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HIL-214 with Pediatric Vaccines 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 6 months

Awards & highlights

Study Summary

This trial tests if a drug, HIL-214, is safe to use with routine vaccinations in infants and if it helps the body respond better to the vaccines.

Who is the study for?

Healthy infants aged 2 months (+14 days) can join this trial. They must be in good health as confirmed by medical history and physical exams, with no growth abnormalities or serious chronic diseases. Infants with severe reactions to vaccines, certain infections, or a history of immune system issues are excluded.Check my eligibility

What is being tested?

The trial is testing HIL-214's safety and its effect on the body's response to routine pediatric vaccines compared to a placebo. It's double-blind (neither doctors nor participants know who gets what), randomized (assigned by chance), and involves two doses of HIL-214.See study design

What are the potential side effects?

While specific side effects aren't listed here, the study will monitor infants for any adverse reactions due to HIL-214 when given alongside their regular vaccinations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months 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 Immunogenicity Response

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExperimentalExperimental Treatment1 Intervention

HIL-214 (1 dose at 4 months of age and 1 dose at 6 months of age) and routine childhood vaccines according to schedule.

Group II: PlaceboPlacebo Group1 Intervention

Placebo (1 dose at 4 months of age and 1 dose at 6 months of age) and routine childhood vaccines according to schedule.

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

3,186 Total Patients Enrolled

3 Trials studying Gastroenteritis

3,186 Patients Enrolled for Gastroenteritis

Media Library

Experimental Clinical Trial Eligibility Overview. Trial Name: NCT05836012 — Phase 2 & 3

Gastroenteritis Research Study Groups: Placebo, Experimental

Gastroenteritis Clinical Trial 2023: Experimental Highlights & Side Effects. Trial Name: NCT05836012 — Phase 2 & 3

Experimental 2023 Treatment Timeline for Medical Study. Trial Name: NCT05836012 — Phase 2 & 3

Frequently Asked Questions

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

Is the age limit for this clinical research inclusive of individuals aged 35 and younger?

"In accordance with the trial's criteria, participants must be between 2 Months and 2 Months old to qualify for enrollment."

Answered by AI

How many health facilities are administering this experiment?

"Across the United States of America, there are 15 clinical trial sites recruiting participants. These include Velocity Clinical Research - Lafayette in Lafayette, Boeson Research MSO in Missoula and Velocity Clinical Research - Hastings in Hastings as well as a dozen more locations."

Answered by AI

Are participants being actively recruited for this research?

"According to the information presented on clinicaltrials.gov, this trial is no longer recruiting participants due to its initial posting date of June 2nd 2023 and recent update recorded on June 6th 2023. Fortunately, there are still other studies that require volunteers at present."

Answered by AI

Is it possible to take part in this clinical trial?

"Eligibility for entry in this study necessitates an age range of 2 Months to 2 Months and a diagnosis of gastroenteritis. 400 candidates are sought out by the trial organisers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Immunogenicity of HIL-214 With Routine Pediatric Vaccines

2023. "Safety and Immunogenicity of HIL-214 With Routine Pediatric Vaccines". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05836012.

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