Efficacy and Safety of Two Doses of HIL-214 in Children

Inclusion Criteria * The subject should be 5 months of age (within plus or minus 14 days) male or female * Children who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator * The subject's LAR signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements * Children whose LARs can and are willing to comply with trial procedures and are available for the duration of follow-up Exclusion Criteria * Clinically significant abnormality in growth by height, weight, or head circumference (according to local guidelines) * Gastrointestinal abnormalities or any chronic gastrointestinal disease, including any uncorrected congenital malformation of the gastrointestinal tract according to medical history and/or physical examination * Known hypersensitivity or allergy to any of the investigational vaccine components (including excipients) * Any clinically significant active infection (as assessed by the investigator) or temperature ≥38.0°C (\>100.4°F), within 3 days of intended trial vaccination * Any serious chronic or progressive disease according to the judgment of the investigator (e.g., cardiac, renal or hepatic disease) * Individuals with history of, e.g., convulsions/febrile convulsions, or …