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.
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.
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.
Parallel
LR20062
Biological/VaccineDTaP-HepB-IPV-Hib vaccine
DTaP-HepB-IPV-Hib vaccine
Biological/VaccineControl hexavalent vaccine
Seroprotection/vaccine-response rate
* Proportion of subjects achieving seroprotection to each antigenic components * Proportion of subjects with vaccine response for pertussis antigens
Geometric mean concentration (GMC) or Geometric mean titer (GMT)
GMC or GMT and their ratio of all types of antibodies
Seroconversion rate
Proportion of subjects achieving seroconversion to pertussis and poliovirus
Long-term seroprotection rate
Proportion of subjects with seroconversion for diphtheria, tetanus, and Hib antigens
Solicited adverse event
Expected local or systemic side effects after vaccination
This trial is not recruiting at the moment. You can still explore other options:
