A Phase 2 clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in the pediatric population aged 2 months (minimum 42 days) to 5 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, positive controlled phase 2 clinical trial.
A phase 2 clinical trial of the study of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV24) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in the Chinese pediatric population aged 2 months (minimum 42 days) to 5 years. The trial is a randomized, double-blind, positive-controlled study. The objective of this study is to evaluate the safety and immunogenicity of PCV24 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Prevenar13®, manufactured by Pfizer. A total of at least 420 participants aged 2 months (minimum 42 days) to 5 years will be enrolled. Participants will be randomized in a 1:1 ratio to the test group and control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
420
Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules.
Prevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules.
Qichun District Center for Disease Prevention and Control
Huanggang, Hubei, China
RECRUITINGXiangzhou District Center for Disease Prevention and Control
Xiangyang, Hubei, China
RECRUITINGXian'an District Center for Disease Prevention and Control
Xianning, Hubei, China
RECRUITINGPneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
Time frame: 30 days after primary vaccination
Incidence of adverse reactions
Time frame: 0-30 days after vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)
Time frame: 30 days after the 2nd dose of the primary vaccination (2-month-olds), 30 days after primary vaccination (all participants)
OPA antibody levels for each pneumococcal serotype
Time frame: 30 days after vaccination
Incidence of adverse reactions
Time frame: 0-7 days after vaccination
Incidence of serious adverse events (SAE)
Time frame: from vaccination to 6 months after final dose
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