A Phase 1b clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 42 days)-23 months. 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 Ib clinical trial.
A phase 1b 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 Chinese pediatric population aged 2 months (minimum 42 days)-23 months. 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 180 participants aged 2 months (minimum 42 days)-23 months will be enrolled. Participants will be randomized in 1:1 ratio to the test group and control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
180
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.
Shandong Provincial Center for Disease Control and Prevention
Jinan, Shandong, China
NOT_YET_RECRUITINGShanxian Center for Disease Control and Prevention
Shancheng, Shandong, China
RECRUITINGIncidence of adverse reactions
Incidence of adverse reactions within 30 days after vaccination
Time frame: 0-30 days after vaccination
Incidence of adverse reactions
Incidence of adverse reactions within 7 days after vaccination
Time frame: 0-7 days after vaccination
Incidence of serious adverse events (SAE)
Incidence of SAE during the period of safety monitoring
Time frame: from vaccination to 6 months after final dose
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
IgG GMC 30 days after primary vaccination
Time frame: 30 days after primary vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)
IgG GMI 30 days after primary vaccination
Time frame: 30 days after primary vaccination
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Time frame: 30 days after primary vaccination
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate)
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate)
Time frame: 30 days after primary vaccination
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