Phase
Condition
Throat And Tonsil Infections
Healthy Volunteers
Respiratory Syncytial Virus (Rsv)
Treatment
RSV/hMPV vaccine candidate Dose A
Placebo
RSV/hMPV vaccine candidate Dose L
Clinical Study ID
Ages > 60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 60 years or older on the day of inclusion
A female participant is eligible to participate if she is not pregnant orbreastfeeding and is of non-childbearing potential.
Participants who are determined by medical history, physical examination (ifrequired), and clinical judgment of the investigator to be eligible for inclusionNote: Participants with pre-existing stable disease, defined as disease notrequiring significant change in therapy or hospitalization for worsening diseaseduring the 6 weeks before enrollment, can be included.
Exclusion
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Any screening laboratory parameter with laboratory abnormalities deemed clinicallysignificant by the investigator
Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive therapy. Persons living with stable human immunodeficiency virus (HIV) are not excluded
Known systemic hypersensitivity to any of the study intervention components (eg,polyethylene glycol, polysorbate); history of a life-threatening reaction to thestudy interventions used in the study or to a product containing any of the samesubstances; any allergic reaction (eg, anaphylaxis) after administration of mRNAcoronavirus disease 2019 (COVID-19) vaccine
History of RSV and/or hMPV-associated illness, diagnosed clinically, serologically,or microbiologically in the last 12 months
Previous history of myocarditis, pericarditis, and/or myopericarditis
Screening electrocardiogram that is consistent with possible myocarditis,pericarditis, and/or myopericarditis or, in the opinion of the investigator,demonstrates clinically relevant abnormalities that may affect participant safety orstudy results
Thrombocytopenia or bleeding disorder, contraindicating intramuscular (IM) injectionbased on investigator's judgment
Receipt of anticoagulants in the 3 weeks preceding inclusion
Chronic illness that, in the opinion of the investigator, is at a stage where itmight interfere with study conduct or completion
Alcohol, prescription drug, or substance abuse that, in the opinion of theinvestigator, might interfere with the study conduct or completion
History of acute infection symptoms or a positive severe acute respiratory syndromecoronavirus reverse transcription polymerase chain reaction (SARS-CoV-2 RT-PCR) orantigen test in the 10 days prior to the visit. A prospective participant should notbe included in the study until the condition has resolved
Receipt of any vaccine other than mRNA vaccine in the 4 weeks preceding any studyintervention administration or planned receipt of any vaccine other than mRNAvaccine in the 4 weeks following any study intervention administration
Receipt of any mRNA vaccine in the 60 days preceding any study interventionadministration or planned receipt of any mRNA vaccine in the 60 days following anystudy intervention administration
Previous vaccination against RSV and/or hMPV (with a licensed or investigationalvaccine either as a monovalent vaccine or any combination of the antigens)
Receipt of immune globulins, blood, or blood-derived products in the past 3 months
Participation at the time of study enrollment (or in the 4 weeks preceding the firststudy intervention administration) or planned participation during the present studyperiod in another clinical study investigating a vaccine, drug, medical device, ormedical procedure The above information is not intended to contain allconsiderations relevant to a potential participation in a clinical trial.
Study Design
Study Description
Connect with a study center
Investigational Site Number : 6300002
Guayama, 000784
Puerto RicoSite Not Available
Investigational Site Number : 6300002
Guayama 4565105, 000784
Puerto RicoSite Not Available
Investigational Site Number : 6300001
San Juan, 00909
Puerto RicoSite Not Available
Investigational Site Number : 6300003
San Juan, 00918
Puerto RicoSite Not Available
Investigational Site Number : 6300001
San Juan 4568127, 00909
Puerto RicoSite Not Available
Investigational Site Number : 6300003
San Juan 4568127, 00918
Puerto RicoSite Not Available
Collaborative Neuroscience Research Site Number : 8400017
Los Alamitos, California 90720
United StatesSite Not Available
Matrix Clinical Research Site Number : 8400011
Los Angeles, California 90057
United StatesSite Not Available
Peninsula Research Associates Site Number : 8400001
Rolling Hills Estates, California 90274
United StatesSite Not Available
Collaborative Neuroscience Research Site Number : 8400017
Los Alamitos 5368304, California 5332921 90720
United StatesSite Not Available
Matrix Clinical Research Site Number : 8400011
Los Angeles 5368361, California 5332921 90057
United StatesSite Not Available
Peninsula Research Associates Site Number : 8400001
Rolling Hills Estates 5388601, California 5332921 90274
United StatesSite Not Available
Suncoast Research Associates, LLC Site Number : 8400002
Miami, Florida 33173
United StatesSite Not Available
Suncoast Research Associates, LLC Site Number : 8400002
Miami 4164138, Florida 4155751 33173
United StatesSite Not Available
AMR Chicago, Oakbrook Terrace Site Number : 8400019
Oakbrook Terrace, Illinois 60181
United StatesSite Not Available
AMR Chicago, Oakbrook Terrace Site Number : 8400019
Oakbrook Terrace 4904447, Illinois 4896861 60181
United StatesSite Not Available
Velocity Clinical Research, Sioux City Site Number : 8400012
Sioux City, Iowa 51106
United StatesSite Not Available
Velocity Clinical Research, Sioux City Site Number : 8400012
Sioux City 4876523, Iowa 4862182 51106
United StatesSite Not Available
AMR Lexington Site Number : 8400008
Lexington, Kentucky 40509
United StatesSite Not Available
AMR Lexington Site Number : 8400008
Lexington 4297983, Kentucky 6254925 40509
United StatesSite Not Available
AMR Kansas City Site Number : 8400014
Kansas City, Missouri 64114
United StatesSite Not Available
AMR Kansas City Site Number : 8400014
Kansas City 4393217, Missouri 4398678 64114
United StatesSite Not Available
AMR Knoxville Site Number : 8400010
Knoxville, Tennessee 37919
United StatesSite Not Available
AMR Knoxville Site Number : 8400010
Knoxville 4634946, Tennessee 4662168 37919
United StatesSite Not Available
DM Clinical Research - Tomball Site Number : 8400004
Tomball, Texas 77375
United StatesSite Not Available
DM Clinical Research - Tomball Site Number : 8400004
Tomball 4737094, Texas 4736286 77375
United StatesSite Not Available

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