PoliomyelitisPhase 4NCT04220515
Inactivated Poliomyelitis Vaccine Made From Sabin Strain
A Phase 4 study testing Inactivated Poliomyelitis Vaccine Made From Sabin Strain in people with Poliomyelitis, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study includes both active and passive safety monitoring in large pupulations for the phase IV safety monitoring study of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV). Read more about this study
- Who is it for?
- Ages 2 to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Inactivated Poliomyelitis Vaccine Made From Sabin Strain
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49,731 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2018to 14 Oct 2019
- 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 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants of 2 months of age
- The legal identity certificate (birth/household register) and vaccination certificate of the participants can be provided, and the legal guardian can provide the legal identity certificate (identity card).
- Guardians are able to understand the experimental vaccine, volunteer to participate in the study and sign informed consent for participation.
- Guardians are capable of using thermometer, graduated scale, filling diary card and contact card.
- Participants are not vaccinated with polio vaccine and immunoglobulin (except for Hepatitis b specific immunoglobulin) after birth, no vaccination of live vaccine within 28 days before enrollment and no vaccination of inactivated vaccine within 14 days before enrollment.
- Participants or guardians are able to obey and follow all study instructions, complete all the monitoring, and cooperate to complete collection of blood sample.
- Axillary temperature ≤37℃
Who cannot join
- Allergic to any active substance, inactive substance or materials used during production such as kanamycin.
- Patients with fever or acute disease.
- Have thrombocytopenia or hemorrhagic diseases
- Patients undergoing immunosuppressive therapy or immunodeficiency
- Have uncontrolled epilepsy or other progressive neurological disorders
- Other situations that the investigator consider as non-eligible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Safety Monitoring Study of Inactivated Poliomyelitis Vaccine Made From Sabin Strain
This study includes both active and passive safety monitoring in large pupulations for the phase IV safety monitoring study of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV).
Read the detailed description
For active safety monitoring in expanding populations, a total of 20,019 participants in Shanghai CDC have been enrolled in accordance with GCP for close safety monitoring for immediate adverse events and telephone or visiting follow-up (30 min, 24h, 3d, 7d, 14d, 30d) For passive safety monitoring in larger populations, the purpose is to observe rare adverse events after primary and booster immunization with sIPV by passive safety surveillance via AEFI monitoring system in Shanghai CDC. A total of 29,712 infants have been enrolled, and the adverse events of the participates have been collected via AEFI monitoring system and evaluated after 3-dose sIPV for primary immunization.
- Conditions
- Poliomyelitis
- Being tested
- Inactivated Poliomyelitis Vaccine Made From 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.
Inactivated Poliomyelitis Vaccine Made From Sabin StrainBiological
Type I D antigen 30DU;Type II D antigen 32DU;Type III D antigen 45 DU
| Study group | Role | What they receive |
|---|---|---|
| Inactivated Poliomyelitis Vaccine Made From Sabin Strain | Experimental | Primary 3-dose of sIPV and booster 1 dose of sIPV Receives: Biological: Inactivated Poliomyelitis Vaccine Made From Sabin Strain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety monitoring
Active and passive monitoring for local and systemic adverse reactions
Measured: 30 days post inoculation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start8 Feb 2018
- Primary completion8 Aug 2019
- Study completion14 Oct 2019
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49,731 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Xiaodong Sun, Principal investigator, Disease prevention and control center of Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220515
- Sponsor's protocol ID
- 20170416
- Status last verified
- Oct 2023
- First submitted
- 6 Jan 2020
- Last updated
- 11 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants do not agree to share the individual data.
Publications
Jiang R, Liu X, Sun X, Wang J, Huang Z, Li C, Li Z, Zhou J, Pu Y, Ying Z, Yin Q, Zhao Z, Zhang L, Lei J, Bao W, Jiang Y, Dou Y, Li J, Yang H, Cai W, Deng Y, Che Y, Shi L, Sun M. Immunogenicity and safety of the inactivated poliomyelitis vaccine made from Sabin strains in a phase IV clinical trial for the vaccination of a large population. Vaccine. 2021 Mar 1;39(9):1463-1471. doi: 10.1016/j.vaccine.2021.01.027. Epub 2021 Jan 22.
