and dated
- A female participant is eligible to participate if she 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.
Key exclusion criteria (3 listed)
- -Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
- Note: 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 |
|---|---|---|
| parainfluenza virus type 3 vaccine (PIV3)Pharmaceutical form:Frozen liquid solution -Route of administration:Intramuscular | Biological | PIV3 Dose 1, PIV3 Dose 2, PIV3 Dose 3, PIV3 Dose 4 |
| RSV/hMPV/PIV3 vaccinePharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular | Biological | RSV/hMPV /PIV3 Formulation 1 |
| RSV/hMPV vaccinePharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular | Biological | RSV/hMPV Formulation 1, RSV/hMPV Formulation 2 |
| RSV vaccine 1Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular | Biological | RSV vaccine 1 |
| RSV vaccine 2Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular | Biological | RSV vaccine 2 |
Primary outcome
Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination
Time frame: Within 30 minutes after each vaccination
Number of participants experiencing immediate unsolicited systemic AEs
Presence of solicited administration site reactions within 7 days after vaccination
Time frame: Within 7 days after vaccination
Number of participants reporting: - injection site reactions: pain, erythema and swelling
Presence of solicited systemic reactions within 7 days after vaccination
Time frame: Within 7 days after vaccination
Number of participants reporting: * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills
Presence of unsolicited AEs within 28 days after vaccination
Time frame: Within 28 days after vaccination
Number of participants experiencing unsolicited AEs
Presence of serious adverse events (SAEs)
Time frame: Within 6 months after vaccination
Number of participants experiencing SAEs regardless of causality
Presence of adverse events of special interest (AESIs)
Time frame: Within 6 months after vaccination
Number of participants experiencing AESIs regardless of causality
Presence of related SAEs throughout the study
Time frame: Throughout the study, approximately 12 months
Number of participants experiencing related SAEs regardless of causality
Presence of related AESIs throughout the study
Time frame: Throughout the study, approximately 12 months
Number of participants experiencing related AESIs regardless of causality
Presence of related fatal SAEs throughout the study
Time frame: Throughout the study, approximately 12 months
Number of participants experiencing related fatal SAEs regardless of causality
Presence of out-of-range biological test results (including shift from baseline values)
Time frame: Within 7 days after vaccination
Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)
4 secondary outcomes
RSV A serum neutralizing antibody (nAb) titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines
Time frame: At Day 01 and Day 29
RSV B serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines
Time frame: At Day 01 and Day 29
hMPV A serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 vaccines
Time frame: At Day 01 and Day 29
PIV3 serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV/PIV3 and PIV3 vaccines
Time frame: At Day 01 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 23 Apr 2026.
- VBD00006 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.
8 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 parainfluenza virus type 3 vaccine (PIV3), RSV/hMPV/PIV3 vaccine and RSV/hMPV vaccine in people with Respiratory Syncytial Virus Infection and Metapneumovirus Infection, run by Sanofi Pasteur, a Sanofi Company at 8 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 3 inclusion and 3 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 23 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 8 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 unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination (time frame: Within 30 minutes after each vaccination). The study lists 10 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 23 Apr 2026.