PoliomyelitisPhase 4NCT07457060
Phase IV Clinical Study of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine
A Phase 4 study testing 2wIPV+1sIPV, 1wIPV+2sIPV and 3wIPV in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd at 3 sites in Philippines.
Trial summary
The goal of this study is to compare the immunogenicity and safety of sIPV administered via subcutaneous and intramuscular injection routes Read more about this study
- Who is it for?
- Ages 56 to 84 daysHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- 2wIPV+1sIPV, 1wIPV+2sIPV and 3wIPV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 3 sitesPhilippines
- Study dates
- 27 Nov 2025to 19 Oct 2026
- Phase
- Phase 4
- 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 56 to 84 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants of 2 months old (aged 56-84 days).
- Have a parent/legal guardian who has provided written informed consent after being fully informed about the study.
- Be able to provide the vaccination records since birth.
- The infant's mother is tested negative for HIV, syphilis, hepatitis B, and hepatitis C during or before the infant's enrollment to this study (test results obtained during pregnancy are acceptable, if provided).
Who cannot join
- History of any polio vaccination.
- History of severe allergic reaction to previous vaccinations or hypersensitivity to any vaccine component.
- Premature infants (born before week 37 of gestation).
- History of asphyxia rescue or nervous system injury.
- Congenital malformations, developmental disorders, clinically significant genetic defects, severe malnutrition.
- Autoimmune diseases or immunodeficiency/immunosuppression.
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- Serious chronic diseases such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders.
- Abnormal coagulation functions (e.g., coagulation factor deficiency, blood coagulation diseases, platelet disorders).
- Received immunosuppressant (excluding topical or inhaled corticosteroids), cytotoxic drug, or other immunomodulatory therapies.
- Received blood products before trial vaccine inoculation.
- Received other study drugs within 30 days before enrollment.
- Received live attenuated vaccines within 14 days before enrollment.
- Received subunit or inactivated vaccines within 7 days before enrollment.
- Acute diseases or acute exacerbations of chronic diseases within 7 days before enrollment.
- Significant acute diseases, chronic infections, or axillary temperature ≥ 37.5°C before enrollment.
- Any other factors deemed by the investigators as unsuitable for participation.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Philippines3 sites, 3 recruiting
- Recruiting
Iloilo Doctors' Hospital
Iloilo City
Ivy Minerva Soriano, (033) 3209593, leganesclinicalresearch@outlook.com
- Recruiting
Health Index Multispecialty Clinic - Research and Development on Medical Sciences
Imus
Edison Alberto, (046) 887-7356, himc.rdms@gmail.com
- Recruiting
Centennial Clindev Research and Development of Medical Sciences
Kawit, Cavite
Nancy Bermal, +639392717416, centennialclindevcenter@gmail.com
About this study
Official title: An Open-labelled, Randomized, Controlled, Clinical Trial to Evaluate the Immunogenicity and Tolerability of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine
The goal of this study is to compare the immunogenicity and safety of sIPV administered via subcutaneous and intramuscular injection routes
Read the detailed description
This is an open-labelled, randomized, controlled clinical trial. Totally 480 healthy infants of 2 months old (aged 56-84 days) are planned to be enrolled, and then randomized in a 1:1:1:1 ratio into four groups (group A, B, C, D). Group A-D will receive three doses of primary immunization against polio as per the 2wIPV+1sIPV (First 2 doses: wIPV. 3rd dose: sIPV), 1wIPV+2sIPV (1st dose: wIPV. 2nd \& 3rd doses: sIPV), 3wIPV, 3sIPV vaccination regimen, with an interval of 28 days (+14 days) between doses. In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.
For all the participants, the immediate reactions within 30 minutes after each dose of vaccination will be observed on study site. Guardians of participants will utilize the diary card to record adverse events (AEs) from the time of vaccination for 7 days after each dose of vaccination, and will utilize the diary card to record any AEs from 8 days up to 28 days after each dose of vaccination. SAEs arise from the time of vaccination up to 28 days after the last vaccination will be collected.
About 3.0 ml venous blood will be collected before the first vaccination and 28 days (+14 days) after the last vaccination. Neutralizing antibody (Nab) titer against polioviruses of three serotypes will be determined for immunogenicity evaluation.
