PoliomyelitisPhase 4NCT04224519
Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain
A Phase 4 study testing sIPV batch 1, sIPV batch 2 and sIPV batch 3 in people with Poliomyelitis, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
A randomized and blind clinical consistency study for three commercial batches of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV) for immunogenicity and safety evaluation. 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?
- sIPV batch 1, sIPV batch 2 and sIPV batch 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2018to 12 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.
China1 site
Disease prevention and control center of Yunnan province
Kunming, Yunnan, 650022
About this study
A randomized and blind clinical consistency study for three commercial batches of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV) for immunogenicity and safety evaluation.
Read the detailed description
This randomized and blind clinical study includes three test groups with 400 infants for each group. Sample estimation for this study has been conducted using statistical methods.
A total of 1,200 2-month old healthy subjects were enrolled for inoculation of vaccine from 3 different lots with 1 month interval. All subjects received blood collection for immunogenicity test before and after primary immunization for evaluation of immunogenicity consistency, while safety observation was conducted within 30 days after each vaccination (30min via close safety monitoring, 0-7 days via participant diary card and 8-30 days via contact card for collection of adverse events) for safety evaluation of sIPV of 3 commercial lots.
- Conditions
- Poliomyelitis
- Being tested
- sIPV batch 1, sIPV batch 2, sIPV batch 3
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sIPV batch 1Biological
Type I 30 DU, Type II 32 DU, Type III 45 DU
sIPV batch 2Biological
Type I 30 DU, Type II 32 DU, Type III 45 DU
sIPV batch 3Biological
Type I 30 DU, Type II 32 DU, Type III 45 DU
| Study group | Role | What they receive |
|---|---|---|
| Batch 1 of sIPV | Experimental | The first commercial batch of sIPV Receives: Biological: sIPV batch 1 |
| Batch 2 of sIPV | Experimental | The second commercial batch of sIPV Receives: Biological: sIPV batch 2 |
| Batch 3 of sIPV | Experimental | The third commercial batch of sIPV Receives: Biological: sIPV batch 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate of neutralizing antibody
Blood samples were collected before and after immunization. Seroconversion rate of serum neutralizing antibody was determined. Intergroup differences analysis of the post-immunization positive conversion and ≥4-fold increase rate of antibody was performed.
Measured: 1 month after primary immunization
Local and systemic adverse reactions
Safety monitoring for local and systemic adverse reaction within 30 days after 3-dose primary immunization via close monitoring or diary card.
Measured: Within 1 month after primary immunization
Secondary outcomes (1)
GMT of neutralizing antibody
Blood samples were taken before and after immunization for the determination of antibody level of serum neutralizing antibody. Intergroup differences analysis of antibody level was conducted.
Measured: 1 month after primary immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start15 Apr 2018
- Primary completion25 Feb 2019
- Study completion12 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Yunnan Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Xiaoqiang Liu, Principal investigator, Disease prevention and control center of Yunnan province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224519
- Sponsor's protocol ID
- 20171217
- Status last verified
- Oct 2023
- First submitted
- 6 Jan 2020
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants do not agree to share the individual data.
Publications
Yin Q, Zheng Y, Ying Z, Li J, Jiang Y, Bao W, Dou Y, Pu Y, Lei J, Yang H, Jiang R, Deng Y, Zhao Z, Pu J, Yang J, Li Y, Xu M, Cai W, Che Y, Shi L. Quantitative Analysis of the Instant and Persistent Inhibition Effects of Maternal Poliovirus Antibodies on the Immune Response in a Phase IV Trial of a Sabin Strain-Based Inactivated Poliovirus Vaccine. Vaccines (Basel). 2024 Feb 19;12(2):217. doi: 10.3390/vaccines12020217.
PubMed 38400200Yin Q, Zheng Y, Ying Z, Li J, Jiang Y, Bao W, Dou Y, Pu Y, Lei J, Yang H, Jiang R, Deng Y, Zhao Z, Pu J, Yang J, Li Y, Xu M, Cai W, Che Y, Shi L. Immunogenicity and lot-to-lot consistency of booster shot with Sabin inactivated poliomyelitis vaccine in Chinese children aged 18-24 Months: A phase Ⅳ clinical trial. Vaccine. 2024 Mar 19;42(8):1973-1979. doi: 10.1016/j.vaccine.2024.02.042. Epub 2024 Feb 21.
