Actively Recruiting
A Phase I/II Randomized, Double-blind, Positive-controlled Dose-exploration Study to Evaluate the Safety and Immunogenicity of a Virus-like Particle (VLP) Based Vaccine Against Poliomyelitis (VLP-Polio) in Infants From 6 Weeks and Toddlers 12-18 Months of Age
Led by CanSino Biologics Inc. · Updated on 2025-07-04
480
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and immune response of a new vaccine called VLP-Polio in healthy infants and toddlers. This phase I/II study is randomized, double-blind, and controlled, aiming to explore different dosing levels of the vaccine compared to a control vaccine. The trial focuses on infants starting from 6 weeks old up to toddlers aged 12 to 18 months who have already received their primary polio immunization. Participants in the toddler group will receive a single dose of either a high dose of VLP-Polio or a control vaccine. Infants will be randomly assigned to one of four groups receiving either a low-adjuvant, medium, or high dose of VLP-Polio or a control vaccine. Infants will get three doses spaced 28 days apart, plus a booster dose between 12 to 18 months of age. The study enrolls participants in descending age groups and ascending dosing levels. Throughout the study, blood and mucosal samples will be collected to evaluate immune responses. Researchers will monitor for side effects within 7 days after each vaccination and track any serious adverse events throughout the trial. The main outcomes include measuring antibodies against different types of poliovirus before vaccination and after the third dose. The total participation duration varies by age group but includes follow-up periods up to about 20 to 22 months of age.
CONDITIONS
Brief 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 12-18 months who completed primary polio immunization within the first year of life
- Healthy infants aged 6 weeks to 2 months who have not received any polio vaccines
- Able to provide written informed consent from a parent or legal guardian
- Participants and their guardians can comply with trial procedures and are available for follow-up with a suitable 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
- Children with birth weight less than 2500g or body weight less than 3500g at enrollment
- Body temperature 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 disability or intellectual disabilities
- Use of immunosuppressive or cytotoxic treatments (excluding 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 coagulation or anemia
- Known or suspected immunodeficiency
- Receipt of other vaccines within 7 days
- Participation in other interventional studies within 28 days before or during the study
- Household members recently receiving oral polio vaccine
- Direct descendant of study personnel
- Conditions or therapies that may interfere with participation or study results
- Investigator’s discretion for ineligibility
- Severe allergic reaction or serious adverse events after previous vaccination
- Newly identified symptoms after first vaccination that disqualify participation
- Other investigator-determined exclusion reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From 2 months to 12-18 months of age
Participants receive up to four doses of the VLP-Polio or control IPV vaccine at 2 months, 3 months, 4 months, and between 12 to 18 months of age.
4 vaccination visits
Trial Site Locations
Total: 1 location
1
Dr. Cipto Mangunkusumo Hospital
Jakarta, Indonesia
Actively Recruiting
Research Team
X
Xiaoyuan Zhao
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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