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A PHASE 1/2, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY ADULTS 50 THROUGH 85 YEARS OF AGE
This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage. In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group). In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 \>=2 months prior to investigational product administration will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the licensed 23-valent pneumococcal polysaccharide vaccine (control group).
Age
50 - 85 years
Sex
ALL
Healthy Volunteers
Yes
Achieve Clinical Research LLC
Birmingham, Alabama, United States
Core Healthcare Group
Cerritos, California, United States
Meridian Clinical Research, LLC
Savannah, Georgia, United States
Augusta Family Practice
Augusta, Kansas, United States
Heartland Research Associates, LLC
Augusta, Kansas, United States
Axtell Clinic, P.A.
Newton, Kansas, United States
Heartland Research Associates, LLC
Newton, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States
Start Date
October 12, 2017
Primary Completion Date
May 24, 2019
Completion Date
May 24, 2019
Last Updated
June 4, 2020
511
ACTUAL participants
Multivalent
BIOLOGICAL
Tdap
BIOLOGICAL
polysaccharide
BIOLOGICAL
Lead Sponsor
Pfizer
NCT06998251
NCT06822907
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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