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

Inclusion 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) infecti