PoliomyelitisPhase 1/2NCT06577298
A Study to Evaluate the Safety and Immunogenicity of VLP-Polio in Infants and Toddlers
A Phase 1/2 study testing Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose, VLP-Polio medium dose and VLP-Polio high dose in people with Poliomyelitis, run by CanSino Biologics Inc. at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 weeks to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose, VLP-Polio medium dose and VLP-Polio high dose
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteIndonesia
- Study dates
- 19 Dec 2024to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Poliomyelitis
- Being tested
- Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose, VLP-Polio medium dose, VLP-Polio high dose, Vaccine Poliomyelitis Inactivated (IPV)
- Keywords
- Vaccine, Trivalent, Immunogenicity, Safety, 12-18 months toddlers, 2 months infants
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant doseBiological
4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
VLP-Polio medium doseBiological
4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
VLP-Polio high doseBiological
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)Biological
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
| Study group | Role | What they receive |
|---|---|---|
| Phase I, Toddler Group A, Experimental vaccine, High dose, IM | Experimental | One dose of VLP-Polio on Day 0 Receives: Biological: VLP-Polio high dose |
| Phase I, Toddler Group A, Control vaccine, IM | Active comparator | One dose of IPV control on Day 0 Receives: Biological: Vaccine Poliomyelitis Inactivated (IPV) |
| Phase I, Infant Group B, Experimental vaccine, Low-adjuvant dose, IM | Experimental | 4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age Receives: Biological: Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose |
| Phase I, Infant Group B, Control vaccine, IM | Active comparator | 4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age Receives: Biological: Vaccine Poliomyelitis Inactivated (IPV) |
| Phase I, Infant Group C, Experimental vaccine, Medium dose, IM | Experimental | 4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age Receives: Biological: VLP-Polio medium dose |
| Phase I, Infant Group C, Control vaccine, IM | Active comparator | 4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age Receives: Biological: Vaccine Poliomyelitis Inactivated (IPV) |
| Phase I, Infant Group D, Experimental vaccine, High dose, IM | Experimental | 4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age Receives: Biological: VLP-Polio high dose |
| Phase I, Infant Group D, Control vaccine, IM | Active comparator | 4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age Receives: Biological: Vaccine Poliomyelitis Inactivated (IPV) |
| Phase II, Infant Group E, Experimental vaccine, Low-adjuvant dose, IM | Experimental | 4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age Receives: Biological: Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose |
| Phase II, Infant Group E, Control vaccine, IM | Active comparator | 4 dose of IPV vaccine on Day 0, Day 28, Day 56 and Month 12-18 of age Receives: Biological: Vaccine Poliomyelitis Inactivated (IPV) |
| Phase II, Infant Group F, Experimental vaccine, Medium dose, IM | Experimental | 4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age Receives: Biological: VLP-Polio medium dose |
| Phase II, Infant Group F, Control vaccine, IM | Active comparator | 4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age Receives: Biological: Vaccine Poliomyelitis Inactivated (IPV) |
| Phase II, Infant Group G, Experimental vaccine, High dose, IM | Experimental | 4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age Receives: Biological: VLP-Polio high dose |
| Phase II, Infant Group G, Control vaccine, IM | Active comparator | 4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age Receives: Biological: Vaccine Poliomyelitis Inactivated (IPV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Percentage of participants with solicited adverse events (AEs)
Measured: Within 7 days after each vaccination
Phase II: Percentage of participants with solicited adverse events (AEs)
Measured: Within 7 days after each vaccination
Phase II: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3
Measured: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Secondary outcomes (17)
Phase I: Percentage of participants with unsolicited AEs
Measured: Within 28 days after each vaccination
Phase I: Percentage of participants with solicited AEs
Measured: Within 30 minutes after each vaccination
Phase I: Percentage of participants experiencing serious adverse events (SAEs)
Measured: Through study completion, Toddlers about 6 months, Infant about 20-22 months.
Phase I: Geometric mean titer (GMT) of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in toddlers
Measured: Day 0 before vaccination and on Day 28 after the vaccination
Phase I: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in toddlers
Measured: Day 0 before vaccination and on Day 28 after the vaccination
Phase I: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in toddlers
Measured: Day 0 before vaccination and on Day 28 after the vaccination
Phase I: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in infants
Measured: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Phase I: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in infants
Measured: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Phase I: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in infants
Measured: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Phase II: Percentage of participants with unsolicited AEs
Measured: Within 28 days after each vaccination
Phase II: Percentage of participants with solicited AEs
Measured: Within 30 minutes after each vaccination
Phase II: Percentage of participants experiencing SAEs
Measured: Through study completion, Toddlers about 6 months, Infant about 20-22 months.
Phase II: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3
Measured: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Phase II: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3
Measured: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Phase II: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants.
Measured: Month 6 after the 3rd dose vaccination
Phase II: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants.
Measured: Month 6 after the 3rd dose vaccination
Phase II: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants.
Measured: Month 6 after the 3rd dose vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start19 Dec 2024
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PoliomyelitisStudies of the same condition, open and under way.
