The purpose of this experiment is to evaluate the safety and immunogenicity of the 26 valent pneumococcal conjugate vaccine in the population aged 2 months and above.
A single-center, randomized, double-blind, active-controlled trial design (Phase I/II) was used. In addition, according to the requirements in the approval letter of this product (2024LP01053), serum standards need to be established for the newly added types (24F, 35B). Therefore, a calibration group is set and an open study design is adopted.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
450
As an experimental group. The active ingredient of 26-valent pneumococcal conjugate vaccine is the capsular polysaccharide of 26 pneumococcal serotypes conjugated to the tetanus toxoid carrier protein. Administer one dose of 0.5mL each time.
As a control group. The effective ingredients of 23-valent pneumococcal polysaccharide vaccine are 23 serotypes of pneumococcal capsular polysaccharides. Administer one dose of 0.5mL each time.
As a control group. The active ingredient of 13-valent pneumococcal conjugate vaccine is the capsular polysaccharide of 13 pneumococcal serotypes conjugated to the tetanus toxoid carrier protein. Administer one dose of 0.5mL each time.
Henan Provincial Center for Disease Control and Prevention
Shangqiu, Henan, China
AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ)
All AE occurrences within 0-30 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination)
Time frame: 30 day after each vaccination
Solicited AE occurrences within 0-30 minutes after each dose of vaccination (for phase Ⅰ/Ⅱ)
The occurrence of Solicited adverse events (AE) within 0-30 minutes after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination)
Time frame: 30 minutes after each vaccination
Solicited AE occurrences within 0-7 days after each dose of vaccination (for phase Ⅰ/Ⅱ)
The occurrence of solicited adverse events (AE) within 0-7 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination);
Time frame: 0-7 days after each vaccination
Unsolicited AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ)
The occurrence of unsolicited adverse events (AE) within 0-30 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination);
Time frame: 0-30 days after each vaccination
Grade 3 and above AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ)
The occurrence of grade 3 and above adverse events within 0-30 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination).
Time frame: 0-30 days after each vaccination
All SAE occurrences within 0-6 months after vaccination (for Phase Ⅱ)
The occurrence of all serious adverse reactions within 6 months after vaccination (number of cases, incidence rate, and relationship with vaccination)
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Time frame: 0-6 months after each vaccination
Positive rate of serotype-specific pneumococcal IgG antibody on the 30th day after immunization in subjects aged 2-5 years (for phase Ⅱ)
Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 μg/ml on Day 30 after vaccination in subjects aged 2-5 years
Time frame: 30 day after vaccination
All SAE in the population aged ≥12 months during 0-6 months after vaccination (for phase Ⅰ)
All SAE in the population aged 12 months and older from the first dose to 6 months after the full course of vaccination
Time frame: 0-6 months after vaccination
All SAE in the population aged <12 months from the first dose to 6 months after the primary immunization and from the booster to 6 months after the booster(for phase Ⅰ)
All SAE from the first dose to 6 months after the primary immunization and from the booster to 6 months after the booster in the population less than 12 months of age.
Time frame: From the first dose to 6 months after the primary immunization and from the booster to 6 months after the booster
Proportion of IgG antibodies ≥ 1.0 µg/mL and GMC results on Day 30 post-immunization(for phase Ⅱ)
Proportion of subjects with serotype-specific pneumococcal IgG antibodies ≥ 1.0 µg/mL and GMC results on Day 30 post-immunization in subjects 2 to 5 years of age.
Time frame: 30 day after vaccination