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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Gastroenteritis

In brief

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 children who will be 5 months of age at the time of the first dose study vaccine. The second dose of study vaccine will be given 28 days after the first dose.

Key facts

Study ID

NCT05281094

Run by

HilleVax

People needed

3084

Starts

2022-04-28

Expected to finish

2024-09-30

Last updated by the study team

2025-07-10

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• DM Clinical Research — Houston, Texas, United States
• Policlinico Social del Norte — Bogotá, Bogota D.C., Colombia
• Cntro de Estudios en Infectologia Pediatrica (CEIP) — Cali, Valle del Cauca Department, Colombia
• Hospital Pediátrico Dr. Hugo Mendoza — Santo Domingo, Nacional, Dominican Republic
• Hospital General Regional Marcelino Velez Santana — Santo Domingo, Dominican Republic
• CAIMED - Dominican Center for Clinical Studies — Santo Domingo, Dominican Republic
• Clínica Cruz Jiminian — Santo Domingo, Dominican Republic
• Fundacion Dominicana de Perinatologia Pro Bebe — Santo Domingo, Dominican Republic
• Demedica — San Pedro Sula, Honduras
• INVERIME - Inversiones en Investigación Medica — Tegucigalpa, Honduras
• Investigación Sin Limite — Tegucigalpa, Honduras
• CEVAXIN David — David, Chiriquí Province, Panama
• CEVAXIN La Chorrera — La Chorrera, Panama
• CEVAXIN 24 Decembre — Panama City, Panama
• CEVAXIN Av. México — Panama City, Panama
• Instituto de Investigacion Nutricional — Lima, Peru
• Clinical Research Puerto Rico — Guayama, Puerto Rico

Full record on ClinicalTrials.gov

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