PubMed 38388236Jiang 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
- Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain
- ClinicalTrials.gov ID
- NCT04224519
- Acronym / sponsor ID
- 20171217
- Conditions
- Poliomyelitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Yunnan Center for Disease Control and Prevention
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 12 Oct 2019 (actual)
- First posted
- 13 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.
A randomized and blind clinical consistency study for three commercial batches of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV) for immunogenicity and safety evaluation.
Detailed description
This randomized and blind clinical study includes three test groups with 400 infants for each group. Sample estimation for this study has been conducted using statistical methods.
A total of 1,200 2-month old healthy subjects were enrolled for inoculation of vaccine from 3 different lots with 1 month interval. All subjects received blood collection for immunogenicity test before and after primary immunization for evaluation of immunogenicity consistency, while safety observation was conducted within 30 days after each vaccination (30min via close safety monitoring, 0-7 days via participant diary card and 8-30 days via contact card for collection of adverse events) for safety evaluation of sIPV of 3 commercial lots.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Batch 1 of sIPV | Experimental | Biological: sIPV batch 1The first commercial batch of sIPV |
| Batch 2 of sIPV | Experimental | Biological: sIPV batch 2The second commercial batch of sIPV |
| Batch 3 of sIPV | Experimental | Biological: sIPV batch 3The third commercial batch 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 |
|---|---|---|
| sIPV batch 1Type I 30 DU, Type II 32 DU, Type III 45 DU | Biological | Batch 1 of sIPV |
| sIPV batch 2Type I 30 DU, Type II 32 DU, Type III 45 DU | Biological | Batch 2 of sIPV |
| sIPV batch 3Type I 30 DU, Type II 32 DU, Type III 45 DU | Biological | Batch 3 of sIPV |
Primary outcome
Seroconversion rate of neutralizing antibody
Time frame: 1 month after primary immunization
Blood samples were collected before and after immunization. Seroconversion rate of serum neutralizing antibody was determined. Intergroup differences analysis of the post-immunization positive conversion and ≥4-fold increase rate of antibody was performed.
Local and systemic adverse reactions
Time frame: Within 1 month after primary immunization
Safety monitoring for local and systemic adverse reaction within 30 days after 3-dose primary immunization via close monitoring or diary card.
1 secondary outcome
GMT of neutralizing antibody
Time frame: 1 month after primary immunization
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 38400200Yin Q, Zheng Y, Ying Z, Li J, Jiang Y, Bao W, Dou Y, Pu Y, Lei J, Yang H, Jiang R, Deng Y, Zhao Z, Pu J, Yang J, Li Y, Xu M, Cai W, Che Y, Shi L. Quantitative Analysis of the Instant and Persistent Inhibition Effects of Maternal Poliovirus Antibodies on the Immune Response in a Phase IV Trial of a Sabin Strain-Based Inactivated Poliovirus Vaccine. Vaccines (Basel). 2024 Feb 19;12(2):217. doi: 10.3390/vaccines12020217.
- Derived from this study: PubMed 38388236Yin Q, Zheng Y, Ying Z, Li J, Jiang Y, Bao W, Dou Y, Pu Y, Lei J, Yang H, Jiang R, Deng Y, Zhao Z, Pu J, Yang J, Li Y, Xu M, Cai W, Che Y, Shi L. Immunogenicity and lot-to-lot consistency of booster shot with Sabin inactivated poliomyelitis vaccine in Chinese children aged 18-24 Months: A phase Ⅳ clinical trial. Vaccine. 2024 Mar 19;42(8):1973-1979. doi: 10.1016/j.vaccine.2024.02.042. Epub 2024 Feb 21.
- 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.
Related trials for Poliomyelitis
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
RecruitingPhase 1
Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
Polio Immunity
Active, not recruiting
Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
Severe Mobility Impairment, Spinal Cord Injuries (SCI)
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.
Xiaoqiang Liu principal investigator
Disease prevention and control center of Yunnan province
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 batch 1, sIPV batch 2 and sIPV batch 3 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?
Seroconversion rate of neutralizing antibody (time frame: 1 month after primary immunization). 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?
On the ClinicalTrials.gov record for NCT04224519, which also lists 3 linked publications.
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.