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This is a randomized, blinded, peer-controlled study. There will be 3 treatment groups, screened subjects were randomized in a 1:1:1 ratio to receive three batches of the DTcP trial vaccine, and completed the primary immunization according to the procedure of one dose each at 2, 4, and 6 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental vaccine group A, 2 months old | Experimental | 3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4 |
|
| Experimental vaccine group B, 2 months old | Experimental | 3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4 |
|
| Experimental vaccine group C, 2 months old | Experimental | 3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 1) | Biological | Three doses of basic immunization were completed at 2, 4 and 6 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration (GMC) of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine. | 30 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine. | 30 days after vaccination | |
| Seropositivity rate of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine |
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Inclusion Criteria:
Exclusion Criteria:
First dose exclusion criteria
Exclusion Criteria for Doses 2,3
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| Name | Affiliation | Role |
|---|---|---|
| Yanxia Wang | Henan Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changge Center for Disease Control and Prevention | Xuchang | Henan | 461500 | China |
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| Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2) | Biological | Three doses of basic immunization were completed at 2, 4 and 6 months of age |
|
| Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3) | Biological | Three doses of basic immunization were completed at 2, 4 and 6 months of age |
|
| 30 days after vaccination |
| Incidence of solicited adverse reactions for each vaccine dose in 2-month-old subjects. | Within 30 minutes post-vaccination |
| Incidence of solicited adverse reactions for each vaccine dose in 2-month-old subjects. | Within 0-7 days |
| Incidence of unsolicited adverse reactions for each vaccine dose in 2-month-old subjects. | Within 0-30 days |
| Incidence of Serious Adverse Events (SAEs) in 2-month-old subjects. | From first vaccination to 30 days after the third dose |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| D017778 | Vaccines, Combined |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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