Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age

Exclusion Criteria

• •≤ 6 months of age and \> 25 months of age at the time of inoculation
• •Born at less than 34 weeks gestation
• •Born at less than 37 weeks gestation, and at the date of inoculation less than 1 year of age
• •Maternal history of a positive HIV test before or during pregnancy
• •Evidence of chronic disease
• •Known or suspected infection or impairment of immunological functions
• •Bone marrow/solid organ transplant recipient
• •Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities
• •Suspected or documented developmental disorder, delay, or other developmental problem
• •Cardiac abnormality requiring treatment
• •Lung disease or reactive airway disease
• •More than one episode of medically diagnosed wheezing in the first year of life
• •Wheezing episode or received bronchodilator therapy within the past 12 months
• •Wheezing episode or received bronchodilator therapy after the age of 12 months
• •Previous receipt of supplemental oxygen therapy in a home setting
• •Previous receipt of an investigational RSV vaccine
• •Previous receipt or planned administration of anti-RSV antibody product including ribavirin, RSV Ig, or RSV mAb
• •Previous receipt of immunoglobulin or any antibody products within the past 6 months
• •Previous receipt of any blood products within the past 6 months
• •Previous anaphylactic reaction
• •Previous vaccine-associated adverse reaction that was Grade 3 or above
• •Known hypersensitivity to any study product component
• •Member of a household that contains an infant who is less than 6 months of age at the date of inoculation through the 28th day after inoculation
• •Member of a household that, at the date of inoculation through the 28th day after inoculation, contains an immunocompromised individual including but not limited to:
• •* a person who is HIV-infected
• •* a person who has cancer and has received chemotherapy within the 12 months prior to enrollment
• •* a person living with a solid organ or bone marrow transplant
• •Attends a daycare facility that does not separate children by age and contains an infant \<6 months of age at the date of inoculation through the 28th day after inoculation
• •Receipt of any of the following prior to enrollment:
• •* inactivated influenza vaccine within 3 days prior, or
• •* any other 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, or
• •* salicylate (aspirin) or salicylate-containing products within the past 28 days
• •Scheduled administration of any of the following after planned inoculation
• •* 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
• •Receipt of any of the following medications within 3 days of study enrollment:
• •* systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or
• •* intranasal medications, or
• •* other prescription medications except the permitted concomitant medications listed below
• •Permitted concomitant medications (prescription or non-prescription) include 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.
• •Any of the following events at the time of enrollment:
• •* fever (temporal or rectal temperature of ≥100.4°F), or
• •* upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis) or
• •* nasal congestion significant enough to interfere with successful inoculation, or
• •* otitis media
• •* contact with a person diagnosed with COVID-19 disease or active severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) infection within the preceding 10 days