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Purpose

A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine 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 infant born at >36 weeks of gestation and aged 2 months (42 to 98 days) at the time of consent (the day of birth is considered day of life 1). - Healthy infant determined by medical history, physical examination, and clinical judgment to be eligible for the study.

Exclusion Criteria

  • Previous vaccination with licensed or investigational pneumococcal vaccine. - Prior receipt of diphtheria, tetanus, pertussis, or polio vaccines. - Previous receipt of >1 dose of hepatitis B vaccine. - Prior hepatitis B vaccine must have been administered at age <30 days. - Major known congenital malformation or serious chronic disorder. Receipt of blood/plasma products or immunoglobulins

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Multivalent 		Pneumococcal conjugate vaccines
  • Biological: Multivalent
    Pneumococcal conjugate vaccine
    Other names:
    • Pneumococcal conjugate vaccine
Active Comparator
Control 		13vPnC
  • Biological: 13vPnC
    Pneumococcal conjugate vaccine

More Details

Status
Completed
Sponsor
Pfizer

Study Contact

Detailed Description

NOTE: Detailed description has not been entered.

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.