This study is a randomized, blinded, parallel controlled phase 3 clinical trial to evaluate the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,920
23-valent pneumococcal polysaccharide vaccine from Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
23-valent pneumococcal polysaccharide vaccine from Merck Sharp \& Dohme Corp
Sichuan Center For Disease Control and Prevention
Chengdu, Sichuan, China
RECRUITING2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,
2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,
Time frame: 30 days
Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination
Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination
Time frame: 30 days
Incidence of adverse reactions/events within 30 minutes of vaccination
Incidence of adverse reactions/events within 30 minutes of vaccination
Time frame: 30 min after vaccination
Incidence of adverse reactions/events on days 0 to 7 after vaccination
Incidence of adverse reactions/events on days 0 to 7 after vaccination
Time frame: 7 days
Incidence of adverse reaction/event on days 0 to 30 after vaccination
Incidence of adverse reaction/event on days 0 to 30 after vaccination
Time frame: 30 days
Incidence of serious adverse events (SAE) within 6 months after vaccination
Incidence of serious adverse events (SAE) within 6 months after vaccination
Time frame: 6 months
Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination
Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination
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Time frame: 30 days
GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination
GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination
Time frame: 3, 6 years after vaccination