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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group 1 | Experimental | Low dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib) |
|
| Test group 2 | Experimental | Middle dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib) |
|
| Test group 3 | Experimental | High dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib) |
|
| Test group 4 | Active Comparator | Control hexavalent vaccine (DTaP-HepB-IPV-Hib) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LR20062 | Biological | DTaP-HepB-IPV-Hib vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection/vaccine-response rate |
| 1 month after the third dose primary series |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean concentration (GMC) or Geometric mean titer (GMT) | GMC or GMT and their ratio of all types of antibodies | 1 month after the third dose primary series |
| Seroconversion rate | Proportion of subjects achieving seroconversion to pertussis and poliovirus |
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Inclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Lead | Contact | 82-2-6987-4427 | lgclinical@lgchem.com |
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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.
| DTaP-HepB-IPV-Hib vaccine | Biological | Control hexavalent vaccine |
|
| 1 month after the third dose primary series |
| Long-term seroprotection rate | Proportion of subjects with seroconversion for diphtheria, tetanus, and Hib antigens | 1 month after the third dose primary series |
| Solicited adverse event | Expected local or systemic side effects after vaccination | 7 days after each vaccination |
| Unsolicited adverse event | Any AEs other than solicited AEs | 1 month after each vaccinations |
| Immediate reactions after vaccination | Any AEs that occur within 30 minutes after the study vaccine administration | 30 minutes after each vaccination |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D006509 | Hepatitis B |
| D011051 | Poliomyelitis |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D016871 | Pasteurellaceae Infections |
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