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| Name | Class |
|---|---|
| Jiangsu Province Centers for Disease Control and Prevention | NETWORK |
| Anhui Provincial Center for Disease Control and Prevention | OTHER_GOV |
| Sichuan Center for Disease Control and Prevention | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 (sIPV+DTaP+MMR) | Experimental | 150 subjects; simultaneously administration of sIPV+DTaP+MMR as booster immunization at the age of 18 months old, 0.5 ml each, respectively |
|
| group 2 (sIPV) | Active Comparator | 150 subjects; vaccination of 0.5 ml sIPV as booster immunization at the age of 18 months old |
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| group 3 (DTaP) | Active Comparator | 150 subjects; vaccination of 0.5 ml DTaP as booster immunization at the age of 18 months old |
|
| group 4 (MMR) | Active Comparator | 150 subjects; vaccination of 0.5 ml MMR as booster immunization at the age of 18 months old |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sIPV+DTaP+MMR | Biological | sIPV+DTaP+MMR at the age of 18 month old |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate (sIPV) | 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 | Baseline (before vaccination) results |
| Seroconversion rate (sIPV) | 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 | Results obtained 30 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 days after vaccination |
| Seroconversion rate (MMR) | determine the positive seroconversion rate of measles, mumps, rubella antibodies of the subjects | Baseline (before vaccination) results |
| Seroconversion rate (MMR) | determine the positive seroconversion rate of measles, mumps, rubella antibodies of the subjects | Results obtained 30 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Following Immunization (AEFI) | analyse the incidence of adverse events following immunization, both solicited and unsolicited | 0-6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fenyang Tang | Contact | +86-25-83759419 | tfyepi@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Fenyang Tang | Jiangsu Province Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Center for Disease Control and Prevention | Recruiting | Hefei | Anhui | 230601 | China |
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| Beijing Institute of Biological Products Co Ltd. | INDUSTRY |
| Chengdu Institute of Biological Products Co.,Ltd. | INDUSTRY |
| Peking University | OTHER |
| National Institutes for Food and Drug Control, China | OTHER |
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| sIPV |
| Biological |
sIPV at the age of 18 month old |
|
| DTaP | Biological | DTaP at the age of 18 month old |
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| MMR | Biological | MMR at the age of 18 month old |
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| 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 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 days after vaccination |
| Geometric Mean Concentration (GMC) (MMR) | GMCs of measles, mumps, rubella antibodies of the subjects | Baseline (before vaccination) results |
| Geometric Mean Concentration (GMC) (MMR) | GMCs of measles, mumps, rubella antibodies of the subjects | Results obtained 30 days after vaccination |
| Jiangsu Province Centers for Disease Control and Prevention | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| Sichuan Center for Disease Control and Prevention | Not yet recruiting | Chengdu | Sichuan | 610041 | China |
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