The purpose of this clinical trial is to learn about a pneumococcal vaccine with a new ingredient (PF-07872411) intended to enhance the effects of the vaccine. This pneumococcal vaccine with the new ingredient may prevent the diseases caused by pneumococcal bacteria like meningitis, sepsis, ear infections and sinusitis. Meningitis is an infection in which the tissue around the brain and spine is swollen. Sepsis is a very serious infection in your blood caused by a germ (a bacteria). Sinusitis is when your sinuses (the air-filled spaces inside your nose and head), are infected. This study is seeking for healthy participants who: * are above 50 years of age and less than 64 years of age. * have not taken any vaccine for pneumococcal diseases before. * have not taken any vaccines with additional ingredients within 1 year before administration of the study vaccine. All participants will receive a single study vaccine shot in the upper arm muscle at the study clinic. The study will compare the experiences of people receiving the vaccine with a new ingredient in the vaccine to those without the new ingredient. This will be done by comparing 2 different dose levels of the new ingredient. It will also be compared against people who receive the vaccine without the new ingredient and at different dose levels. This will help the study team establish if the vaccine with a new ingredient is safe and effective. Participants will take part in this study for about 12 months. During this time participants will have up to 6 clinic 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 these visits. Some participants will need to have blood taken for laboratory tests before they can be judged to be eligible to be included in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
90
low dose multivalent pneumococcal conjugate vaccine
multivalent pneumococcal conjugate vaccine
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Research Centers of America ( Hollywood )
Hollywood, Florida, United States
Research Centers of America
Hollywood, Florida, United States
Centennial Medical Group
Columbia, Maryland, United States
Centennial Medical Group
Elkridge, Maryland, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
Percentage of participants reporting local reactions within 7 days after vaccination
Local reactions (redness, swelling, pain at the injection site) after vaccination.
Time frame: 7 days
Percentage of participants reporting systemic events within 7 days after vaccination
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, 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
Percentage of participants reporting Serious Adverse Events (SAEs) withing 12 months after vaccination
SAEs occurring within 12 months after vaccination.
Time frame: 12 months
Percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) within 6 months after vaccination
NDCMCs occurring within 6 months after vaccination.
Time frame: 6 months
Percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) withing 12 months after vaccination
NDCMCs occurring within 12 months after vaccination.
Time frame: 12 months
Percentage of participants reporting Medically Attended Adverse Events (MAAEs) within 6 months after vaccination
MAAEs occurring within 6 months after vaccination.
Time frame: 6 months
Percentage of participants reporting Medically Attended Adverse Events (MAAEs) within 12 months after vaccination
MAAEs occurring within 12 months after vaccination.
Time frame: 12 months
Stage 1 and Stage 2 Only - Percentage of participants with abnormal hematology and chemistry laboratory values 2 weeks after vaccination
Abnormal hematology and chemistry laboratory values occurring 2 weeks after vaccination.
Time frame: 2 weeks
Pneumococcal opsonophagocytic activity (OPA) titers
OPA geometric mean titers (GMTs) 1 month after vaccination
Time frame: 1 month
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