Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.
NCT ID: NCT02124161
Last Updated: 2016-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
882 participants
INTERVENTIONAL
2014-09-30
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
BASIC_SCIENCE
TRIPLE
Study Groups
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13vPnC+SIIV/Placebo
13-valent pneumococcal conjugate vaccine
One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
Seasonal Inactivated Influenza Vaccine
One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.
Placebo
One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
Placebo+SIIV/13vPnC
Placebo
One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
Seasonal Inactivated Influenza Vaccine
One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.
13-valent pneumococcal conjugate vaccine
One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
Interventions
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13-valent pneumococcal conjugate vaccine
One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
Seasonal Inactivated Influenza Vaccine
One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.
Placebo
One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
Placebo
One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
Seasonal Inactivated Influenza Vaccine
One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.
13-valent pneumococcal conjugate vaccine
One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female adults 50 years of age or older.
3. Documented vaccination with 1 or more prior doses of 23vPS, the last given at least 1 year prior to study enrollment.
4. Negative urine pregnancy test for all female subjects who are of child bearing potential.
Exclusion Criteria
2. History of severe adverse reactions associated with any vaccine or vaccine-related component.
3. Allergic to egg proteins (egg or egg products) and chicken proteins.
4. History of Guillain-Barré syndrome.
5. Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.
6. Documented S pneumoniae infection within the past 5 years before investigational product administration.
50 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Optimal Research (Formerly Accelovance)
Huntsville, Alabama, United States
Radiant Research, Inc.
Scottsdale, Arizona, United States
Kaiser Permanente Vaccine Study Center
Oakland, California, United States
Kaiser Permanante South. Sacramento
Sacramento, California, United States
Benchmark Research
San Francisco, California, United States
Kaiser Pemanente Santa Clara
Santa Clara, California, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Radiant Research, Inc.
Pinellas Park, Florida, United States
Meridian Clinical Research
Savannah, Georgia, United States
Optimal Research, LLC
Mishawaka, Indiana, United States
Clinical Research Advantage, Inc/Ridge Family Practice
Council Bluffs, Iowa, United States
Johnson County Clin-Trials, Inc.
Lenexa, Kansas, United States
Benchmark Research
Metairie, Louisiana, United States
Meridian Clinical Research
Bellevue, Nebraska, United States
Meridian Clinical Research
Norfolk, Nebraska, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Clinical Research Center of Nevada, LLC
Las Vegas, Nevada, United States
Clinical Research Advantage, Inc.
Las Vegas, Nevada, United States
United Medical Associates
Binghamton, New York, United States
Regional Clinical Research, Inc.
Endwell, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
Cary, North Carolina, United States
PharmQuest
Greensboro, North Carolina, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, United States
Clinical Trials of America, Inc.
Winston-Salem, North Carolina, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Radiant Research, Inc
Columbus, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
Preferred Primary Care Physicians, Inc.
Carnegie, Pennsylvania, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
PMG Research of Charleston
Mt. Pleasant, South Carolina, United States
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol, Tennessee, United States
Volunteer Research Group
Knoxville, Tennessee, United States
Benchmark Research
Austin, Texas, United States
Benchmark Research
Fort Worth, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
Radiant Research, Inc.
Murray, Utah, 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
J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1851138
Identifier Type: -
Identifier Source: org_study_id
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