Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants

Purpose

A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants

Condition

  • Pneumococcal Infections

Eligibility

Eligible Ages
Between 42 Days and 98 Days
Eligible Sex
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.