The purpose of this study is to learn about the safety and immune effects of a pneumococcal vaccine in adults. This vaccine can possibly provide protection against further pneumococcal disease. This study will happen in 4 stages: Stage 1 is seeking participants who are between 18 years to 49 years of age. The participants will receive 1 of 2 pneumococcal vaccine candidates (different formulations) or 20vPnC (Prevnar 20) as a single shot given into the upper arm muscle. Stage 2 will begin after participants have completed Stage 1, and a pneumococcal vaccine candidate has been decided. Stage 2 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or 20vPnC (Prevnar 20). The vaccines will be given as a single shot into the upper arm muscle. Stage 3 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or a licensed pneumococcal comparator vaccine. The vaccines will be given as a single shot into the upper arm muscle. Stage 4 is seeking participants who are adults 50 years of age and older. The participants will receive either one of three pneumococcal vaccine candidates or one of two licensed pneumococcal comparator vaccines. The vaccines will be given as a single shot into the upper arm muscle. Participants will take part in this study for about 6 months for Stage 1, Stage 3, and Stage 4 and 12 months for Stage 2. During this time participants will have from 2 to 4 clinic visits and 1 phone visit. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during these clinic visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,710
Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4).
Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4).
20-valent pneumococcal conjugate vaccine (20vPnC)
A licensed pneumococcal comparator vaccine
Multivalent pneumococcal conjugate vaccine
Multivalent pneumococcal conjugate vaccine
Alliance for Multispecialty Research, LLC
Doral, Florida, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Optimal Research
Peoria, Illinois, United States
Alliance for Multispecialty Research, LLC
New Orleans, Louisiana, United States
Headlands Research - Detroit
Southfield, Michigan, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
IMA Evaluations, LLC dba IMA Clinical Research
Tarrytown, New York, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
AMR Clinical
Knoxville, Tennessee, United States
...and 10 more locations
Percentage of participants reporting prespecified local reactions within 7 days after vaccination
Prespecified local reactions (redness, swelling, and pain at the injection site) after vaccination
Time frame: 7 days
Percentage of participants reporting prespecified systemic events within 7 days after vaccination
Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain) after vaccination
Time frame: 7 days
Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination
Adverse events occurring within 1 month after vaccination
Time frame: 1 month
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
SAEs occurring within 6 months after vaccination
Time frame: 6 months
Phase 2 (Stage 2) Only: Percentage of participants reporting related Serious Adverse Events (SAEs) through 12 months after vaccination
Related SAEs occurring through 12 months after vaccination
Time frame: 12 months
Phase 1 (Stage 1) and Phase 2 (Stage 2) Only: Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)
Pneumococcal OPA GMTs 1 month after vaccination
Time frame: 1 month after vaccination
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