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Study of a Respiratory Syncytial Virus Candidate Formulation in Adults Aged 60 Years and Older

PHASE2RECRUITING

The purpose of this Phase IIb study is to evaluate the efficacy of the RSV vaccine candidate for the prevention of lower respiratory tract disease (LRTD) due to RSV. The study will enroll approximately 4500 adults aged 60 years and older in a 1:1 ratio to receive a single intra-muscular (IM) administration of either a pre-determined dose of the RSV vaccine candidate or placebo.

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Study details:

Study duration per participant:. 6 months. Treatment Duration:.

1 IM injection. Participants will be followed for approximately 6 months post- vaccination.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Aged 60 years or older on the day of inclusion
  • A female participant is eligible to participate if she is not pregnant or breastfeeding and: Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year or surgically sterile.
  • Participants with high-risk medical conditions who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion.
  • Exclusion criteria

  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of an mRNA vaccine
  • History of RSV-associated illness, diagnosed clinically, serologically, or microbiologically in the last 12 months
  • Previous history of myocarditis, pericarditis, and/or myopericarditis
  • Thrombocytopenia, contraindicating IM injection based on investigator's judgment
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
  • Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
  • Receipt of any vaccine in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine in the 4 weeks following any study intervention administration
  • Receipt of any mRNA vaccine in the 60 days preceding any study intervention administration or planned receipt of any mRNA vaccine in the 60 days following any study intervention administration
  • Previous vaccination against RSV with a licensed or investigational vaccine or planned receipt during study participation, of vaccination against RSV with a licensed or investigational vaccine other than the study vaccine
  • 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 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
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    Eligibility

    Age eligible for study : 60 and older

    Healthy volunteers accepted : Yes

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2024-04-02

    Primary completion: 2025-02-18

    Study completion finish: 2025-02-18

    study type

    Study type

    PREVENTION

    phase

    Phase

      PHASE2

    trial

    Trial ID

    NCT06251024

    Intervention or treatment

    BIOLOGICAL: RSV vaccine candidate

    BIOLOGICAL: Placebo

    Conditions

    • Healthy Volunteers
    • Respiratory Syncytial Virus Infection
    Image related to Healthy Volunteers
    • Condition: Healthy Volunteers, Respiratory Syncytial Virus Infection

    • BIOLOGICAL: RSV vaccine candidate and other drugs

    • Botany, New South Wales, Australia and more

    • Sponsor: Sanofi Pasteur, a Sanofi Company

    Find a site

    Closest Location:

    Investigational Site Number : 0360003

    Research sites nearby

    Select from list below to view details:

    • Investigational Site Number : 0360003

      Botany, New South Wales, Australia

    • Investigational Site Number : 0360004

      Sippy Downs, Queensland, Australia

    • Investigational Site Number : 0360001

      Southport, Queensland, Australia

    • Investigational Site Number : 0360002

      Camberwell, Victoria, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Group 1: RSV vaccine candidate
    • Participants will be enrolled in a 1:1 ratio to receive a single IM administration of the RSV vaccine candidate.
    BIOLOGICAL: RSV vaccine candidate
    • Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
    PLACEBO_COMPARATOR: Group 2: placebo
    • Participants will be enrolled in a 1:1 ratio to receive a single IM administration of the placebo.
    BIOLOGICAL: Placebo
    • Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Presence of the first episode of RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccinationNumber of participants experiencing RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination≥ 14 days after vaccination

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Presence of the first episode of RSV-ARD (RSV A and/or RSV B) ≥ 14 days after vaccinationNumber of participants experiencing RSV-ARD (RSV A and/or RSV B) ≥ 14 days after vaccination≥ 14 days after vaccination
    Presence of the first episode of RSV MAARD (RSV A and/or RSV B) ≥ 14 days after vaccinationNumber of participants experiencing RSV-MAARD (RSV A and/or RSV B) ≥ 14 days after vaccination≥ 14 days after vaccination
    Presence of the first episode of RSV LRTD (RSV A) occurring ≥ 14 days after vaccination)Number of participants experiencing RSV-LRTD (RSV A) ≥ 14 days after vaccination≥ 14 days after vaccination
    Presence of the first episode of RSV LRTD (RSV B) occurring ≥ 14 days after vaccinationNumber of participants experiencing RSV-LRTD (RSV B) ≥ 14 days after vaccination≥ 14 days after vaccination
    Presence of the first episode of RSV-LRTD (RSV A and/or RSV B and by each one) by age groupNumber of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by age group≥ 14 days after vaccination
    Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline comorbiditiesNumber of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by baseline comorbidities≥ 14 days after vaccination
    Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline frailty statusNumber of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by baseline frailty status≥ 14 days after vaccination
    Presence of hospitalization due to RSV-ARD and/or RSV-LRTDNumber of participants hospitalized due to RSV-ARD and/or RSV-LRTD≥ 14 days after vaccination
    Duration (number of days) of RSV LRTD episodes (RSV A and/or RSV B)Duration (number of days) of RSV LRTD episodes (RSV A and/or RSV B)≥ 14 days after vaccination
    Duration (number of days) of RSV ARD episodes (RSV A and/or RSV B)Duration (number of days) of RSV ARD episodes (RSV A and/or RSV B)≥ 14 days after vaccination
    Presence of the first episode of severe RSV LRTD (RSV A and/or RSV B and by each one) occurring ≥ 14 days after vaccinationNumber of participants experiencing severe RSV-LRTD (RSV A and/or B and by each one)≥ 14 days after vaccination
    RSV A serum neutralizing antibodies (nAb) titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity SubsetRSV A serum neutralizing antibodies (nAb) titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity SubsetDay 1 and Day 29
    RSV B serum nAb titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity SubsetRSV B serum nAb titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity SubsetDay 1 and Day 29
    Serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity SubsetSerum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity SubsetDay 1 and Day 29
    RSV A serum nAb titers at 6 months post-vaccination in the Immunogenicity SubsetRSV A serum nAb titers at 6 months post-vaccination in the Immunogenicity SubsetMonth 6
    RSV B serum nAb titers at 6 months post-vaccination in the Immunogenicity SubsetRSV B serum nAb titers at 6 months post-vaccination in the Immunogenicity SubsetMonth 6
    Serum anti-F IgG Ab titers at 6 months post-vaccination in the Immunogenicity SubsetSerum anti-F IgG Ab titers at 6 months post-vaccination in the Immunogenicity SubsetMonth 6
    Presence of solicited injection site or systemic reactionsNumber of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chillsWithin 7 days after primary vaccination
    Presence of unsolicited immediate systemic adverse events (AEs)Number of participants experiencing an unsolicited immediate systemic adverse eventWithin 30 minutes after primary vaccination
    Presence of unsolicited AEsNumber of participants experiencing unsolicited AEsWithin 28 days after primary vaccination
    Presence of serious adverse events (SAEs)Number of participants experiencing SAEsThroughout study (approximately 6 months)
    Presence of medically attended adverse events (MAAEs)Number of participants experiencing MAAEsThroughout study (approximately 6 months)
    Presence of adverse events of special interest (AESIs)Number of participants experiencing AESIsThroughout study (approximately 6 months)

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Study of a Respiratory Syncytial Virus Candidate Formulation in Adults Aged 60 Years and Older

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