Actively Recruiting
A Study to Evaluate the Safety and Immunogenicity of VLP-Polio in Infants and Toddlers
Led by CanSino Biologics Inc. · Updated on 2025-07-04
480
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety and Immunogenicity of VLP-Polio in Infants and Toddlers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy toddlers aged 12 to 18 months who completed primary polio vaccination according to the national program
- Healthy infants aged 6 weeks to 2 months who have not received any polio vaccines
- Written informed consent obtained from parent or legal guardian
- Participants and their guardians able to follow study procedures, attend follow-up, and maintain telephone contact
You will not qualify if you...
- Current or past polio disease
- Toddlers with less than 5 months since their last polio vaccine dose
- Infants born before 37 weeks of gestation
- Birth weight under 2500g or body weight under 3500g at enrollment
- Body temperature of 37.5°C or higher at visit
- Congenital malformations, developmental disorders, genetic defects, or severe malnutrition
- Moderate or severe acute illness
- Abnormal vital signs
- History of epilepsy, convulsions, or family history of cognitive disabilities
- Use of immunosuppressive, cytotoxic, or glucocorticoid treatments (except certain local treatments)
- Receipt or planned receipt of blood/plasma products or immunoglobulins during the study
- History of serious allergic reactions to vaccine components
- Known blood disorders affecting bleeding or anemia
- Known or suspected immunodeficiency or related organ diseases
- Other vaccines administered within 7 days
- Participation in other interventional studies within 28 days before or during the study
- Household members receiving oral polio vaccine within specified time frame
- Direct descendants of study staff
- Conditions or treatments that could affect study results or participation
- Family history that could affect trial outcomes
- Any other reason deemed sufficient by the investigator
- Severe allergic reaction or serious adverse event after previous vaccination
- New symptoms or conditions after first vaccination that do not meet inclusion criteria or meet exclusion criteria
- Other investigator-determined reasons for exclusion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dr. Cipto Mangunkusumo Hospital
Jakarta, Indonesia
Actively Recruiting
Research Team
X
Xiaoyuan Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
14
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