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

September 26, 2024 updated by: LG Chem

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

336

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

Medical conditions:

  1. Has a history of diphtheria, tetanus, pertussis, poliovirus, Hep B, or Hib infection.
  2. Has a known SARS-CoV-2 infection at Screening.
  3. Was born to a mother with a known history of Hep B infection based on HBsAg seropositivity.
  4. Was born to a mother with a known history of HIV infection based on HIV antibody seropositivity.

  5. 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:

  6. Has previously received vaccination against diphtheria, tetanus, pertussis, poliovirus, and/or Hib infections since birth.
  7. Has received or is expected to receive immunosuppressive agents or other immune-modifying drugs during the conduct of the study.

  8. Meets one or more of the following systemic corticosteroid exclusion criteria:

    1. 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.
    2. 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.

  9. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group 1
Low dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
Biological: LR20062
DTaP-HepB-IPV-Hib vaccine
Experimental: Test group 2
Middle dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
Biological: LR20062
DTaP-HepB-IPV-Hib vaccine
Experimental: Test group 3
High dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
Biological: LR20062
DTaP-HepB-IPV-Hib vaccine
Active Comparator: Test group 4
Control hexavalent vaccine (DTaP-HepB-IPV-Hib)
Biological: DTaP-HepB-IPV-Hib vaccine
Control hexavalent vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroprotection/vaccine-response rate
Time Frame: 1 month after the third dose primary series
  • 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Solicited adverse event
Time Frame: 7 days after each vaccination
Expected local or systemic side effects after vaccination
7 days after each vaccination
Geometric mean concentration (GMC) or Geometric mean titer (GMT)
Time Frame: 1 month after the third dose primary series
GMC or GMT and their ratio of all types of antibodies
1 month after the third dose primary series
Seroconversion rate
Time Frame: 1 month after the third dose primary series
Proportion of subjects achieving seroconversion to pertussis and poliovirus
1 month after the third dose primary series
Long-term seroprotection rate
Time Frame: 1 month after the third dose primary series
Proportion of subjects with seroconversion for diphtheria, tetanus, and Hib antigens
1 month after the third dose primary series
Unsolicited adverse event
Time Frame: 1 month after each vaccinations
Any AEs other than solicited AEs
1 month after each vaccinations
Immediate reactions after vaccination
Time Frame: 30 minutes after each vaccination
Any AEs that occur within 30 minutes after the study vaccine administration
30 minutes after each vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Chem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 2, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 26, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-VGCL002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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