Evaluation of Safety and Immunogenicity of Combined Immunization of sIPV, DTaP and HepA
- Conditions
- Vaccination
- Interventions
- Biological: sIPVBiological: DTaPBiological: sIPV+DTaP+HepABiological: HepA
- Registration Number
- NCT04636827
- Lead Sponsor
- China National Biotec Group Company Limited
- 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.
The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30-40 days after vaccination.
- Detailed Description
Following the clinical trial of "Combined Immunization of sIPV and DTaP" in 2019, this study recruits 600 18-month-old subjects who have received 3 doses of sIPV + DTaP, and gives them a 4th dose of vaccination (booster immunization). They are divided into 4 different groups, with 150 subjects in each group, and are innoculated with different vaccines.
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
- 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℃.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group 2 (sIPV) sIPV 150 subjects; vaccination of 0.5 ml sIPV as booster immunization at the age of 18 months old group 3 (DTaP) DTaP 150 subjects; vaccination of 0.5 ml DTaP as booster immunization at the age of 18 months old group 1 (sIPV+DTaP+HepA) 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 group 4 (HepA) HepA 150 subjects; vaccination of 0.5 ml HepA as booster immunization at the age of 18 months old
- Primary Outcome Measures
Name Time Method Seroconversion rate (DTaP) Results obtained 30-40 days after vaccination determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Seroconversion rate (HepA) Results obtained 30-40 days after vaccination determine the rate of positive seroconversion rate of anti-hepatitis A virus antibody of the subjects
Geometric Mean Concentration (GMC) (sIPV) Results obtained 30-40 days after vaccination GMCs of poliovirus type I, II and III of the subjects
Geometric Mean Concentration (GMC) (HepA) Results obtained 30-40 days after vaccination GMCs of anti-hepatitis A virus antibody of the subjects
Seroconversion rate (sIPV) Results obtained 30-40 days after vaccination determine the rate of positive seroconversion against poliovirus type I, II and III of the subjects
Geometric Mean Concentration (GMC) (DTaP) Results obtained 30-40 days after vaccination GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
- Secondary Outcome Measures
Name Time Method Adverse Events Following Immunization (AEFI) 0-6 months analyse the incidence of adverse events following immunization, both solicited and unsolicited
Trial Locations
- Locations (3)
Hebei Provincial Center for Disease Control and Prevention
🇨🇳Shijia Zhuang, 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