Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (VAD00001)

September 28, 2023 updated by: Sanofi Pasteur, a Sanofi Company

Safety, Immunogenicity, Infectivity, and Dose-Finding Study of an Investigational Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Infants and Toddlers

The primary objectives of the study are:

  • To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline serostatus.
  • To characterize the Respiratory Syncytial Virus (RSV) A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-naïve participants.

The secondary objectives of the study are:

  • To quantify the amount of vaccine virus shed by each participant by baseline serostatus.
  • To determine the proportion of vaccinated infants and toddlers in each vaccine group infected with the vaccine virus at D56 (56 days after vaccination 1) for Cohorts 1, 2, 3 and 4, and at Day 84 (28 days after vaccination 2) for Cohorts 2 and 4 by baseline serostatus.
  • To characterize the RSV A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-experienced participants.
  • To characterize serum RSV anti-F immunoglobulin G (IgG) antibody responses to the study product in each vaccine group after vaccination by baseline serostatus.
  • To characterize serum RSV antibody responses (RSV A-neutralizing and anti-RSV F IgG) to the study product in each vaccine group after the RSV surveillance season or at least 5 months after the last vaccine administration by baseline serostatus.

Study Overview

Detailed Description

Study duration per participant is maximum 12 months

Study Type

Interventional

Enrollment (Actual)

259

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Reg Metropolitana De Santiago
      • Santiago, Reg Metropolitana De Santiago, Chile, 8380453
        • Investigational Site Number :1520001
      • Santiago, Reg Metropolitana De Santiago, Chile, 8420383
        • Investigational Site Number :1520004
      • Municipio Del Distrito Central, Honduras, 11101
        • Investigational Site Number :3400002
      • San Pedro Sula, Honduras, 21104
        • Investigational Site Number :3400001
    • California
      • Gardena, California, United States, 90247
        • Matrix Clinical Research-Site Number:8400012
      • La Mesa, California, United States, 91942
        • Paradigm Clinical Research-Site Number:8400026
      • Los Angeles, California, United States, 90057
        • Matrix Clinical Research-Site Number:8400032
      • San Diego, California, United States, 92123-1881
        • California Research Foundation-Site Number:8400016
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials, Inc.-Site Number:8400001
      • Idaho Falls, Idaho, United States, 83404
        • Leavitt Clinical Research-Site Number:8400036
      • Idaho Falls, Idaho, United States, 83404
        • Snake River Research-Site Number:8400022
    • Indiana
      • South Bend, Indiana, United States, 46617
        • The South Bend Clinic Center for Research-Site Number:8400024
    • Kansas
      • El Dorado, Kansas, United States, 67042
        • Alliance for Multispeciality Research-Site Number:8400014
      • Newton, Kansas, United States, 67114
        • AMR - Newton-Site Number:8400002
    • Kentucky
      • Lexington, Kentucky, United States, 40517
        • Michael W. Simon, MD, PSC-Site Number:8400013
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Benchmark Research-Site Number:8400006
      • New Orleans, Louisiana, United States, 70125
        • Nola Research Works-Site Number:8400017
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute-Site Number:8400053
    • Montana
      • Missoula, Montana, United States, 59804
        • Boeson Research-Site Number:8400011
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Be Well Clinical Studies-Site Number:8400054
      • Norfolk, Nebraska, United States, 68701
        • Meridian Clinical Research - Norfolk-Site Number:8400005
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • MedPharmics Inc-Site Number:8400040
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • East Carolina University/Brody Medical Sciences Building-Site Number:8400043
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Coastal Pediatric Research-Site Number:8400031
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research-Site Number:8400027
    • Texas
      • Lampasas, Texas, United States, 76550-1820
        • FMC Science-Site Number:8400042
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • JBR Clinical Research-Site Number:8400041
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Pediatric Associates of Charlottesville North-Site Number:8400007
      • Richmond, Virginia, United States, 23294
        • National Clinical Research Inc-Site Number:8400004

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:

Inclusion criteria :

  • Aged 6 through 18 months at Day 0.
  • Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by independent witness if required by local regulations).
  • Participant and parent / guardian / legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

