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
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.
Exclusion Criteria:
Medical conditions:
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:
Meets one or more of the following systemic corticosteroid exclusion criteria:
Note: Topical, ophthalmic, and inhaled steroids are permitted at the discretion of the Investigator.
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.
Low dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
Biological: LR20062
Middle dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
Biological: LR20062
High dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
Biological: LR20062
Control hexavalent vaccine (DTaP-HepB-IPV-Hib)
Biological: DTaP-HepB-IPV-Hib vaccine
DTaP-HepB-IPV-Hib vaccine
Control hexavalent vaccine
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
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
Seroconversion rate
Proportion of subjects achieving seroconversion to pertussis and poliovirus
Time frame: 1 month after the third dose primary series
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
Solicited adverse event
Expected local or systemic side effects after vaccination
Time frame: 7 days after each vaccination
Unsolicited adverse event
Any AEs other than solicited AEs
Time frame: 1 month after each vaccinations
Immediate reactions after vaccination
Any AEs that occur within 30 minutes after the study vaccine administration
Time frame: 30 minutes after each vaccination
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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LG Chem