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.
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…
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