This Phase 3 will describe the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine formulation in adults 65 years of age or older with prior pneumococcal vaccination
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
875
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Time frame: Within 10 days after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as temperature \>=38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity).
Time frame: Within 7 days after vaccination
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Time frame: Within 1 month after vaccination
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event.
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Coastal Clinical Research, Inc.
Mobile, Alabama, United States
East Valley Gastroenterology and Hepatology Associates
Chandler, Arizona, United States
The Pain Center of Arizona
Peoria, Arizona, United States
HOPE Research Institute
Phoenix, Arizona, United States
The Pain Center of Arizona
Phoenix, Arizona, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Clinical Research Consulting, LLC
Milford, Connecticut, United States
Optimal Research, LLC
Melbourne, Florida, United States
Synexus Clinical Research US, Inc
The Villages, Florida, United States
...and 32 more locations
Time frame: Within 6 months after vaccination
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects.
Time frame: Within 6 months after vaccination
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution.
Time frame: 1 month after vaccination
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
OPA GMFR is the ratio of OPA GMTs, 1 month after vaccination to before vaccination. OPA GMFRs from before to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Time frame: From before vaccination to 1 month after vaccination
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Percentage of participants with a \>=4-fold rise in pneumococcal OPA titers from before vaccination to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Time frame: From before vaccination to 1 month after vaccination
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
The percentage of participants with OPA titers \>=LLOQ at 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Time frame: 1 month after vaccination