A phase 1b clinical trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2 months (42-89 days) and 2 to 5 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV13. The trial is a randomized, double blinded, positive controlled study.
A phase Ⅰb clinical trial of the study of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese children aged 2 months (42-89 days) and 2 to 5 years. The trial is an randomized, double-blind and active controlled study. The objective of this study is to evaluate the safety and immunogenicity of PCV13 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is the PREVNAR 13 manufactured by Pfizer Inc. A total of 140 participants will be enrolled, including 70 children aged 2-5 years old, and 70 infants aged 2 months (42-89 days). Participants will be randomized to receive either Sinovac PCV13 or Pfizer PCV13 in a 1:1 ratio. Children aged 2-5 years old will receive 1 dose; Infants aged 2 months will receive 4 doses, including 3 doses (two-month interval) in primary vaccination and a booster dose at the age of 12-15 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
140
0.5 mL dose of Sinovac PCV13 contains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.
0.5 mL dose of PREVNAR 13 contains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.
Binchuan County Center for Diseases Control and Prevention
Dali, Yunnan, China
Incidence of adverse reactions
Incidence of adverse reactions within 30 days after each dose
Time frame: 0-30 days after each dose
Incidence of adverse reactions
Incidence of adverse reactions within 7 days after each dose
Time frame: 0-7 days after each dose
Incidence of SAE
Incidence of SAE during the period of safety monitoring
Time frame: 6 months after vaccination for children aged 2-5 years; 1 month after completion of booster vaccination for infants aged 2 months.
IgG concentration ≥0.35μg/mL for infants aged 2 months
The proportion of participants achieving an IgG concentration ≥0.35μg/mL (seropositivity rate) for each serotype 30 days after primary/booster immunization.
Time frame: 30 days after primary/booster immunization
IgG concentration ≥1.0μg/mL for infants aged 2 months
The proportion of participants achieving an IgG concentration ≥1.0μg/mL for each serotype 30 days after primary/booster immunization.
Time frame: 30 days after primary/booster immunization
GMCs for infants aged 2 months
GMCs for each serotype 30 days after primary/booster immunization
Time frame: 30 days after primary/booster immunization
GMIs for infants aged 2 months
GMIs (GMC increase folds) for each serotype 30 days after primary/booster immunization
Time frame: 30 days after primary/booster immunization
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IgG concentration ≥0.35μg/mL for children aged 2-5 years
The proportion of participants achieving an IgG concentration ≥0.35μg/mL (seropositivity rate) for each serotype 30 days after vaccination.
Time frame: 30 days after vaccination
IgG concentration ≥1.0μg/mL for children aged 2-5 years
The proportion of participants achieving an IgG concentration ≥1.0μg/mL for each serotype 30 days after vaccination.
Time frame: 30 days after vaccination
GMCs for children aged 2-5 years
GMCs for each serotype 30 days after vaccination
Time frame: 30 days after vaccination
GMIs for children aged 2-5 years
GMIs (GMC increase folds) for each serotype 30 days after vaccination
Time frame: 30 days after vaccination