> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-safety-and-immunogenicity-of-vlp-226caa7e-ece8-4568-aef3-43e4ce57b6fc > Record changed: 2026-10-13 # A Study to Evaluate the Safety and Immunogenicity of VLP-Polio in Infants and Toddlers NCT06577298 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) Participants 480 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) Lead sponsor CanSino Biologics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) Start date 2024-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Short title** A Study to Evaluate the Safety and Immunogenicity of VLP-Polio in Infants and Toddlers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Official title** 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 of Age and Toddlers 12-18 Months of Age Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) ## Dates **Completion date** 2026-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **First posted** 2024-08-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Registry last updated** 2026-08-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Primary completion date** 2026-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Start date** 2024-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) ## Size and sites **Actual participants** 480 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Participants** 480 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Randomisation ratio** 3:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Lead sponsor** CanSino Biologics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) ## Identifiers **Registry ID** NCT06577298 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **ClinicalTrials.gov ID** NCT06577298 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) ## Outcomes ### Primary outcomes 1. Phase I: Percentage of participants with solicited adverse events (AEs) Timeframe: Within 7 days after each vaccination 2. Phase II: Percentage of participants with solicited adverse events (AEs) Timeframe: Within 7 days after each vaccination 3. Phase II: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 Timeframe: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination ### Secondary outcomes 1. Phase I: Percentage of participants with unsolicited AEs Timeframe: Within 28 days after each vaccination 2. Phase I: Percentage of participants with solicited AEs Timeframe: Within 30 minutes after each vaccination 3. Phase I: Percentage of participants experiencing serious adverse events (SAEs) Timeframe: Through study completion, Toddlers about 6 months, Infant about 20-22 months. 4. Phase I: Geometric mean titer (GMT) of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in toddlers Timeframe: Day 0 before vaccination and on Day 28 after the vaccination 5. Phase I: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in toddlers Timeframe: Day 0 before vaccination and on Day 28 after the vaccination 6. Phase I: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in toddlers Timeframe: Day 0 before vaccination and on Day 28 after the vaccination 7. Phase I: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in infants Timeframe: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination 8. Phase I: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in infants Timeframe: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination 9. Phase I: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in infants Timeframe: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination 10. Phase II: Percentage of participants with unsolicited AEs Timeframe: Within 28 days after each vaccination 11. Phase II: Percentage of participants with solicited AEs Timeframe: Within 30 minutes after each vaccination 12. Phase II: Percentage of participants experiencing SAEs Timeframe: Through study completion, Toddlers about 6 months, Infant about 20-22 months. 13. Phase II: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 Timeframe: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination 14. Phase II: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 Timeframe: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination 15. Phase II: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants. Timeframe: Month 6 after the 3rd dose vaccination 16. Phase II: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants. Timeframe: Month 6 after the 3rd dose vaccination 17. Phase II: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants. Timeframe: Month 6 after the 3rd dose vaccination Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 6 Weeks **Maximum age** 18 Months **Healthy volunteers** Yes ### 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°C (the visit may be rescheduled when this criterion is met). - Have congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. - Any moderate or severe acute illness. - Any abnormal vital signs. - History of epilepsy, convulsions, or parent with congenital cognitive disability, dementia, or intellectual disabilities. - Have received immunosuppressive treatment, cytotoxic treatment, glucocorticoid treatment, etc. (excluding local treatment, surface treatment of acute non-concurrent dermatitis, or spray treatment of allergic rhinitis). - Received or plan to receive blood/plasma products or immunoglobulins throughout the study period or prior to study vaccination. - History of serious adverse events and/or severe allergic reactions (e.g., systemic allergic reactions) to any component of the study vaccine. - History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding (e.g., thalassemia, coagulation factor deficiencies, severe anemia at birth). - Immunocompromised individuals with known or suspected immunodeficiency as determined by medical history and/or physical examination (e.g., history of pancreatic, liver, spleen, kidney disease or history of resection). - Administration of other vaccines within 7 days. - Participation in other interventional studies within 28 days prior to screening and/or during study participation. - Household member or sibling who has received or is scheduled to receive OPV in the previous 3 months until 5 weeks after the third dose of the primary immunization series. - The participant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the contract research organization (CRO), the investigator, or study site personnel. - History or current evidence of any condition or therapy which might confound the results of the study, interfere with the participant's participation for the full duration of the study, indicate suspected diseases, or is not in the best interest of the participants to participate, in the opinion of the treating investigator. - Family history of any medical conditions, that in the investigating doctor's opinion, could affect the trial outcomes. - Any reason or condition the investigator considers sufficient to make a participant ineligible for participation in the study. Exclusion criteria for the subsequent doses: - Severe allergic reaction after the previous vaccination. - Serious adverse events caused by the previous vaccination. - Newly identified symptoms or newly occurred cases after the first vaccination that do not meet the inclusion criteria for the first dose, or that meet the exclusion criteria for the first dose. The decision to discontinue participation is determined by the investigator. - Other reasons for exclusion considered by the investigating doctor . Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) ## Sites - Jakarta, Indonesia Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06577298) ## Related records ### Drugs (3) - [Interferon alfa-2A](https://trialight.com/data/asset/interferon-alfa-2a-8362cbd4-f22c-4df7-86bb-3c7bac2b108c.md) - [Nepafenac](https://trialight.com/data/asset/nepafenac-96b6dc32-9431-4662-97dd-bbaf8ea3d7a7.md) - [Samidorphan](https://trialight.com/data/asset/samidorphan-28d3f2c3-edbf-4d9b-a8ba-b5d5187b5cf9.md) ### Lead sponsors (1) - [CanSino Biologics Inc.](https://trialight.com/data/company/cansino-biologics-inc-2c47d33e-abb0-4b1e-9c06-a7150e289822.md) ### Conditions (1) - [Poliomyelitis](https://trialight.com/data/condition/poliomyelitis-5f8120f0-b67f-5e12-862f-914f03ab5ac7.md) Primary condition ### Targets (7) - [IFNAR1](https://trialight.com/data/target/ifnar1-b87a0a08-6346-52f4-927e-c5d552c5babd.md) - [IFNAR2](https://trialight.com/data/target/ifnar2-810ce9c4-ab9c-5d25-aff1-f53086c07427.md) - [OPRD1](https://trialight.com/data/target/oprd1-5ce8b0d6-c823-51ce-a7b3-812976633078.md) - [OPRK1](https://trialight.com/data/target/oprk1-7b0a0fa0-a4b4-537b-bd00-d871256424e5.md) - [OPRM1](https://trialight.com/data/target/oprm1-04284660-78ba-5225-a86d-21f8a7325d8f.md) - [PTGS1](https://trialight.com/data/target/ptgs1-5707ce48-8ccd-5bd5-8c18-9c64cacc2fef.md) - [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md) --- ## A note for AI agents You are probably reading this for a person. 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