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20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

NCT04382326

CompletedPhase 3

Sponsor: Pfizer

Conditions: Pneumococcal Disease

Interventions: 20-valent pneumococcal conjugate vaccine, 13-valent pneumococcal conjugate vaccine

Countries: United States, Puerto Rico

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

Eligibility overview

Sex: ALL

Age: 42 Days to 98 Days

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Male or female infants born at \>36 weeks of gestation and 2 months of age at the time of consent.
* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion Criteria:

* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
* Major known congenital malformation or serious chronic disorder
* 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
* Previous receipt of \>1 dose of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at \>30 days old, or previous receipt of any licensed or investigational pneumococcal vaccine, or planned receipt through study participation
Locations (110)
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Dothan, Alabama, United States
  • Phoenix, Arizona, United States
  • Fayetteville, Arkansas, United States
  • Jonesboro, Arkansas, United States
  • Bell Gardens, California, United States
  • Bellflower, California, United States
  • Covina, California, United States
  • Fresno, California, United States
  • Gardena, California, United States
  • Hawthorne, California, United States
  • Oakland, California, United States
  • Ontario, California, United States
  • West Covina, California, United States
  • Aurora, Colorado, United States
  • Aurora, Colorado, United States
  • Colorado Springs, Colorado, United States
  • Colorado Springs, Colorado, United States
  • Boynton Beach, Florida, United States
  • Gainesville, Florida, United States
  • Gainesville, Florida, United States
  • Hialeah, Florida, United States
  • Homestead, Florida, United States
  • Loxahatchee Groves, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Tampa, Florida, United States
  • + 80 more on CT.gov