Clinical trial NCT04642079: Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age
Official title: A PHASE 3, SINGLE-ARM TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHILDREN 15 MONTHS THROUGH 17 YEARS OF AGE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-11-24
Enrollment: 839
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is designed to evaluate the safety and immunogenicity of 20vPnC in healthy children 15 months through 17 years of age


Eligibility criteria: Inclusion Criteria:

* Male or female children ≥15 months to \<18 years of age at the time of consent.
* Healthy children determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
* For children \<5 years of age, written documentation of receipt of at least 3 doses of 13vPnC. The last dose of 13vPnC must have been administered \>2 months before enrolment into the study

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
* Previous vaccination with any investigational pneumococcal vaccine or with PPSV23, or planned receipt through study participation
* Cohorts 3 and 4: Pregnant or breastfeeding female participants

Primary outcomes:
measure: Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination
timeFrame: Within 7 days after vaccination on Day 1
measure: Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
timeFrame: Within 7 days after vaccination on Day 1
measure: Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
timeFrame: Within 7 days after vaccination on Day 1
measure: Percentage of Participants Reporting Adverse Events (AEs) up to 1 Month After Vaccination
timeFrame: From vaccination (on Day 1) up to 1 month after vaccination
measure: Percentage of Participants Reporting Serious Adverse Events (SAEs) up to 6 Months After Vaccination
timeFrame: From vaccination (on Day 1) up to 6 months after vaccination
measure: Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 Months After Vaccination
timeFrame: From vaccination (on Day 1) up to 6 months after vaccination
measure: Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2
timeFrame: Before vaccination on Day 1 to 1 month after vaccination
measure: GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4
timeFrame: Before vaccination on Day 1 to 1 month after vaccination
Secondary outcomes:
measure: Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only
timeFrame: At 1 Month after vaccination on Day 1
measure: Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only
timeFrame: Before vaccination on Day 1 to 1 month after vaccination
measure: Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
timeFrame: Before vaccination and 1 month after vaccination
measure: GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2
timeFrame: Before vaccination on Day 1 to 1 month after vaccination
measure: GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
timeFrame: Before vaccination on Day 1 to 1 month after vaccination
measure: Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
timeFrame: Before vaccination on Day 1 and 1 month after vaccination
measure: GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
timeFrame: Before vaccination on Day 1 to 1 month after vaccination
measure: GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4
timeFrame: Before vaccination on Day 1 to 1 month after vaccination
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Northwest Arkansas Pediatrics
state: Arkansas
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro, P.A.
state: Arkansas
city: Jonesboro
country: United States
facility: The Children's Clinic
state: Arkansas
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: Miami
country: United States
facility: Pharmax Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Bio-Medical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Children's Health Center
state: Florida
city: Chamblee
country: United States
facility: Tekton Research, Inc
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Sioux City
country: United States
facility: Meridian Clinical Research, LLC
state: Iowa
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/ Adult Research
state: Kentucky
city: Lexington
country: United States
facility: Michael W. Simon, M.D., PSC
state: Kentucky
city: Gulfport
country: United States
facility: MedPharmics, LLC
state: Mississippi
city: Grand Island
country: United States
facility: Velocity Clinical Research, Grand Island
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
city: Norfolk
country: United States
facility: Velocity Clinical Research, Norfolk
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research, Sioux City
state: Nebraska
city: Henderson
country: United States
facility: Wr-Crcn, Llc
state: Nevada
city: Albuquerque
country: United States
facility: MedPharmic's, LLC
state: New Mexico
city: Binghamton
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association Inc.
state: Ohio
city: Dayton
country: United States
facility: PriMed Clinical Research
state: Ohio
city: Erie
country: United States
facility: Allegheny Health and Wellness Pavilion
state: Pennsylvania
city: Fort Washington
country: United States
facility: Lockman & Lubell Pediatric Associates
state: Pennsylvania
city: North Charleston
country: United States
facility: Palmetto Pediatrics, PA
state: South Carolina
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: San Antonio
country: United States
facility: Tekton Research, Inc
state: Texas
city: Layton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Utah
city: Murray
country: United States
facility: Wasatch Pediatrics, Cottonwood Office
state: Utah
city: Provo
country: United States
facility: Pediatric Care
state: Utah
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc./ Foothill Family Clinic South
state: Utah
city: South Jordan
country: United States
facility: CopperView Medical Center
state: Utah
city: South Jordan
country: United States
facility: J. Lewis Research, Inc. / Jordan River Family Medicine
state: Utah
city: Syracuse
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
state: Virginia
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: