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20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants

NCT04546425

CompletedPhase 3

Sponsor: Pfizer

Conditions: Pneumococcal Disease

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

Countries: Australia, Belgium, Czechia, Denmark, Estonia, Finland, Italy, Netherlands

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants

Eligibility overview

Sex: ALL

Age: 42 Days to 112 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 and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
Locations (66)
  • Nedlands, Western Australia, Australia
  • Nedlands, Western Australia, Australia
  • Brussels, Belgium
  • Edegem, Belgium
  • Jindřichův Hradec, Czechia
  • Jindřichův Hradec, Czechia
  • Jindřichův Hradec, Czechia
  • Pardubice, Czechia
  • Prague, Czechia
  • Prague, Czechia
  • Prague, Czechia
  • Hvidovre, Denmark
  • Kadrina, Estonia
  • Tallinn, Estonia
  • Tallinn, Estonia
  • Tallinn, Estonia
  • Tallinn, Estonia
  • Tartu, Estonia
  • Espoo, Finland
  • Helsinki, Finland
  • Helsinki, Finland
  • Jarvenpaa, Finland
  • Kokkola, Finland
  • Oulu, Finland
  • Oulu, Finland
  • Pori, Finland
  • Seinäjoki, Finland
  • Tampere, Finland
  • Turku, Finland
  • Milan, Milan, Italy
  • + 36 more on CT.gov