Pneumococcal Disease
Conditions
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.
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key inclusion criteria: 1.Generally healthy adults including those with preexisting stable disease determined to be eligible based on clinical assessment, medical history and clinical judgment. Key
Exclusion criteria
1. History of microbiologically-proven invasive disease caused by Streptococcus pneumoniae 2. Previous vaccination with any licensed or investigational pneumococcal vaccine or planned receipt through study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 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 serious adverse events (SAEs) throughout the study | Within 6 months after vaccination | SAEs occurring within 6 months 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pneumococcal serotype-specific Opsonophagocytic activity (OPA) geometric mean titer (GMT) | 1 month after vaccination | Pneumococcal serotype-specific OPA GMTs |
| Pneumococcal serotype-specific OPA geometric mean fold rise (GMFR) | Before vaccination to 1 month after vaccination | Pneumococcal serotype-specific OPA GMFRs |
Countries
China
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed