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
- Phase
- Phase 2
- Intervention
- LR20062
- Conditions
- Diphtheria
- Sponsor
- LG Chem
- Enrollment
- 336
- Primary Endpoint
- Seroprotection/vaccine-response rate
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
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:
Arms & Interventions
Test group 1
Low dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
Intervention: LR20062
Test group 2
Middle dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
Intervention: LR20062
Test group 3
High dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
Intervention: LR20062
Test group 4
Control hexavalent vaccine (DTaP-HepB-IPV-Hib)
Intervention: DTaP-HepB-IPV-Hib vaccine
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Geometric mean concentration (GMC) or Geometric mean titer (GMT)(1 month after the third dose primary series)
- Seroconversion rate(1 month after the third dose primary series)
- Long-term seroprotection rate(1 month after the third dose primary series)
- Solicited adverse event(7 days after each vaccination)
- Unsolicited adverse event(1 month after each vaccinations)
- Immediate reactions after vaccination(30 minutes after each vaccination)