RSV/hMPV Vaccine for Respiratory Infections
Recruiting at 12 trial locations
TT
Overseen ByTrial Transparency email recommended (Toll free for US & Canada)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Sanofi Pasteur, a Sanofi Company
Trial Summary
What is the purpose of this trial?
This trial is testing a new vaccine for lung infections caused by RSV and hMPV in adults aged 60 and older. The vaccine aims to help the immune system recognize and fight these viruses.
Eligibility Criteria
Adults aged 60 or older can join this vaccine study if they're not pregnant, breastfeeding, and don't have a history of severe allergies to the vaccine's ingredients. They should be generally healthy or have stable chronic diseases. People with recent serious infections, heart inflammation history, bleeding disorders, or on certain medications may not qualify.Inclusion Criteria
I am not pregnant, breastfeeding, and cannot become pregnant.
My doctor agrees I am fit for the trial and my condition has been stable without major treatment changes for 6 weeks.
I am 60 years old or older.
Exclusion Criteria
Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
I have a weak immune system or I am taking medication that weakens my immune system, but I am stable if I have HIV.
I have not had COVID-19 or its symptoms in the last 10 days.
See 13 more
Treatment Details
Interventions
- RSV/hMPV vaccine candidate (Cancer Vaccine)
Trial OverviewThe trial is testing different doses of an RSV/hMPV vaccine candidate in seniors to see how safe it is and how well it works (immunogenicity). Participants will get one shot and some will receive a booster after 12 months. A placebo group is included for comparison.
Participant Groups
9Treatment groups
Experimental Treatment
Placebo Group
Group I: Sentinel Cohort: RSV/hMPV Group 2 (Dose B)Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
Group II: Sentinel Cohort: RSV/hMPV Group 1 (Dose A)Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
Group III: Sentinel Cohort: RSV/hMPV Group 0 (Dose L)Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
Group IV: Main Cohort: RSV/hMPV Group 2 (Dose B)Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
Group V: Main Cohort: RSV/hMPV Group 1 (Dose A)Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
Group VI: Booster Cohort-RSV/hMPVExperimental Treatment2 Interventions
Participants will be randomized to receive a determined dose of single IM injection of RSV/hMPV vaccine candidate from a subset of Main cohort
Group VII: Main Cohort: Placebo-Group 3Placebo Group1 Intervention
Participants will be randomized to receive a single IM injection of placebo
Group VIII: Booster Cohort-PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive of single IM injection of placebo from a subset of Main cohort
Group IX: Sentinel Cohort: Placebo-Group 3Placebo Group1 Intervention
Participants will be randomized to receive a single IM injection of placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi Pasteur, a Sanofi Company
Lead Sponsor
Trials
429
Recruited
6,140,000+
Paul Hudson
Sanofi Pasteur, a Sanofi Company
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Dr. Thomas Triomphe
Sanofi Pasteur, a Sanofi Company
Chief Medical Officer since 2020
MD from Tehran University of Medical Sciences