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| Name | Class |
|---|---|
| Beijing Institute of Biological Products Co Ltd. | INDUSTRY |
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The study will evaluate the safety, immunogenicity,immune persistence and lot-to-lot consistency of Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, (DTacP) including 2 parts:
PART 1 will evaluate the safety and immunogenicity of DTacP in health infants aged 2 months and 3 months compared with an adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine and Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine (PENTAXIM),compare the safety and immunogenicity of DTacP with different immunization schedules, and observe the immune persistence.
PART 2 will evaluate the lot-to-lot consistency of DTacP in health infants aged 3 months with the 3-dose schedule of 3-4-5 month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental | subjects aged 3 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old |
|
| A2 | Active Comparator | subjects aged 3 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old |
|
| A3 | Active Comparator | subjects aged 3 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old |
|
| B1 | Experimental | subjects aged 2 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old |
|
| B2 | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The seroconversion rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody | seroconversion is defined as post-third dose antibody concentrations ≥ protective antibody concentration if pre-vaccination concentration is < protective antibody concentration, or ≥ 4 x protective antibody concentration if pre-vaccination concentrations ≥ protective antibody concentration. | 1 month after Dose 3 |
| Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody | As measured at the central laboratory | 1 month after Dose 3 |
| Percentage of participants reporting local reactions | As elicited by investigational site staff | Day 7 post-each dose |
| Percentage of participants reporting systemic events | As elicited by investigational site staff | Day 7 post-each dose |
| Percentage of participants reporting adverse events | As elicited by investigational site staff | within 30 days post-each dose |
| Measure | Description | Time Frame |
|---|---|---|
| The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody | Seropositivity is defined as post-3 dose antibody concentrations ≥ protective antibody concentration | Day 30 post-dose 3 |
| Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody | As measured at the central laboratory | 12th month, 24th month, 36th month post-dose 4 , before 6 years old and day 30 post-dose 5 |
| The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lili Huang | Henan Province Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neihuang County Center for Disease Control and Prevention | Anyang | Henan | 456300 | China | ||
| Wen County Center for Disease Control and Prevention |
In order to maintain the rights of the subject, do not open the IPD
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subjects aged 2 months receive 3 doses of vaccines with a interval of 30 days for primary immunization, and a booster dose at 18 month old
|
| B3 | Experimental | subjects aged 2 months receive 3 doses of vaccines with a interval of 2 months for primary immunization, and a booster dose at 18 month old |
|
| C1 | Experimental | subjects aged 3 months receive 3 doses of lot-1 vaccines with a interval of 30 days for primary immunization |
|
| C2 | Experimental | subjects aged 3 months receive 3 doses of lot-2 vaccines with a interval of 30 days for primary immunization |
|
| C3 | Experimental | subjects aged 3 months receive 3 doses of lot-3 vaccines with a interval of 30 days for primary immunization |
|
|
| Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed | Biological | Intramuscular injection |
|
|
| Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine | Biological | Intramuscular injection |
|
|
As measured at the central laboratory |
| before dose 4 at 18 months old(booster) |
| The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody | Seropositivity is defined as antibody concentrations ≥ protective antibody concentration | before dose 4 at 18 months old(booster) |
| Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody | As measured at the central laboratory | Day 30 post-dose 4 at 18 months old(booster) |
| The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody | eropositivity is defined as antibody concentrations ≥ protective antibody concentration | Day 30 post-dose 4 at 18 months old(booster) |
Seropositivity is defined as antibody concentrations ≥ protective antibody concentration |
| 12th month, 24th month, 36th month post-dose 4 , before 6 years old and day 30 post-dose 5 |
| Jiaozuo |
| Henan |
| 454850 |
| China |
| Wuyang County Center for Disease Control and Prevention | Luohe | Henan | 462400 | China |
| Yanjin County Center for Disease Control and Prevention | Xinxiang | Henan | 453200 | China |
| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| D004165 | Diphtheria |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D003015 | Clostridium Infections |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| D017778 | Vaccines, Combined |
| C426945 | Pentavac |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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