PoliomyelitisPhase 4NCT03546634
Sero-conversion Study for a Two-dose Schedule of Sabin IPV in China
A Phase 4 study testing Sabin IPV in people with Poliomyelitis, run by Centers for Disease Control and Prevention, China at 1 site in China.
Trial summary
This study aims to obtain the direct domestic IPV vaccine monitoring data for the CNBG products, and provide scientific evidence for the National Immunization Program and long-term polio vaccine immunization policy. Read more about this study
- Who is it for?
- Ages 2 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Sabin IPV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2018to 15 Jan 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 2 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent or legal guardian agree to participate in our study.
- The family is living locally with legal residency status.
Who cannot join
- Parent or legal guardian does not agree to participate in our study.
- The potential subject has received IPV or OPV before 4 months of age in the two-dose schedule group.
- The potential subject has one or more contraindications to IPV (although we will note the contraindications).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sero-conversion Study for a Two-dose Schedule of Sabin Strain Inactivated Poliovirus Vaccine in China
This study aims to obtain the direct domestic IPV vaccine monitoring data for the CNBG products, and provide scientific evidence for the National Immunization Program and long-term polio vaccine immunization policy.
The overall objective of this research is to determine the seroconversion rates of two reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.
Read the detailed description
In April 2017, WHO/SAGE recommended that a two-dose, IPV-only schedule can be used after polio eradication, with a schedule seroconversion target of at least 90%. The recommendation was based in part on a study conducted in Cuba using Salk-IPV at 4 months and 8 months of age. However, for domestic Sabin IPVs, there are no such data to support a 2-dose schedule among Chinese infants.Two Sabin IPV products that are available to China's National Immunization Program - produced by Kunming Bio institute and China National Biotec Group (CNBG).The monitoring study on sIPV produced by Kunming Bio institute has already applied for approval.This study aims to obtain the direct domestic IPV vaccine monitoring data for the CNBG products, and provide scientific evidence for the National Immunization Program and long-term polio vaccine immunization policy.
The overall objective of this research is to determine the seroconversion rates of two reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.
The specific objectives of the study are to:
- Determine whether the seroconversion rate is above 90% with a 2-dose Sabin IPV schedule, with the first dose given at 4 months and the second dose given ≥4 months after the first dose.
- Measure neutralizing antibody titers against poliovirus type I, II and III among two-dose Sabin IPV alone schedule, compared with three-dose Sabin IPV alone schedule.
- Conditions
- Poliomyelitis
- Being tested
- Sabin IPV
- Keywords
- Inactivated Poliovirus Vaccine, Sabin strain
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sabin IPVBiological
Also called Sabin strain Inactivated Poliovirus Vaccine
We select one Sabin IPV product, produced by China National Biotec Group, which is available for China's National Immunization Program in the selected study sites.
| Study group | Role | What they receive |
|---|---|---|
| Three-dose schedule for Sabin IPV | Active comparator | Subjects vaccinate Sabin IPV at 2, 3, and 4 months of age,will be collected blood specimens twice - right before the first dose of IPV, and one month after the 3rd dose of IPV. Receives: Biological: Sabin IPV |
| Two-dose schedule for Sabin IPV | Experimental | Subjects first dose IPV vaccinate at 4 months of age, and the second dose IPV given between 8 and 11 months of age,will be collected blood specimens twice - right before the first dose of IPV, and one month after the 2nd dose of IPV. Receives: Biological: Sabin IPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate
Determine whether the seroconversion rate is above 90% using a two-dose Sabin IPV alone schedule with the first dose Sabin IPV given at 4 months and the second dose Sabin IPV given ≥4 months after the first dose.
Measured: 10 months
Secondary outcomes (1)
Neutralizing antibody titers
Measure neutralizing antibody titers against poliovirus type I, II and III among two-dose Sabin IPV-only schedules compared with three-dose Sabin IPV alone schedule.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start24 May 2018
- Primary completion5 Jun 2019
- Study completion15 Jan 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.
- 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
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention, China
- Sponsor type
- Other government
- Collaborators
- Shandong Province Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, AN Zhijie, Centers for Disease Control and Prevention, China
- Investigators
- Zijian Feng, Study chair, Centers for Disease Control and Prevention, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546634
- Sponsor's protocol ID
- 201806
- Status last verified
- Jun 2020
- First submitted
- 23 May 2018
- Last updated
- 24 Jun 2020
- 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 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sero-conversion Study for a Two-dose Schedule of Sabin Strain Inactivated Poliovirus Vaccine in China
- ClinicalTrials.gov ID
- NCT03546634
- Acronym / sponsor ID
- 201806
- Conditions
- Poliomyelitis
- Keywords
- Inactivated Poliovirus Vaccine, Sabin strain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Centers for Disease Control and Prevention, ChinaOther government
- Collaborators
- Shandong Province Centers for Disease Control and Prevention
- Study start
- 24 May 2018 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 6 Jun 2018 (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 aims to obtain the direct domestic IPV vaccine monitoring data for the CNBG products, and provide scientific evidence for the National Immunization Program and long-term polio vaccine immunization policy.
The overall objective of this research is to determine the seroconversion rates of two reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.
Detailed description
In April 2017, WHO/SAGE recommended that a two-dose, IPV-only schedule can be used after polio eradication, with a schedule seroconversion target of at least 90%. The recommendation was based in part on a study conducted in Cuba using Salk-IPV at 4 months and 8 months of age. However, for domestic Sabin IPVs, there are no such data to support a 2-dose schedule among Chinese infants.Two Sabin IPV products that are available to China's National Immunization Program - produced by Kunming Bio institute and China National Biotec Group (CNBG).The monitoring study on sIPV produced by Kunming Bio institute has already applied for approval.This study aims to obtain the direct domestic IPV vaccine monitoring data for the CNBG products, and provide scientific evidence for the National Immunization Program and long-term polio vaccine immunization policy.
The overall objective of this research is to determine the seroconversion rates of two reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.
The specific objectives of the study are to:
- Determine whether the seroconversion rate is above 90% with a 2-dose Sabin IPV schedule, with the first dose given at 4 months and the second dose given ≥4 months after the first dose.
- Measure neutralizing antibody titers against poliovirus type I, II and III among two-dose Sabin IPV alone schedule, compared with three-dose Sabin IPV alone schedule.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three-dose schedule for Sabin IPV | Active comparator | Biological: Sabin IPVSubjects vaccinate Sabin IPV at 2, 3, and 4 months of age,will be collected blood specimens twice - right before the first dose of IPV, and one month after the 3rd dose of IPV. |
| Two-dose schedule for Sabin IPV | Experimental | Biological: Sabin IPVSubjects first dose IPV vaccinate at 4 months of age, and the second dose IPV given between 8 and 11 months of age,will be collected blood specimens twice - right before the first dose of IPV, and one month after the 2nd dose of IPV. |
Who may qualify
- Ages
- 2 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parent or legal guardian agree to participate in our study.
- The family is living locally with legal residency status.
Key exclusion criteria (3 listed)
- Parent or legal guardian does not agree to participate in our study.
- The potential subject has received IPV or OPV before 4 months of age in the two-dose schedule group.
- The potential subject has one or more contraindications to IPV (although we will note the contraindications).
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 |
|---|---|---|
| Sabin IPVAlso: Sabin strain Inactivated Poliovirus VaccineWe select one Sabin IPV product, produced by China National Biotec Group, which is available for China's National Immunization Program in the selected study sites. | Biological | Three-dose schedule for Sabin IPV, Two-dose schedule for Sabin IPV |
Primary outcome
Seroconversion rate
Time frame: 10 months
Determine whether the seroconversion rate is above 90% using a two-dose Sabin IPV alone schedule with the first dose Sabin IPV given at 4 months and the second dose Sabin IPV given ≥4 months after the first dose.
1 secondary outcome
Neutralizing antibody titers
Time frame: 10 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 24 Jun 2020.
- Individual participant dataSharing planned: No
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Poliomyelitis
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.
Zijian Feng study chair
Centers for Disease Control and Prevention, China
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 Sabin IPV in people with Poliomyelitis, run by Centers for Disease Control and Prevention, China 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 2 inclusion and 3 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 24 Jun 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: 10 months). 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 24 Jun 2020.