RSV+HMPV vaccine
BiologicalRSV + HMPV Candidate Vaccine
NCT Number: NCT07734649
This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate.
The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV [6 dose levels], placebo and 4 control groups).
The duration of the study will be approximately 12 months for each participant.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Phase 1 / Phase 2
Hawthorne Health - Gadsden- Site Number : 8400025, Gadsden, Alabama, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
RSV + HMPV Candidate Vaccine
Control Vaccine 3
Control Vaccine 4
Control Vaccine 2
Placebo
Control Vaccine 1
Time frame: At Day 1 and Day 29
nAb titers expressed as geometric mean titers (GMTs)
Time frame: At Day 1 and Day 29
nAb titers expressed as GMTs
Time frame: At Day 1 and Day 29
nAb titers expressed as GMTs
Time frame: At Day 1 and Day 29
nAb titers expressed as GMTs
Time frame: Within 30 minutes after vaccination
Number of participants reporting immediate unsolicited systemic AEs
Time frame: For 8 days, including the day of vaccination
Number of participants reporting:
Time frame: For 28 days, including day of vaccination
Number of participants reporting unsolicited AEs
Time frame: Within 6 months after vaccination
Number of participants reporting MAAEs
Time frame: Throughout the study (approximately 12 months)
Number of participants reporting SAEs, fatal SAEs and AESIs
Time frame: At Day 09
Number of participants with biological safety assessment values out of normal range (including shift from baseline values)
Time frame: 3, 6, 9, and 12-months post-vaccination
nAb titers expressed as geometric mean titers (GMTs)
Time frame: 3, 6, 9, and 12 months post-vaccination
nAb titers expressed as GMTs
Time frame: 3, 6, 9, and 12 months post-vaccination
nAb titers expressed as GMTs
Time frame: 3, 6, 9, and 12 months post-vaccination
nAb titers expressed as GMTs
Time frame: pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination
Ab concentration expressed as geometric mean concentrations (GMCs)
Time frame: pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination
Ab concentration expressed as GMCs
Time frame: Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01)
Time frame: Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01)
Interested in participating?
Request InfoSanofi
Industry
A Phase 1/2, Randomized, Controlled, Observer-Blind Study in Adults 60 Years of Age and Older to Evaluate the Immunogenicity and Safety of Different Dose Levels of a Bivalent Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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