VaccinationPhase 4NCT04051736
Immunogenicity and Safety of Sabin-IPV Replacement Vaccination
A Phase 4 study testing Inactivated Polio Vaccine in people with Vaccination, run by China National Biotec Group Company Limited at 1 site in China.
Trial summary
This study replaced the 2nd and 3rd dose of Salk-IPV (produced by Sanofi) with Sabin-IPV (produced by CNBG) and then reviewed the safety and immunogenicity of the vaccination, aiming to acquire scientific evidence for the feasibility of immunization involving different viral strains replacement. Read more about this study
- Who is it for?
- Ages 60 to 89 daysHealthy volunteers can take part
- Conditions the study is for
- Vaccination
- What is being tested?
- Inactivated Polio Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 31 Aug 2020
- 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 60 to 89 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- subjects aged from 60 days to 89 days old at the date of recruitment;
- with informed consent signed by parent(s) or guardians;
- parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;
- subjects did not receive any vaccines within 14 days;
- axillary temperature ≤37.0℃
Who cannot join
- allergic to any ingredient of vaccine or with allergy history to any vaccine;
- acute febrile disease or infectious disease;
- serious chronic diseases;
- any other factor that makes the investigator determines the subject is unsuitable for this study;
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Center for Disease Control and Prevention
Beijing, Beijing Municipality, 100013
About this study
Official title: a Randomized, Controlled Clinical Trial of Immunogenicity and Safety of Sabin-based Inactivated Polio Vaccine Replacing Salk-based Inactivated Polio Vaccine
This study replaced the 2nd and 3rd dose of Salk-IPV (produced by Sanofi) with Sabin-IPV (produced by CNBG) and then reviewed the safety and immunogenicity of the vaccination, aiming to acquire scientific evidence for the feasibility of immunization involving different viral strains replacement.
Read the detailed description
It is required by China Food and Drug Administration (CFDA) that considering in the real situation IPV receivers may be immuned by different viral strains of this vaccine, a phase 4 clinical trial aiming to demonstrate the safety and immunogenicity of the immunization schedule should be carried out. To be specific, the subjects were divided into 2 groups.
Group 1 received Salk-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old.
Group 2 received Salk-IPV+Salk-IPV+Salk-IPV respectively at the age of 2,3,4 months old.
Blood sample was collected before vaccination and 30 days after the third dose of vaccination. Neutralization antibody against type I, Type II and Type III poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will also been monitored.
- Conditions
- Vaccination
- Being tested
- Inactivated Polio Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated Polio VaccineBiological
Inactivated Polio Vaccine at age of 2,3,4 months old, respectively
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | 180 2-month-old subjects will be enrolled with vaccination schedule as follows: 1st: Salk-IPV; 2nd: Sabin-IPV; 3rd: Sabin-IPV Receives: Biological: Inactivated Polio Vaccine |
| group 2 | Active comparator | 180 2-month-old subjects will be enrolled with vaccination schedule as follows: 1st: Salk-IPV; 2nd: Salk-IPV; 3rd: Salk-IPV Receives: Biological: Inactivated Polio Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate
determine the seroconversion rate of both groups
Measured: 4 months
Secondary outcomes (1)
Neutralizing antibody titers
Measure neutralizing antibody titers against poliovirus type I, II and III
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start1 Mar 2018
- Primary completion28 Dec 2018
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VaccinationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- China National Biotec Group Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Institute of Biological Products Co Ltd., Beijing Center for Disease Control and Prevention, Peking University
- Responsible party
- Sponsor
- Investigators
- Jiang WU, Study director, Beijing Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051736
- Sponsor's protocol ID
- ChinaNBG
- Status last verified
- Sep 2020
- First submitted
- 8 Aug 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen H, Gao Z, Bai S, Liu X, Han S, Xiao Y, Liu F, Yu Y, Sun H, Yang X. Immunogenicity and safety of sabin-strain based inactivated poliovirus vaccine replacing salk-strain based inactivated poliovirus vaccine: An innovative application of different strain-IPVs replacement. Vaccine. 2021 Apr 22;39(17):2467-2474. doi: 10.1016/j.vaccine.2021.02.073. Epub 2021 Mar 31.
PubMed 33810904
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Randomized, Controlled Clinical Trial of Immunogenicity and Safety of Sabin-based Inactivated Polio Vaccine Replacing Salk-based Inactivated Polio Vaccine
- ClinicalTrials.gov ID
- NCT04051736
- Acronym / sponsor ID
- ChinaNBG
- Conditions
- Vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Institute of Biological Products Co Ltd., Beijing Center for Disease Control and Prevention, Peking University
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 9 Aug 2019 (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.
This study replaced the 2nd and 3rd dose of Salk-IPV (produced by Sanofi) with Sabin-IPV (produced by CNBG) and then reviewed the safety and immunogenicity of the vaccination, aiming to acquire scientific evidence for the feasibility of immunization involving different viral strains replacement.
Detailed description
It is required by China Food and Drug Administration (CFDA) that considering in the real situation IPV receivers may be immuned by different viral strains of this vaccine, a phase 4 clinical trial aiming to demonstrate the safety and immunogenicity of the immunization schedule should be carried out. To be specific, the subjects were divided into 2 groups.
Group 1 received Salk-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old.
Group 2 received Salk-IPV+Salk-IPV+Salk-IPV respectively at the age of 2,3,4 months old.
Blood sample was collected before vaccination and 30 days after the third dose of vaccination. Neutralization antibody against type I, Type II and Type III poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will also been monitored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Biological: Inactivated Polio Vaccine180 2-month-old subjects will be enrolled with vaccination schedule as follows: 1st: Salk-IPV; 2nd: Sabin-IPV; 3rd: Sabin-IPV |
| group 2 | Active comparator | Biological: Inactivated Polio Vaccine180 2-month-old subjects will be enrolled with vaccination schedule as follows: 1st: Salk-IPV; 2nd: Salk-IPV; 3rd: Salk-IPV |
Who may qualify
- Ages
- 60 to 89 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- subjects aged from 60 days to 89 days old at the date of recruitment;
- with informed consent signed by parent(s) or guardians;
- parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;
- subjects did not receive any vaccines within 14 days;
- axillary temperature ≤37.0℃
Key exclusion criteria (4 listed)
- allergic to any ingredient of vaccine or with allergy history to any vaccine;
- acute febrile disease or infectious disease;
- serious chronic diseases;
- any other factor that makes the investigator determines the subject is unsuitable for this study;
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 |
|---|---|---|
| Inactivated Polio VaccineInactivated Polio Vaccine at age of 2,3,4 months old, respectively | Biological | group 1, group 2 |
Primary outcome
Seroconversion rate
Time frame: 4 months
determine the seroconversion rate of both groups
1 secondary outcome
Neutralizing antibody titers
Time frame: 4 months
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 9 Sep 2020.
- Derived from this study: PubMed 33810904Chen H, Gao Z, Bai S, Liu X, Han S, Xiao Y, Liu F, Yu Y, Sun H, Yang X. Immunogenicity and safety of sabin-strain based inactivated poliovirus vaccine replacing salk-strain based inactivated poliovirus vaccine: An innovative application of different strain-IPVs replacement. Vaccine. 2021 Apr 22;39(17):2467-2474. doi: 10.1016/j.vaccine.2021.02.073. Epub 2021 Mar 31.
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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.
Jiang WU study director
Beijing 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 Inactivated Polio Vaccine in people with Vaccination, run by China National Biotec Group Company Limited 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 4 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 9 Sep 2020. 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?
Seroconversion rate (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04051736, which also lists 1 linked publication.
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 Sep 2020.