The purpose of this study is to learn about the safety and tolerability of a pneumococcal vaccine in adults. Participants will receive either: * an experimental PG4 vaccine * a PG4 vaccine comparator * a standard 20vPnC vaccine comparator * placebo. A placebo does not have any medicine in it but looks just like the study medicine. Participants will take part in this study for up to 18 months depending on which group they are assigned to. During this time, the participants will receive up to two doses of study vaccine or comparator and take part in follow-up visits. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during clinic visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
380
Multivalent pneumococcal conjugate vaccine
Multivalent pneumococcal conjugate vaccine
Multivalent pneumococcal conjugate vaccine
Multivalent pneumococcal conjugate vaccine
Multivalent pneumococcal conjugate vaccine
(20vPnC)
Placebo
Orange County Research Center
Lake Forest, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Finlay Medical Research
Greenacres City, Florida, United States
Indago Research & Health Center, Inc.
Miami Lakes, Florida, United States
Johnson County Clinical Trials
Lenexa, Kansas, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
Springfield, Missouri, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, United States
Upstate Global Health Institute
East Syracuse, New York, United States
...and 10 more locations
Percentage of participants reporting prespecified local reactions after each dose.
Prespecified local reactions (redness, swelling, and pain at the injection site) occurring within 7 days of each dose administered in the study.
Time frame: Within 7 days after each study intervention.
Percentage of participants reporting prespecified systemic reactions after each dose.
Prespecified systemic reactions (fever, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain) occurring within 7 days of each dose administered in the study.
Time frame: Within 7 days after each study intervention.
Percentage of participants reporting adverse events.
Adverse Events (AEs) occurring from Dose 1 through 1 month after the last vaccination
Time frame: From signing of the ICD to 1 month after last study intervention.
Percentage of participants reporting serious adverse events.
Serious Adverse Events (SAEs) occurring from Dose 1 through 6 months after the last vaccination.
Time frame: From signing of the ICD to 6 months after the last study intervention.
Percentage of participants reporting serious adverse events.
Serious Adverse Events (SAEs) occurring from Dose 1 through 12 months after the last vaccination.
Time frame: From signing of the ICD to 12 months after the last study intervention.
Percentage of participants with abnormal hematology and chemistry laboratory values.
Any abnormal hematology or chemistry laboratory values as compared to baseline within 2 weeks after each study intervention.
Time frame: Within 2 weeks after each study intervention.
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