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

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ClinicalTrials.gov Identifier: NCT04491877
Recruitment Status : Recruiting
First Posted : July 29, 2020
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE July 27, 2020
First Posted Date  ICMJE July 29, 2020
Last Update Posted Date February 24, 2021
Actual Study Start Date  ICMJE September 17, 2020
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2020)
  • 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.
  • 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.
  • Number of participants reporting unsolicited adverse events [ Time Frame: Within 28 days after vaccination ]
    Unsolicited adverse events are spontaneously reported adverse events.
  • 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.
  • 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.
  • 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 up to 1 month after the end of the RSV season.
  • Vaccine-induced RSV-A serum neutralizing antibody levels after first vaccine administration [ Time Frame: Day 56 ]
    Vaccine induced RSV-A serum neutralizing antibody levels assessed in RSV seronegative participants in Cohorts 1, 2, 3, and 4.
  • Vaccine-induced RSV-A serum neutralizing antibody levels after second vaccine administration [ Time Frame: Day 84 ]
    Vaccine induced RSV-A serum neutralizing antibody levels are assessed in RSV seronegative participants in Cohorts 2 and 4.
Original Primary Outcome Measures  ICMJE
 (submitted: July 27, 2020)
  • 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.
  • 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.
  • Number of participants reporting unsolicited adverse events [ Time Frame: Within 28 days after vaccination ]
    Unsolicited adverse events are spontaneously reported non-serious adverse events.
  • 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.
  • 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.
  • 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 up to 1 month after the end of the RSV season.
  • Vaccine-induced RSV-A serum neutralizing antibody levels after first vaccine administration [ Time Frame: Day 56 ]
    Vaccine induced RSV-A serum neutralizing antibody levels assessed in RSV seronegative participants in Cohorts 1, 2, 3, and 4.
  • Vaccine-induced RSV-A serum neutralizing antibody levels after second vaccine administration [ Time Frame: Day 84 ]
    Vaccine induced RSV-A serum neutralizing antibody levels are assessed in RSV seronegative participants in Cohorts 2 and 4.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2020)
  • Titer of vaccine virus shedding (plaque assay) [ Time Frame: 7 and 10 days after vaccination ]
    Titers are assessed by plaque assay.
  • Titer of vaccine virus shedding (polymerase chain reaction [RT-PCR]) [ Time Frame: 7 and 10 days after vaccination ]
    Titers are assessed by PCR.
  • 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.
  • Vaccine-induced RSV-A serum neutralizing antibody levels [ Time Frame: Day 56 and Day 84 ]
    RSV-A serum neutralizing antibody levels assessed in seropositive participants on Day 56 for Cohorts 1, 2, 3 and 4, and after vaccination 2 (Day 84) for Cohorts 2 and 4.
  • Vaccine-induced RSV-A F binding antibody levels [ Time Frame: Day 56 and Day 84 ]
    RSV-A 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.
  • RSV-A antibody titers after the RSV surveillance season [ Time Frame: Within 1 month after the end of the RSV season ]
    Serum RSV-A antibody titers (neutralizing and anti-F) 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Official Title  ICMJE Safety, Immunogenicity, Infectivity, and Dose-Finding Study of an Investigational Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Infants and Toddlers
Brief Summary

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 neutralizing antibody serostatus.
  • To characterize the RSV-A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in Respiratory Syncytial Virus (RSV) seronegative participants.

The secondary objectives of the study are:

  • To quantify the amount of vaccine virus shed by each participant by baseline neutralizing antibody serostatus.
  • To determine the proportion of vaccinated infants and toddlers in each vaccine group infected with the vaccine virus after vaccination by baseline neutralizing antibody serostatus.
  • To characterize the RSV-A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV seropositive participants.
  • To characterize serum RSV-A anti-F immunoglobulin G antibody responses to the study product in each vaccine group after vaccination by baseline neutralizing antibody serostatus.
  • To characterize serum RSV-A antibody responses (neutralizing and anti-F immunoglobulin G) to the study product in each vaccine group after the RSV season by baseline neutralizing antibody serostatus.
Detailed Description Study duration per participant is maximum 12 months
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Respiratory Syncytial Virus Infection
Intervention  ICMJE
  • Biological: RSV vaccine formulation 1
    Pharmaceutical form: Suspension of virus Route of administration: Intranasal
  • Biological: RSV vaccine formulation 2
    Pharmaceutical form: Suspension of virus Route of administration: Intranasal
  • Biological: Placebo
    Pharmaceutical form: Suspension Route of administration: Intranasal
Study Arms  ICMJE
  • Experimental: Cohort 1 (RSV vaccine formulation 1)
    1 administration of RSV vaccine formulation 1 on Day 0
    Intervention: Biological: RSV vaccine formulation 1
  • Placebo Comparator: Cohort 1 (Placebo)
    1 administration of placebo on Day 0
    Intervention: Biological: Placebo
  • Experimental: Cohort 2 (RSV vaccine formulation 1)
    2 administrations of RSV vaccine formulation 1 on Day 0 and Day 56
    Intervention: Biological: RSV vaccine formulation 1
  • Placebo Comparator: Cohort 2 (Placebo)
    2 administrations of placebo on Day 0 and Day 56
    Intervention: Biological: Placebo
  • Experimental: Cohort 3 (RSV vaccine formulation 2)
    1 administration of RSV vaccine formulation 2 on Day 0
    Intervention: Biological: RSV vaccine formulation 2
  • Placebo Comparator: Cohort 3 (Placebo)
    1 administration of placebo on Day 0
    Intervention: Biological: Placebo
  • Experimental: Cohort 4 (RSV vaccine formulation 1)
    2 administrations of RSV vaccine formulation 1 on Day 0 and Day 56
    Intervention: Biological: RSV vaccine formulation 1
  • Experimental: Cohort 4 (RSV vaccine formulation 2)
    2 administrations of RSV vaccine formulation 2 on Day 0 and Day 56
    Intervention: Biological: RSV vaccine formulation 2
  • Placebo Comparator: Cohort 4 (Placebo)
    2 administrations of placebo on Day 0 and Day 56
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 27, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • 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.
  • 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 or RSV monoclonal antibody).
  • Receipt of immune globulins, blood or blood-derived products in the past 6 months prior to enrolment.
  • 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.

    o 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. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
  • 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).
  • 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.
  • Any previous anaphylactic reaction.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • Born at less than 34 weeks gestation.
  • Born at less than 37 weeks gestation and less than 1 year of age at the time

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 18 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com
Listed Location Countries  ICMJE Chile,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04491877
Other Study ID Numbers  ICMJE VAD00001
U1111-1238-1869 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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://www.clinicalstudydatarequest.com/
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company
PRS Account Sanofi
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP