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Safety and Immunogenicity of HIL-214 in Healthy Japanese Infants

NCT06007781 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-03-14

Study results available
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Summary

This is a phase 1, randomized, double-blind multi-center, placebo-controlled trial in Japan to evaluate the safety and immunogenicity of HIL-214 in healthy infants 5 months of age (-14/+14 days) at first trial vaccine administration. In this protocol, because the trial is blinded, trial vaccine refers to both the investigational vaccine (HIL-214) and placebo.

Conditions

Interventions

BIOLOGICAL

Placebo

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

BIOLOGICAL

HIL-214

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
2023-08-18
Primary Completion
2024-05-27
Completion
2024-05-27
FDA Drug
Yes

Countries

  • Japan

Study Locations

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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 NCT06007781 on ClinicalTrials.gov