> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-a-respiratory-syncytial-virus-human-metapneumovirus-791f9312-b59e-44a6-8c99-e47d7b033f7d > Record changed: 2026-10-13 # Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older NCT06604767 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) Participants 390 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) Lead sponsor Sanofi Pasteur, a Sanofi Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) Start date 2024-09-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) Number of sites 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) ## Title and summary **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). 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **Short title** Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) ## Dates **Completion date** 2026-03-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **First posted** 2024-09-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **Registry last updated** 2026-04-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **Primary completion date** 2026-03-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **Start date** 2024-09-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) ## Size and sites **Actual participants** 390 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **Participants** 390 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **Number of sites** 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **Lead sponsor** Sanofi Pasteur, a Sanofi Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) ## Identifiers **Registry ID** NCT06604767 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **ClinicalTrials.gov ID** NCT06604767 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Triple masking **Masking description** \-Investigators, Sponsor and study site staff, laboratory personnel, and participants will be blinded. Study staff preparing/administering the study interventions will be unblinded. Specific Sponsor personnel will be unblinded for the assessment of safety in the sentinel cohorts **Masked roles** Participants, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) ## Outcomes ### Primary outcomes 1. Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination Timeframe: Within 30 minutes after each vaccination Number of participants experiencing immediate unsolicited systemic AEs 2. Presence of solicited administration site reactions within 7 days after vaccination Timeframe: Within 7 days after vaccination Number of participants reporting: \\- injection site reactions: pain, erythema and swelling 3. Presence of solicited systemic reactions within 7 days after vaccination Timeframe: Within 7 days after vaccination Number of participants reporting: \* systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills 4. Presence of unsolicited AEs within 28 days after vaccination Timeframe: Within 28 days after vaccination Number of participants experiencing unsolicited AEs 5. Presence of serious adverse events (SAEs) Timeframe: Within 6 months after vaccination Number of participants experiencing SAEs regardless of causality 6. Presence of adverse events of special interest (AESIs) Timeframe: Within 6 months after vaccination Number of participants experiencing AESIs regardless of causality 7. Presence of related SAEs throughout the study Timeframe: Throughout the study, approximately 12 months Number of participants experiencing related SAEs regardless of causality 8. Presence of related AESIs throughout the study Timeframe: Throughout the study, approximately 12 months Number of participants experiencing related AESIs regardless of causality 9. Presence of related fatal SAEs throughout the study Timeframe: Throughout the study, approximately 12 months Number of participants experiencing related fatal SAEs regardless of causality 10. Presence of out-of-range biological test results (including shift from baseline values) Timeframe: 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) ### Secondary outcomes 1. 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 Timeframe: At Day 01 and Day 29 Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination 2. RSV B serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines Timeframe: At Day 01 and Day 29 Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination 3. hMPV A serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 vaccines Timeframe: At Day 01 and Day 29 Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination 4. PIV3 serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV/PIV3 and PIV3 vaccines Timeframe: At Day 01 and Day 29 Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 60 Years **Healthy volunteers** Yes ### Inclusion criteria - 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. ### Exclusion criteria 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) ## Sites - Investigational Site Number : 0360006Blacktown, Australia - Investigational Site Number : 0360001Botany, Australia - Investigational Site Number : 0360009Brookvale, Australia - Investigational Site Number : 0360005Kanwal, Australia - Investigational Site Number : 0360004Miranda, Australia - Investigational Site Number : 0360008Herston, Australia - Investigational Site Number : 0360003Bayswater, Australia - Investigational Site Number : 0360002Camberwell, Australia Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) ## References ### Other registry identifiers - U1111-1304-9362 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06604767) ## Related records ### Drugs (1) - [Spunoleucel](https://trialight.com/data/asset/spunoleucel-3e670e80-ab3a-49e2-8479-bf7835c06da2.md) ### Lead sponsors (1) - [Sanofi Pasteur, a Sanofi Company](https://trialight.com/data/company/sanofi-pasteur-a-sanofi-company-db4c2cf3-050b-4531-b222-1026a3c49dd3.md) ### Conditions (2) - [Paramyxoviridae infectious disease](https://trialight.com/data/condition/paramyxoviridae-infectious-disease-c87d2774-268a-5c4f-922f-ccfefd0a4386.md) - [Respiratory syncytial virus infectious disease](https://trialight.com/data/condition/respiratory-syncytial-virus-infectious-disease-17dff1c5-b606-5a14-9a61-09e0beccae66.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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