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NCT06686654 · ClinicalTrials.gov registry record · Phase 1
Study of a Human Metapneumovirus/Respiratory Syncytial Virus mRNA Vaccine Candidate Encapsulated in a Lipid Nanoparticle-based Formulation in Adults Aged 60 Years and Older
A Phase 1 study of Human Metapneumovirus Immunization and Respiratory Syncytial Virus Immunization, sponsored by Sanofi Pasteur, a Sanofi Company.
- Active
- Registry status
- Phase 1
- Development phase
- 1,530
- Enrollment target
- 20
- Study locations
NCT06686654: Active Phase 1 study of Human Metapneumovirus Immunization and Respiratory Syncytial Virus Immunization, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT06686654 is a Phase 1 study of Human Metapneumovirus Immunization and Respiratory Syncytial Virus Immunization that is active but no longer recruiting, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,530 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2450% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06686654, a Phase 1 study of Human Metapneumovirus Immunization and Respiratory Syncytial Virus Immunization, is active but no longer recruiting, sponsored by Sanofi Pasteur, a Sanofi Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 1,530 participants
- Enrollment target
- 20
- Study locations
Study Summary
The aim of this study is to evaluate the safety and immunogenicity of a human metapneumovirus (hMPV) / respiratory syncytial virus (RSV) mRNA vaccine candidate encapsulated in a lipid nanoparticle (LNP) based formulation (hereafter referred to as hMPV/RSV vaccine) for the prevention of lower respiratory tract disease (LRTD) caused by hMPV and/or RSV among adults aged 60 years and older. The study will also evaluate the safety and immunogenicity of a booster vaccination using a bivalent hMPV/RSV mRNA vaccine candidate (hereafter referred to as RSV+hMPV mRNA vaccine candidate). Overall, the study is designed to address the following goals: * Assess the safety profile of the candidate formulations. * Describe the immunogenicity profile of the candidate formulations. * Select the vaccine formulations (dose) for future development. * Assess the safety and immunogenicity of a booster vaccination with the RSV + hMPV mRNA vaccine candidate administered 12 months after primary vaccination with a licensed RSV vaccine. The study duration is as follows: -Six months each for the Sentinel and Main Cohorts; up to 12 months for the Expansion Cohort, and 6 additional months for the Booster Cohort Treatment duration: * Stage 1 Sentinel Cohort: 1 intra-muscular (IM) injection. Participants will be followed for 6 months post vaccination * Stage 1 Main Cohort: 1 IM injection. Participants will be followed for 6 months post vaccination * Stage 2 Expansion Cohort: 1 IM injection. Participants in the licensed RSV vaccine arm will be followed for 12 months post-vaccination; the remainder of the participants will be followed up to 8 months post-vaccination * Stage 2 Booster Cohort: 1 IM injection 12 months post-primary vaccination. Participants will be followed for 6 months post-booster vaccination
Primary Outcome
Number of participants reporting immediate unsolicited systemic AEs
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Investigational hMPV/RSV vaccine
- BIOLOGICAL Investigational hMPV vaccine (monovalent)
- BIOLOGICAL Investigational RSV vaccine (monovalent)
- BIOLOGICAL Licensed RSV Vaccine
Study Locations (20)
California
- CenExel CNS-Garden Grove- Site Number : 8400017 - Garden Grove
- National Research Institute - Gardena- Site Number : 8400005 - Gardena
- National Research Institute - Huntington Park- Site Number : 8400014 - Huntington Park
- Velocity Clinical Research - San Diego- Site Number : 8400008 - La Mesa
- Velocity Clinical Research Los Angeles- Site Number : 8400013 - Los Angeles
- National Research Institute - Panorama City- Site Number : 8400012 - Los Angeles
- Providence Clinical Research - North Hollywood- Site Number : 8400018 - North Hollywood
- Peninsula Research Associates- Site Number : 8400002 - Rolling Hills Estates
Florida
- Velocity Clinical Research - Hallandale Beach- Site Number : 8400022 - Hallandale
- Suncoast Research Associates - Miami - Sunset Drive- Site Number : 8400001 - Miami
Nebraska
- Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400023 - Lincoln
- Velocity Clinical Research - Omaha- Site Number : 8400006 - Omaha
Arizona
- Velocity Clinical Research, Phoenix- Site Number : 8400025 - Phoenix
Colorado
- Velocity Clinical Research - Denver- Site Number : 8400016 - Englewood
District of Columbia
- Velocity Clinical Research - Washington DC- Site Number : 8400007 - Washington D.C.
Idaho
- Velocity Clinical Research - Meridian- Site Number : 8400003 - Meridian
Kansas
- Velocity Clinical Research - Kansas City- Site Number : 8400015 - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,530 participants |
| Start Date | 2024-11-11 |
| Est. Completion | 2027-01-18 |
| Phase | Phase 1 |
What the registry record for NCT06686654 still lists
NCT06686654 is an interventional study that assigns participants to a tested intervention. Its 1,530 participants enrollment target places it among the larger protocols in the corpus, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2450% higher).
The record links to 2 conditions, with Human Metapneumovirus Immunization appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT06686654 names 20 study sites across 11 states, led by California, Florida, Nebraska.
Frequently Asked Questions
What is clinical trial NCT06686654 about?
NCT06686654 is a clinical study titled "Study of a Human Metapneumovirus/Respiratory Syncytial Virus mRNA Vaccine Candidate Encapsulated in a Lipid Nanoparticle-based Formulation in Adults Aged 60 Years and Older". The aim of this study is to evaluate the safety and immunogenicity of a human metapneumovirus (hMPV) / respiratory syncytial virus (RSV) mRNA vaccine candidate encapsulated in a lipid nanoparticle (LNP) based formulation (hereafter referred to as hMPV/RSV vaccine) for the prevention of lower respira...
What is the current status of trial NCT06686654?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 1,530 participants. The study started on 2024-11-11. Estimated completion is 2027-01-18.
What conditions does trial NCT06686654 study?
This clinical trial studies the following conditions: Human Metapneumovirus Immunization, Respiratory Syncytial Virus Immunization.
What interventions are being tested in trial NCT06686654?
The interventions under investigation include: Placebo (BIOLOGICAL), Investigational hMPV/RSV vaccine (BIOLOGICAL), Investigational hMPV vaccine (monovalent) (BIOLOGICAL), Investigational RSV vaccine (monovalent) (BIOLOGICAL), Licensed RSV Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT06686654?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06686654 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06686654's enrollment target sits among peer trials
1,530 3rd of 2000 higher than 1,998 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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