Safety and Immunogenicity of HIL-214 With Routine Pediatric Vaccines

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Gastroenteritis

In brief

This is a phase 2, multi-country, randomized, double-blind, placebo-controlled trial to evaluate the immune response to routine pediatric vaccinations when co-administered with HIL-214 or placebo in healthy infants. This trial will also evaluate the safety profile of a 2-dose regimen of HIL-214 co-administered with routine pediatric vaccines.

Key facts

Study ID

NCT05836012

Run by

HilleVax

People needed

329

Starts

2023-06-10

Expected to finish

2024-07-08

Last updated by the study team

2025-03-12

Who can join

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

You may qualify if…

• The subject is aged 2 months (+14 days).
• Male or female.
• Infants 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.
• Infants 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).
• Severe reaction to routine childhood vaccine(s) administered at Visit 1.
• 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 licensed or authorized vaccines not planned in this trial within 14 days (for inactivated vaccines) or within 28 days (for live vaccines) before or after any dose of trial vaccine. Note: Flu and/or COVID vaccine can be administered per local guidelines at any time during the trial.
• Subjects participating in any clinical trial with another investigational product 30 days prior to first trial visit or due 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

• Velocity Clinical Research - Lafayette — Lafayette, Louisiana, United States
• Boeson Research MSO — Missoula, Montana, United States
• Velocity Clinical Research - Hastings — Hastings, Nebraska, United States
• Frontier Pediatric Care — Lincoln, Nebraska, United States
• La Providence Pediatrics Clinic - Chemidox Clinical Trials (Hypercore) — Houston, Texas, United States
• Alliance for Multispecialty Research LLC - Kaysville — Kaysville, Utah, United States
• Alliance for Multispecialty Research LLC - Syracuse — Syracuse, Utah, United States
• CEVAXIN-La Chorrera — La Chorrera, Panama
• Cervaxin-Avenida Mexico — Panama City, Panama
• Cervaxin-Tocumen — Panama City, Panama
• BRCR Global — San Juan, Puerto Rico
• HACTR — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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