Purpose

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

Condition

Eligibility

Eligible Ages
Between 42 Days and 98 Days
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
20-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
  • Biological: 20-valent pneumococcal conjugate vaccine
    20-valent pneumococcal conjugate vaccine
Active Comparator
13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
  • Biological: 13-valent pneumococcal conjugate vaccine
    13-valent pneumococcal conjugate vaccine

Recruiting Locations

University of Maryland, Baltimore
Baltimore, Maryland 21201

University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland 21201

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.