Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
- Conditions
- Pneumococcal Disease
- Interventions
- Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)Other: SalineBiological: Influenza vaccine
- Registration Number
- NCT04526574
- Lead Sponsor
- Pfizer
- Brief Summary
Study of the safety and immunogenicity of 20vPnC and influenza vaccine administered at the same visit or separately
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1796
- Male or female participants ≥65 years of age at the time of consent
- Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease
- Adults who have no history of ever receiving a pneumococcal vaccine, or have a history of receiving a licensed pneumococcal vaccination ≥6 months prior to first study vaccination.
-
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
-
Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation.
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Vaccination with any influenza or pneumococcal vaccine <6 months before investigational product administration, or planned receipt of any licensed or investigational non-study influenza vaccine during study participation.
-- Serious chronic disorder, that in the investigator's opinion would make the participant inappropriate for entry into the study
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Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Coadministration Group Experimental 20-valent pneumococcal conjugate vaccine (20vPnC) Participants receive injections of pneumococcal vaccine (20vPnC) and influenza vaccine at the same visit, and then receive an injection of saline 1 month later. Coadministration Group Saline Participants receive injections of pneumococcal vaccine (20vPnC) and influenza vaccine at the same visit, and then receive an injection of saline 1 month later. Coadministration Group Influenza vaccine Participants receive injections of pneumococcal vaccine (20vPnC) and influenza vaccine at the same visit, and then receive an injection of saline 1 month later. Separate Administration Group Influenza vaccine Participants receive injections of saline and influenza vaccine at the same visit, and then receive an injection of 20vPnC 1 month later. Separate Administration Group Experimental 20-valent pneumococcal conjugate vaccine (20vPnC) Participants receive injections of saline and influenza vaccine at the same visit, and then receive an injection of 20vPnC 1 month later. Separate Administration Group Saline Participants receive injections of saline and influenza vaccine at the same visit, and then receive an injection of 20vPnC 1 month later.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) up to 6 Months After Last Vaccination Up to 6 months after last Vaccination (i.e. up to 7 months) An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with NDCMC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine Within 7 days after each vaccination Systemic events including fever, fatigue, headache, muscle pain and joint pain were recorded by participants using an e-diary. Fever was defined as temperature \>=38.0 degree Celsius (C) and categorized as \>=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 systemic events within 7 days after each vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC 1 month after the 20vPnC administration in each group (1 month after Vaccination 1 in the Coadministration group and 1 month after Vaccination 2 in the Separate Administration group). OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed OPA titers using a regression model
Model-Based Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Titers (GMT) at 1 Month After Vaccination With SIIV At 1 month after Vaccination 1 with SIIV HAI titers to the influenza strains (A/H1N1, A/H3N2, B/Victoria, and B/Phuket) in the SIIV administered sera samples was collected and reported in this outcome measure at 1 month after Vaccination 1. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed HAI titers using a regression model.
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Each Vaccination by Each Vaccine Within 1 month after each vaccination An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Percentage of Participants With Serious Adverse Events (SAEs) From the First Vaccination up to 6 Months After Last Vaccination From Day 1 up to 6 months after last Vaccination (i.e. up to 7 months) An SAE was defined as any untoward medical occurrence that, 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 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 SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC Within 10 days after Vaccination 1 for Coadministration group and within 10 days after Vaccination 2 for Separate Administration group Local reactions were collected at the 20vPnC injection sites after Vaccination 1 and Vaccination 2 and were recorded by the participants 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). Percentage of participants with local reactions at the 20vPnC injection site in the Coadministration group and the Separate administration group and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Greater Than or Equal to (≥4) Fold Rise in Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination With 20vPnC Before Vaccination 1 to 1 month after 20vPnC vaccination in both groups (i.e., 1 month after Vaccination 1 in Coadministration group and 1 month after Vaccination 2 in Separate Administration group) OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. Percentage of participants with \>=4 fold rise in serotype-specific OPA titers from before vaccination to 1 month after vaccination with 20vPnC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC Before Vaccination 1 to 1 month after 20vPnC vaccination in both groups (i.e., 1 month after Vaccination 1 in Coadministration group and 1 month after Vaccination 2 in Separate Administration group) OPA titers were measured from serum samples for serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the OPA titers or fold rises and the corresponding CIs.
Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Fold Rise (GMFR) Before Vaccination to 1 Month After Vaccination With SIIV Before Vaccination 1 to 1 month after Vaccination 1 with SIIV HAI titers were measured from serum samples for serotypes A/H1N1, A/H3N2, B/Victoria, B/Phuket. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with SIIV. GMFRs were calculated for participants with non-missing values both before and after vaccination.
Trial Locations
- Locations (53)
Indago Research and Health Center, Inc.
🇺🇸Hialeah, Florida, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
East Valley Gastroenterology and Hepatology Associates
🇺🇸Chandler, Arizona, United States
Paradigm Clinical Research Center
🇺🇸Redding, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Alliance for Multispecialty Research, LLC - Miami
🇺🇸Coral Gables, Florida, United States
Nature Coast Clinical Research
🇺🇸Crystal River, Florida, United States
Lakes Research
🇺🇸Miami Lakes, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Alpha Science Research, LLC
🇺🇸Miami, Florida, United States
Meridian Clinical Research, LLC
🇺🇸Endwell, New York, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Orlando, Florida, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Advanced Clinical Research
🇺🇸Meridian, Idaho, United States
Sundance Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
PMG Research of Charlotte, LLC
🇺🇸Charlotte, North Carolina, United States
PharmQuest
🇺🇸Greensboro, North Carolina, United States
M3 Wake Research, Inc.
🇺🇸Raleigh, North Carolina, United States
Accellacare - Raleigh
🇺🇸Raleigh, North Carolina, United States
PMG Research of Hickory, LLC
🇺🇸Hickory, North Carolina, United States
PMG Research of Rocky Mount, LLC
🇺🇸Rocky Mount, North Carolina, United States
PMG Research of Wilmington, LLC
🇺🇸Wilmington, North Carolina, United States
Lillestol Research LLC
🇺🇸Fargo, North Dakota, United States
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Main Street Physician's Care
🇺🇸Little River, South Carolina, United States
Internal Medicine and Pediatric Associates of Bristol, PC
🇺🇸Bristol, Tennessee, United States
Velocity Clinical Research, Austin
🇺🇸Cedar Park, Texas, United States
Benchmark Research
🇺🇸Fort Worth, Texas, United States
Texas Health Resource
🇺🇸Fort Worth, Texas, United States
Wellness Clinical Research
🇺🇸McKinney, Texas, United States
LinQ Research, LLC
🇺🇸Pearland, Texas, United States
Martin Diagnostic Clinic
🇺🇸Tomball, Texas, United States
J. Lewis Research Inc. / Foothill Family Clinic Draper
🇺🇸Draper, Utah, United States
J. Lewis Research, Inc / Jordan River Family Medicine
🇺🇸South Jordan, Utah, United States
Alliance for Multispecialty Research - Norfolk
🇺🇸Norfolk, Virginia, United States
National Clinical Research, Inc
🇺🇸Richmond, Virginia, United States
Allegiance Research Specialists, LLC
🇺🇸Wauwatosa, Wisconsin, United States
Centennial Medical Group
🇺🇸Elkridge, Maryland, United States
Suncoast Research Group, LLC
🇺🇸Miami, Florida, United States
Velocity Clinical Research, Inc.
🇺🇸Cleveland, Ohio, United States
Texas Center for Drug Development, Inc.
🇺🇸Houston, Texas, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
California Research Foundation
🇺🇸San Diego, California, United States
Meridian Clinical Research
🇺🇸Cincinnati, Ohio, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Clinical Research Associates, Inc.
🇺🇸Nashville, Tennessee, United States
Diagnostics Research Group
🇺🇸San Antonio, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
Hope Research Institute
🇺🇸Phoenix, Arizona, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Alliance for Multispecialty Research, LLC
🇺🇸New Orleans, Louisiana, United States