Evaluation of Safety and Immunogenicity of Combined Immunization of sIPV, DTaP and HepA
NCT ID: NCT04636827
Last Updated: 2020-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
600 participants
INTERVENTIONAL
2020-11-11
2021-12-31
Brief Summary
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1. Group 1: sIPV + DTaP + HepA,
2. Group 2: sIPV only,
3. Group 3: DTaP only,
4. Group 4: HepA only.
The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30-40 days after vaccination.
Detailed Description
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To be specific, group 1 receives sIPV (0.5ml)+ DTaP (0.5ml)+ HepA(0.5ml); group 2 receives sIPV (0.5ml); group 3 receives DTaP (0.5ml); group 4 receives HepA (0.5ml).
Blood samples will be collected before vaccination and 30-40 days after this booster immunization. Neutralization antibody will be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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group 1 (sIPV+DTaP+HepA)
150 subjects; simultaneously administration of sIPV+DTaP+HepA as booster immunization at the age of 18 months old, 0.5 ml each, respectively
sIPV+DTaP+HepA
sIPV+DTaP+HepA at the age of 18 month old
group 2 (sIPV)
150 subjects; vaccination of 0.5 ml sIPV as booster immunization at the age of 18 months old
sIPV
sIPV at the age of 18 month old
group 3 (DTaP)
150 subjects; vaccination of 0.5 ml DTaP as booster immunization at the age of 18 months old
DTaP
DTaP at the age of 18 month old
group 4 (HepA)
150 subjects; vaccination of 0.5 ml HepA as booster immunization at the age of 18 months old
HepA
HepA at the age of 18 month old
Interventions
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sIPV+DTaP+HepA
sIPV+DTaP+HepA at the age of 18 month old
sIPV
sIPV at the age of 18 month old
DTaP
DTaP at the age of 18 month old
HepA
HepA at the age of 18 month old
Eligibility Criteria
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Inclusion Criteria
* 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℃.
Exclusion Criteria
* 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.
18 Months
19 Months
ALL
Yes
Sponsors
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Shaanxi Provincial Center for Disease Control and Prevention
OTHER
Hubei Provincial Center for Disease Control and Prevention
OTHER
Beijing Institute of Biological Products Co Ltd.
INDUSTRY
China National Biotec Group Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Shaobai Shaobai
Role: PRINCIPAL_INVESTIGATOR
Shaanxi Provincial Center for Disease Control and Prevention
Locations
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Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, China
Shaanxi Provincial Center for Disease Control and Prevention
Xi'an, Shaanxi, China
Shanxi Provincial Center for Disease Control and Prevention
Taiyuan, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Zhenguo Zhang
Role: primary
Shaobai Zhang
Role: primary
Shaoying Chang
Role: primary
References
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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 Oct 27;67:127891. doi: 10.1016/j.vaccine.2025.127891. Online ahead of print.
Other Identifiers
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sIPV-DTaP-HepA-2020
Identifier Type: -
Identifier Source: org_study_id