This clinical study aims to evaluate the mutual influence of combined administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis Vaccine in the target population
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,110
Administer 0.5ml of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) separately at different locations upon enrollment. Both vaccine were immunized according to the 0, 1, and 2 month procedures (calculated as 30 days per month).
Vaccination with 15-Valent Pneumococcal Conjugate Vaccine with a 7-day interval (+15 day window period) followed by vaccination with Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed). Both vaccine were immunized according to the 0, 1, and 2 month procedures (calculated as 30 days per month).
Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, China
Antibody positive conversion rate
The positive conversion rates of diphtheria antibody (anti-D), tetanus antibody (anti-T), pertussis toxin antibody (anti-PT), and pertussis filamentous hemagglutinin antibody (anti-FHA) in P+DTP, P-DTP, and DTP groups,respectively.
Time frame: 30 days after full vaccination
AEs within 0-30 minutes after vaccination
The occurrence of all adverse events within 0-30 minutes after each dose of vaccination
Time frame: 0-30 minutes after vaccination
Solicited AEs within 0-7 days after vaccination
The occurrence of all solicited adverse events within 0-7 days after each dose of vaccination
Time frame: 0-7 days after vaccination
Unsolicited AEs within 0-30 days after vaccination
The occurrence of all unsolicited adverse events within 0-30 days after each dose of vaccination.
Time frame: 0-30 days after vaccination
SAE within 0-6 months after primary immunization
The occurrence of all serious adverse events within 0-6 months after primary immunization.
Time frame: 0-6 months after primary immunization
Positive rate of IgG antibodies
Positive rate of susceptible individuals with 15 serotype specific pneumococcal IgG antibodies (percentage of subjects with antibody concentration ≥ 0.35 μ g/ml)
Time frame: 30 days after full vaccination
GMC of IgG antibody
GMC of IgG antibody against 15 serotype specific pneumococcal.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Only administer the Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) and according to the 0, 1, and 2 month procedures (calculated as 30 days per month).
Time frame: 30 days after full vaccination