A Study to Evaluate the Safety and Immunogenicity of VLP-Polio in Infants and Toddlers

Recruiting Phase 1 Phase 2 Interventional Study
Poliomyelitis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
6 Weeks – 18 Months
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Prevention
Participants needed
480 (estimated)
Sponsor
CanSino Biologics Inc. · Industry
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About This Trial
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 c…
Trial Locations
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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 consid…
Contacts

Xiaoyuan Zhao

022-58213600-6051

xiaoyuan.zhao@cansinotech.com

CONTACT