Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type B Infection
Conditions
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.
Interventions
BIOLOGICALLR20062
DTaP-HepB-IPV-Hib vaccine
BIOLOGICALDTaP-HepB-IPV-Hib vaccine
Control hexavalent vaccine
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Any persons accompanying the subject for the site visits, including parents, other family members, and/or legally acceptable representatives, will be shielded from view by physical barriers while the study vaccine is administered. The unblinded site personnel for the preparation/administration of study vaccines will keep the unblinded information separate from those persons for any study related procedures/assessments after administration of study vaccines, which includes all safety follow-up procedures. Blinded site personnel will be responsible for all safety and immunogenicity follow-up procedures after study vaccine administration.
Eligibility
Sex/Gender
ALL
Age
50 Days to 70 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroprotection/vaccine-response rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Immediate reactions after vaccination | 30 minutes after each vaccination | Any AEs that occur within 30 minutes after the study vaccine administration |
| Geometric mean concentration (GMC) or Geometric mean titer (GMT) | 1 month after the third dose primary series | GMC or GMT and their ratio of all types of antibodies |
| Seroconversion rate | 1 month after the third dose primary series | Proportion of subjects achieving seroconversion to pertussis and poliovirus |
| Long-term seroprotection rate | 1 month after the third dose primary series | Proportion of subjects with seroconversion for diphtheria, tetanus, and Hib antigens |
| Solicited adverse event | 7 days after each vaccination | Expected local or systemic side effects after vaccination |
| Unsolicited adverse event | 1 month after each vaccinations | Any AEs other than solicited AEs |
Contacts
Primary ContactClinical Study Lead
Outcome results
None listed