Nasal spray vaccine aims to shield infants from RSV

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ≥ 6 months of age and \<25 months of age at the time of inoculation * Screening and pre-inoculation serum specimens for respiratory syncytial virus (RSV)-neutralizing antibody are obtained no more than 42 days prior to inoculation * Seronegative for RSV antibody, defined as serum RSV-neutralizing antibody titer \<1:40 * In good health based on review of the medical record, history, and physical examination at the time of inoculation * Received routine immunizations appropriate for age based on the Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger * Growing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND * If \< 1 year of age: has a current height and weight above the 5th percentile for age * If ≥ 1 year of age: has a current height and weight above the 3rd percentile for age * Expected to be available for the duration of the study * Parent/guardian is willing and able to provide written informed consent 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