VaccinationPhase 4NCT04053010
Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP
A Phase 4 study testing Sabin-IPV and DTaP, Sabin-IPV and DTaP in people with Vaccination, run by China National Biotec Group Company Limited at 1 site in China.
Trial summary
Eligible,healthy infants will be recruited and divided into 3 groups:(1)combined immunization of sIPV and DTaP group, (2) sIPV group and (3) DTaP group. After completing the two basic vaccine EPI procedures, the immunogenicity and safety of the combined immunization group and the individual vaccination groups will be… Read more about this study
- Who is it for?
- Ages 3 to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Vaccination
- What is being tested?
- Sabin-IPV and DTaP, Sabin-IPV and DTaP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 702 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2019to 30 May 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 3 to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- subjects aged 3 months 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 have not been vaccinated with IPV vaccine, OPV vaccine, DTP vaccine and related vaccines;
Who cannot join
- subject who has a medical history with Hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
- allergic to any ingredient of vaccine or with allergy history to any vaccine;
- subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
- administration of immunoglobulins within 30 days prior to this study;
- acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
- have a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection;
Show all 10Show fewer
- any serious chronic illness, acute infectious diseases, or respiratory diseases;
- severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
- any kind of infectious, purulent, or allergic skin 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, 1 recruiting
- Recruiting
Shaanxi Provincial Center for Disease Control and Prevention
Xi'an, Shaanxi, 710054
Shaobai ZHANG, +86-29-82231502, maolyzhang@163.com
About this study
Official title: A Randomized, Controlled, Multicenter Vaccine Clinical Trial to Evaluate The Safety and Immunogenicity of Combined Immunization With sIPV and DTaP
Eligible,healthy infants will be recruited and divided into 3 groups:(1)combined immunization of sIPV and DTaP group, (2) sIPV group and (3) DTaP group. After completing the two basic vaccine EPI procedures, the immunogenicity and safety of the combined immunization group and the individual vaccination groups will be compared and analyzed.
Read the detailed description
It is recommended by China Food and Drug Administration (CFDA) that studies on simultaneous immunization of Sabin-IPV and DTaP be carried out as soon as possible, and the immunogenicity and safety studies should also be conducted. Currently in China the vaccination schedules of sIPV and DTaP overlap at infants' 3rd and 4th months of age. In order to avoid the vaccination time conflict and explore the possibility of simultaneous vaccination, we design this clinical study of simultaneous vaccination of the two vaccines.
To be specific, the subjects were divided into 3 groups. Group 1 : sIPV (1st, 2nd, and 3rd doses) and DTaP (1st, 2nd, and 3rd doses) were simultaneously inoculated at 3,4,5 months old ; Group 2 : received 1 dose of sIPV at 3,4,5 months old ; Group 3 : received 1 dose of DTaP at 3,4,5 months old . Blood sample would be collected both before vaccination and 28-40 days after the 3rd dose of vaccination. Neutralization antibody would also be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.
- Conditions
- Vaccination
- Being tested
- Sabin-IPV and DTaP, Sabin-IPV, DTaP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sabin-IPV and DTaPBiological
Sabin-IPV +DTaP at the age of 3/4/5 months old respectively
Sabin-IPVBiological
Sabin-IPV only at the age of 3/4/5 months old respectively
DTaPBiological
DTaP only at the age of 3/4/5 months old respectively
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | 234 subjects; simultaneously administration of Sabin-IPV and DTaP at the age of 3/4/5 months old, 0.5 ml each dose, respectively Receives: Biological: Sabin-IPV and DTaP |
| group 2 | Active comparator | 234 subjects; Sabin-IPV only at the age of 3/4/5 months old, 0.5 ml each dose, respectively Receives: Biological: Sabin-IPV |
| group 3 | Active comparator | 234 subjects; DTaP only at the age of 3/4/5 months old, 0.5 ml each dose, respectively Receives: Biological: DTaP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate I
determine the rate of positive seroconversion against poliovirus type I, II and III of the 3 groups
Measured: 1 month after the 3rd dose
Seroconversion rate II
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the 3 groups
Measured: 1 month after the 3rd dose
Neutralizing antibody titers I
Measure neutralizing antibody titers against poliovirus type I, II and III
Measured: 1 month after the 3rd dose
Neutralizing antibody titers II
Measure neutralizing antibody titers against diphtheria, pertussis toxoid, pertussis filamentous hemagglutinin, and tetanic of the 3 groups
Measured: 1 month after the 3rd dose
Secondary outcomes (1)
safety outcomes
Adverse event following vaccinations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start10 Aug 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion30 May 2020 (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 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
- 702 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Biotec Group Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wuhan Institute of Biological Products Co., Ltd, Beijing Institute of Biological Products Co Ltd., Shaanxi Provincial Center for Disease Control and Prevention, Hubei Provincial Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Shaobai ZHANG, Principal investigator, Shaanxi Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053010
- Sponsor's protocol ID
- sIPV/DTaP-2019-02
- Status last verified
- Aug 2019
- First submitted
- 9 Aug 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu X, Han S, Chen X, Sun L, Wang R, Shi X, Guo Y, Wang H, Chen H, Chang S, Xu X, Zhang C, Wang Y, Zhang D, Hu W, Zhang S. Immunogenicity and safety of co-administration with the Sabin-strain-based inactivated poliovirus vaccine (vero cell) and the diphtheria-tetanus-acellular pertussis vaccine in eligible children in China: a randomized, controlled, multicenter, non-inferiority trial. Front Immunol. 2025 Sep 3;16:1633170. doi: 10.3389/fimmu.2025.1633170. eCollection 2025.
