PolioNCT06058429
Immunogenicity of After Primary Immunization and Booster Immunization of sIPV
An observational study of Polio, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
This study was conducted on the basis of "Safety Observation of Sabin Strain Inactivated Polio Vaccine (Vero Cell) on primary Immunization, Booster Immunization and Simultaneous Vaccination with Other Vaccines in Infants and Young Children(ID: PRO-sIPV-MA4001-JX). Read more about this study
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 27 months
- All sexes
- Child
Study population: Subjects in the Primay immunization group(aged 2-3 months) need to complete 3 doses of sIPV vaccination, and the simultaneous vaccination group DTaP needs to complete 3 doses of vaccination; the booster immunity group(aged more than 18 months) needs to complete sIPV vaccination, and the simultaneous vaccination group needs to complete the corresponding vaccination
Who may be able to join
- Participated in the previous study (ID: PRO-sIPV-MA4001-JX)
- Subjects in the Primay immunization group(aged 2-3 months) need to complete 3 doses of sIPV vaccination, and the simultaneous vaccination group DTaP needs to complete 3 doses of vaccination; the booster immunity group(aged more than 18 months) needs to complete sIPV vaccination, and the simultaneous vaccination group needs to complete the corresponding vaccination;
- There should be an interval of 1-9 months between the last dose of vaccination and the date of blood sample collection;
- The guardian of subjects need to agree to sign the informed consent form.
Who cannot join
- The interval between vaccination and blood collection is less than 1 month, or more than 9 months;
- Subjects were participating in other clinical studies of vaccines or drugs;
- Other conditions that make subjects unsuitable for participating in this study judged by investigator's
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangxi Center for Disease Control and Prevention
Nanchang, Jiangxi, 330029
About this study
Official title: Immunogenicity After Primary Immunization and Booster Immunization of Sabin Strain Inactivated Polio Vaccine (Vero Cells) in Infants and Young Children and Enterovirus Serological Monitoring Study
This study was conducted on the basis of "Safety Observation of Sabin Strain Inactivated Polio Vaccine (Vero Cell) on primary Immunization, Booster Immunization and Simultaneous Vaccination with Other Vaccines in Infants and Young Children(ID: PRO-sIPV-MA4001-JX). Blood samples were collected in about 200 qualified subjects 1-9 months after their last vaccination of sIPV. And immunogenicity of sIPV and other vaccines simultaneously administrated will be tested, the antibodies against enterovirus (including EV71、CA16、CA6 and CA10) will also be tested.
- Conditions
- Polio
- Being tested
- no intervention
- Keywords
- immunogenicity of sIPV, primary immunization, booster immunization, simulteneous immunization, serology of antibodies against enterovirus
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
This is an observation study after vaccination, no intervention will be used
| Study group | Role | What they receive |
|---|---|---|
| 2-3 months infants group | Subjects in this group had recieved three dose of sIPV as primay immunization, and about half of them recieved DTaP simultaneously. Receives: Other: no intervention | |
| 18 months children group | Subjects in this group had recieved one dose of sIPV as booster immunization, and about half of them recieved MMR or hepatitis A vacine(live-attenuated or inactivated) simultaneously. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody positivity rate of sIPV vaccine after primary immunization in infants
Measured: 1 month
Antibody positivity rate of sIPV after booster immunization with sIPV vaccine in young children
Measured: 1 month
seropositive rate of antibodies against different enteroviruses (EV71/CA16/CA6/CA10) in infants and young children
Measured: 1 month
Secondary outcomes (3)
GMT of sIPV vaccine after primary immunization in infants
Measured: 1 month
GMT of sIPV after booster immunization with sIPV vaccine in young children
Measured: 1 month
GMT of antibodies against different enteroviruses
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start16 Aug 2023
- Primary completion7 Sep 2023
- Study completion31 Dec 2023 (estimated)
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 PolioStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jiangxi Center for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058429
- Sponsor's protocol ID
- PRO-sIPV-MA4001-1-JX
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guo S, Li Z, Zheng M, Wu F, Sun J, Tuo L, Li S, Li X, Wei L, Xia Z, Xie P, Chen X, Zhao Y, Gao Y, Yu D. Safety and 6-month immune persistence of inactivated poliovirus vaccine (Sabin strains) simultaneously administrated with other vaccines for primary and booster immunization in Jiangxi Province, China. Vaccine. 2024 Aug 30;42(21):126183. doi: 10.1016/j.vaccine.2024.126183. Epub 2024 Jul 31.
