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Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age

NCT04526574

CompletedPhase 3

Sponsor: Pfizer

Conditions: Pneumococcal Disease

Interventions: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC), Saline, Influenza vaccine

Countries: United States

Study of the safety and immunogenicity of 20vPnC and influenza vaccine administered at the same visit or separately

Eligibility overview

Sex: ALL

Age: 65 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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
* 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
Locations (63)
  • Mobile, Alabama, United States
  • Chandler, Arizona, United States
  • Phoenix, Arizona, United States
  • Redding, California, United States
  • San Diego, California, United States
  • San Diego, California, United States
  • Walnut Creek, California, United States
  • Coral Gables, Florida, United States
  • Crystal River, Florida, United States
  • Hialeah, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Orlando, Florida, United States
  • Savannah, Georgia, United States
  • Stockbridge, Georgia, United States
  • Meridian, Idaho, United States
  • El Dorado, Kansas, United States
  • Wichita, Kansas, United States
  • Wichita, Kansas, United States
  • New Orleans, Louisiana, United States
  • Elkridge, Maryland, United States
  • Rockville, Maryland, United States
  • St Louis, Missouri, United States
  • Norfolk, Nebraska, United States
  • Omaha, Nebraska, United States
  • Binghamton, New York, United States
  • Endwell, New York, United States
  • Charlotte, North Carolina, United States
  • + 33 more on CT.gov