Active, not recruitingNCT06577298Updated Aug 6, 2026

A Study to Evaluate the Safety and Immunogenicity of VLP-Polio in Infants and Toddlers

A Phase 1/2 interventional study of Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose and VLP-Polio medium dose in Poliomyelitis, sponsored by CanSino Biologics Inc.. Active, not recruiting at 1 site in Indonesia. Open to participants aged 6 Weeks to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by CanSino Biologics Inc. · Phase 1/2, Interventional, and Prevention

Phase: Phase 1/2
Study type: Interventional
Enrollment: 480
Allocation: Randomized
Ages: 6 Weeks to 18 Months
Sex: All

Study 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.

Conditions studied

Poliomyelitis

Browse trials for

Poliomyelitis 274

Keywords

Vaccine
Trivalent
Immunogenicity
Safety
12-18 months toddlers
2 months infants

In context

Poliomyelitis

274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.

This study's enrollment of 480 is close to the median of 476 across 249 interventional studies indexed under Poliomyelitis.

Browse Poliomyelitis studies →

Lead sponsor

CanSino Biologics Inc. is the lead sponsor of 41 studies on the registry; 6 are open to participants now.

Browse CanSino Biologics Inc. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Weeks to 18 Months
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

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 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 treatment, cytotoxic treatment, 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 .

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 480 participants (actual)

Study arms

Experimental
Phase I, Toddler Group A, Experimental vaccine, High dose, IM
One dose of VLP-Polio on Day 0
Biological: VLP-Polio high dose
Active comparator
Phase I, Toddler Group A, Control vaccine, IM
One dose of IPV control on Day 0
Biological: Vaccine Poliomyelitis Inactivated (IPV)
Experimental
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
Biological: Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose
Active comparator
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
Biological: Vaccine Poliomyelitis Inactivated (IPV)
Experimental
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
Biological: VLP-Polio medium dose
Active comparator
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
Biological: Vaccine Poliomyelitis Inactivated (IPV)
Experimental
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
Biological: VLP-Polio high dose
Active comparator
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
Biological: Vaccine Poliomyelitis Inactivated (IPV)
Experimental
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
Biological: Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose
Active comparator
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
Biological: Vaccine Poliomyelitis Inactivated (IPV)
Experimental
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
Biological: VLP-Polio medium dose
Active comparator
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
Biological: Vaccine Poliomyelitis Inactivated (IPV)
Experimental
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
Biological: VLP-Polio high dose
Active comparator
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
Biological: Vaccine Poliomyelitis Inactivated (IPV)

Interventions

BiologicalRecombinant 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
BiologicalVLP-Polio medium dose
4 doses of VLP-Polio vaccine (0.5ml) at 2, 3, 4 months and 12-18 months of age for infants
BiologicalVLP-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
BiologicalVaccine 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

What researchers measure

Primary outcomes

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

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

Other outcomes

Phase II: GMT of neutralizing antibodies against Sabin and wild-type poliovirus type 1, 2, and 3 in extended immunogenicity subgroup participants.
Time frame: Day 0 before booster vaccination, on Day 28 and Month 6 after the booster 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: Day 0 before booster vaccination, on Day 28 and Month 6 after the booster 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: Day 0 before booster vaccination, on Day 28 and Month 6 after the booster vaccination
Phase II: GMT of poliovirus type-specific neutralizing and binding antibodies (IgA, IgG, IgM) in stool samples in extended immunogenicity subgroup participants
Time frame: Day 0 before vaccination, on Day 14 and Day 28 after the 3rd dose vaccination, on Day 0 before the booster vaccination, on Day 14 and Day 28 after the booster vaccination
Phase II: GMI (geometric mean fold increase) of poliovirus type-specific neutralizing and binding antibodies (IgA, IgG, IgM) in stool samples in extended immunogenicity subgroup participants
Time frame: Day 0 before vaccination, on Day 14 and Day 28 after the 3rd dose vaccination, on Day 0 before the booster vaccination, on Day 14 and Day 28 after the booster vaccination
Phase II: GMT of poliovirus type-specific neutralizing and binding antibodies (IgA, IgG, IgM) in nasal samples in extended immunogenicity subgroup participants
Time frame: Day 0 before vaccination, on Day 14 and Day 28 after the 3rd dose vaccination, on Day 0 before the booster vaccination, on Day 14 and Day 28 after the booster vaccination
Phase II: GMI of poliovirus type-specific neutralizing and binding antibodies (IgA, IgG, IgM) in nasal samples in extended immunogenicity subgroup participants
Time frame: Day 0 before vaccination, on Day 14 and Day 28 after the 3rd dose vaccination, on Day 0 before the booster vaccination, on Day 14 and Day 28 after the booster vaccination

Study locations

1 site

Dr. Cipto Mangunkusumo Hospital
Jakarta, Indonesia
3 other open studies at this site →

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Started Dec 2024 (actual). Primary completion is estimated for Oct 2026, 22 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 27, 2024
First posted: Aug 29, 2024
StartActual: Dec 19, 2024
Primary completionEst.: Oct 2026
CompletionEst.: Dec 2026
Last update: Aug 6, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06577298
Lead sponsor: CanSino Biologics Inc.
Responsible party: Sponsor
First posted: Aug 29, 2024
Start date: Dec 19, 2024
Primary completion: Oct 2026 (estimated)
Completion: Dec 2026 (estimated)
Last update: Aug 6, 2026

Study contacts

Nina Putri, Dr

principal investigator · Dr. Cipto Mangunkusumo Hospital

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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