Pertussis is an acute respiratory infectious disease caused by Bordetella pertussis, diphtheria is an acute upper respiratory infectious disease caused by Gram-positive Corynebacterium diphtheriae, and tetanus is a highly fatal disease caused by Clostridium tetani infection. Currently, there is no clinical trial registration of Diphtheria, tetanus, and pertussis (DPT) vaccine applicable to ≥6 years of age in China, therefore, the five-component acellular DPT combination vaccine developed by our research has a promising future.
The vaccines used in China's immunization program for the prevention of pertussis, tetanus and diphtheria include the adsorbed cell-free diphtheria-tetanus-acellular pertussis vaccine (DTaP) and the diphtheria-tetanus-acellular tetanus vaccine (DT) and tetanus vaccine. Among them, DTaP vaccination is for children from 3 months of age to 6 years of age, with one dose each at 3, 4, 5, and 18 months of age; DT vaccination is for children under 12 years of age, with one dose at 6 weeks of age after completing four doses of DTaP vaccination. However, infant and young child vaccination is no longer sufficient to prevent the threat of this disease, mainly due to the rapid decay of immune protection in adolescents and adults, and infections in this population, which are the main source of infection leading to infection in infants and young children, have been a number of new preventive strategies are being evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
180
1 dose of Tdcp vaccine (0.5ml) on Day 0
1 dose of PPV23 vaccine (0.5ml) on Day 0
1 dose of DT vaccine (0.5ml) on Day 0
Shaanxi Center for Disease Control and Prevention
Xi'an, Shaanxi, China
Incidence of adverse reactions 0-30 days after vaccination
Time frame: 0-30 days after vaccination
Incidence of adverse reactions within 30 minutes of vaccination
Time frame: Within 30 minutes of vaccination
Incidence of adverse reactions/adverse events 0-7 days after vaccination
Time frame: 0-7 days after vaccination
Incidence of adverse events 0-30 days after vaccination
Time frame: 0-30 days after vaccination
Incidence of severe adverse events (SAE) 360 days after vaccination in the 6-11 years old group
Time frame: 360 days after vaccination
Incidence of SAE 180 days after vaccination in the 12-17 year old group and the ≥18 years old group
Time frame: 180 days after vaccination
Hemoglobin content (HGB) on day 4 after vaccination
Time frame: Day 4 after vaccination
White blood cell count on day 4 after vaccination
Time frame: Day 4 after vaccination
Alanine aminotransferase (ALT) in blood on day 4 after vaccination
Time frame: Day 4 after vaccination
Aspartate aminotransferase (AST) in blood on day 4 after vaccination
Time frame: Day 4 after vaccination
Total bilirubin (TBIL) in blood on day 4 after vaccination
Time frame: Day 4 after vaccination
Protein in urine on day 4 after vaccination
Time frame: Day 4 after vaccination
Erythrocytes in urine on day 4 after vaccination
Time frame: Day 4 after vaccination
Antibody Positive Turnover of Serum Anti-Diphtheria Toxoid(DT), Tetanus Toxoid(TT), Pertussis Toxoid(PT), Filamentous hemagglutmin(FHA), Pertactin(PRN), FIM bridal agglutinogens(FIM) 2&3 at 30 days after vaccination
Time frame: 30 days after vaccination
Antibody Positivity of Serum Anti-DT, TT, PT, FHA, PRN, FIM 2&3 at 30 days after vaccination
Time frame: 30 days after vaccination
Geometric Mean Concentration (GMC) of Serum Anti-DT, TT, PT, FHA, PRN, FIM 2&3 at 30 days after vaccination
Time frame: 30 days after vaccination
Proportion of serum anti-PRN, FIM 2&3 antibodies ≥5, 10, 20 IU/ml 30 days after vaccination
Time frame: 30 days after vaccination
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