A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age
Completed · Phase 2
Conditions studied: Pneumococcal Infections
In brief
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).
Key facts
- Study ID
- NCT03313050
- Run by
- Pfizer
- People needed
- 511
- Starts
- 2017-10-12
- Expected to finish
- 2019-05-24
- Last updated by the study team
- 2020-06-04
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Stage 1: Healthy male or female adults 50 to 64 years of age with no history of pneumococcal vaccination
- Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated with Prevnar 13 >= 2 months prior to investigational product administration
You may not qualify if…
- Stage 1: Vaccination within 12 months before investigational product administration with diphtheria-, pertussis-, or tetanus-containing vaccine
- Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior dose of Prevnar 13
Where it is running
- 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
- Meridian Clinical Research LLC — Omaha, Nebraska, United States
- PMG Research of Charlotte, LLC — Charlotte, North Carolina, United States
- PMG Research of Wilmington, LLC — Wilmington, North Carolina, United States
- Omega Medical Research — Warwick, Rhode Island, United States
- Medical Research South, LLC — Goose Creek, South Carolina, United States
- J. Lewis Research Incorporated, Foothill Family Clinic — Salt Lake City, Utah, United States
- J. Lewis Research, Incorporated/Foothill Family Clinic South — Salt Lake City, Utah, United States
- Advanced Clinical Research — West Jordan, Utah, United States
Full record on ClinicalTrials.gov
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