PubMed 33487470
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Safety Monitoring Study of Inactivated Poliomyelitis Vaccine Made From Sabin Strain
- ClinicalTrials.gov ID
- NCT04220515
- Acronym / sponsor ID
- 20170416
- Conditions
- Poliomyelitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49,731 participants (actual)
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Shanghai Center for Disease Control and Prevention
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 14 Oct 2019 (actual)
- First posted
- 7 Jan 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.
This study includes both active and passive safety monitoring in large pupulations for the phase IV safety monitoring study of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV).
Detailed description
For active safety monitoring in expanding populations, a total of 20,019 participants in Shanghai CDC have been enrolled in accordance with GCP for close safety monitoring for immediate adverse events and telephone or visiting follow-up (30 min, 24h, 3d, 7d, 14d, 30d) For passive safety monitoring in larger populations, the purpose is to observe rare adverse events after primary and booster immunization with sIPV by passive safety surveillance via AEFI monitoring system in Shanghai CDC. A total of 29,712 infants have been enrolled, and the adverse events of the participates have been collected via AEFI monitoring system and evaluated after 3-dose sIPV for primary immunization.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inactivated Poliomyelitis Vaccine Made From Sabin Strain | Experimental | Biological: Inactivated Poliomyelitis Vaccine Made From Sabin StrainPrimary 3-dose of sIPV and booster 1 dose of sIPV |
Who may qualify
- Ages
- 2 to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy infants of 2 months of age
- The legal identity certificate (birth/household register) and vaccination certificate of the participants can be provided, and the legal guardian can provide the legal identity certificate (identity card).
- Guardians are able to understand the experimental vaccine, volunteer to participate in the study and sign informed consent for participation.
- Guardians are capable of using thermometer, graduated scale, filling diary card and contact card.
- Participants are not vaccinated with polio vaccine and immunoglobulin (except for Hepatitis b specific immunoglobulin) after birth, no vaccination of live vaccine within 28 days before enrollment and no vaccination of inactivated vaccine within 14 days before enrollment.
Key exclusion criteria (6 listed)
- Allergic to any active substance, inactive substance or materials used during production such as kanamycin.
- Patients with fever or acute disease.
- Have thrombocytopenia or hemorrhagic diseases
- Patients undergoing immunosuppressive therapy or immunodeficiency
- Have uncontrolled epilepsy or other progressive neurological 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 |
|---|---|---|
| Inactivated Poliomyelitis Vaccine Made From Sabin StrainType I D antigen 30DU;Type II D antigen 32DU;Type III D antigen 45 DU | Biological | Inactivated Poliomyelitis Vaccine Made From Sabin Strain |
Primary outcome
Safety monitoring
Time frame: 30 days post inoculation
Active and passive monitoring for local and systemic adverse reactions
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 11 Oct 2023.
- Derived from this study: PubMed 33487470Jiang R, Liu X, Sun X, Wang J, Huang Z, Li C, Li Z, Zhou J, Pu Y, Ying Z, Yin Q, Zhao Z, Zhang L, Lei J, Bao W, Jiang Y, Dou Y, Li J, Yang H, Cai W, Deng Y, Che Y, Shi L, Sun M. Immunogenicity and safety of the inactivated poliomyelitis vaccine made from Sabin strains in a phase IV clinical trial for the vaccination of a large population. Vaccine. 2021 Mar 1;39(9):1463-1471. doi: 10.1016/j.vaccine.2021.01.027. Epub 2021 Jan 22.
- Individual participant dataSharing planned: No. Participants do not agree to share the individual data.
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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.
Xiaodong Sun principal investigator
Disease prevention and control center of Shanghai
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 Poliomyelitis Vaccine Made From Sabin Strain in people with Poliomyelitis, run by Institute of Medical Biology, Chinese Academy of Medical Sciences 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 7 inclusion and 6 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 11 Oct 2023. 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?
Safety monitoring (time frame: 30 days post inoculation). 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 NCT04220515, 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 11 Oct 2023.