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CompletedNCT07297186Updated Dec 22, 2025

Phase III Clinical Trial of Sabin Strain Inactivated Poliovirus Vaccine (Vero Cell)

A Phase 3 interventional study of sIPV and wIPV in Poliomyelitis, sponsored by Beijing Minhai Biotechnology Co., Ltd. Completed at 1 site in China. Open to participants aged 60 Days to 89 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by Beijing Minhai Biotechnology Co., Ltd · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Registered 8 years 3 months after the study started (first participant enrolled Aug 2017, registered Dec 2025).
Phase
Phase 3
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
60 Days to 89 Days
Sex
All
01

Study 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).

02

Conditions studied

  • Poliomyelitis

Browse trials for

03

In context

Poliomyelitis

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

This study's enrollment of 1,200 is above the median of 476 across 249 interventional studies indexed under Poliomyelitis.

Browse Poliomyelitis studies →

Lead sponsor

Beijing Minhai Biotechnology Co., Ltd is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
60 Days to 89 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy permanent residents aged 2 months (60\~89 days);
  2. Infant's legal guardians agree to sign the forms voluntarily;
  3. Infant's legal guardians are able to comply with the requirements of the clinical trial protocol;
  4. Armpit temperature ≤ 37.0 ℃

Exclusion criteria

Exclusion Criteria:

  1. preterm birth (gestational age \< 37 weeks);
  2. the presence of congenital malformations, developmental disorders, genetic defects, or severe malnutrition;
  3. had a history of poliomyelitis;
  4. had a personal or family history of allergy, convulsions, epilepsy, encephalopathy, or psychiatric disorders;
  5. had known to any component of the study vaccine or a history of severe allergic reaction (e.g., anaphylaxis) to any previous vaccination;
  6. had immunodeficiency or receipt of therapy;
  7. diagnosed coagulation disorders (including factor deficiencies, coagulopathies, abnormalities) or evidence of significant bruising/bleeding diathesis;
  8. had known or investigator-suspected concurrent acute or active chronic diseases (including respiratory, cardiovascular, hepatic, renal, or dermatological conditions) or acute infection, or maternal infection;
  9. occurrence of fever (axillary temperature ≥ 38.0 °C) within the 3 days preceding enrollment;
  10. had acute illness requiring systemic antibiotic or antiviral treatment within the 7 days preceding enrollment;
  11. administration of blood products within the 3 months preceding enrollment;
  12. had receipt of any within the 14 days preceding enrollment;
  13. had receipt of any inactivated or subunit vaccine within the 7 days preceding enrollment;
  14. 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.
Terms in these criteria, in plain language(6)

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,200 participants (actual)

Study arms

  • Experimental
    study group

    600 participants

    Biological: sIPV

  • Active comparator
    control group

    600 participants

    Biological: wIPV

Interventions

  • BiologicalsIPV

    sIPVs were developed by Biominhai (Beijing Minhai Biotechnology Co. Ltd.)

  • BiologicalwIPV

    wIPVs were developed by Sanofi Pasteur

06

What researchers measure

Primary outcomes

  1. the seroconversion rates of poliovirus type I, type II and type III neutralizing antibodies

    Time frame: 30 days after the primary immunization

07

Study locations

1 site
  • Jiangsu Provincial Center for Diseases Control and Prevention
    Nanjing, Jiangsu 210009, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in Apr 2023, 67 months.

Of 35 industry-sponsored phase 3 interventional studies under Poliomyelitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 21. This study's 67 months is above that.

Counting every sponsor, half of 44 studies reached it within 12 months; a quarter within 7 and three quarters within 21.

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

Registered
Dec 9, 2025
First posted
Dec 22, 2025
StartActual
Aug 21, 2017
Primary completionActual
Apr 10, 2023
CompletionActual
Apr 10, 2023
Last update
Dec 22, 2025
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 Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07297186
Lead sponsor
Beijing Minhai Biotechnology Co., Ltd
Responsible party
Sponsor
First posted
Dec 22, 2025
Start date
Aug 21, 2017
Primary completion
Apr 10, 2023
Completion
Apr 10, 2023
Last update
Dec 22, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Poliovirus Vaccine, Inactivated

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