NCT06577298 A Study to Evaluate the Safety and Immunogenicity of VLP-Polio in Infants and Toddlers
| NCT ID | NCT06577298 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | CanSino Biologics Inc. |
| Condition | Poliomyelitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2024-12-19 |
| Primary Completion | 2026-10 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a phase I/II randomized, double-blind, and positive-controlled study. Participants in the phase I toddler group will receive 1 dose of either high dose VLP-Polio (Dose H) or control vaccine in a ratio of 3:1. The phase I infant cohort will have 4 arms randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio or control vaccine in a ratio of 3:1. Phase II infant cohort will have 4 arms randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio or control vaccine in a ratio of 3:1. Each infant participant will be administrated 3 doses of the assigned vaccine with 28 days apart, and the booster dose will be given when the infant is 12-18 months old. Enrollment of Phase I and Phase II will be staggered in descending order of age group but ascending order of dosing levels. Blood and mucosal samples will be collected for immunogenicity evaluation over the time course of the study.
Eligibility Criteria
Inclusion Criteria: * Healthy toddlers aged 12-18 months at the time of screening, and have completed primary immunization of polio vaccine according to the national government program in the first year of life. * Healthy infants aged 6 weeks to 2 months (42 to 98 days, with the day of birth considered day of life 1), and who have not received any polio vaccines. * Able to obtain written informed consent from parent(s) or legal guardian(s). * Participants and their parents or legal guardian(s) can comply with trial procedures, are available for the duration of follow-up, and have a suitable telephone contact available. Exclusion Criteria: Exclusion criteria for the first dose: * Current polio disease or history of polio disease. * Toddlers who have an interval of less than 5 months since their last dose of the polio vaccine. * Infants born at \< 37 weeks of gestation. * Children with a birth weight \< 2500g and a body weight \< 3500g at the time of enrollment. * Body temperature ≥37.5°