Healthy VolunteersPhase 1NCT06850051
A Study on the Safety and Immunogenicity of Influenza, Respiratory Syncytial Virus, Human Metapneumovirus and Parainfluenza Vaccines in Adults 18 to 49 Years of Age.
A Phase 1 study testing TIV-HA Vaccine formulation 1 at low dose, TIV-HA formulation 1 at high dose and TIV-HA formulation 2 at low dose in people with Healthy Volunteers and Influenza Vaccination, run by Sanofi at 6 sites in Australia.
Trial summary
The objective of this study is to evaluate the safety and immunogenicity of different vaccines of hemagglutinin formulations of trivalent influenza vaccine or of a combined respiratory syncytial virus / human metapneumovirus / parainfluenza virus type 3 vaccine in healthy participants 18 to 49 years of age. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Influenza Vaccination, Respiratory Syncytial Virus Vaccination
- What is being tested?
- TIV-HA Vaccine formulation 1 at low dose, TIV-HA formulation 1 at high dose and TIV-HA formulation 2 at low dose
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 6 sitesAustralia
- Study dates
- 19 Mar 2025to 11 Dec 2025
- 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 one of the following conditions applies:
- Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile OR
- Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration.
Who cannot join
- Any medical condition or circumstance 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
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
Paratus Clinical
Blacktown, New South Wales, 2148
Emeritus Research
Camberwell, Victoria, 3124
Paratus Clinical
Herston, Queensland, 4006
University of Sunshine Coast Clinical Trials
Morayfield, Queensland, 4506
University of Sunshine Coast Clinical Trials
South Brisbane, Queensland, 4101
Griffith University
Southport, Queensland, 4215
About this study
Official title: A Phase 1, Parallel, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Different Formulations of Multivalent Influenza and Respiratory Syncytial Virus (RSV)/Human Metapneumovirus (hMPV)/Parainfluenza Virus Type 3 (PIV3) Vaccines in Healthy Participants 18 to 49 Years of Age.
The objective of this study is to evaluate the safety and immunogenicity of different vaccines of hemagglutinin formulations of trivalent influenza vaccine or of a combined respiratory syncytial virus / human metapneumovirus / parainfluenza virus type 3 vaccine in healthy participants 18 to 49 years of age. A lipid nanoparticle will be used in this study.
Overall, the study is designed to:
Read more
- Assess the safety profile of the candidate formulations
- Describe the immunogenicity profile of the candidate formulations
- Eligible participants will be randomized to receive a single intramuscular injection of either one of the vaccine formulations.
Participants will be provided with a diary to solicit reporting of injection site reactions and systemic reactions, unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest AESIs).
Participants will also be required to record their daily temperature on the diary.
Read the detailed description
The duration of study participation will be approximately 6 months for each participant.
- Conditions
- Healthy Volunteers, Influenza Vaccination, Respiratory Syncytial Virus Vaccination, Parainfluenza Vaccination, Human Metapneumovirus Vaccination
- Being tested
- TIV-HA Vaccine formulation 1 at low dose, TIV-HA formulation 1 at high dose, TIV-HA formulation 2 at low dose, TIV-HA formulation 2 at high dose, RSV/hMPV/PIV3 formulation 2 at low dose
- Keywords
- influenza, respiratory syncytial virus, parainfluenza, human metapneumovirus
- Medical subject headings
- Influenza, Human, Paramyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIV-HA Vaccine formulation 1 at low doseBiological
Suspension for injection in a vial. Route of administration: IM injection
TIV-HA formulation 1 at high doseBiological
Suspension for injection in a vial. Route of administration: IM injection
TIV-HA formulation 2 at low doseBiological
Suspension for injection in a vial. Route of administration: IM injection
TIV-HA formulation 2 at high doseBiological
Suspension for injection in a vial. Route of administration: IM injection
RSV/hMPV/PIV3 formulation 2 at low doseBiological
Suspension for injection in a vial. Route of administration: IM injection
RSV/hMPV/PIV3 formulation 1 at high doseBiological
Suspension for injection in a vial. Route of administration: IM injection
RSV/hMPV/PIV3 formulation 2 at high doseBiological
Suspension for injection in a vial. Route of administration: IM injection
RSV/hMPV/PIV3 formulation 1 at low doseBiological
Suspension for injection in a vial. Route of administration: IM injection
RIV4 (Supemtek®)Biological
