Clinical trial NCT06531538: A Study to Learn About How a New Pneumococcal Vaccine Works in Children
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of participants reporting prespecified local reactions within 7 days after each dose
timeFrame: 7 days after each dose
measure: Percentage of participants reporting prespecified systemic events within 7 days after each dose
timeFrame: 7 days after each dose
measure: Percentage of participants reporting Adverse Events (AEs) within 1 month after the last assigned vaccination
timeFrame: From signing of ICD to 1 month after last assigned vaccination
measure: Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
timeFrame: From signing of ICD to 6 months after last assigned vaccination
Secondary outcomes:
measure: Pneumococcal serotype specific IgG concentrations
timeFrame: 1 month after last assigned vaccination
Other outcomes:
Locations:
city: Miami Lakes
country: United States
facility: Riveldi Biomedical Research and Associates - Miami Lakes
state: Florida
city: Miami
country: United States
facility: Bio-Medical Research LLC
state: Florida
city: Chamblee
country: United States
facility: Tekton Research, LLC.
state: Georgia
city: Fayetteville
country: United States
facility: Javara - Privia Medical Group Georgia - Fayetteville
state: Georgia
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Rexburg
country: United States
facility: Clinical Research Prime Rexburg
state: Idaho
city: Ankeny
country: United States
facility: The Iowa Clinic
state: Iowa
city: Louisville
country: United States
facility: All Children Pediatrics
state: Kentucky
city: Louisville
country: United States
facility: Bluegrass Clinical Research, Inc.
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Shreveport - Fairfield avenue
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Shreveport
state: Louisiana
city: Shreveport
country: United States
facility: Ochsner/LSU Health Ambulatory Care Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland, Baltimore, Center for Vaccine Development and Global Health
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: Columbia
country: United States
facility: The Pediatric Center
state: Maryland
city: Frederick
country: United States
facility: The Pediatric Center of Frederick
state: Maryland
city: East Syracuse
country: United States
facility: Child Health Care Associates
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, LLC
state: New York
city: Charlotte
country: United States
facility: Atrium Health - Strive Vaccine Research Clinic
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health-Myers Park
state: North Carolina
city: Durham
country: United States
facility: Duke Vaccine and Trials Unit
state: North Carolina
city: Durham
country: United States
facility: Durham Pediatrics at North Duke Street
state: North Carolina
city: Matthews
country: United States
facility: Atrium Health-Matthews
state: North Carolina
city: Winston-Salem
country: United States
facility: Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics
state: North Carolina
city: South Euclid
country: United States
facility: Senders Pediatrics
state: Ohio
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Erie
country: United States
facility: Allegheny Health and Wellness Pavilion
state: Pennsylvania
city: Summerville
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Beaumont
country: United States
facility: Tekton Research, LLC.
state: Texas
city: Dallas
country: United States
facility: Javara - Privia Medical Group North Texas - Dallas
state: Texas
city: Dallas
country: United States
facility: Oak Cliff Research Company, LLC
state: Texas
city: Dallas
country: United States
facility: Oak Cliff Research Company, LLC
state: Texas
city: Edinburg
country: United States
facility: PAS Research - McAllen
state: Texas
city: Houston
country: United States
facility: Mercury Clinical Research - Houston
state: Texas
city: Houston
country: United States
facility: DM Clinical Research
state: Texas
city: Houston
country: United States
facility: Kool Kids Pediatrics
state: Texas
city: Houston
country: United States
facility: Sunrise Pediatrics
state: Texas
city: Houston
country: United States
facility: Pediatric Associates
state: Texas
city: League City
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Tomball
country: United States
facility: North Houston Internal Medicine & Pediatric Clinic
state: Texas
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc.
city: Ponce
country: Puerto Rico
facility: BRCR Medical Center - Ponce
city: San Juan
country: Puerto Rico
facility: BRCR Global Puerto Rico
city: San Juan
country: Puerto Rico
facility: BRCR Global Puerto Rico
city: San Juan
country: Puerto Rico
facility: Caribbean Medical Research Center
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: