Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate

Last updated: March 11, 2026
Sponsor: Sanofi Pasteur, a Sanofi Company
Overall Status: Completed

Phase

1/2

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

NCT06134648
VBD00003
U1111-1287-8547
  • Ages > 60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of different doses of an respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine candidate, in adult participants aged 60 years and older. In addition, the study will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population.

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

Total Participants: 646
Treatment Group(s): 4
Primary Treatment: RSV/hMPV vaccine candidate Dose A
Phase: 1/2
Study Start date:
November 01, 2023
Estimated Completion Date:
February 27, 2026

Study Description

Study duration per participant:

12 months for the Sentinel and Main Cohorts and 24 months overall for the subset of participants enrolled in the Booster Cohort.

Treatment Duration:

Sentinel Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination.

Main Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination.

Booster Cohort: 1 IM injection 12 months after the primary vaccination (Main Cohort). Participants will be followed for 12 months after administration of the booster dose.

Connect with a study center

  • Investigational Site Number : 6300002

    Guayama, 000784
    Puerto Rico

    Site Not Available

  • Investigational Site Number : 6300002

    Guayama 4565105, 000784
    Puerto Rico

    Site Not Available

  • Investigational Site Number : 6300001

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Investigational Site Number : 6300003

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • Investigational Site Number : 6300001

    San Juan 4568127, 00909
    Puerto Rico

    Site Not Available

  • Investigational Site Number : 6300003

    San Juan 4568127, 00918
    Puerto Rico

    Site Not Available

  • Collaborative Neuroscience Research Site Number : 8400017

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Matrix Clinical Research Site Number : 8400011

    Los Angeles, California 90057
    United States

    Site Not Available

  • Peninsula Research Associates Site Number : 8400001

    Rolling Hills Estates, California 90274
    United States

    Site Not Available

  • Collaborative Neuroscience Research Site Number : 8400017

    Los Alamitos 5368304, California 5332921 90720
    United States

    Site Not Available

  • Matrix Clinical Research Site Number : 8400011

    Los Angeles 5368361, California 5332921 90057
    United States

    Site Not Available

  • Peninsula Research Associates Site Number : 8400001

    Rolling Hills Estates 5388601, California 5332921 90274
    United States

    Site Not Available

  • Suncoast Research Associates, LLC Site Number : 8400002

    Miami, Florida 33173
    United States

    Site Not Available

  • Suncoast Research Associates, LLC Site Number : 8400002

    Miami 4164138, Florida 4155751 33173
    United States

    Site Not Available

  • AMR Chicago, Oakbrook Terrace Site Number : 8400019

    Oakbrook Terrace, Illinois 60181
    United States

    Site Not Available

  • AMR Chicago, Oakbrook Terrace Site Number : 8400019

    Oakbrook Terrace 4904447, Illinois 4896861 60181
    United States

    Site Not Available

  • Velocity Clinical Research, Sioux City Site Number : 8400012

    Sioux City, Iowa 51106
    United States

    Site Not Available

  • Velocity Clinical Research, Sioux City Site Number : 8400012

    Sioux City 4876523, Iowa 4862182 51106
    United States

    Site Not Available

  • AMR Lexington Site Number : 8400008

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • AMR Lexington Site Number : 8400008

    Lexington 4297983, Kentucky 6254925 40509
    United States

    Site Not Available

  • AMR Kansas City Site Number : 8400014

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • AMR Kansas City Site Number : 8400014

    Kansas City 4393217, Missouri 4398678 64114
    United States

    Site Not Available

  • AMR Knoxville Site Number : 8400010

    Knoxville, Tennessee 37919
    United States

    Site Not Available

  • AMR Knoxville Site Number : 8400010

    Knoxville 4634946, Tennessee 4662168 37919
    United States

    Site Not Available

  • DM Clinical Research - Tomball Site Number : 8400004

    Tomball, Texas 77375
    United States

    Site Not Available

  • DM Clinical Research - Tomball Site Number : 8400004

    Tomball 4737094, Texas 4736286 77375
    United States

    Site Not Available

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