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A Phase Ia clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2-17 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, controlled combined with open-label phase Ia clinical trial.
Full description
A phase Ia clinical trial of the study of 24-valent Pneumococcal Conjugate Vaccine (PCV24) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese children aged 2-17 years. The trial is a randomized, double-blind, controlled combined with open-label 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 for participants aged 2-5 years is the Prevenar13® manufactured by Pfizer.
A total of at least 114 participants will be enrolled, including 24 children aged 6-17 years and 90 children aged 2-5 years. Children aged 6-17 years will receive PCV24 formulation 1 and PCV24 formulation 2 in a 1:1 ratio. Children aged 2-5 years will receive PCV24 formulation 1, PCV24 formulation 2 and Prevenar13® in a 1:1:1 ratio.
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114 participants in 3 patient groups
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Kai Chu
Data sourced from clinicaltrials.gov
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