PubMed 39088987
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity After Primary Immunization and Booster Immunization of Sabin Strain Inactivated Polio Vaccine (Vero Cells) in Infants and Young Children and Enterovirus Serological Monitoring Study
- ClinicalTrials.gov ID
- NCT06058429
- Acronym / sponsor ID
- PRO-sIPV-MA4001-1-JX
- Conditions
- Polio
- Keywords
- immunogenicity of sIPV, primary immunization, booster immunization, simulteneous immunization, serology of antibodies against enterovirus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Jiangxi Center for Disease Control and Prevention
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Sep 2023 (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 was conducted on the basis of "Safety Observation of Sabin Strain Inactivated Polio Vaccine (Vero Cell) on primary Immunization, Booster Immunization and Simultaneous Vaccination with Other Vaccines in Infants and Young Children(ID: PRO-sIPV-MA4001-JX). Blood samples were collected in about 200 qualified subjects 1-9 months after their last vaccination of sIPV. And immunogenicity of sIPV and other vaccines simultaneously administrated will be tested, the antibodies against enterovirus (including EV71、CA16、CA6 and CA10) will also be tested.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-3 months infants group | – | Other: no interventionSubjects in this group had recieved three dose of sIPV as primay immunization, and about half of them recieved DTaP simultaneously. |
| 18 months children group | – | Other: no interventionSubjects in this group had recieved one dose of sIPV as booster immunization, and about half of them recieved MMR or hepatitis A vacine(live-attenuated or inactivated) simultaneously. |
Who may qualify
- Ages
- 2 to 27 months
- Sex
- All
- Age groups
- Child
- Study population
- Subjects in the Primay immunization group(aged 2-3 months) need to complete 3 doses of sIPV vaccination, and the simultaneous vaccination group DTaP needs to complete 3 doses of vaccination; the booster immunity group(aged more than 18 months) needs to complete sIPV vaccination, and the simultaneous vaccination group needs to complete the corresponding vaccination
Key inclusion criteria (4 listed)
- Participated in the previous study (ID: PRO-sIPV-MA4001-JX)
- Subjects in the Primay immunization group(aged 2-3 months) need to complete 3 doses of sIPV vaccination, and the simultaneous vaccination group DTaP needs to complete 3 doses of vaccination; the booster immunity group(aged more than 18 months) needs to complete sIPV vaccination, and the simultaneous vaccination group needs to complete the corresponding vaccination;
- There should be an interval of 1-9 months between the last dose of vaccination and the date of blood sample collection;
- The guardian of subjects need to agree to sign the informed consent form.
Key exclusion criteria (3 listed)
- The interval between vaccination and blood collection is less than 1 month, or more than 9 months;
- Subjects were participating in other clinical studies of vaccines or drugs;
- Other conditions that make subjects unsuitable for participating in this study judged by investigator's
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 |
|---|---|---|
| no interventionThis is an observation study after vaccination, no intervention will be used | Other | 18 months children group, 2-3 months infants group |
Primary outcome
Antibody positivity rate of sIPV vaccine after primary immunization in infants
Time frame: 1 month
Antibody positivity rate of sIPV after booster immunization with sIPV vaccine in young children
Time frame: 1 month
seropositive rate of antibodies against different enteroviruses (EV71/CA16/CA6/CA10) in infants and young children
Time frame: 1 month
3 secondary outcomes
GMT of sIPV vaccine after primary immunization in infants
Time frame: 1 month
GMT of sIPV after booster immunization with sIPV vaccine in young children
Time frame: 1 month
GMT of antibodies against different enteroviruses
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Derived from this study: PubMed 39088987Guo S, Li Z, Zheng M, Wu F, Sun J, Tuo L, Li S, Li X, Wei L, Xia Z, Xie P, Chen X, Zhao Y, Gao Y, Yu D. Safety and 6-month immune persistence of inactivated poliovirus vaccine (Sabin strains) simultaneously administrated with other vaccines for primary and booster immunization in Jiangxi Province, China. Vaccine. 2024 Aug 30;42(21):126183. doi: 10.1016/j.vaccine.2024.126183. Epub 2024 Jul 31.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polio, run by Sinovac Biotech Co., Ltd 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 4 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: status not confirmed, as of the sponsor's last update on 26 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.
Are results available for this study?
Results are not available in the source record.
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?
Antibody positivity rate of sIPV vaccine after primary immunization in infants (time frame: 1 month). The study lists 3 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 NCT06058429, 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 26 Oct 2023.