Solution for injection in a prefilled syringe. Route of administration: IM injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 trivalent influenza vaccine-hemagglutinin (TIV-HA) formulation 1 at high dose | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule. Receives: Biological: TIV-HA formulation 1 at high dose |
| Group 2 TIV-HA formulation 2 at high dose | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule. Receives: Biological: TIV-HA formulation 2 at high dose |
| Group 3 TIV-HA formulation 1 at low dose | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule. Receives: Biological: TIV-HA Vaccine formulation 1 at low dose |
| Group 4 TIV-HA formulation 2 at low dose | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule. Receives: Biological: TIV-HA formulation 2 at low dose |
| Group 5 RSV/hMPV/PIV3 formulation 1 at high dose | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule. Receives: Biological: RSV/hMPV/PIV3 formulation 1 at high dose |
| Group 6 RSV/hMPV/PIV3 formulation 2 at high dose | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule. Receives: Biological: RSV/hMPV/PIV3 formulation 2 at high dose |
| Group 7 RSV/hMPV/PIV3 formulation 1 at low dose | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule. Receives: Biological: RSV/hMPV/PIV3 formulation 1 at low dose |
| Group 8 RSV/hMPV/PIV3 formulation 2 at low dose | Experimental | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule. Receives: Biological: RSV/hMPV/PIV3 formulation 2 at low dose |
| Group 9 recombinant influenza vaccine quadrivalent (RIV4) | Active comparator | Participants will receive a single IM (Intramuscular) injection on day 1 of the RIV4 vaccine according to their randomization schedule. Receives: Biological: RIV4 (Supemtek®) |
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) reported within 30 minutes after vaccination
Number of participants with unsolicited systemic AEs
Measured: Within 30 minutes after each vaccination
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination
Number of participants with solicited injection site and systemic reactions
Measured: Through 7 days after each vaccination
Presence of unsolicited AEs reported through 28 days after vaccination
Number of participants with unsolicited AEs
Measured: Through 28 days after each vaccination
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study
: Number of participants with SAEs and AESIs
Measured: Throughout study, approximately 6 months
Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination
: Number of participants with out-of-range biological tests
Measured: Through 7 days after vaccination
Hemagglutinin Inhibition Assay (HAI) antibody (Ab) response to each homologous influenza strain at Day 1 and Day 29
Measured: Day 1 and Day 29
RSV A, hMPV A and PIV3 serum neutralizing antibodies (nAb) titers at Day 1 and Day 29
Measured: Day 1 and Day 29
Secondary outcomes (2)
RSV B and hMPV A nAb titers at Day 1 and Day 29
Measured: Day 1 and Day 29
Neutralization Test (NT) Ab response to each homologous influenza strain at Day 29
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start19 Mar 2025
- Primary completion11 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850051
- Sponsor's protocol ID
- VAV00030
- Other IDs
- U1111-1311-1743
- Status last verified
- Jan 2026
- First submitted
- 11 Feb 2025
- Last updated
- 16 Jan 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 16 Jan 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 Formulations of Multivalent Influenza and Respiratory Syncytial Virus (RSV)/Human Metapneumovirus (hMPV)/Parainfluenza Virus Type 3 (PIV3) Vaccines in Healthy Participants 18 to 49 Years of Age.
- ClinicalTrials.gov ID
- NCT06850051
- Acronym / sponsor ID
- VAV00030
- Conditions
- Healthy Volunteers, Influenza Vaccination, Respiratory Syncytial Virus Vaccination, Parainfluenza Vaccination, Human Metapneumovirus Vaccination
- Keywords
- influenza, respiratory syncytial virus, parainfluenza, human metapneumovirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 27 Feb 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 objective of this study is to evaluate the safety and immunogenicity of different vaccines of hemagglutinin formulations of trivalent influenza vaccine or of a combined respiratory syncytial virus / human metapneumovirus / parainfluenza virus type 3 vaccine in healthy participants 18 to 49 years of age. A lipid nanoparticle will be used in this study.
Overall, the study is designed to:
- Assess the safety profile of the candidate formulations
- Describe the immunogenicity profile of the candidate formulations
- Eligible participants will be randomized to receive a single intramuscular injection of either one of the vaccine formulations.
Participants will be provided with a diary to solicit reporting of injection site reactions and systemic reactions, unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest AESIs).
Participants will also be required to record their daily temperature on the diary.