Approximately 5.0 ml of venous blood will be drawn from the mothers to test for these disease infections. Alternatively, mothers may provide relevant test results obtained during pregnancy for these infections. This approach will enable the investigators to identify any potential perinatal transmission to the infant and offer appropriate guidance and management for both the mother and the child.
- Conditions
- Poliomyelitis
- Being tested
- 2wIPV+1sIPV, 1wIPV+2sIPV, 3wIPV, 3sIPV
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2wIPV+1sIPVBiological
First 2 doses: wIPV. 3rd dose: sIPV In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.
1wIPV+2sIPVBiological
1st dose: wIPV. 2nd \& 3rd doses: sIPV In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.
3wIPVBiological
three doses of wIPV with an interval of 28 days (+14 days) between doses; In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.
3sIPVBiological
Three doses of sIPV with an interval of 28 days (+14 days) between doses. In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.
| Study group | Role | What they receive |
|---|---|---|
| 2wIPV+1sIPV | Experimental | First 2 doses: wIPV. 3rd dose: sIPV Receives: Biological: 2wIPV+1sIPV |
| 1wIPV+2sIPV | Experimental | 1st dose: wIPV. 2nd \& 3rd doses: sIPV Receives: Biological: 1wIPV+2sIPV |
| 3wIPV | Active comparator | Not described Receives: Biological: 3wIPV |
| 3sIPV | Active comparator | Not described Receives: Biological: 3sIPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
The SPR of nab against polioviruses of three types at day 28 after three doses of vaccination
SPR indicates seropositivity rate; seropositivity is defined as a nab titer ≥1:8
Measured: day 28 after three doses of vaccination
The frequency of adverse reactions within 28 days after vaccination
Measured: day 0-28 after vaccination
Secondary outcomes (4)
The SCR of nab against polioviruses of three serotypes at day 28 after three doses of vaccination
SCR indicates seroconversion rat；nab indicates neutralizing antibody; seroconversion is defined as a fold increase in nab titer after vaccination for participants who are seropositive (≥1:8) at baseline, or a post-vaccination nab titer ≥1:8 for participants who are seronegative (<1:8) at baseline
Measured: day 28 after three doses of vaccination
The GMT of nab against polioviruses of three serotypes at day 28 after three doses of vaccination
GMT indicates geometric mean titer
Measured: day 28 after three doses of vaccination
The GMFR of nab against polioviruses of three serotypes at day 28 after three doses of vaccination
GMFR indicates geometric mean fold increase
Measured: day 28 after three doses of vaccination
The frequency of SAEs from the first vaccination to 28 days after the last vaccination
SAE indicates serious adverse events
Measured: From the first vaccination to 28 days after the last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start27 Nov 2025
- Primary completion8 Sep 2026 (estimated)
- Study completion19 Oct 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 Sinovac Biotech Co., LtdThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aga Khan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457060
- Sponsor's protocol ID
- PRO-sIPV-4005
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-labelled, Randomized, Controlled, Clinical Trial to Evaluate the Immunogenicity and Tolerability of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine
- ClinicalTrials.gov ID
- NCT07457060
- Acronym / sponsor ID
- PRO-sIPV-4005
- Conditions
- Poliomyelitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Aga Khan University
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- 8 Sep 2026 (estimated)
- Study completion
- 19 Oct 2026 (estimated)
- First posted
- 9 Mar 2026 (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.
The goal of this study is to compare the immunogenicity and safety of sIPV administered via subcutaneous and intramuscular injection routes
Detailed description
This is an open-labelled, randomized, controlled clinical trial. Totally 480 healthy infants of 2 months old (aged 56-84 days) are planned to be enrolled, and then randomized in a 1:1:1:1 ratio into four groups (group A, B, C, D). Group A-D will receive three doses of primary immunization against polio as per the 2wIPV+1sIPV (First 2 doses: wIPV. 3rd dose: sIPV), 1wIPV+2sIPV (1st dose: wIPV. 2nd \& 3rd doses: sIPV), 3wIPV, 3sIPV vaccination regimen, with an interval of 28 days (+14 days) between doses. In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.
