PoliomyelitisPhase 3NCT04386707
Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine
A Phase 3 study testing Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age, Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age and Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd at 4 sites in China.
Trial summary
The purpose of this study is to evaluate the lot consistency, immunogenicity and safety of three lots of Sabin strain inactivated polio vaccine (Vero Cell) (sIPV) manufactured at commercial scale by Sinovac Biotech Co., Ltd., and evaluate the non-inferiority of investigational vaccine against a post-market inactivated… 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?
- Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age, Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age and Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 4 sitesChina
- Study dates
- 11 May 2020to 20 Oct 2020
- 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 infants aged 60-89 days;
- legal identity;
- Informed consent form has been signed by guardians.
Who cannot join
- Vaccination history of polio vaccine;
- Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc.;
- Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.;
- Autoimmune disease or immunodeficiency/immunosuppression;
- Serious nervous system disorders (epilepsy, convulsion or tic) or mental disorders;
- Abnormal coagulation functions (such as coagulation factor deficiency, blood coagulation disease and blood platelet disorders) or obvious bruise or blood coagulation disorders diagnosed by the doctors;
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- Receipt of immunosuppressant therapy, cytotoxic drug therapy and inhaled corticosteroid therapy (excluding the corticosteroid aerosol therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis);
- Receipt of blood products prior to this study;
- Receipt of other study drugs within 30 days prior to this study;
- Receipt of live attenuated vaccines within 14 days prior to this study;
- Receipt of subunit or inactivated vaccines within 7 days prior to this study;
- Acute diseases or acute exacerbation of chronic diseases within recent 7 days;
- Axillary temperature >37.0℃;
- Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Yanshan County Center for Disease Control and Prevention
Wenshan, Yunnan, 663100
Qiubei County Center for Disease Control and Prevention
Wenshan, Yunnan, 663200
Mile City Center for Disease Control and Prevention
Yisa, Yunnan, 652399
Gejiu County Center for Disease Control and Prevention
Yisa, Yunnan, 661000
About this study
Official title: A Randomized, Double-blinded, Controlled Clinical Trial to Evaluate Lot Consistency, Immunogenicity and Safety of Sabin Inactivated Polio Vaccine (Vero Cell) in 2-month-old Infants
The purpose of this study is to evaluate the lot consistency, immunogenicity and safety of three lots of Sabin strain inactivated polio vaccine (Vero Cell) (sIPV) manufactured at commercial scale by Sinovac Biotech Co., Ltd., and evaluate the non-inferiority of investigational vaccine against a post-market inactivated polio vaccine.
Read the detailed description
This study is a randomized, double-blinded, and positive-controlled clinical trial. A total of 1300 infants aged 2 months will be enrolled and assigned to 4 groups in a ratio of 1:1:1:1 to receive vaccination of 3 lots of investigational sIPV and control IPV manufactured by Sanofi Pasteur S.A respectively. Each subjects should finish the three-doses primary vaccination at the schedule of 2,3,4 months of age. Thirty-days safety observation after each dose of vaccination will be carried out. Venous blood should be collected from all the subjects before and 30 days after the three-doses primary vaccination, for the neutralizing antibody assay, and further to evaluate the immunogenicity.
- Conditions
- Poliomyelitis
- Being tested
- Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age, Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age, Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age, Three doses control wIPV at the schedule of 2,3,4 months of age
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of ageBiological
Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age
Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of ageBiological
Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age
Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of ageBiological
Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age
Three doses control wIPV at the schedule of 2,3,4 months of ageBiological
Three doses control wIPV at the schedule of 2,3,4 months of age
| Study group | Role | What they receive |
|---|---|---|
| Experimental Vaccine-lot 1 | Experimental | sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale. Receives: Biological: Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age |
| Experimental Vaccine-lot 2 | Experimental | sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale. Receives: Biological: Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age |
| Experimental Vaccine-lot 3 | Experimental | sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale. Receives: Biological: Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age |
| Control Vaccine | Active comparator | Wild strain IPV (wIPV）manufactured by Sanofi Pasteur S.A. Receives: Biological: Three doses control wIPV at the schedule of 2,3,4 months of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity index-Geometric mean titer of neutralizing antibody
Micro-neutralization method will be used in the neutralizing antibody assay
Measured: The 30th day after the third dose vaccination
Immunogenicity index-Seroconversion rates of neutralizing antibody
Micro-neutralization method will be used in the neutralizing antibody assay; Seropositive rates will be calculated based on the internationally accepted threshold value of ≥1:8. Seroconversion (1:8) is defined as a change from seronegative (<1:8) to seropositive (≥1:8) or a 4-fold increase from baseline titers if seropositive.
Measured: The 30th day after the third dose vaccination
Secondary outcomes (5)
Immunogenicity index-Seropositive rate of neutralizing antibody
Micro-neutralization method will be used in the neutralizing antibody assay; Seropositive rates will be calculated based on the internationally accepted threshold value of ≥1:8.
Measured: The 30th day after the third dose vaccination
Immunogenicity index-Geometric mean ratio of neutralizing antibody
Micro-neutralization method will be used in the neutralizing antibody assay; Geometric mean ratio of neutralizing antibody titer after vaccination divided by that before vaccination
Measured: The 30th day after the third dose vaccination
Safety index-Incidence of solicited adverse events
Solicited adverse events refer to the adverse events occur within day 0-7 after each dose vaccination with the solicited symptoms including injection-site induration, redness, swelling, rashes, or pruritus, and fever, allergic reactions, abnormal activity level, loss of appetite, nausea, vomiting and diarrhea.
