PoliomyelitisPhase 3NCT07297186
Phase III Clinical Trial of Sabin Strain Inactivated Poliovirus Vaccine (Vero Cell)
A Phase 3 study testing sIPV and wIPV in people with Poliomyelitis, run by Beijing Minhai Biotechnology Co., Ltd at 1 site in China.
Trial summary
The study aimed to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine in infants aged two months (60~89 days). Read more about this study
- Who is it for?
- Ages 60 to 89 daysHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- sIPV and wIPV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2017to 10 Apr 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 60 to 89 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy permanent residents aged 2 months (60~89 days);
- Infant's legal guardians agree to sign the informed consent forms voluntarily;
- Infant's legal guardians are able to comply with the requirements of the clinical trial protocol;
- Armpit temperature ≤ 37.0 ℃
Who cannot join
- preterm birth (gestational age < 37 weeks);
- the presence of congenital malformations, developmental disorders, genetic defects, or severe malnutrition;
- had a history of poliomyelitis;
- had a personal or family history of allergy, convulsions, epilepsy, encephalopathy, or psychiatric disorders;
- had known hypersensitivity to any component of the study vaccine or a history of severe allergic reaction (e.g., anaphylaxis) to any previous vaccination;
- had immunodeficiency or receipt of immunosuppressive therapy;
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- diagnosed coagulation disorders (including factor deficiencies, coagulopathies, platelet abnormalities) or evidence of significant bruising/bleeding diathesis;
- had known or investigator-suspected concurrent acute or active chronic diseases (including respiratory, cardiovascular, hepatic, renal, or dermatological conditions) or acute infection, or maternal HIV infection;
- occurrence of fever (axillary temperature ≥ 38.0 °C) within the 3 days preceding enrollment;
- had acute illness requiring systemic antibiotic or antiviral treatment within the 7 days preceding enrollment;
- administration of blood products within the 3 months preceding enrollment;
- had receipt of any live attenuated vaccine within the 14 days preceding enrollment;
- had receipt of any inactivated or subunit vaccine within the 7 days preceding enrollment;
- had recent administration of any other experimental product and any other condition deemed by the investigator as potentially interfering with the assessment of trial outcomes.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: A Randomized, Blinded, Parallel Positive-controlled Clinical Trial of Sabin Strain Inactivated Poliovirus Vaccine (Vero Cell) Conducted in Healthy Infants Aged Two Months.
The study aimed to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine in infants aged two months (60~89 days).
- Conditions
- Poliomyelitis
- Being tested
- sIPV, wIPV
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sIPVBiological
sIPVs were developed by Biominhai (Beijing Minhai Biotechnology Co. Ltd.)
wIPVBiological
wIPVs were developed by Sanofi Pasteur
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | 600 participants Receives: Biological: sIPV |
| control group | Active comparator | 600 participants Receives: Biological: wIPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
the seroconversion rates of poliovirus type I, type II and type III neutralizing antibodies
Measured: 30 days after the primary immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start21 Aug 2017
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Minhai Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297186
- Sponsor's protocol ID
- 2017L00935
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Parallel Positive-controlled Clinical Trial of Sabin Strain Inactivated Poliovirus Vaccine (Vero Cell) Conducted in Healthy Infants Aged Two Months.
- ClinicalTrials.gov ID
- NCT07297186
- Acronym / sponsor ID
- 2017L00935
- Conditions
- Poliomyelitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Beijing Minhai Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 22 Dec 2025 (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 study aimed to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine in infants aged two months (60~89 days).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Biological: sIPV600 participants |
| control group | Active comparator | Biological: wIPV600 participants |
Who may qualify
- Ages
- 60 to 89 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy permanent residents aged 2 months (60~89 days);
- Infant's legal guardians agree to sign the informed consent forms voluntarily;
- Infant's legal guardians are able to comply with the requirements of the clinical trial protocol;
- Armpit temperature ≤ 37.0 ℃
Key exclusion criteria (14 listed)
- preterm birth (gestational age < 37 weeks);
- the presence of congenital malformations, developmental disorders, genetic defects, or severe malnutrition;
- had a history of poliomyelitis;
- had a personal or family history of allergy, convulsions, epilepsy, encephalopathy, or psychiatric disorders;
- had known hypersensitivity to any component of the study vaccine or a history of severe allergic reaction (e.g., anaphylaxis) to any previous vaccination;
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 |
|---|---|---|
| sIPVsIPVs were developed by Biominhai (Beijing Minhai Biotechnology Co. Ltd.) | Biological | study group |
| wIPVwIPVs were developed by Sanofi Pasteur | Biological | control group |
Primary outcome
the seroconversion rates of poliovirus type I, type II and type III neutralizing antibodies
Time frame: 30 days after the primary immunization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sIPV and wIPV in people with Poliomyelitis, run by Beijing Minhai Biotechnology Co., Ltd at 1 site in China.
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 14 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: finished, as of the sponsor's last update on 22 Dec 2025. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the seroconversion rates of poliovirus type I, type II and type III neutralizing antibodies (time frame: 30 days after the primary immunization). 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 22 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.