A Study to Evaluate the Safety and Immunogenicity of VLP-Polio in Infants and Toddlers
NCT ID: NCT06577298
Last Updated: 2025-07-04
Study Results
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Basic Information
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RECRUITING
PHASE1/PHASE2
480 participants
INTERVENTIONAL
2024-12-19
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Phase I, Toddler Group A, Experimental vaccine, High dose, IM
One dose of VLP-Polio on Day 0
VLP-Polio high dose
1 dose of VLP-Polio vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants
Phase I, Toddler Group A, Control vaccine, IM
One dose of IPV control on Day 0
Vaccine Poliomyelitis Inactivated (IPV)
1 dose of IPV vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants
Phase I, Infant Group B, Experimental vaccine, Low-adjuvant dose, IM
4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose
4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
Phase I, Infant Group B, Control vaccine, IM
4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age
Vaccine Poliomyelitis Inactivated (IPV)
1 dose of IPV vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants
Phase I, Infant Group C, Experimental vaccine, Medium dose, IM
4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
VLP-Polio medium dose
4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
Phase I, Infant Group C, Control vaccine, IM
4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age
Vaccine Poliomyelitis Inactivated (IPV)
1 dose of IPV vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants
Phase I, Infant Group D, Experimental vaccine, High dose, IM
4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
VLP-Polio high dose
1 dose of VLP-Polio vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants
Phase I, Infant Group D, Control vaccine, IM
4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age
Vaccine Poliomyelitis Inactivated (IPV)
1 dose of IPV vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants
Phase II, Infant Group E, Experimental vaccine, Low-adjuvant dose, IM
4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose
4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
Phase II, Infant Group E, Control vaccine, IM
4 dose of IPV vaccine on Day 0, Day 28, Day 56 and Month 12-18 of age
Vaccine Poliomyelitis Inactivated (IPV)
1 dose of IPV vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants
Phase II, Infant Group F, Experimental vaccine, Medium dose, IM
4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
VLP-Polio medium dose
4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
Phase II, Infant Group F, Control vaccine, IM
4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age
Vaccine Poliomyelitis Inactivated (IPV)
1 dose of IPV vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants
Phase II, Infant Group G, Experimental vaccine, High dose, IM
4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age
VLP-Polio high dose
1 dose of VLP-Polio vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants
Phase II, Infant Group G, Control vaccine, IM
4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age
Vaccine Poliomyelitis Inactivated (IPV)
1 dose of IPV vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants
Interventions
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Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose
4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
VLP-Polio medium dose
4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
VLP-Polio high dose
1 dose of VLP-Polio vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants
Vaccine Poliomyelitis Inactivated (IPV)
1 dose of IPV vaccine (0.5ml) on day 0 for toddlers, 4 doses at 2, 3, 4 months and 12-18 months of age for infants
Eligibility Criteria
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Inclusion Criteria
* 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.
* Other reasons for exclusion considered by the investigating doctor .
Exclusion Criteria
* 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.
* Severe allergic reaction after the previous vaccination.
* Serious adverse events caused by the previous vaccination.
6 Weeks
18 Months
ALL
Yes
Sponsors
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CanSino Biologics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nina Putri, Dr
Role: PRINCIPAL_INVESTIGATOR
Dr. Cipto Mangunkusumo Hospital
Locations
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Dr. Cipto Mangunkusumo Hospital
Jakarta, , Indonesia
Countries
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Central Contacts
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Other Identifiers
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CTP-VLP-002
Identifier Type: -
Identifier Source: org_study_id
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