  • Born at less than 34 weeks gestation
  • Born at less than 37 weeks gestation and less than 1 year of age at the time
  • 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).
  • Probable or confirmed case of Coronavirus Disease 2019 (COVID-19).
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
  • Any chronic illness

    • Chronic illness may include, but is not limited to, cardiac disorders, lung disease (including any history of reactive airway disease, receipt of bronchodilator therapy, or medically diagnosed wheezing), renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases

  • Any history of medically diagnosed wheezing
  • Any acute febrile, respiratory or gastrointestinal illness in the past 24 hours that according to investigator judgment is significant enough to interfere with successful inoculation on the day of vaccination. ebrile event has subsided
  • Any previous anaphylactic reaction
  • Current suspected or documented developmental disorder, delay, or other developmental problem
  • Receipt of any of the following vaccines prior to enrollment:

    • any influenza vaccine within 7 days prior, or
    • any inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days prior, or
    • any live vaccine, other than rotavirus vaccine, within the 28 days prior, or
    • another investigational vaccine or investigational drug within 28 days prior
  • Previous receipt of a licensed or investigational RSV vaccine or previous receipt or planned administration of any anti-RSV product (such as ribavirin or RSV immune immune globulins [IG] or RSV monoclonal antibody)
  • Receipt of immune globulins, blood or blood-derived products in the past 6 months prior to enrolment
  • Receipt of any of the following medications within 3 days prior to study enrollment (Day 0):

    • systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or
    • intranasal medications, or
    • other prescription medication except as permitted concomitant medications (prescription or non-prescription) including nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) cutaneous (topical) steroids, topical antibiotics, and topical antifungal agents
  • Receipt of salicylate (aspirin) or salicylate-containing products within the 28 days prior to enrollment (Day 0)
  • Any previous vaccine-associated adverse reaction that was Grade 3 or above. Note: if grading is not possible, determine if the reaction was considered severe or life threatening; if so, it is exclusionary.
  • Scheduled administration of the following after planned inoculation:

    • any influenza vaccine within 7 days after, or
    • inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or
    • any live vaccine other than rotavirus in the 28 days after, or
    • another investigational vaccine or investigational drug in the 56 days after.
  • Any previous receipt of supplemental oxygen therapy in a home or hospital setting, except the temporary receipt of supplemental oxygen for transient tachypnea in newborn
  • 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 enrollment
    • a person receiving immunosuppressant agents
    • a person living with a solid organ or bone marrow transplant
  • Participation at the time of study enrollment (or in the 6 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  • Member of a household that contains, or will contain, an infant who is less than 6 months of age at the enrollment date (or in the 6 weeks preceding the first trial vaccination) through Day 28
  • Member of a household that contains another child/other children who is/are, or is/are scheduled to be, enrolled in this study in the same year AND the date of enrollment will not be concurrent with the other participant(s) living in the household (i.e., all eligible children from the same household must be enrolled on the same date)
  • Attends a daycare facility and shares a daycare room with infants less than 6 months of age, and parent/guardian is unable or unwilling to suspend daycare for 28 days following inoculation
  • 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 participant's 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: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 (RSV vaccine formulation 1)
1 administration of RSV vaccine formulation 1 on Day 0
Pharmaceutical form: Suspension of virus Route of administration: Intranasal
Placebo Comparator: Cohort 1 (Placebo)
1 administration of placebo on Day 0
Pharmaceutical form: Suspension Route of administration: Intranasal
Experimental: Cohort 2 (RSV vaccine formulation 1)
2 administrations of RSV vaccine formulation 1 on Day 0 and Day 56
Pharmaceutical form: Suspension of virus Route of administration: Intranasal
Placebo Comparator: Cohort 2 (Placebo)
2 administrations of placebo on Day 0 and Day 56
Pharmaceutical form: Suspension Route of administration: Intranasal
Experimental: Cohort 3 (RSV vaccine formulation 2)
1 administration of RSV vaccine formulation 2 on Day 0
Pharmaceutical form: Suspension of virus Route of administration: Intranasal
Placebo Comparator: Cohort 3 (Placebo)
1 administration of placebo on Day 0
Pharmaceutical form: Suspension Route of administration: Intranasal
Experimental: Cohort 4 (RSV vaccine formulation 1)
2 administrations of RSV vaccine formulation 1 on Day 0 and Day 56
Pharmaceutical form: Suspension of virus Route of administration: Intranasal
Experimental: Cohort 4 (RSV vaccine formulation 2)
2 administrations of RSV vaccine formulation 2 on Day 0 and Day 56
Pharmaceutical form: Suspension of virus Route of administration: Intranasal
Placebo Comparator: Cohort 4 (Placebo)
2 administrations of placebo on Day 0 and Day 56
Pharmaceutical form: Suspension Route of administration: Intranasal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants reporting immediate adverse events
Time Frame: Within 30 minutes after vaccination
Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination.
Within 30 minutes after vaccination
Number of participants reporting solicited reactions
Time Frame: Within 28 days after vaccination
Solicited administrative site reaction: rhinorrhea. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability.
Within 28 days after vaccination
Number of participants reporting unsolicited adverse events
Time Frame: Within 28 days after vaccination
Unsolicited adverse events are spontaneously reported adverse events.
Within 28 days after vaccination
Number of participants reporting adverse events of special interest
Time Frame: Within 28 days after vaccination
Adverse events of special interest pre-defined adverse event collected using the same process as for other adverse events.
Within 28 days after vaccination
Number of participants reporting medically attended adverse events
Time Frame: Within 28 days after vaccination
Medically attended adverse events are adverse events with a new onset or a worsening of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department.
Within 28 days after vaccination
Number of participants reporting serious adverse events
Time Frame: Day 0 to maximum Month 12
Serious adverse events are collected throughout the study, from Day 0 until the end of the study.
Day 0 to maximum Month 12
RSV A serum neutralizing antibody levels after first vaccine administration
Time Frame: Day 56
RSV A serum neutralizing antibody levels assessed in RSV-naïve participants in Cohorts 1, 2, 3, and 4.
Day 56
RSV A serum neutralizing antibody levels after second vaccine administration
Time Frame: Day 84
RSV A serum neutralizing antibody levels are assessed in RS-naïve participants in Cohorts 2 and 4.
Day 84

