PoliomyelitisPhase 4NCT06346834
Sequential Vaccination of Poliomyelitis Vaccine (Vero Cells), Inactivated, Sabin Strains From Different Manufacturers
A Phase 4 study testing sIPV in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
To evaluate the immunogenicity and safety of sequential vaccination with Sinovac sIPV among infants who have received two doses of Biological Products Co., Ltd. sIPV. Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- sIPV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2024to 6 Dec 2024
- Phase
- Phase 4
- 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 Up to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- (1) Healthy infants of ≤ 12 months of age;
- (2) Can provide proof of legal identity;
- (3) Have completed two doses of sIPV vaccination at Beijing Institute;
- (4) Able to provide proof of sIPV vaccination;
- (5) The participant's guardian can understand and agree to sign the informed consent form.
Who cannot join
- (1) Known severe allergy to vaccines or vaccine components, such as urticaria, dyspnea, angioneurotic edema;
- (2) Received immunoglobulins or other blood products, or plan to receive such treatment during the study;
- (3) Received ≥14 days of immunosuppressive or other immunomodulatory therapy or cytotoxic therapy, or plan to receive such therapy during the study;
- (4) Received another investigational vaccine within 28 days before receiving the study vaccine;
- (5) Received a live attenuated vaccine within 14 days before receiving the trial vaccine;
- (6) Received a subunit or inactivated vaccine within 7 days before receiving the trial vaccine;
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- (7) Acute exacerbation of various acute illnesses or chronic diseases within the last 7 days;
- (8) Those who had a fever with an axillary temperature >37.0°C before receiving the study vaccine;
- (9) Participants who, in the judgment of the investigator, have any other factors that make them unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Disease Control and Prevention Center, Xiaonan District, Xiaogan City
Xiaogan
About this study
Official title: A Study to Evaluate the Immunogenicity and Safety of Sequential Vaccination Among Infants With Poliomyelitis Vaccine (Vero Cells), Inactivated, Sabin Strains （Hereinafter as "sIPV") From Different Manufacturers.
To evaluate the immunogenicity and safety of sequential vaccination with Sinovac sIPV among infants who have received two doses of Biological Products Co., Ltd. sIPV.
Read the detailed description
In this study, two hundred infants ≤ 12 months of age vaccinated with two doses of sIPV produced by Beijing Institute of Biological Products Co., Ltd., will be enrolled with a balanced male-to-female ratio. After enrollment with informed consent from the guardians of the participants, they will be divided into two groups, i.e., the study group and the control group, according to the 1:1 ratio. They will be vaccinated with one dose of the sIPV produced by Sinovac or the sIPV produced by Beijing Institute, respectively. The 30-minute observation will be conducted after the vaccination. Immediate reactions will be observed and solicited adverse events within 0-7 days, while unsolicited adverse events within 0-30 days will be collected to evaluate vaccine safety. About 2.5-3.0 ml of venous blood will be collected from all participants before and 30 days after vaccination, and anti-poliovirus type 1, type 2, and type 3 neutralizing antibody tests will be performed to evaluate immunogenicity.
- Conditions
- Poliomyelitis
- Being tested
- sIPV
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sIPVBiological
One dose of the experimental/control vaccine will be administered to 4-month-old infants who have already received two doses of sIPV from Beijing Institute of Biological Products Co., LTD.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | sIPV: Sinovac Biotech Co., Ltd., Beijing Receives: Biological: sIPV |
| control group | Active comparator | sIPV: Beijing Institute of Biological Products Co., LTD. Receives: Biological: sIPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Increase (GMI)
-The neutralizing antibody GMI against different types (Type I, II and III) at day 30 after vaccination;
Measured: 30 days
Geometric Mean Titer (GMT)
-The neutralizing antibody GMT against different types (Type I, II and III) at day 30 after vaccination;
Measured: 30 days
Seropositivity rate
-The seropositivity rate of neutralizing antibody against different types (Type I, II and III) at day 30 after vaccination;
Measured: 30 days
Seroconversion rate
-The seroconversion rate of neutralizing antibody against different types (Type I, II and III) at day 30 after vaccination;
Measured: 30 days
Adverse reaction incidence
-The incidence of adverse reaction within 30 days after vaccination;
Measured: 30 days
Serious adverse events incidence
-The incidence of serious adverse events within 30 days after vaccination.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start20 May 2024
- Primary completion6 Sep 2024
- Study completion6 Dec 2024
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lei Wang, Principal investigator, Hubei Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346834
- Sponsor's protocol ID
- PRO-sIPV-4002
- Status last verified
- Mar 2025
- First submitted
- 29 Jan 2024
- Last updated
- 14 Mar 2025
- Results posted
- 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 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Immunogenicity and Safety of Sequential Vaccination Among Infants With Poliomyelitis Vaccine (Vero Cells), Inactivated, Sabin Strains （Hereinafter as "sIPV") From Different Manufacturers.
