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Safety and Immunogenicity of HIL-214 With Routine Pediatric Vaccines

NCT05836012 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 329

Last updated 2025-03-12

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

HIL-214

2 injections - given at 4 months and the second at 6 months of age.

BIOLOGICAL

Placebo

2 injections - given at 4 months and the second at 6 months of age.

Sponsors & Collaborators

  • HilleVax

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-06-10
Primary Completion
2024-01-19
Completion
2024-07-08
FDA Drug
Yes

Countries

  • United States
  • Panama
  • 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 NCT05836012 on ClinicalTrials.gov