> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-an-rsv-hmpv-piv3-trivalent-vaccine-candidate-vxb-9f64287e-bc0e-4006-bbce-5ad08556366e > Record changed: 2026-10-13 # Study of an RSV-hMPV-PIV3 Trivalent Vaccine Candidate VXB-251 in Older Adults NCT07295028 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) Participants 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) Lead sponsor Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) Start date 2025-11-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) Number of sites 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) ## Title and summary **Summary** This study is being done to find out how safe and effective a new combined vaccine candidate, called VXB-251, is for older adults. The vaccine candidate is designed to protect against three common viruses that can cause respiratory tract infections: \* RSV (respiratory syncytial virus) \* hMPV (human metapneumovirus) \* PIV3 (parainfluenza virus type 3) Two components of this vaccine (RSV and hMPV) have already been tested in people before, as part of another study for a two-in-one vaccine. However, this is the first time that the PIV3 component and all three components together (RSV, hMPV, and PIV3) are being tested in people. The vaccine candidate will be given as a single intramuscular injection. The study will also test unlicensed comparator vaccines and a placebo (a substance that looks like the real vaccine but doesn't contain any active ingredients) that target none, one or two of these viruses to see whether combining all three components affects safety or how well the immune system responds. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Acronym** VXB251-001 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Short title** Study of an RSV-hMPV-PIV3 Trivalent Vaccine Candidate VXB-251 in Older Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Official title** A Phase 1 Randomized, Placebo- and Comparator-controlled (Bivalent and Monovalent Components), Observer-blind Study in Older Adults to Evaluate the Safety, Reactogenicity, and Immunogenicity of 3 Dose-levels of VXB-251 (Trivalent), for the Prevention of LRTD Caused RSV, hMPV, PIV3 and to Assess Immunological Interference and Cross-reactivity. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) ## Dates **Completion date** 2027-04-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **First posted** 2025-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Registry last updated** 2026-05-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Primary completion date** 2026-04-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Start date** 2025-11-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) ## Size and sites **Actual participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Randomisation ratio** 4:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Number of sites** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Lead sponsor** Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) ## Identifiers **Registry ID** NCT07295028 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **ClinicalTrials.gov ID** NCT07295028 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Prevention **Masking** Double masking **Masking description** Double **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) ## Outcomes ### Primary outcomes 1. Proportion of Participants With 1 or More Unsolicited Adverse Events (AEs) Timeframe: 1 month after IMP injection 2. Proportion of Participants With 1 or More Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and Premature Discontinuation Associated AEs (PDAEs) Timeframe: 1 month after IMP injection 3. Proportion of Participants With 1 or More Solicited AEs Timeframe: 7 days after IMP injection ### Secondary outcomes 1. Proportion of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and Premature Discontinuation Associated AEs (PDAEs) Timeframe: 6 and 12 months after IMP injection 2. Proportion of Participants With 1 or More Severe Solicited AEs Timeframe: 7 days after IMP injection 3. Geometric Mean Fold Increase (GMFI) of RSV-A, RSV-B, hMPV-A, hMPV-B, and PIV3 Serum Neutralizing Antibody Titers Timeframe: Pre-injection baseline to 1 month, 6 months, and 12 months, after IMP injection GMFI is defined as geometric mean of ratios of specific antibody titer/concentration at each post-injection time point over pre-injection baseline. 4. Geometric Mean Titers (GMTs) of RSV-A, RSV-B, hMPV-A, hMPV-B, and PIV3 Serum Neutralizing Antibody Titers Timeframe: Pre-injection baseline to 1 month, 6 months, and 12 months after IMP injection 5. Proportion of Participants with Sero-response Greater Than or Equal to (>=) 4-fold (SRR-4) and 8-fold (SRR-8) Increase from Baseline in Neutralizing Antibody Titers for RSV-A, RSV-B, hMPV-A, hMPV-B, and PIV3 Timeframe: Pre-injection baseline up to 1 month, 6 months, and 12 months after IMP injection 6. GMFI of RSV PreF, hMPV PreF, and PIV3 PreF Serum Immunoglobulins G (IgG) Concentrations Timeframe: Pre-injection baseline to 1 month, 6 months, and 12 months after IMP injection 7. Geometric Mean Concentrations (GMC) of RSV PreF, hMPV PreF, and PIV3 PreF Serum IgG Timeframe: 1 month, 6 months, and 12 months after IMP injection 8. Geometric Mean Ratios (GMRs) of Fold Increase of RSV-A and RSV-B Neutralizing Serum Antibody Titers Versus Fold Increase of RSV PreF Serum IgG Concentration Timeframe: Pre-injection baseline to 1 month, 6 months, and 12 months after IMP injection 9. GMR of Fold Increase of hMPV-A and hMPV-B Neutralizing Serum Antibody Titers Versus Fold Increase of hMPV PreF Serum IgG Concentration Timeframe: Pre-injection baseline to 1 month, 6 months, and 12 months after IMP injection 10. GMR of Fold Increase of PIV3 Neutralizing Serum Antibody Titers Versus Fold Increase PIV3 PreF Serum IgG Concentration Timeframe: Pre-injection baseline to 1 month, 6 months, and 12 months after IMP injection Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 60 Years **Maximum age** 83 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Males and females aged 60 to 83 years of age at inclusion. 2. Evidence of signed and dated participant informed consent form (PICF) prior to any study procedure, indicating that the subject has been informed of all pertinent aspects of the study. 3. Willingness and ability to comply with the planned study visits and calls, procedures, and restrictions for the duration of the study. 