MedTrace Logo

Study to Evaluate the Immunogenicity of LR20062 Compared to Control When Administered Intramuscularly in Healthy Infants At 2, 4, 6 Months of Age

NCT06618196 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2024-10-01

No results posted yet for this study

Summary

This is a phase II, randomized, double-blind, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of DTaP-HepB-IPV-Hib hexavalent vaccine LR20062 in healthy infants as primary series at 2, 4, 6 months of age.

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis
  • Hepatitis B
  • Poliomyelitis
  • Haemophilus Influenzae Type B Infection

Interventions

BIOLOGICAL

LR20062

DTaP-HepB-IPV-Hib vaccine

BIOLOGICAL

DTaP-HepB-IPV-Hib vaccine

Control hexavalent vaccine

Sponsors & Collaborators

  • LG Chem

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Days
Max Age
70 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-02
Primary Completion
2025-06-30
Completion
2026-04-30

More Related Trials

Entities

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 NCT06618196 on ClinicalTrials.gov