Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP
A Randomized, Controlled, Multicenter Vaccine Clinical Trial to Evaluate The Safety and Immunogenicity of Combined Immunization With sIPV and DTaP
1 other identifier
interventional
702
1 country
1
Brief 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 compared and analyzed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2019
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2019
CompletedStudy Start
First participant enrolled
August 10, 2019
CompletedFirst Posted
Study publicly available on registry
August 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2020
CompletedAugust 12, 2019
August 1, 2019
5 months
August 9, 2019
August 9, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Seroconversion rate I
determine the rate of positive seroconversion against poliovirus type I, II and III of the 3 groups
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
1 month after the 3rd dose
Neutralizing antibody titers I
Measure neutralizing antibody titers against poliovirus type I, II and III
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
1 month after the 3rd dose
Secondary Outcomes (1)
safety outcomes
6 months
Study Arms (3)
group 1
EXPERIMENTAL234 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 COMPARATOR234 subjects; Sabin-IPV only at the age of 3/4/5 months old, 0.5 ml each dose, respectively
group 3
ACTIVE COMPARATOR234 subjects; DTaP only at the age of 3/4/5 months old, 0.5 ml each dose, respectively
Interventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- China National Biotec Group Company Limitedlead
- Wuhan Institute of Biological Products Co., Ltdcollaborator
- Beijing Institute of Biological Products Co Ltd.collaborator
- Shaanxi Provincial Center for Disease Control and Preventioncollaborator
- Hubei Provincial Center for Disease Control and Preventioncollaborator
Study Sites (1)
Shaanxi Provincial Center for Disease Control and Prevention
Xi'an, Shaanxi, 710054, China
Related Publications (1)
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.
PMID: 40969746DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Shaobai ZHANG
Shaanxi Provincial Center for Disease Control and Prevention
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2019
First Posted
August 12, 2019
Study Start
August 10, 2019
Primary Completion
December 31, 2019
Study Completion
May 30, 2020
Last Updated
August 12, 2019
Record last verified: 2019-08