Evaluation of Immunogenicity and Safety of Combined Immunization of sIPV, DTaP and MMR
Study Details
Study Description
Brief Summary
Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04054882) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows:
Group 1: sIPV + DTaP + MMR, Group 2: sIPV only, Group 3: DTaP only, Group 4: MMR only.
The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30 days after vaccination.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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)+ MMR(0.5ml); group 2 receives sIPV (0.5ml); group 3 receives DTaP (0.5ml); group 4 receives MMR (0.5ml).
Blood samples will be collected before vaccination and 30 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: group 1 (sIPV+DTaP+MMR) 150 subjects; simultaneously administration of sIPV+DTaP+MMR as booster immunization at the age of 18 months old, 0.5 ml each, respectively |
Biological: sIPV+DTaP+MMR
sIPV+DTaP+MMR at the age of 18 month old
|
| Active Comparator: group 2 (sIPV) 150 subjects; vaccination of 0.5 ml sIPV as booster immunization at the age of 18 months old |
Biological: sIPV
sIPV at the age of 18 month old
|
| Active Comparator: group 3 (DTaP) 150 subjects; vaccination of 0.5 ml DTaP as booster immunization at the age of 18 months old |
Biological: DTaP
DTaP at the age of 18 month old
|
| Active Comparator: group 4 (MMR) 150 subjects; vaccination of 0.5 ml MMR as booster immunization at the age of 18 months old |
Biological: MMR
MMR at the age of 18 month old
|
Outcome Measures
Primary Outcome Measures
- Seroconversion rate (sIPV) [Baseline (before vaccination) results]
determine the rate of positive seroconversion against poliovirus type I, II and III of the subjectsdetermine the rate of positive seroconversion against poliovirus type I, II and III of the subjects
- Seroconversion rate (sIPV) [Results obtained 30 days after vaccination]
determine the rate of positive seroconversion against poliovirus type I, II and III of the subjectsdetermine the rate of positive seroconversion against poliovirus type I, II and III of the subjects
- Seroconversion rate (DTaP) [Baseline (before vaccination) results]
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
- Seroconversion rate (DTaP) [Results obtained 30 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 (MMR) [Baseline (before vaccination) results]
determine the positive seroconversion rate of measles, mumps, rubella antibodies of the subjects
- Seroconversion rate (MMR) [Results obtained 30 days after vaccination]
determine the positive seroconversion rate of measles, mumps, rubella antibodies of the subjects
- Geometric Mean Concentration (GMC) (sIPV) [Baseline (before vaccination) results]
GMCs of poliovirus type I, II and III of the subjects
- Geometric Mean Concentration (GMC) (sIPV) [Results obtained 30 days after vaccination]
GMCs of poliovirus type I, II and III of the subjects
- Geometric Mean Concentration (GMC) (DTaP) [Baseline (before vaccination) results]
GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
- Geometric Mean Concentration (GMC) (DTaP) [Results obtained 30 days after vaccination]
GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
- Geometric Mean Concentration (GMC) (MMR) [Baseline (before vaccination) results]
GMCs of measles, mumps, rubella antibodies of the subjects
- Geometric Mean Concentration (GMC) (MMR) [Results obtained 30 days after vaccination]
GMCs of measles, mumps, rubella antibodies of the subjects
Secondary Outcome Measures
- Adverse Events Following Immunization (AEFI) [0-6 months]
analyse the incidence of adverse events following immunization, both solicited and unsolicited
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects must have participated the clinical trial titled "Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP" (NCT04054882) in 2019, and have finished 3 doses of combined immunization of sIPV and DTaP;
-
Subjects aged 18 months old at the date of recruitment;
-
With informed consent form (ICF) signed by parent(s) or guardian(s);
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Parent(s) or guardian(s) are able to attend all planned clinical appointments and obey/follow all study instructions;
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Subjects have been vaccinated with a first dose of MMR, but have not been vaccinated with the 2nd dose of MMR and the booster (4th) dose of sIPV and DTaP;
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No less than 14 days since the last dose of vaccination;
-
Axillary temperature ≤37.0℃.
Exclusion Criteria:
-
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;
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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);
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Administration of immunoglobulins within 30 days prior to this study;
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Acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anhui Provincial Center for Disease Control and Prevention | Hefei | Anhui | China | 230601 |
| 2 | Jiangsu Province Centers for Disease Control and Prevention | Nanjing | Jiangsu | China | 210009 |
| 3 | Sichuan Center for Disease Control and Prevention | Chengdu | Sichuan | China | 610041 |
Sponsors and Collaborators
- China National Biotec Group Company Limited
- Jiangsu Province Centers for Disease Control and Prevention
- Anhui Provincial Center for Disease Control and Prevention
- Sichuan Center for Disease Control and Prevention
- Beijing Institute of Biological Products Co Ltd.
- Chengdu Institute of Biological Products Co.,Ltd.
- Peking University
- National Institutes for Food and Drug Control, China
Investigators
- Principal Investigator: Fenyang Tang, Jiangsu Province Centers for Disease Control and Prevention
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- sIPV-DTaP-MMR-2020