The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) in healthy children, adults and elderly. The control vaccine is a commercialized 23-valent PPV.
This study is a randomized, double-blind, single-center, controlled phase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) manufactured by Sinovac Biotech Co., Ltd. The primary objective of this study is to demonstrate that the immunogenicity of the investigational vaccine is non-inferior to that of a commercialized 23-valent PPV manufactured by Chengdu Institute of Biological products Co., Ltd.; the secondary objective is to assess the safety of the investigational and control vaccines. Participants will be grouped into three cohorts by age: child cohort (2 - 17 years old), adult cohort (18 - 60 years old) and elderly cohort (≥ 61 years old). In each cohort, the participants will be randomly assigned into experimental group or control group in the ratio 1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,760
The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.
The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd.
Kaifeng County Center for Disease Control and Prevention
Kaifeng, Henan, China
The seroconversion rates (SCR) of each of the 23 pneumococcal serotypes
For each serotype, the SCR is the percentage of participants with the increase of relative antibody concentration ≥ 2 folds after vaccination. The relative antibody concentrations were measured using Enzyme Linked Immunosorbent Assay (ELISA).
Time frame: 28 days
The incidences of adverse events (AEs)
After each injection, a 30-minute safety observation was conducted immediately. The body temperature, occurrence of solicited local and general AEs on day 0 - 7 were reported. Unsolicited AEs occurred during day 0 - 28 were also reported. Each AE case was reviewed by the investigator to determine whether or not it was an adverse reaction (related to the vaccination).
Time frame: 28 days
The increases of relative antibody concentration against each of the 23 pneumococcal serotypes
The relative antibody concentrations in the pre- and post-immunization serum samples were measured using ELISA.
Time frame: 28 days
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