PubMed 40969746
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter Vaccine Clinical Trial to Evaluate The Safety and Immunogenicity of Combined Immunization With sIPV and DTaP
- ClinicalTrials.gov ID
- NCT04053010
- Acronym / sponsor ID
- sIPV/DTaP-2019-02
- Conditions
- Vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 702 participants (estimated)
- Lead sponsor
- China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Wuhan Institute of Biological Products Co., Ltd, Beijing Institute of Biological Products Co Ltd., Shaanxi Provincial Center for Disease Control and Prevention, Hubei Provincial Center for Disease Control and Prevention
- Study start
- 10 Aug 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 12 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.
Eligible,healthy infants will be recruited and divided into 3 groups:(1)combined immunization of sIPV and DTaP group, (2) sIPV group and (3) DTaP group. After completing the two basic vaccine EPI procedures, the immunogenicity and safety of the combined immunization group and the individual vaccination groups will be compared and analyzed.
Detailed description
It is recommended by China Food and Drug Administration (CFDA) that studies on simultaneous immunization of Sabin-IPV and DTaP be carried out as soon as possible, and the immunogenicity and safety studies should also be conducted. Currently in China the vaccination schedules of sIPV and DTaP overlap at infants' 3rd and 4th months of age. In order to avoid the vaccination time conflict and explore the possibility of simultaneous vaccination, we design this clinical study of simultaneous vaccination of the two vaccines.
To be specific, the subjects were divided into 3 groups. Group 1 : sIPV (1st, 2nd, and 3rd doses) and DTaP (1st, 2nd, and 3rd doses) were simultaneously inoculated at 3,4,5 months old ; Group 2 : received 1 dose of sIPV at 3,4,5 months old ; Group 3 : received 1 dose of DTaP at 3,4,5 months old . Blood sample would be collected both before vaccination and 28-40 days after the 3rd dose of vaccination. Neutralization antibody would also be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Biological: Sabin-IPV and DTaP234 subjects; simultaneously administration of Sabin-IPV and DTaP at the age of 3/4/5 months old, 0.5 ml each dose, respectively |
| group 2 | Active comparator | Biological: Sabin-IPV234 subjects; Sabin-IPV only at the age of 3/4/5 months old, 0.5 ml each dose, respectively |
| group 3 | Active comparator | Biological: DTaP234 subjects; DTaP only at the age of 3/4/5 months old, 0.5 ml each dose, respectively |
Who may qualify
- Ages
- 3 to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- subjects aged 3 months 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 have not been vaccinated with IPV vaccine, OPV vaccine, DTP vaccine and related vaccines;
Key exclusion criteria (10 listed)
- subject who has a medical history with Hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
- allergic to any ingredient of vaccine or with allergy history to any vaccine;
- subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
- administration of immunoglobulins within 30 days prior to this study;
- acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
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-IPV and DTaPSabin-IPV +DTaP at the age of 3/4/5 months old respectively | Biological | group 1 |
| Sabin-IPVSabin-IPV only at the age of 3/4/5 months old respectively | Biological | group 2 |
| DTaPDTaP only at the age of 3/4/5 months old respectively | Biological | group 3 |
Primary outcome
Seroconversion rate I
Time frame: 1 month after the 3rd dose
determine the rate of positive seroconversion against poliovirus type I, II and III of the 3 groups
Seroconversion rate II
Time frame: 1 month after the 3rd dose
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the 3 groups
Neutralizing antibody titers I
Time frame: 1 month after the 3rd dose
Measure neutralizing antibody titers against poliovirus type I, II and III
Neutralizing antibody titers II
Time frame: 1 month after the 3rd dose
Measure neutralizing antibody titers against diphtheria, pertussis toxoid, pertussis filamentous hemagglutinin, and tetanic of the 3 groups
1 secondary outcome
safety outcomes
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Derived from this study: PubMed 40969746Liu X, Han S, Chen X, Sun L, Wang R, Shi X, Guo Y, Wang H, Chen H, Chang S, Xu X, Zhang C, Wang Y, Zhang D, Hu W, Zhang S. Immunogenicity and safety of co-administration with the Sabin-strain-based inactivated poliovirus vaccine (vero cell) and the diphtheria-tetanus-acellular pertussis vaccine in eligible children in China: a randomized, controlled, multicenter, non-inferiority trial. Front Immunol. 2025 Sep 3;16:1633170. doi: 10.3389/fimmu.2025.1633170. eCollection 2025.
Related trials for Vaccination
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Recruiting
Assessment of Communication Interventions on Vaccination Knowledge and Acceptance
Vaccination Knowledge and Acceptance, Informed Vaccine-decision Making
Active, not recruiting
Working Towards Empowered Community-driven Approaches to Increase Vaccination and Preventive Care Engagement
COVID-19
RecruitingPhase 2
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
Diarrhoea
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.
Shaobai ZHANG principal investigator
Shaanxi Provincial 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 Sabin-IPV and DTaP, Sabin-IPV and DTaP 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 4 inclusion and 10 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 12 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaobai ZHANG (+86-29-82231502, maolyzhang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate I (time frame: 1 month after the 3rd dose). The study lists 4 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 NCT04053010, 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 12 Aug 2019.