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

NCT05281094 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 3084

Last updated 2025-07-10

Study results available
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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 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.

Conditions

Interventions

BIOLOGICAL

HIL-214

2 injections - given on Day 1 and the second given between Day 29 - Day 57

BIOLOGICAL

Placebo

2 injections - given on Day 1 and the second given between Day 29 - Day 57

Sponsors & Collaborators

  • HilleVax

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
5 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2023-12-28
Completion
2024-09-30
FDA Drug
Yes

Countries

  • United States
  • Colombia
  • Dominican Republic
  • Honduras
  • Panama
  • Peru
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05281094 on ClinicalTrials.gov