- ClinicalTrials.gov ID
- NCT06346834
- Acronym / sponsor ID
- PRO-sIPV-4002
- Conditions
- Poliomyelitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 May 2024 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 4 Apr 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.
To evaluate the immunogenicity and safety of sequential vaccination with Sinovac sIPV among infants who have received two doses of Biological Products Co., Ltd. sIPV.
Detailed description
In this study, two hundred infants ≤ 12 months of age vaccinated with two doses of sIPV produced by Beijing Institute of Biological Products Co., Ltd., will be enrolled with a balanced male-to-female ratio. After enrollment with informed consent from the guardians of the participants, they will be divided into two groups, i.e., the study group and the control group, according to the 1:1 ratio. They will be vaccinated with one dose of the sIPV produced by Sinovac or the sIPV produced by Beijing Institute, respectively. The 30-minute observation will be conducted after the vaccination. Immediate reactions will be observed and solicited adverse events within 0-7 days, while unsolicited adverse events within 0-30 days will be collected to evaluate vaccine safety. About 2.5-3.0 ml of venous blood will be collected from all participants before and 30 days after vaccination, and anti-poliovirus type 1, type 2, and type 3 neutralizing antibody tests will be performed to evaluate immunogenicity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Biological: sIPVsIPV: Sinovac Biotech Co., Ltd., Beijing |
| control group | Active comparator | Biological: sIPVsIPV: Beijing Institute of Biological Products Co., LTD. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- (1) Healthy infants of ≤ 12 months of age;
- (2) Can provide proof of legal identity;
- (3) Have completed two doses of sIPV vaccination at Beijing Institute;
- (4) Able to provide proof of sIPV vaccination;
- (5) The participant's guardian can understand and agree to sign the informed consent form.
Key exclusion criteria (9 listed)
- (1) Known severe allergy to vaccines or vaccine components, such as urticaria, dyspnea, angioneurotic edema;
- (2) Received immunoglobulins or other blood products, or plan to receive such treatment during the study;
- (3) Received ≥14 days of immunosuppressive or other immunomodulatory therapy or cytotoxic therapy, or plan to receive such therapy during the study;
- (4) Received another investigational vaccine within 28 days before receiving the study vaccine;
- (5) Received a live attenuated vaccine within 14 days before receiving the trial vaccine;
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 |
|---|---|---|
| sIPVOne dose of the experimental/control vaccine will be administered to 4-month-old infants who have already received two doses of sIPV from Beijing Institute of Biological Products Co., LTD. | Biological | control group, experimental group |
Primary outcome
Geometric Mean Increase (GMI)
Time frame: 30 days
-The neutralizing antibody GMI against different types (Type I, II and III) at day 30 after vaccination;
Geometric Mean Titer (GMT)
Time frame: 30 days
-The neutralizing antibody GMT against different types (Type I, II and III) at day 30 after vaccination;
Seropositivity rate
Time frame: 30 days
-The seropositivity rate of neutralizing antibody against different types (Type I, II and III) at day 30 after vaccination;
Seroconversion rate
Time frame: 30 days
-The seroconversion rate of neutralizing antibody against different types (Type I, II and III) at day 30 after vaccination;
Adverse reaction incidence
Time frame: 30 days
-The incidence of adverse reaction within 30 days after vaccination;
Serious adverse events incidence
Time frame: 30 days
-The incidence of serious adverse events within 30 days after vaccination.
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 14 Mar 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.
Lei Wang principal investigator
Hubei Provincial Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sIPV in people with Poliomyelitis, run by Sinovac Biotech 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 5 inclusion and 9 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 14 Mar 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 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?
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?
Geometric Mean Increase (GMI) (time frame: 30 days). The study lists 6 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 14 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.