Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination
- Conditions
- Pneumococcal Disease
- Interventions
- Biological: PPSV23Biological: 20vPnCBiological: 13vPnC
- Registration Number
- NCT03835975
- Lead Sponsor
- Pfizer
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 875
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PPSV23 PPSV23 Pneumococcal polysaccharide vaccine 20vPnC 20vPnC Pneumococcal conjugate vaccine 13vPnC 13vPnC Pneumococcal conjugate vaccine
- Primary Outcome Measures
Name Time Method Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination 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.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 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).
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 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.
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination 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.
Percentage of Participants With Local Reactions Within 10 Days After Vaccination 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).
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination 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.
- Secondary Outcome Measures
Name Time Method Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination 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.
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination 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.
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination 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.
Trial Locations
- Locations (37)
East Valley Gastroenterology and Hepatology Associates
🇺🇸Chandler, Arizona, United States
The Pain Center of Arizona
🇺🇸Phoenix, Arizona, United States
Meridian Clinical Research, LLC
🇺🇸Norfolk, Nebraska, United States
Medical Research South, LLC
🇺🇸Goose Creek, South Carolina, United States
Ladulaas Kliniska Studier
🇸🇪Boras, Sweden
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Synexus Clinical Research US, Inc
🇺🇸The Villages, Florida, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Clinical Research Consulting, LLC
🇺🇸Milford, Connecticut, United States
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
Kaiser Permanente Center For Health Research
🇺🇸Portland, Oregon, United States
Sterling Research Group, Ltd.
🇺🇸Cincinnati, Ohio, United States
Infektionskliniken
🇸🇪Eskilstuna, Sweden
CTC Gothia Forum
🇸🇪Goteborg, Sweden
Akardo Med Site
🇸🇪Stockholm, Sweden
Karolinska Trial Alliance, KTA Prim
🇸🇪Stockholm, Sweden
MedPharmics, LLC
🇺🇸Albuquerque, New Mexico, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Columbia Research Group, Inc.
🇺🇸Portland, Oregon, United States
Carolina Institute for Clinical Research
🇺🇸Fayetteville, North Carolina, United States
Ventavia Research Group
🇺🇸Keller, Texas, United States
ProbarE i Lund
🇸🇪Lund, Sweden
J. Lewis Research, Inc. / Jordan River Family Medicine
🇺🇸South Jordan, Utah, United States
PharmaSite
🇸🇪Malmo, Skane, Sweden
Avdelningen for Kliniska Provningar
🇸🇪Orebro, Sweden
J. Lewis Research, Inc. / Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Optimal Research, LLC
🇺🇸Melbourne, Florida, United States
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
Kaiser Permanente Washington Health Research Institute
🇺🇸Seattle, Washington, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
PMG Research of Wilmington, LLC
🇺🇸Wilmington, North Carolina, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
J. Lewis Research Inc. / Foothill Family Clinic Draper
🇺🇸Draper, Utah, United States
J. Lewis Research, Inc. - Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States