ACTIVE_NOT_RECRUITING

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

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Conditions

Pneumococcal Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-07-30
Study Completion:2026-02-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06531538

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.

Ages Eligible for Study:12 Months to 15 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Male or female toddlers ≥12 to ≤15 months of age at the time of consent.
  2. * Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
  3. * Have received 3 infant doses of 20vPnC with the last dose administered \>56 days before enrollment into the study. Documented confirmation of receipt will be collected prior to randomization.
  1. * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
  2. * Major known congenital malformation or serious chronic disorder.
  3. * 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.
  4. * Previous vaccination with any licensed or investigational pneumococcal vaccine (other than 20vPnC) or planned receipt during study participation.

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Emerson Clinical Research Institute
Washington, District of Columbia, 20009
United States
Riveldi Biomedical Research and Associates - Miami Lakes
Miami Lakes, Florida, 33014
United States
Bio-Medical Research LLC
Miami, Florida, 33144
United States
Tekton Research, LLC.
Chamblee, Georgia, 30341
United States
Javara - Privia Medical Group Georgia - Fayetteville
Fayetteville, Georgia, 30214
United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
United States
Clinical Research Prime
Idaho Falls, Idaho, 83404
United States
Clinical Research Prime Rexburg
Rexburg, Idaho, 83440
United States
The Iowa Clinic
Ankeny, Iowa, 50023
United States
All Children Pediatrics
Louisville, Kentucky, 40243
United States
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, 40291
United States
Louisiana State University Health Sciences Shreveport - Fairfield avenue
Shreveport, Louisiana, 71101
United States
Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana, 71103
United States
Ochsner/LSU Health Ambulatory Care Center
Shreveport, Louisiana, 71103
United States
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, 21201
United States
University of Maryland, Baltimore
Baltimore, Maryland, 21201
United States
The Pediatric Center
Columbia, Maryland, 21045
United States
The Pediatric Center of Frederick
Frederick, Maryland, 21702
United States
Child Health Care Associates
East Syracuse, New York, 13057
United States
Atrium Health - Strive Vaccine Research Clinic
Charlotte, North Carolina, 28207
United States
Atrium Health-Myers Park
Charlotte, North Carolina, 28207
United States
Duke Vaccine and Trials Unit
Durham, North Carolina, 27703
United States
Durham Pediatrics at North Duke Street
Durham, North Carolina, 27704
United States
Atrium Health-Matthews
Matthews, North Carolina, 28105
United States
Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics
Winston-Salem, North Carolina, 27103
United States
Senders Pediatrics
South Euclid, Ohio, 44121
United States
Cyn3rgy Research
Gresham, Oregon, 97030
United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, 16506
United States
Coastal Pediatric Research
Charleston, South Carolina, 29414
United States
Coastal Pediatric Research
Summerville, South Carolina, 29486
United States
Holston Medical Group
Kingsport, Tennessee, 37660
United States
Pediatric Clinical Trials of Tennessee,LLc
Tullahoma, Tennessee, 37388
United States
Javara - Privia Medical Group North Texas - Dallas
Dallas, Texas, 75230
United States
Oak Cliff Research Company, LLC
Dallas, Texas, 75252
United States
Oak Cliff Research Company, LLC
Dallas, Texas, 75287
United States
PAS Research - McAllen
Edinburg, Texas, 78539
United States
Mercury Clinical Research - Houston
Houston, Texas, 77054
United States
DM Clinical Research
Houston, Texas, 77065
United States
Kool Kids Pediatrics
Houston, Texas, 77065
United States
Mercury Clinical Research - Sunrise Pediatrics
Houston, Texas, 77077
United States
Mercury Clinical Research - Pediatric Associates
Houston, Texas, 77087
United States
University of Texas Medical Branch
League City, Texas, 77573
United States
Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic
Tomball, Texas, 77375
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-30
Study Completion Date2026-02-16

Study Record Updates

Study Start Date2024-07-30
Study Completion Date2026-02-16

Terms related to this study

Additional Relevant MeSH Terms

  • Pneumococcal Disease