Status:
TERMINATED
Efficacy and Safety of Two Doses of HIL-214 in Children
Lead Sponsor:
HilleVax
Conditions:
Gastroenteritis
Eligibility:
All Genders
5-5 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a randomized, placebo-controlled study that is being done to evaluate the safety and effectiveness of two doses of the HIL-214 vaccine compared to a placebo. The study will enroll 3000 childre...
Detailed Description
Noroviruses have emerged as the single most significant cause of gastroenteritis in both middle-high income countries and low resource settings worldwide. Those most at risk of severe illness include ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
3084 Patients enrolled
Trial Details
Trial ID
NCT05281094
Start Date
April 28 2022
End Date
September 30 2024
Last Update
July 10 2025
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
DM Clinical Research
Houston, Texas, United States, 77065
2
Policlinico Social del Norte
Bogotá, Bogota D.C., Colombia
3
Cntro de Estudios en Infectologia Pediatrica (CEIP)
Cali, Valle del Cauca Department, Colombia, 760042
4
Hospital Pediátrico Dr. Hugo Mendoza
Santo Domingo, Nacional, Dominican Republic