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A Study to Evaluate Safety and Immunogenicity of APV006 in Healthy Adults

NCT05952596 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-07-19

No results posted yet for this study

Summary

This is a single-center, randomized, active-controlled, parallel-design, double-blind, phase I study to evaluate the safety and immunogenicity of a single dose of APV006 in healthy adults.

Conditions

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

Interventions

BIOLOGICAL

DTaP-HepB-IPV-Hib vaccine

Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acelluar Pertussis-Hepatitis B-Sabin Inactivated Poliovirus-Haemophilus influenzae type b vaccine)

BIOLOGICAL

DTaP-HepB-IPV-Hib vaccine

Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acellular Pertussis-Hepatitis B-poliomyelitis(inactived)-Haemophilus influenzae type b vaccine)

Sponsors & Collaborators

  • LG Chem

    lead INDUSTRY

Principal Investigators

  • Nam Joong Kim · Seoul National University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-17
Primary Completion
2023-10-31
Completion
2024-03-31

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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 NCT05952596 on ClinicalTrials.gov