For all the participants, the immediate reactions within 30 minutes after each dose of vaccination will be observed on study site. Guardians of participants will utilize the diary card to record adverse events (AEs) from the time of vaccination for 7 days after each dose of vaccination, and will utilize the diary card to record any AEs from 8 days up to 28 days after each dose of vaccination. SAEs arise from the time of vaccination up to 28 days after the last vaccination will be collected.
About 3.0 ml venous blood will be collected before the first vaccination and 28 days (+14 days) after the last vaccination. Neutralizing antibody (Nab) titer against polioviruses of three serotypes will be determined for immunogenicity evaluation.
Approximately 5.0 ml of venous blood will be drawn from the mothers to test for these disease infections. Alternatively, mothers may provide relevant test results obtained during pregnancy for these infections. This approach will enable the investigators to identify any potential perinatal transmission to the infant and offer appropriate guidance and management for both the mother and the child.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2wIPV+1sIPV | Experimental | Biological: 2wIPV+1sIPVFirst 2 doses: wIPV. 3rd dose: sIPV |
| 1wIPV+2sIPV | Experimental | Biological: 1wIPV+2sIPV1st dose: wIPV. 2nd \& 3rd doses: sIPV |
| 3wIPV | Active comparator | Biological: 3wIPV |
| 3sIPV | Active comparator | Biological: 3sIPV |
Who may qualify
- Ages
- 56 to 84 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants of 2 months old (aged 56-84 days).
- Have a parent/legal guardian who has provided written informed consent after being fully informed about the study.
- Be able to provide the vaccination records since birth.
- The infant's mother is tested negative for HIV, syphilis, hepatitis B, and hepatitis C during or before the infant's enrollment to this study (test results obtained during pregnancy are acceptable, if provided).
Key exclusion criteria (16 listed)
- History of any polio vaccination.
- History of severe allergic reaction to previous vaccinations or hypersensitivity to any vaccine component.
- Premature infants (born before week 37 of gestation).
- History of asphyxia rescue or nervous system injury.
- Congenital malformations, developmental disorders, clinically significant genetic defects, severe malnutrition.
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 |
|---|---|---|
| 2wIPV+1sIPVFirst 2 doses: wIPV. 3rd dose: sIPV In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections. | Biological | 2wIPV+1sIPV |
| 1wIPV+2sIPV1st dose: wIPV. 2nd \& 3rd doses: sIPV In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections. | Biological | 1wIPV+2sIPV |
| 3wIPVthree doses of wIPV with an interval of 28 days (+14 days) between doses; In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections. | Biological | 3wIPV |
| 3sIPVThree doses of sIPV with an interval of 28 days (+14 days) between doses. In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections. | Biological | 3sIPV |
Primary outcome
The SPR of nab against polioviruses of three types at day 28 after three doses of vaccination
Time frame: day 28 after three doses of vaccination
SPR indicates seropositivity rate; seropositivity is defined as a nab titer ≥1:8
The frequency of adverse reactions within 28 days after vaccination
Time frame: day 0-28 after vaccination
4 secondary outcomes
The SCR of nab against polioviruses of three serotypes at day 28 after three doses of vaccination
Time frame: day 28 after three doses of vaccination
The GMT of nab against polioviruses of three serotypes at day 28 after three doses of vaccination
Time frame: day 28 after three doses of vaccination
The GMFR of nab against polioviruses of three serotypes at day 28 after three doses of vaccination
Time frame: day 28 after three doses of vaccination
The frequency of SAEs from the first vaccination to 28 days after the last vaccination
Time frame: From the first vaccination to 28 days after the last 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 9 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Centennial Clindev Research and Development of Medical Sciences
Kawit, Philippines
Health Index Multispecialty Clinic - Research and Development on Medical Sciences
Imus, Philippines
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2wIPV+1sIPV, 1wIPV+2sIPV and 3wIPV in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd at 3 sites in Philippines.
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 16 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: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Philippines. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The SPR of nab against polioviruses of three types at day 28 after three doses of vaccination (time frame: day 28 after three doses of vaccination). The study lists 2 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 9 Mar 2026.