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

This is an interventional prevention trial for Gastroenteritis Read More

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 any illness, that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the subjects due to participation in the trial
• Known or suspected impairment/alteration of immune function
• Subjects with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
• Subjects who received or are scheduled to receive any other vaccines within 14 days (for inactivated vaccines and oral polio vaccine) or 28 days (for other live vaccines) before or after any dose of trial vaccine
• Subjects participating in any clinical trial with another investigational product 30 days prior to first trial visit or intend to participate in another clinical trial at any time during the conduct of this trial
• Subjects known to be positive for or in evaluation for possible human immunodeficiency virus infection
• Subject's LAR or subject's first-degree relatives involved in the trial conduct