Measured: Day 0-7 after each dose vaccination, day 0 refers to the day of vaccination
Safety index-Incidence of unsolicited adverse events
Unsolicited adverse events refer to the unsolicited symptoms occur within day 0-7, and any symptoms occur out of that period
Measured: Day 0-30 after each dose vaccination, day 0 refers to the day of vaccination
Safety index-Incidence of serious adverse events (SAEs)
SAEs refers to the events occur in the process of clinical trial which may need hospitalization, prolongation of hospitalization time, disability, dysfunction, be life-threatening or death or lead to congenital malformation.
Measured: From the beginning of vaccination to 30 days after the third dose vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start11 May 2020
- Primary completion11 May 2020
- Study completion20 Oct 2020
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan Zheng, Master, Principal investigator, Yunnan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386707
- Sponsor's protocol ID
- PRO-sIPV-3002
- Status last verified
- Aug 2021
- First submitted
- 8 May 2020
- Last updated
- 18 Aug 2021
- 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 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Controlled Clinical Trial to Evaluate Lot Consistency, Immunogenicity and Safety of Sabin Inactivated Polio Vaccine (Vero Cell) in 2-month-old Infants
- ClinicalTrials.gov ID
- NCT04386707
- Acronym / sponsor ID
- PRO-sIPV-3002
- Conditions
- Poliomyelitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 May 2020 (actual)
- Primary completion
- 11 May 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 13 May 2020 (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 purpose of this study is to evaluate the lot consistency, immunogenicity and safety of three lots of Sabin strain inactivated polio vaccine (Vero Cell) (sIPV) manufactured at commercial scale by Sinovac Biotech Co., Ltd., and evaluate the non-inferiority of investigational vaccine against a post-market inactivated polio vaccine.
Detailed description
This study is a randomized, double-blinded, and positive-controlled clinical trial. A total of 1300 infants aged 2 months will be enrolled and assigned to 4 groups in a ratio of 1:1:1:1 to receive vaccination of 3 lots of investigational sIPV and control IPV manufactured by Sanofi Pasteur S.A respectively. Each subjects should finish the three-doses primary vaccination at the schedule of 2,3,4 months of age. Thirty-days safety observation after each dose of vaccination will be carried out. Venous blood should be collected from all the subjects before and 30 days after the three-doses primary vaccination, for the neutralizing antibody assay, and further to evaluate the immunogenicity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental Vaccine-lot 1 | Experimental | Biological: Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of agesIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale. |
| Experimental Vaccine-lot 2 | Experimental | Biological: Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of agesIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale. |
| Experimental Vaccine-lot 3 | Experimental | Biological: Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of agesIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale. |
| Control Vaccine | Active comparator | Biological: Three doses control wIPV at the schedule of 2,3,4 months of ageWild strain IPV (wIPV）manufactured by Sanofi Pasteur S.A. |
Who may qualify
- Ages
- 60 to 89 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy infants aged 60-89 days;
- legal identity;
- Informed consent form has been signed by guardians.
Key exclusion criteria (14 listed)
- Vaccination history of polio vaccine;
- Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc.;
- Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.;
- Autoimmune disease or immunodeficiency/immunosuppression;
- Serious nervous system disorders (epilepsy, convulsion or tic) or mental disorders;
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 |
|---|---|---|
| Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of ageThree doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age | Biological | Experimental Vaccine-lot 1 |
| Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of ageThree doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age | Biological | Experimental Vaccine-lot 2 |
| Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of ageThree doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age | Biological | Experimental Vaccine-lot 3 |
| Three doses control wIPV at the schedule of 2,3,4 months of ageThree doses control wIPV at the schedule of 2,3,4 months of age | Biological | Control Vaccine |
Primary outcome
Immunogenicity index-Geometric mean titer of neutralizing antibody
Time frame: The 30th day after the third dose vaccination
Micro-neutralization method will be used in the neutralizing antibody assay
Immunogenicity index-Seroconversion rates of neutralizing antibody
Time frame: The 30th day after the third dose vaccination
Micro-neutralization method will be used in the neutralizing antibody assay; Seropositive rates will be calculated based on the internationally accepted threshold value of ≥1:8. Seroconversion (1:8) is defined as a change from seronegative (<1:8) to seropositive (≥1:8) or a 4-fold increase from baseline titers if seropositive.
5 secondary outcomes
Immunogenicity index-Seropositive rate of neutralizing antibody
Time frame: The 30th day after the third dose vaccination
Immunogenicity index-Geometric mean ratio of neutralizing antibody
Time frame: The 30th day after the third dose vaccination
Safety index-Incidence of solicited adverse events
Time frame: Day 0-7 after each dose vaccination, day 0 refers to the day of vaccination
Safety index-Incidence of unsolicited adverse events
Time frame: Day 0-30 after each dose vaccination, day 0 refers to the day of vaccination
Safety index-Incidence of serious adverse events (SAEs)
Time frame: From the beginning of vaccination to 30 days after the third dose 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 18 Aug 2021.
- 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.
Yan Zheng, Master principal investigator
Yunnan Center for Disease Control and Prevention
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age, Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age and Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd at 4 sites 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 3 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 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Immunogenicity index-Geometric mean titer of neutralizing antibody (time frame: The 30th day after the third dose 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 18 Aug 2021.