4. Good health, which allows for pre-existing well controlled and low impact chronic diseases, except for the diseases listed in the exclusion criteria. A disease is defined as well controlled and has a low impact if it did not require meaningful change in therapy or unplanned medical visit(s) in the previous 3 months and allows participant's primary responsibility for self-care and daily living activities. 5. Non-smoker or occasional smoker, defined as smoking less than 10 nicotine-containing cigarettes/ vapes/cigars/pipe fills per week. 6. Contraception and childbearing/conception potential: only female participants with non-childbearing potential will be included. Male participants in a relationship with a female partner of childbearing potential must be willing to use a double contraceptive method together with their female partner for at least 4 weeks before and 12 weeks after the IMP injection at Visit 2 (day 1). 7. Body mass index (BMI) ≥ 17.0 kg/m2 and ≤ 35.0 kg/m2. ### Exclusion criteria 1. History of RSV, hMPV, and/or PIV3 infection affecting the participant and/or the participant's household in the previous 12 months. 2. History of autoimmune disease (AID) or possibly autoimmune disease (pAID) requiring therapeutic intervention, even if stable and well controlled, including, but not limited to, systemic lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, temporal arteritis, psoriasis, insulin-dependent diabetes mellitus, celiac disease. 3. Confirmed or suspected immunodeficiency, even if stable and well controlled. 4. Ongoing severe asthma. Other allergic diseases (e.g., allergic rhinitis, atopic dermatitis / eczema, mild to moderate asthma, food allergies) are allowed at the investigator's or delegate's discretion. 5. History of significant allergic reaction (e.g., anaphylaxis, hypersensitivity, angioedema) to medication or food or known allergy to vaccine, or any excipients in the formulation, and latex. 6. History of severe AE associated with vaccine administration. 7. Ongoing disorders of coagulation, which contraindicate IM injections. 8. Donation or loss of ≥ 500 mL whole blood on the previous 2 months, and/or donation of plasma in the previous 1 week, and/or intention to donate blood or plasma during the study. 9. Positive serum test results indicating ongoing HIV, HBV and/or HCV infection, and/or documented ongoing HIV, HBV, or HCV infection. 10. Other poorly controlled and/or impactful chronic disease. A disease is defined as poorly controlled if it requires meaningful change in therapy and/or unplanned medical visit(s) in the previous 3 months. A disease is defined as impactful if, in the investigator's judgment, it meaningfully affects the participant's ability to manage self-care and/or activities of daily living. 11. Disease expected to prevent completion of the study (i.e. to rapidly deteriorate within the timeframe of the study). 12. Prior treatments. 1. Receipt of licensed RSV vaccine and/or enrollment in clinical trials(s) evaluating investigational RSV, hMPV, PIV3, and/or molecular clamp-based vaccine candidates at any time, unless it was documented that the participant received a placebo. 2. Other investigational drug or vaccine received in the previous 6 months. 3. Chemotherapy, radiotherapy, and/or other immunosuppressive medication (including biologics) received in the previous 6 months. 4. IgGs or any blood product received in the previous 3 months. 5. Systemic corticosteroids (oral/intravenous/IM) at doses equivalent to ≥ 20 mg prednisone per day received for ≥ 14 days, even if not consecutive, during the previous 3 months. Inhaled/nebulized, intra-articular, intra-bursal, skin, and eye topical corticosteroids are permitted. 6. Received or plan to receive licensed non-live vaccine(s) for the period starting 2 weeks before to 4 weeks after of the study IMP injection or licensed live vaccine(s) for the period starting from 4 weeks before to 4 weeks after the study IMP injection. Pandemic or emergency vaccines are always allowed as per country guidelines. 13. Clinically meaningful abnormal finding from physical examination, vital sign assessment, electrocardiogram (ECG), safety laboratory test results. If deemed appropriate, the investigator or delegate may repeat these assessments. 14. History of alcohol abuse in the previous year determined at the investigator's discretion. 15. History of recreational drug abuse in the previous year and/or positive test for drugs of abuse at Visit 2 (day 1), unless there is an explanation acceptable to the investigator (e.g., the participant has informed in advance that he/she consumed a prescription or over-the-counter product that contained the detected drug). 16. Intention to participate in any investigational drug/vaccine/medical device clinical trial at any time throughout the planned duration of this study. 17. Presence of tattoo, scarring, skin discoloration, or any other skin disturbances at the injection site which may interfere with effective assessment of the injection site. 18. Intention to move to a location that would prevent participating in the study until study end. 19. Any other reason which would prevent the participant from participating in the study or interfere with the participant's compliance with study procedures. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) ## Sites - University of Sunshine Coast, South BankBrisbane, Australia - Emeritus ResearchCamberwell, Australia - Momentum Clinical ResearchDarlinghurst, Australia - Veritus ResearchMelbourne, Australia - University of the Sunshine CoastMorayfield, Australia - University of the Sunshine Coast, Sippy DownsSippy Downs, Australia Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) ## References ### Other registry identifiers - VCB23397 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07295028) ## Related records ### Drugs (2) - [Artesunate](https://trialight.com/data/asset/artesunate-586f50f5-bb73-43da-8a18-5a2743da577b.md) - [Spunoleucel](https://trialight.com/data/asset/spunoleucel-3e670e80-ab3a-49e2-8479-bf7835c06da2.md) ### Lead sponsors (1) - [Sanofi](https://trialight.com/data/company/sanofi-241d6a3a-4341-499a-adf8-1c63e9a2e2fd.md) ### Conditions (1) - [Lower respiratory tract disorder](https://trialight.com/data/condition/lower-respiratory-tract-disorder-cfa96f5e-8af8-555b-a663-55befbd68962.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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