This Phase 1, randomized, double-blind, third-party-unblinded study will be conducted at investigational sites in China. The purpose of the study is to learn about the safety and immune response of 20vPnC and 13vPnC in Chinese adults 50 years of age and older who did not receive any of pneumococcal vaccine in the past
The purpose of the study is to learn about the safety and immune response of 20vPnC and 13vPnC vaccines in Chinese adults. This study is seeking for participants who: * are 50 years of age and older * did not receive any of vaccines used to treat infections caused by the bacteria called Streptococcus pneumonia in the past. The participants will be grouped by three age groups: * Adults between 50 to 59 years of age * Adults between 60 to 64 years of age * Adults who are 65 years of age or above All participants in this study will receive a single dose of 20vPnC or 13vPnC at study clinic. The study will look at the experiences of people receiving 20vPnC and 13vPnC. This will help decide if the study vaccine is safe. The total duration of taking part in the study will be around 6 months, with 6 visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
400
Zhejiang provincial center for disease control and prevention
Hangzhou, Zhejiang, China
Kaihua County Center For Disease Prevention and Control
Kaihua, Zhejiang, China
Kaihua County Center For Disease Prevention and Control
Quzhou, Zhejiang, China
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
Prespecified local reactions (redness, swelling, and pain at the injection site)
Time frame: Within 7 days after vaccination
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain)
Time frame: Within 7 days after vaccination
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration
Adverse events occurring within 1 month after vaccination
Time frame: Within 1 month after vaccination
Percentage of participants reporting serious adverse events (SAEs) throughout the study
SAEs occurring within 6 months after vaccination
Time frame: Within 6 months after vaccination
Percentage of participants reporting abnormal hematology, biochemistry, and urinalysis and microscopy laboratory values
Abnormal hematology, biochemistry, and urinalysis and microscopy laboratory values
Time frame: 3 to 5 days after vaccination
Pneumococcal serotype-specific Opsonophagocytic activity (OPA) geometric mean titer (GMT)
Pneumococcal serotype-specific OPA GMTs
Time frame: 1 month after vaccination
Pneumococcal serotype-specific OPA geometric mean fold rise (GMFR)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pneumococcal serotype-specific OPA GMFRs
Time frame: Before vaccination to 1 month after vaccination