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Not yet recruitingNCT06618196Updated Oct 1, 2024

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 2 interventional study of LR20062 and DTaP-HepB-IPV-Hib vaccine in Diphtheria, Tetanus and Pertussis, sponsored by LG Chem. Not yet recruiting. Open to participants aged 50 Days to 70 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-01.

Sponsored by LG Chem · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
336
Allocation
Randomized
Ages
50 Days to 70 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Diphtheria
  • Tetanus
  • Pertussis
  • Hepatitis B
  • Poliomyelitis
  • Haemophilus Influenzae Type B Infection
03

Who can participate

Ages eligible
50 Days to 70 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

04

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
336 participants (estimated)

Study arms

  • Experimental
    Test group 1

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

    Biological: LR20062

  • Experimental
    Test group 2

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

    Biological: LR20062

  • Experimental
    Test group 3

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

    Biological: LR20062

  • Active comparator
    Test group 4

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

    Biological: DTaP-HepB-IPV-Hib vaccine

Interventions

  • BiologicalLR20062

    DTaP-HepB-IPV-Hib vaccine

  • BiologicalDTaP-HepB-IPV-Hib vaccine

    Control hexavalent vaccine

05

What researchers measure

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

    Time frame: 1 month after the third dose primary series

Secondary outcomes

  1. Geometric mean concentration (GMC) or Geometric mean titer (GMT)

    GMC or GMT and their ratio of all types of antibodies

    Time frame: 1 month after the third dose primary series

  2. Seroconversion rate

    Proportion of subjects achieving seroconversion to pertussis and poliovirus

    Time frame: 1 month after the third dose primary series

  3. Long-term seroprotection rate

    Proportion of subjects with seroconversion for diphtheria, tetanus, and Hib antigens

    Time frame: 1 month after the third dose primary series

  4. Solicited adverse event

    Expected local or systemic side effects after vaccination

    Time frame: 7 days after each vaccination

  5. Unsolicited adverse event

    Any AEs other than solicited AEs

    Time frame: 1 month after each vaccinations

  6. Immediate reactions after vaccination

    Any AEs that occur within 30 minutes after the study vaccine administration

    Time frame: 30 minutes after each vaccination

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06618196
Lead sponsor
LG Chem
Responsible party
Sponsor
First posted
Oct 1, 2024
Start date
Oct 2, 2024 (estimated)
Primary completion
Jun 30, 2025 (estimated)
Completion
Apr 30, 2026 (estimated)
Last update
Oct 1, 2024

Study contacts

Clinical Study Lead
Contact
lgclinical@lgchem.com
82-2-6987-4427

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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