Detailed description
The duration of study participation will be approximately 6 months for each participant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Group 1 trivalent influenza vaccine-hemagglutinin (TIV-HA) formulation 1 at high dose | Experimental | Biological: TIV-HA formulation 1 at high doseParticipants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule. |
| Group 2 TIV-HA formulation 2 at high dose | Experimental | Biological: TIV-HA formulation 2 at high doseParticipants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule. |
| Group 3 TIV-HA formulation 1 at low dose | Experimental | Biological: TIV-HA Vaccine formulation 1 at low doseParticipants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule. |
| Group 4 TIV-HA formulation 2 at low dose | Experimental | Biological: TIV-HA formulation 2 at low doseParticipants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule. |
| Group 5 RSV/hMPV/PIV3 formulation 1 at high dose | Experimental | Biological: RSV/hMPV/PIV3 formulation 1 at high doseParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule. |
| Group 6 RSV/hMPV/PIV3 formulation 2 at high dose | Experimental | Biological: RSV/hMPV/PIV3 formulation 2 at high doseParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule. |
| Group 7 RSV/hMPV/PIV3 formulation 1 at low dose | Experimental | Biological: RSV/hMPV/PIV3 formulation 1 at low doseParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule. |
| Group 8 RSV/hMPV/PIV3 formulation 2 at low dose | Experimental | Biological: RSV/hMPV/PIV3 formulation 2 at low doseParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule. |
| Group 9 recombinant influenza vaccine quadrivalent (RIV4) | Active comparator | Biological: RIV4 (Supemtek®)Participants will receive a single IM (Intramuscular) injection on day 1 of the RIV4 vaccine 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 one of the following conditions applies:
Key exclusion criteria (2 listed)
- Any medical condition or circumstance 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 |
|---|---|---|
| TIV-HA Vaccine formulation 1 at low doseSuspension for injection in a vial. Route of administration: IM injection | Biological | Group 3 TIV-HA formulation 1 at low dose |
| TIV-HA formulation 1 at high doseSuspension for injection in a vial. Route of administration: IM injection | Biological | Group 1 trivalent influenza vaccine-hemagglutinin (TIV-HA) formulation 1 at high dose |
| TIV-HA formulation 2 at low doseSuspension for injection in a vial. Route of administration: IM injection | Biological | Group 4 TIV-HA formulation 2 at low dose |
| TIV-HA formulation 2 at high doseSuspension for injection in a vial. Route of administration: IM injection | Biological | Group 2 TIV-HA formulation 2 at high dose |
| RSV/hMPV/PIV3 formulation 2 at low doseSuspension for injection in a vial. Route of administration: IM injection | Biological | Group 8 RSV/hMPV/PIV3 formulation 2 at low dose |
| RSV/hMPV/PIV3 formulation 1 at high doseSuspension for injection in a vial. Route of administration: IM injection | Biological | Group 5 RSV/hMPV/PIV3 formulation 1 at high dose |
| RSV/hMPV/PIV3 formulation 2 at high doseSuspension for injection in a vial. Route of administration: IM injection | Biological | Group 6 RSV/hMPV/PIV3 formulation 2 at high dose |
| RSV/hMPV/PIV3 formulation 1 at low doseSuspension for injection in a vial. Route of administration: IM injection | Biological | Group 7 RSV/hMPV/PIV3 formulation 1 at low dose |
| RIV4 (Supemtek®)Solution for injection in a prefilled syringe. Route of administration: IM injection | Biological | Group 9 recombinant influenza vaccine quadrivalent (RIV4) |
Primary outcome
Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
Time frame: Within 30 minutes after each vaccination
Number of participants with unsolicited systemic AEs
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination
Time frame: Through 7 days after each vaccination
Number of participants with solicited injection site and systemic reactions
Presence of unsolicited AEs reported through 28 days after vaccination
Time frame: Through 28 days after each vaccination
Number of participants with unsolicited AEs
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study
Time frame: Throughout study, approximately 6 months
: Number of participants with SAEs and AESIs
Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination
Time frame: Through 7 days after vaccination
: Number of participants with out-of-range biological tests
Hemagglutinin Inhibition Assay (HAI) antibody (Ab) response to each homologous influenza strain at Day 1 and Day 29
Time frame: Day 1 and Day 29
RSV A, hMPV A and PIV3 serum neutralizing antibodies (nAb) titers at Day 1 and Day 29
Time frame: Day 1 and Day 29
2 secondary outcomes
RSV B and hMPV A nAb titers at Day 1 and Day 29
Time frame: Day 1 and Day 29
Neutralization Test (NT) Ab response to each homologous influenza strain at Day 29
Time frame: 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 16 Jan 2026.
- 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.
Clinical Sciences & Operations study director
Sanofi
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 TIV-HA Vaccine formulation 1 at low dose, TIV-HA formulation 1 at high dose and TIV-HA formulation 2 at low dose in people with Healthy Volunteers and Influenza Vaccination, 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 16 Jan 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) reported within 30 minutes after vaccination (time frame: Within 30 minutes after each vaccination). 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 16 Jan 2026.