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

NCT06618196 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: LG-VGCL002
• Study Type: interventional
• Target: 336
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Seroprotection/vaccine-response rate

  * Proportion of subjects achieving seroprotection to each antigenic components * Proportion of subjects with vaccine response for pertussis antigens

  1 month after the third dose primary series

Secondary Outcomes (6)

• Geometric mean concentration (GMC) or Geometric mean titer (GMT)

  1 month after the third dose primary series

• Seroconversion rate

  1 month after the third dose primary series

• Long-term seroprotection rate

  1 month after the third dose primary series

• Solicited adverse event

  7 days after each vaccination

• Unsolicited adverse event

  1 month after each vaccinations

Study Arms (4)

Test group 1

EXPERIMENTAL

Low dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)

Biological: LR20062

Test group 2

EXPERIMENTAL

Middle dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)

Biological: LR20062

Test group 3

EXPERIMENTAL

High dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)

Biological: LR20062

Test group 4

ACTIVE COMPARATOR

Control hexavalent vaccine (DTaP-HepB-IPV-Hib)

Biological: DTaP-HepB-IPV-Hib vaccine

Interventions

LR20062 BIOLOGICAL

DTaP-HepB-IPV-Hib vaccine

Test group 1; Test group 2; Test group 3

DTaP-HepB-IPV-Hib vaccine BIOLOGICAL

Control hexavalent vaccine

Test group 4

Eligibility Criteria

• Age: 50 Days - 70 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Is male or female aged two months (50 to 70 days inclusive) on the day of the first dose of study vaccine.
• Is born at full term of pregnancy (≥37 weeks of gestation) with a birth weight of ≥2.5 kg.

You may not qualify if:

• Medical conditions:
• Has a history of diphtheria, tetanus, pertussis, poliovirus, Hep B, or Hib infection.
• Has a known SARS-CoV-2 infection at Screening.
• Was born to a mother with a known history of Hep B infection based on HBsAg seropositivity.
• Was born to a mother with a known history of HIV infection based on HIV antibody seropositivity.
• Had a recent febrile illness, defined as axillary temperature ≥38.0℃ \[≥100.4℉\] occurring at or within 72 hours prior to receipt of study vaccine.
• Prior/concomitant therapy:
• Has previously received vaccination against diphtheria, tetanus, pertussis, poliovirus, and/or Hib infections since birth.
• Has received or is expected to receive immunosuppressive agents or other immune-modifying drugs during the conduct of the study.
• Has received systemic corticosteroids (equivalent of ≥0.5 mg/kg total daily dose of prednisone) for ≥14 consecutive days and has not completed treatment at least 30 days prior to Screening.
• Is expected to require any systemic corticosteroids during conduct of the study.
• Note: Topical, ophthalmic, and inhaled steroids are permitted at the discretion of the Investigator.
• Has received any non-study vaccine within 30 days before the first dose of study vaccine or is scheduled to receive any other vaccine within one month after the third dose of study vaccine.
• Exception: Vaccines against BCG and Hep B at birth, rotavirus, MMR, and PCV if received according to the routine immunization schedule, and inactivated influenza vaccine, are allowed.

Sponsors & Collaborators

• LG Chem: lead

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis; Haemophilus Infections

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Pasteurellaceae Infections

Central Study Contacts

Clinical Study Lead

CONTACT

82-2-6987-4427; lgclinical@lgchem.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Any persons accompanying the subject for the site visits, including parents, other family members, and/or legally acceptable representatives, will be shielded from view by physical barriers while the study vaccine is administered. The unblinded site personnel for the preparation/administration of study vaccines will keep the unblinded information separate from those persons for any study related procedures/assessments after administration of study vaccines, which includes all safety follow-up procedures. Blinded site personnel will be responsible for all safety and immunogenicity follow-up procedures after study vaccine administration.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 1, 2024
• Study Start: October 2, 2024
• Primary Completion: June 30, 2025
• Study Completion: April 30, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09