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Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers

Recruiting
6 - 21 years of age
Both
Phase 3

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Overview

This study is a phase III, randomized, observer-blind, placebo-controlled, multinational, multi-center study to be conducted in approximately 6300 children 6 months to < 22 months of age. The purpose of the study is to evaluate the efficacy, immunogenicity, and safety of Respiratory Syncytial Virus Toddler (RSVt) vaccine administered by intranasal route compared to placebo.

Eligible participants will be randomized in a 1:1 ratio to receive 2 intranasal administrations of either the RSVt vaccine or placebo.

Study duration will be 24 months for each participant. The safety follow-up will start after the first vaccination and up to the end of the study.

Description

Study duration will be 24 months for each participant. The safety follow-up will start at inclusion and up to the end of the study.

Eligibility

Inclusion Criteria: -Aged 6 months to < 22 months on the day of inclusion (means the day of

the 6-month birthday to the day before the 22-month birthday)

  • Participants who are healthy as determined by medical evaluation including medical history
  • Born at full term of pregnancy (≥ 37 weeks)
        Exclusion Criteria: Participants are excluded from the study if any of the following
        criteria apply:
          -  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, or
             history of a life-threatening reaction to the study intervention used in the study or
             to a product containing any of the same substances
          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might
             interfere with study conduct or completion
          -  History of medically diagnosed wheezing
          -  Any acute febrile illness in the past 48 hours that according to investigator judgment
             is significant enough to interfere with successful inoculation on the day of
             vaccination. A prospective participant should not be included in the study until the
             condition has resolved or the febrile event has subsided.
          -  Probable or confirmed ongoing case of viral respiratory infection (including COVID-19,
             influenza, rhinovirus, etc.) at the time of enrollment. A prospective participant
             should not be included in the study until the respiratory infection has resolved.
          -  Member of a household that contains an immunocompromised individual, including, but
             not limited to:
               -  a person who is HIV infected
               -  a person who has received chemotherapy within the 12 months prior to study
                  enrollment
               -  a person who has received (within the past 6 months) or is receiving (at the time
                  of enrollment) immunosuppressant agents
               -  a person living with a solid organ or bone marrow transplant
          -  Potential close contact with other immunocompromised individual within 30 days after
             each vaccination as per investigator's discretion
          -  Participant's biological mother's previous receipt or planned administration of an
             investigational RSV vaccine during pregnancy and/or breastfeeding.
          -  Receipt or planned receipt of any of the following vaccines prior to enrollment or
             after the first study intervention administration:
               -  Any other intranasal live attenuated vaccine within the 28 days prior to and
                  after Dose 1 study administration
               -  Unless given on the day of Dose 1 study administration, any other injectable live
                  attenuated vaccines within the 28 days prior to and after. Concomitant receipt on
                  the day of Dose 1 study administration is allowed.
          -  Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product
             (such as ribavirin or RSV immune globulin) at the time of enrollment. Previous receipt
             of an RSV monoclonal antibody within 6 months prior to the first study vaccine
             administration.
          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months
          -  Receipt of intranasal and intra-ocular medications within 3 days prior to study
             enrollment
          -  Participation at the time of study enrollment or planned participation during the
             present study period in another clinical study investigating a vaccine, drug, medical
             device, or medical procedure The above information is not intended to contain all
             considerations relevant to a patient's potential participation in a clinical trial.

Study details

RSV Immunisation

NCT06252285

Sanofi Pasteur, a Sanofi Company

19 March 2024

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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