MedTrace Logo

Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series

NCT05457946 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1438

Last updated 2023-03-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate immunogenicity and safety of different doses of candidate hexavalent vaccine in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants and thereby to select the optimal dose of candidate vaccine(Stage 1) and to demonstrate lot-to-lot consistency of three lots of LBVD (Stage 2)

Conditions

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

Interventions

BIOLOGICAL

LBVD (Hexavalent vaccine)

Injection within the muscle into the front area of the thigh

BIOLOGICAL

Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)

Injection within the muscle into the front area of the thigh

Sponsors & Collaborators

  • LG Chem

    lead INDUSTRY

Principal Investigators

  • Edison Alberto, MD · Health Index Multispecialty Clinic

  • Josefina Carlos, MD · UERM Memorial Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-09-30
Completion
2025-09-30

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 NCT05457946 on ClinicalTrials.gov