- More trials run by CanSino Biologics Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- CanSino Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nina Putri, Dr, Principal investigator, Dr. Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577298
- Sponsor's protocol ID
- CTP-VLP-002
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06577298
- Acronym / sponsor ID
- CTP-VLP-002
- Conditions
- Poliomyelitis
- Keywords
- Vaccine, Trivalent, Immunogenicity, Safety, 12-18 months toddlers, 2 months infants
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 480 participants (actual)
- Lead sponsor
- CanSino Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Phase I, Toddler Group A, Experimental vaccine, High dose, IM | Experimental | Biological: VLP-Polio high doseOne dose of VLP-Polio on Day 0 |
| Phase I, Toddler Group A, Control vaccine, IM | Active comparator | Biological: Vaccine Poliomyelitis Inactivated (IPV)One dose of IPV control on Day 0 |
| Phase I, Infant Group B, Experimental vaccine, Low-adjuvant dose, IM | Experimental | Biological: Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age |
| Phase I, Infant Group B, Control vaccine, IM | Active comparator | Biological: Vaccine Poliomyelitis Inactivated (IPV)4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age |
| Phase I, Infant Group C, Experimental vaccine, Medium dose, IM | Experimental | Biological: VLP-Polio medium dose4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age |
| Phase I, Infant Group C, Control vaccine, IM | Active comparator | Biological: Vaccine Poliomyelitis Inactivated (IPV)4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age |
| Phase I, Infant Group D, Experimental vaccine, High dose, IM | Experimental | Biological: VLP-Polio high dose4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age |
| Phase I, Infant Group D, Control vaccine, IM | Active comparator | Biological: Vaccine Poliomyelitis Inactivated (IPV)4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age |
| Phase II, Infant Group E, Experimental vaccine, Low-adjuvant dose, IM | Experimental | Biological: Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age |
| Phase II, Infant Group E, Control vaccine, IM | Active comparator | Biological: Vaccine Poliomyelitis Inactivated (IPV)4 dose of IPV vaccine on Day 0, Day 28, Day 56 and Month 12-18 of age |
| Phase II, Infant Group F, Experimental vaccine, Medium dose, IM | Experimental | Biological: VLP-Polio medium dose4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age |
| Phase II, Infant Group F, Control vaccine, IM | Active comparator | Biological: Vaccine Poliomyelitis Inactivated (IPV)4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age |
| Phase II, Infant Group G, Experimental vaccine, High dose, IM | Experimental | Biological: VLP-Polio high dose4 dose of VLP-Polio on Day 0, Day 28, Day 56 and Month 12-18 of age |
| Phase II, Infant Group G, Control vaccine, IM | Active comparator | Biological: Vaccine Poliomyelitis Inactivated (IPV)4 dose of IPV on Day 0, Day 28, Day 56 and Month 12-18 of age |
Who may qualify
- Ages
- 6 weeks to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (25 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants | Biological | Phase I, Infant Group B, Experimental vaccine, Low-adjuvant dose, IM, Phase II, Infant Group E, Experimental vaccine, Low-adjuvant dose, IM |
| VLP-Polio medium dose4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants | Biological | Phase I, Infant Group C, Experimental vaccine, Medium dose, IM, Phase II, Infant Group F, Experimental vaccine, Medium dose, IM |
| VLP-Polio high dose1 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 | Biological | Phase I, Infant Group D, Experimental vaccine, High dose, IM, Phase I, Toddler Group A, Experimental vaccine, High dose, IM, Phase II, Infant Group G, Experimental vaccine, High dose, IM |
| 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 | Biological | Phase I, Infant Group B, Control vaccine, IM, Phase I, Infant Group C, Control vaccine, IM, Phase I, Infant Group D, Control vaccine, IM, Phase I, Toddler Group A, Control vaccine, IM, Phase II, Infant Group E, Control vaccine, IM, Phase II, Infant Group F, Control vaccine, IM, Phase II, Infant Group G, Control vaccine, IM |
Primary outcome
Phase I: Percentage of participants with solicited adverse events (AEs)
Time frame: Within 7 days after each vaccination
Phase II: Percentage of participants with solicited adverse events (AEs)
Time frame: Within 7 days after each vaccination
Phase II: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3
Time frame: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
17 secondary outcomes
Phase I: Percentage of participants with unsolicited AEs
Time frame: Within 28 days after each vaccination
Phase I: Percentage of participants with solicited AEs
Time frame: Within 30 minutes after each vaccination
Phase I: Percentage of participants experiencing serious adverse events (SAEs)
Time frame: Through study completion, Toddlers about 6 months, Infant about 20-22 months.
Phase I: Geometric mean titer (GMT) of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in toddlers
Time frame: Day 0 before vaccination and on Day 28 after the vaccination
Phase I: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in toddlers
Time frame: Day 0 before vaccination and on Day 28 after the vaccination
Phase I: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in toddlers
Time frame: Day 0 before vaccination and on Day 28 after the vaccination
Phase I: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in infants
Time frame: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Phase I: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in infants
Time frame: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Phase I: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in infants
Time frame: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Phase II: Percentage of participants with unsolicited AEs
Time frame: Within 28 days after each vaccination
Phase II: Percentage of participants with solicited AEs
Time frame: Within 30 minutes after each vaccination
Phase II: Percentage of participants experiencing SAEs
Time frame: Through study completion, Toddlers about 6 months, Infant about 20-22 months.
Phase II: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3
Time frame: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Phase II: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3
Time frame: Day 0 before vaccination and on Day 28 after the 3rd dose vaccination
Phase II: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants.
Time frame: Month 6 after the 3rd dose vaccination
Phase II: Seroprotection rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants.
Time frame: Month 6 after the 3rd dose vaccination
Phase II: Seroconversion rate of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants.
Time frame: Month 6 after the 3rd dose vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Putri, Dr principal investigator
Dr. Cipto Mangunkusumo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose, VLP-Polio medium dose and VLP-Polio high dose in people with Poliomyelitis, run by CanSino Biologics Inc. at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Percentage of participants with solicited adverse events (AEs) (time frame: Within 7 days after each vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.