The purpose of this study is to evaluate a study vaccine called 20-valent pneumococcal conjugate vaccine (20vPnC). The study will assess whether the study vaccine is safe to use in healthy infants. It will also evaluate if the study vaccine can help the body make antibodies (known as immune response). These antibodies help protect against 20 types of pneumococcal bacteria. The study will compare 20vPnC with 13vPnC (control vaccine), which is approved for use in infants. The study is seeking participants who: * Are healthy infants * Aged 42 to 98 days of age at the time of consent. Infants will receive either 20vPnC or 13vPnC. Doses will be given at approximately 2, 4, and 6 months of age (Doses 1 through 3). A fourth dose will be given at 12 to 15 months of age. Infants will receive the same vaccine (20vPnC or 13vPnC) for all 4 doses. The total time of the study will be about 16 to 19 months. A subset of infants will be asked to stay in the study for longer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,250
20vPnC vaccine
13vPnC vaccine
Hezhou Center for Disease Control and Prevention
Hezhou, Guangxi, China
RECRUITINGGuangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Nanning, Guangxi, China
RECRUITINGWuming District Center for Disease Control and Prevention
Nanning, Guangxi, China
RECRUITINGZhongshan County Center for Disease Control and Prevention
Zhongshan Town, Guangxi, China
RECRUITINGPercentage of participants reporting prespecified local reactions
Time frame: From Day 1 (the day of vaccination) through Day 7 following Vaccinations 1, 2, 3, and 4
Percentage of participants reporting prespecified systemic events
Time frame: From Day 1 (the day of vaccination) through Day 7 following Vaccinations 1, 2, 3, and 4
Percentage of participants reporting Adverse Events (AEs) from the first study vaccination through 1 month following the third study vaccination.
Time frame: From the first study vaccination to 1 month after the third study vaccination
Percentage of participants reporting AEs from the fourth study vaccination to 1 month following the fourth study vaccination.
Time frame: From the fourth study vaccination to 1 month after the fourth study vaccination
Percentage of participants reporting serious adverse events (SAEs) through 6 months post last vaccination
Time frame: From the first study vaccination to 6 months after the last study vaccination
The percentages of participants with predefined serotype-specific immunoglobulin G (IgG) concentrations in 20vPnC group compared to 13vPnC group at 1 month after Dose 3
Time frame: At 1 month after Dose 3
The serotype-specific IgG geometric mean concentrations (GMCs) in 20vPnC group compared to 13vPnC group at 1 month after Dose 3
Time frame: At 1 month after Dose 3
The percentages of participants with predefined serotype-specific immunoglobulin G (IgG) concentrations in 20vPnC group compared to 13vPnC group at 1 month after Dose 4
Time frame: At 1 month after Dose 4
The serotype-specific IgG geometric mean concentrations (GMCs) in 20vPnC group compared to 13vPnC group at 1 month after Dose 4
Time frame: At 1 month after Dose 4
To further describe the immune response of 20vPnC
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Time frame: At prior to Dose 1, 1 months after Dose 3, prior to Dose 4 and 1 month after Dose 4
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