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Virus Therapy

HIL-214 Vaccine for Gastroenteritis

Phase 2 & 3

Waitlist Available

Research Sponsored by HilleVax

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 28 days post dose 2

Awards & highlights

Study Summary

This trial is testing a new vaccine to see if it's safe and effective. 3000 kids will get either the vaccine or a placebo, and then get the second dose 28 days later.

Who is the study for?

This trial is for healthy children who are exactly 5 months old, can follow the study's schedule, and have legal guardian consent. It excludes those with immune issues, bleeding disorders, serious infections or fevers within 3 days of vaccination, chronic diseases, a history that may affect results or increase risk due to participation in the trial (like seizures), HIV positive status or evaluation for it, relatives involved in the trial conduct, abnormal growth patterns, gastrointestinal abnormalities or diseases.Check my eligibility

What is being tested?

The study tests two doses of HIL-214 vaccine against a placebo to see if it's safe and works well in preventing gastroenteritis. The vaccine is given twice: once at enrollment when children are around 5 months old and again after 28 days. Participants are randomly assigned to receive either HIL-214 or a placebo.See study design

What are the potential side effects?

While not specified here, common side effects from vaccines include pain at injection site, fever, fatigue and irritability. Since this is an investigational vaccine for gastroenteritis in children there might be specific side effects related to digestive system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 28 days post dose 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 28 days post dose 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 28 days post dose 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Objective

Secondary outcome measures

Secondary Objective

Other outcome measures

AEs Leading to Withdrawal

Adverse Events and Serious Adverse Events

Immunogenicity Objectives

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExperimentalExperimental Treatment1 Intervention

One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57.

Group II: PlaceboPlacebo Group1 Intervention

One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HIL-214

2023

Completed Phase 2

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

HilleVaxLead Sponsor

3 Previous Clinical Trials

501 Total Patients Enrolled

3 Trials studying Gastroenteritis

501 Patients Enrolled for Gastroenteritis

Media Library

HIL-214 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05281094 — Phase 2 & 3

Gastroenteritis Research Study Groups: Experimental, Placebo

Gastroenteritis Clinical Trial 2023: HIL-214 Highlights & Side Effects. Trial Name: NCT05281094 — Phase 2 & 3

HIL-214 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05281094 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any patients needed to complete this clinical trial?

"That is correct. The study, which is currently looking for 3000 volunteers at a single location, was first posted on clinicaltrials.gov on 3/16/2022. The most recent update to the posting was on 10/19/2022."

Answered by AI