Clinical trial NCT06618196: Study to Evaluate the Immunogenicity of LR20062 Compared to Control When Administered Intramuscularly in Healthy Infants At 2, 4, 6 Months of Age
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
Haemophilus Influenzae Type B Infection
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 336
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Seroprotection/vaccine-response rate
timeFrame: 1 month after the third dose primary series
Secondary outcomes:
measure: Geometric mean concentration (GMC) or Geometric mean titer (GMT)
timeFrame: 1 month after the third dose primary series
measure: Seroconversion rate
timeFrame: 1 month after the third dose primary series
measure: Long-term seroprotection rate
timeFrame: 1 month after the third dose primary series
measure: Solicited adverse event
timeFrame: 7 days after each vaccination
measure: Unsolicited adverse event
timeFrame: 1 month after each vaccinations
measure: Immediate reactions after vaccination
timeFrame: 30 minutes after each vaccination
Other outcomes:
Locations:
Study officials:
References: