- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05687279
Study on a Live-attenuated Respiratory Syncytial Virus Vaccine for Assessment of Safety, Transmissibility, and Genetic Stability of the Vaccine Virus Among Close Contacts in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)
March 27, 2024 updated by: Sanofi Pasteur, a Sanofi Company
Phase II, Randomized, Observer-blind, Placebo-controlled, Multi-center Study of a Live Attenuated Respiratory Syncytial Virus Vaccine to Assess the Vaccine Virus' Transmissibility in Household or Daycare Center Settings, Shedding, and Genetic Stability, and to Describe the Immunogenicity and Safety of the Vaccine in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)
The primary purpose of the study is to assess the shedding, transmission, and genetic stability of the live-attenuated RSVt vaccine after each intranasal vaccination (56 days apart) in infants and toddlers 6 to < 24 months of age.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The duration of each participant's participation is up to 8 months, including the 6 months safety follow-up phone call after the second study intervention administration for the pediatric participants The treatment administration for the pediatric participants will be on D01 and D57 (1 intranasal administration each).
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Trial Transparency email recommended (Toll free for US & Canada)
- Phone Number: option 6 800-633-1610
- Email: Contact-US@sanofi.com
Study Locations
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Bayamón, Puerto Rico, 00960
- Recruiting
- Investigational Site Number : 6300004
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Carolina, Puerto Rico, 984
- Recruiting
- Investigational Site Number : 6300002
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Guayama, Puerto Rico, 00784
- Recruiting
- Investigational Site Number : 6300003
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San Juan, Puerto Rico, 00918
- Completed
- Investigational Site Number : 6300001
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Nebraska
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Norfolk, Nebraska, United States, 68701
- Recruiting
- Meridian Clinical Research Norfolk Site Number : 8400003
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Omaha, Nebraska, United States, 68134
- Recruiting
- Velocity Clinical Research, Omaha Site Number : 8400001
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 1 year (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Aged 6 months to < 24 months on the day of inclusion (from the day of the 6 months after birth to the day before the 2nd birthday)
- Participants who are healthy as determined by medical evaluation including medical history.
- Born at full term of pregnancy (≥ 37 weeks) or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention
- Attends a daycare facility at least 3 days per week and 4 hours per day at which the participant would be in a contact group/playroom of at least one other child 6 to < 24 months of age who will participate in this study or is a member of a household, which includes at least one other child 6 to < 24 months of age who will participate in this study
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, 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
- 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 COVID-19 at the time of enrollment
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
- Member of a household that includes, or will include, an infant who is less than 6 months of age at the time of enrollment
- Attends a daycare facility and shares a daycare room with infants less than 6 months of age, and parent/legally acceptable representative is unable or unwilling to suspend attendance at the daycare facility for 28 days following study intervention administration
- Any need of supplemental oxygen therapy in a home or hospital setting at the time of enrollment.
- Participant's mother previous receipt or planned administration of an investigational RSV vaccine or any monoclonal antibody (such as Infliximab) during pregnancy and/or breastfeeding.
Receipt or planned receipt of any of the following vaccines prior to or after the first study intervention administration:
- any influenza vaccine within 7 days prior to and after, or any COVID-19 or inactivated vaccine or live-attenuated rotavirus vaccine within 14 days prior to and after, or
- any live vaccine, other than rotavirus vaccine, within 28 days prior to and after
- Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV Immunoglobulin (IG) or RSV monoclonal antibody) at the time of enrollment.
- 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
- Receipt at the time of enrollment or previous receipt of salicylate (aspirin) or salicylate-containing products
- Participation at the time of study enrollment (or in the 6 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
- Deprived of freedom in an emergency setting, or hospitalized involuntarily
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RSVt Vaccine Group
2 intranasal administrations (56 days apart) of the RSVt vaccine at D01 and D57
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Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal
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Placebo Comparator: Control Group
2 intranasal administrations (56 days apart) of the placebo at D01 and D57
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Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of vaccine virus
Time Frame: Day 1 through Day 22
|
Proportion of vaccinees infected with vaccine virus in the placebo group, defined as vaccine virus shedding, detected by quantitative reverse transcription polymerase chain reaction (qRT-PCR)
|
Day 1 through Day 22
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Change in the Geometric Mean Titers (GMTs) of vaccine virus shedding
Time Frame: Day 1 through Day 71
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Titer of vaccine virus shedding in nasal swabs, quantified by qRT-PCR Assay in all pediatric participants
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Day 1 through Day 71
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Number of differences detected in genetic sequence of NS2 segment
Time Frame: Approximately Day 1 through Day 85
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Number of differences detected in genetic sequence of NS2 segment of the vaccine virus compared to the reference strain vaccine virus isolates in the vaccine virus positive swabs from pediatric participants receiving placebo and ad hoc close contact participants
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Approximately Day 1 through Day 85
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Titers (GMTs) of RSV A serum neutralizing antibody (nAb) titers
Time Frame: Day 1, Day 57 and Day 85
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RSV A serum Nab titers
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Day 1, Day 57 and Day 85
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GMTs of RSV serum anti-F Immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) antibody titers up to 28 days after the second administration (D01, D57, and D85)
Time Frame: Day 1, Day 57 and Day 85
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RSV serum anti-F IgG ELISA antibody titers
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Day 1, Day 57 and Day 85
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Presence of immediate unsolicited systemic Adverse Events (AEs)
Time Frame: Within 30 minutes after each vaccination administration
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Number of participants experiencing immediate unsolicited systemic AEs
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Within 30 minutes after each vaccination administration
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Presence of solicited injection site or systemic reactions
Time Frame: Within 21 days after each vaccination administration
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Number of participants reporting:
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Within 21 days after each vaccination administration
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Presence of unsolicited AEs
Time Frame: Within 28 days after each vaccination administration
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Number of participants experiencing unsolicited AEs
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Within 28 days after each vaccination administration
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Presence of adverse events of special interest (AESIs)
Time Frame: Within 28 days after each vaccination administration
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Number of participants experiencing AESIs
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Within 28 days after each vaccination administration
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Presence of medically attended adverse events (MAAEs)
Time Frame: Within 28 days after each vaccination administration
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Number of participants experiencing MAAEs
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Within 28 days after each vaccination administration
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Presence of serious adverse events (SAEs)
Time Frame: From Day 1 until the end of the study (approximately 8 months)
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Number of participants experiencing SAEs
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From Day 1 until the end of the study (approximately 8 months)
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Presence of vaccine virus at Day 64 through Day 71
Time Frame: Day 64 through Day 71
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Proportion of vaccinees infected with vaccine virus in the placebo group, defined as vaccine virus shedding, detected by quantitative reverse transcription polymerase chain reaction (qRT-PCR)
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Day 64 through Day 71
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi Pasteur, a Sanofi Company
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 6, 2023
Primary Completion (Estimated)
January 23, 2025
Study Completion (Estimated)
January 23, 2025
Study Registration Dates
First Submitted
January 6, 2023
First Submitted That Met QC Criteria
January 17, 2023
First Posted (Actual)
January 18, 2023
Study Record Updates
Last Update Posted (Actual)
March 29, 2024
Last Update Submitted That Met QC Criteria
March 27, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VAD00014
- U1111-1278-3910 (Registry Identifier: ICTRP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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