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Titer of vaccine virus shedding (polymerase chain reaction [RT-PCR])
Time Frame: 7 days after vaccination
Titers are assessed by PCR at Day 7 for Cohorts 1, 2, 3 and 4 and Day 63 for Cohorts 2 and 4.
7 days after vaccination
Number of participants infected with the vaccine virus
Time Frame: Day 56 and Day 84
Infection is defined as detection of vaccine in nasal wash by culture or PCR and / or a ≥ 4-fold rise in serum neutralizing antibodies or in serum antibodies to RSV F. Infectivity is assessed on Day 56 for Cohorts 1, 2, 3 and 4, and after vaccination 2 (Day 84) for Cohorts 2 and 4
Day 56 and Day 84
RSV serum anti-F binding antibody levels
Time Frame: Day 56 and Day 84
RSV serum anti-F binding antibody levels assessed on Day 56 for Cohorts 1, 2, 3 and 4, and after vaccination 2 (Day 84) for Cohorts 2 and 4.
Day 56 and Day 84
RSV A serum neutralizing and serum anti-RSV F IgG antibody titers after the RSV surveillance season or at least 5 months after the last vaccine administration
Time Frame: Within 1 month after the end of the RSV season or at least 5 months after the last vaccine administration.
RSV A serum neutralizing and serum anti-RSV F IgG antibody titers are assessed after the end of the RSV season (on average end of March in the Northern Hemisphere and end of September in the Southern Hemisphere) or at least 5 months after the last vaccine administration.
Within 1 month after the end of the RSV season or at least 5 months after the last vaccine administration.
RSV A serum neutralizing antibody levels
Time Frame: Day 56 and Day 84
RSV serum neutralizing antibody levels assessed in RSV-experienced participants on Day 56 for Cohorts 1, 2, 3 and 4, and after vaccination 2 (Day 84) for Cohorts 2 and 4.
Day 56 and Day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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)

September 17, 2020

Primary Completion (Actual)

April 13, 2023

Study Completion (Actual)

April 13, 2023

Study Registration Dates

First Submitted

July 27, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (Actual)

July 29, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

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

product manufactured in and exported from the U.S.

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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