Evaluation of Safety and Immunogenicity of Combined Immunization of sIPV, DTaP and HepA
A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis (DTaP) Vaccine and Live Attenuated Hepatitis A Vaccine (HepA)
1 other identifier
interventional
600
1 country
3
Brief Summary
Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04053010) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows:
- 1.Group 1: sIPV + DTaP + HepA,
- 2.Group 2: sIPV only,
- 3.Group 3: DTaP only,
- 4.Group 4: HepA only.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2020
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2020
CompletedFirst Submitted
Initial submission to the registry
November 16, 2020
CompletedFirst Posted
Study publicly available on registry
November 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedNovember 19, 2020
November 1, 2020
9 months
November 16, 2020
November 16, 2020
Conditions
Outcome Measures
Primary Outcomes (12)
Seroconversion rate (sIPV)
determine the rate of positive seroconversion against poliovirus type I, II and III of the subjects
Baseline (before vaccination) results
Seroconversion rate (sIPV)
determine the rate of positive seroconversion against poliovirus type I, II and III of the subjects
Results obtained 30-40 days after vaccination
Seroconversion rate (DTaP)
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Baseline (before vaccination) results
Seroconversion rate (DTaP)
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Results obtained 30-40 days after vaccination
Seroconversion rate (HepA)
determine the rate of positive seroconversion rate of anti-hepatitis A virus antibody of the subjects
Baseline (before vaccination) results
Seroconversion rate (HepA)
determine the rate of positive seroconversion rate of anti-hepatitis A virus antibody of the subjects
Results obtained 30-40 days after vaccination
Geometric Mean Concentration (GMC) (sIPV)
GMCs of poliovirus type I, II and III of the subjects
Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (sIPV)
GMCs of poliovirus type I, II and III of the subjects
Results obtained 30-40 days after vaccination
Geometric Mean Concentration (GMC) (DTaP)
GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (DTaP)
GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Results obtained 30-40 days after vaccination
Geometric Mean Concentration (GMC) (HepA)
GMCs of anti-hepatitis A virus antibody of the subjects
Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (HepA)
GMCs of anti-hepatitis A virus antibody of the subjects
Results obtained 30-40 days after vaccination
Secondary Outcomes (1)
Adverse Events Following Immunization (AEFI)
0-6 months
Study Arms (4)
group 1 (sIPV+DTaP+HepA)
EXPERIMENTAL150 subjects; simultaneously administration of sIPV+DTaP+HepA as booster immunization at the age of 18 months old, 0.5 ml each, respectively
group 2 (sIPV)
ACTIVE COMPARATOR150 subjects; vaccination of 0.5 ml sIPV as booster immunization at the age of 18 months old
group 3 (DTaP)
ACTIVE COMPARATOR150 subjects; vaccination of 0.5 ml DTaP as booster immunization at the age of 18 months old
group 4 (HepA)
ACTIVE COMPARATOR150 subjects; vaccination of 0.5 ml HepA as booster immunization at the age of 18 months old
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must have participated the clinical trial titled "Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP" (NCT04053010) in 2019, and have finished 3 doses of combined immunization of sIPV and DTaP;
- Subjects aged 18-19 months old at the date of recruitment;
- With informed consent form (ICF) signed by parent(s) or guardian(s);
- Parent(s) or guardian(s) are able to attend all planned clinical appointments and obey/follow all study instructions;
- Subjects have not been vaccinated with sIPV/DTaP/HepA at the age of 18-month-old yet;
- No less than 14 days since the last dose of vaccination;
- Axillary temperature ≤37.0℃.
You may not qualify if:
- With 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;
- With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection;
- With any serious chronic illness, acute infectious diseases, or respiratory diseases;
- With severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
- With any kind of infectious, purulent, or allergic skin diseases;
- With any other factor that makes the investigator determines the subject is unsuitable for this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, 050024, China
Shaanxi Provincial Center for Disease Control and Prevention
Xi'an, Shaanxi, 710054, China
Shanxi Provincial Center for Disease Control and Prevention
Taiyuan, Shanxi, 030012, China
Related Publications (1)
Liu X, Han S, Wang H, Sun L, Zhang C, Chen X, Wang R, Chang S, Shi X, Chen H, Wang Y, Zhang D, Guo Y, Zhang S, Hu W. Immunogenicity and safety of co-administration of sabin-strain-based inactivated poliovirus vaccine, diphtheria-tetanus-acellular pertussis vaccine, and live attenuated hepatitis A vaccine in 18-month-old children: A multicenter randomized controlled non-inferiority trial in China. Vaccine. 2025 Nov 20;67:127891. doi: 10.1016/j.vaccine.2025.127891. Epub 2025 Oct 27.
PMID: 41151164DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Shaobai Shaobai
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
November 16, 2020
First Posted
November 19, 2020
Study Start
November 11, 2020
Primary Completion
August 1, 2021
Study Completion
December 1, 2021
Last Updated
November 19, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share