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Purpose

This study is designed to evaluate the safety and tolerability of 20vPnC 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 ≥34 weeks of gestation and who are 2 months of age (≥42 to ≤98 days) at the time of consent (the day of birth is considered day of life 1). - Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion Criteria

  • Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation. - Major known congenital malformation or serious chronic disorder.

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
    Pneumococcal conjugate vaccine
Active Comparator
13-valent pneumococcal conjugate vaccine 		Pneumococcal conjugate vaccine
  • Biological: 13-valent pneumococcal conjugate vaccine
    Pneumococcal conjugate vaccine

More Details

Status
Completed
Sponsor
Pfizer

Study Contact

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.