A Study to Learn About How Safe and Effective is 20vPnC and 13vPnC Vaccines in Chinese Adults
- Conditions
- Pneumococcal Disease
- Interventions
- Registration Number
- NCT07019909
- Lead Sponsor
- Pfizer
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 20vPnC 20vPnC Single dose of 20-valent pneumococcal conjugate vaccine 13vPnC 13vPnC Single dose of 13-valent pneumococcal conjugate vaccine
- Primary Outcome Measures
Name Time Method Percentage of participants reporting prompted systemic events within 7 days following investigational product administration Within 7 days after vaccination Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain)
Percentage of participants reporting serious adverse events (SAEs) throughout the study Within 6 months after vaccination SAEs occurring within 6 months after vaccination
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration Within 1 month after vaccination Adverse events occurring within 1 month after vaccination
Percentage of participants reporting abnormal hematology, biochemistry, and urinalysis and microscopy laboratory values 3 to 5 days after vaccination Abnormal hematology, biochemistry, and urinalysis and microscopy laboratory values
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration Within 7 days after vaccination Prespecified local reactions (redness, swelling, and pain at the injection site)
- Secondary Outcome Measures
Name Time Method Pneumococcal serotype-specific OPA geometric mean fold rise (GMFR) Before vaccination to 1 month after vaccination Pneumococcal serotype-specific OPA GMFRs
Pneumococcal serotype-specific Opsonophagocytic activity (OPA) geometric mean titer (GMT) 1 month after vaccination Pneumococcal serotype-specific OPA GMTs
Related Research Topics
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Trial Locations
- Locations (2)
Zhejiang provincial center for disease control and prevention
🇨🇳Hangzhou, Zhejiang, China
Kaihua County Center For Disease Prevention and Control
🇨🇳Kaihua, Zhejiang, China
Zhejiang provincial center for disease control and prevention🇨🇳Hangzhou, Zhejiang, China