NCT06618196

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

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 Versus Hexaxim Administered Intramuscularly in Healthy Infants As Primary Series At 2, 4, 6 Months of Age

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: LG Chem · Industry
• Sex: All
• Age: 50 Days – 70 Days
• Healthy volunteers: Accepted

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

Type	Name	Description
BIOLOGICAL	LR20062	DTaP-HepB-IPV-Hib vaccine
BIOLOGICAL	DTaP-HepB-IPV-Hib vaccine	Control hexavalent vaccine

Timeline

• Start date: 2024-10-02
• Primary completion: 2025-06-30
• Completion: 2026-04-30
• First posted: 2024-10-01
• Last updated: 2024-10-01