Study to Evaluate the Immunogenicity of LR20062 Compared to Control When Administered Intramuscularly in Healthy Infants At 2, 4, 6 Months of Age
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LR20062, DTaP-HepB-IPV-Hib vaccine.
- Who it may be relevant to
- Registry conditions: Diphtheria, Tetanus, Pertussis, Hepatitis B. Basic parameters: 50 Days — 70 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Biological LR20062
DTaP-HepB-IPV-Hib vaccine - Biological DTaP-HepB-IPV-Hib vaccine
Control hexavalent vaccine
Primary outcome measures
- Seroprotection/vaccine-response rate [Time frame: 1 month after the third dose primary series]
Secondary outcome measures (6)
- Geometric mean concentration (GMC) or Geometric mean titer (GMT) [Time frame: 1 month after the third dose primary series]
- Seroconversion rate [Time frame: 1 month after the third dose primary series]
- Long-term seroprotection rate [Time frame: 1 month after the third dose primary series]
- Solicited adverse event [Time frame: 7 days after each vaccination]
- Unsolicited adverse event [Time frame: 1 month after each vaccinations]
- Immediate reactions after vaccination [Time frame: 30 minutes after each vaccination]
Eligibility criteria
Inclusion criteria
- Is male or female aged two months (50 to 70 days inclusive) on the day of the first dose of study vaccine.
- Is born at full term of pregnancy (≥37 weeks of gestation) with a birth weight of ≥2.5 kg.
Exclusion criteria
Medical conditions:
- Has a history of diphtheria, tetanus, pertussis, poliovirus, Hep B, or Hib infection.
- Has a known SARS-CoV-2 infection at Screening.
- Was born to a mother with a known history of Hep B infection based on HBsAg seropositivity.
- Was born to a mother with a known history of HIV infection based on HIV antibody seropositivity.
- 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:
- Has previously received vaccination against diphtheria, tetanus, pertussis, poliovirus, and/or Hib infections since birth.
- Has received or is expected to receive immunosuppressive agents or other immune-modifying drugs during the conduct of the study.
- Meets one or more of the following systemic corticosteroid exclusion criteria:
- 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.
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06618196 · LG-VGCL002