A Study to Learn About How a New Pneumococcal Vaccine Works in Children

Description

The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers. Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group, or 3 clinic visits and 1 phone visit for the 2-Dose group. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during some clinic visits.

Conditions

Pneumococcal Disease

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Study Overview

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Study Details

Study overview

The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers. Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group, or 3 clinic visits and 1 phone visit for the 2-Dose group. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during some clinic visits.

A PHASE 2, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE ADMINISTERED IN HEALTHY TODDLERS 12 THROUGH 15 MONTHS OF AGE

A Study to Learn About How a New Pneumococcal Vaccine Works in Children

Condition
Pneumococcal Disease
Intervention / Treatment

-

Contacts and Locations

Miami Lakes

Riveldi Biomedical Research and Associates - Miami Lakes, Miami Lakes, Florida, United States, 33014

Miami

Bio-Medical Research LLC, Miami, Florida, United States, 33144

Chamblee

Tekton Research, LLC., Chamblee, Georgia, United States, 30341

Fayetteville

Javara - Privia Medical Group Georgia - Fayetteville, Fayetteville, Georgia, United States, 30214

Union City

Rophe Adult and Pediatric Medicine/SKYCRNG, Union City, Georgia, United States, 30291

Idaho Falls

Clinical Research Prime, Idaho Falls, Idaho, United States, 83404

Rexburg

Clinical Research Prime Rexburg, Rexburg, Idaho, United States, 83440

Ankeny

The Iowa Clinic, Ankeny, Iowa, United States, 50023

Louisville

All Children Pediatrics, Louisville, Kentucky, United States, 40243

Louisville

Bluegrass Clinical Research, Inc., Louisville, Kentucky, United States, 40291

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female toddlers ≥12 to ≤15 months of age at the time of consent.
  • * Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
  • * Have received 3 infant doses of 20vPnC at 2, 4, and 6 months of age, with the last dose administered \>56 days before enrollment into the study. Documented confirmation of receipt will be collected prior to randomization.
  • * 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 and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • * Previous vaccination with any licensed or investigational pneumococcal vaccine (other than 20vPnC) or planned receipt during study participation.

Ages Eligible for Study

12 Months to 15 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2025-09-19