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

  • STATUS
    Recruiting
  • End date
    Apr 27, 2023
  • participants needed
    300
  • sponsor
    Sanofi Pasteur, a Sanofi Company
Updated on 26 May 2022
vaccination
respiratory syncytial virus vaccines
Accepts healthy volunteers

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 Respiratory Syncytial Virus (RSV) A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in 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 anti-F immunoglobulin G (IgG) antibody responses to the study product in each vaccine group after vaccination by baseline neutralizing antibody 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 neutralizing antibody serostatus.

Description

Study duration per participant is maximum 12 months

Details
Condition Respiratory Syncytial Virus Infection
Treatment Placebo, RSV vaccine formulation 1, RSV vaccine formulation 2
Clinical Study IdentifierNCT04491877
SponsorSanofi Pasteur, a Sanofi Company
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 6 through 18 months at Day 0
Inclusion criteria
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

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
• Chronic illness may include, but is not limited to, cardiac disorders, lung
planned administration of any anti-RSV product (such as ribavirin or RSV
Receipt of immune globulins, blood or blood-derived products in the past 6 months prior to enrolment
disease (including any history of reactive airway disease, receipt of
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)
bronchodilator therapy, or medically diagnosed wheezing), renal disorders
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
auto-immune disorders, diabetes, psychomotor diseases, and known congenital or
Any chronic illness
genetic diseases
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 history of medically diagnosed wheezing
Receipt of any of the following medications within 3 days prior to study enrollment (Day 0)
Current suspected or documented developmental disorder, delay, or other developmental problem
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
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
Receipt of salicylate (aspirin) or salicylate-containing products within the 28 days
Any previous anaphylactic reaction
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
immune immune globulins [IG] or RSV monoclonal antibody)
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
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
Any previous receipt of supplemental oxygen therapy in a home or hospital setting
Born at less than 37 weeks gestation and less than 1 year of age at the time
except the temporary receipt of supplemental oxygen for transient tachypnea in
newborn
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
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
The above information is not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial
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