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

  • STATUS
    Recruiting
  • participants needed
    2000
  • sponsor
    Pfizer
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Updated on 16 February 2024
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conjugate vaccine
pneumococcal conjugate

Summary

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

Details
Condition pneumococcal disease
Age 1years - 1years
Treatment 20-valent pneumococcal conjugate vaccine, 13-valent pneumococcal conjugate vaccine
Clinical Study IdentifierNCT04382326
SponsorPfizer
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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