Clinical trial NCT04382326: 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-05-11
Enrollment: 1997
Sex: ALL
Minimum age (years): 42
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants


Eligibility criteria: Inclusion Criteria:

* Male or female infants born at \>36 weeks of gestation and 2 months of age at the time of consent.
* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for 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 receipt of \>1 dose of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at \>30 days old, or previous receipt of any licensed or investigational pneumococcal vaccine, or planned receipt through study participation

Primary outcomes:
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 1
timeFrame: Within 7 days after Dose 1
measure: Percentage of Participants With Local Reaction Within 7 Days After Dose 2
timeFrame: Within 7 Days After Dose 2
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 3
timeFrame: Within 7 days after Dose 3
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 4
timeFrame: Within 7 days after Dose 4
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 1
timeFrame: Within 7 days after Dose 1
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 2
timeFrame: Within 7 days after Dose 2
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 3
timeFrame: Within 7 days after Dose 3
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 4
timeFrame: Within 7 days after Dose 4
measure: Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3
timeFrame: From Dose 1 to 1 Month after Dose 3
measure: Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4
timeFrame: From Dose 4 to 1 month after Dose 4
measure: Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months Following Dose 4
timeFrame: From Dose 1 to 6 months following Dose 4
measure: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 6 Months Following Dose 4
timeFrame: From Dose 1 to 6 months following Dose 4
measure: Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
timeFrame: 1 month after Dose 3
measure: Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
timeFrame: From Dose 1 to 6 months following Dose 4
measure: Percentage of Participants With Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens 1 Month After Dose 3
timeFrame: 1 month after Dose 3
Secondary outcomes:
measure: Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
timeFrame: 1 month after Dose 3
measure: Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
timeFrame: 1 month after Dose 4
measure: Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
timeFrame: 1 month after Dose 3
measure: Serotype-specific OPA GMTs at 1 Month After Dose 4
timeFrame: 1 month after Dose 4
measure: Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
timeFrame: 1 month after Dose 3 to before Dose 4
measure: Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
timeFrame: From 1 month before to 1 month after Dose 4
measure: Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
timeFrame: from 1 month after Dose 3 to 1 month after Dose 4
measure: Percentage of Participants With Alternative Prespecified Hib Antibody Level 1 Month After Dose 3
timeFrame: 1 month after Dose 3
measure: Geometric Mean Ratios (GMRs) of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Measles) 1 Month After Dose 4
timeFrame: 1 month after Dose 4
measure: GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Mumps) 1 Month After Dose 4
timeFrame: 1 month after Dose 4
measure: GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens (Rubella) 1 Month After Dose 4
timeFrame: 1 month after Dose 4
measure: GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Varicella) 1 Month After Dose 4
timeFrame: 1 month after Dose 4
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama
state: Alabama
city: Birmingham
country: United States
facility: UAB Pediatric Primary Care Clinic at Children's of Alabama
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatric Associates
state: Alabama
city: Phoenix
country: United States
facility: MedPharmics, LLC
state: Arizona
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: Bell Gardens
country: United States
facility: Gardens Medical Center
state: California
city: Bellflower
country: United States
facility: Coast Clinical Research, LLC
state: California
city: Covina
country: United States
facility: Priti Desai, M.D. Inc.
state: California
city: Fresno
country: United States
facility: Universal Biopharma Research Institute Inc.
state: California
city: Gardena
country: United States
facility: Matrix Clinical Research
state: California
city: Hawthorne
country: United States
facility: Advanced Investigative Medicine, Inc.
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Oakland
state: California
city: Ontario
country: United States
facility: Orange County Research Institute
state: California
city: West Covina
country: United States
facility: Center for Clinical Trials of San Gabriel
state: California
city: Aurora
country: United States
facility: Children's Colorado Health Pavilion (Child Health Clinic)
state: Colorado
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Colorado Springs
country: United States
facility: Optumcare Colorado Springs, LLC
state: Colorado
city: Colorado Springs
country: United States
facility: Optumcare Colorado Springs, LLC
state: Colorado
city: Boynton Beach
country: United States
facility: Gentle Medicine Associates
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Gainesville
country: United States
facility: Benton Pediatrics
state: Florida
city: Hialeah
country: United States
facility: Qway Research
state: Florida
city: Homestead
country: United States
facility: Next Phase Research Alliance
state: Florida
city: Loxahatchee Groves
country: United States
facility: Axcess Medical Research
state: Florida
city: Miami Lakes
country: United States
facility: Crystal Biomedical Research, LLC
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates, LLC
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: Columbus
country: United States
facility: Uptown Pediatrics
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Macon
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Roswell
country: United States
facility: Omega Pediatrics
state: Georgia
city: Ammon
country: United States
facility: Idaho Falls Pediatrics
state: Idaho
city: Idaho Falls
country: United States
facility: Idaho Falls Pediatrics
state: Idaho
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Idaho Falls
country: United States
facility: Family First Medical Center
state: Idaho
city: Idaho Falls
country: United States
facility: Snake River Research, PLLC
state: Idaho
city: Idaho Falls
country: United States
facility: The Pediatric Center
state: Idaho
city: Nampa
country: United States
facility: Saltzer Health
state: Idaho
city: Nampa
country: United States
facility: ASR, LLC
state: Idaho
city: Ankeny
country: United States
facility: The Iowa Clinic
state: Iowa
city: Des Moines
country: United States
facility: Blank Children's Pediatric Clinic
state: Iowa
city: Des Moines
country: United States
facility: Unity Point Health
state: Iowa
city: West Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: El Dorado
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, MD, PSC
state: Kentucky
city: Louisville
country: United States
facility: Novak Center for Children's Health
state: Kentucky
city: Louisville
country: United States
facility: Brownsboro Park Pediatrics
state: Kentucky
city: Baton Rouge
country: United States
facility: Velocity Clinical Research at Primary Pediatrics, Macon
state: Louisiana
city: Covington
country: United States
facility: Benchmark Research
state: Louisiana
city: Haughton
country: United States
facility: ACC Pediatric Research
state: Louisiana
city: Metairie
country: United States
facility: Velocity Clinical Research, Covington
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland, Baltimore, Center for Vaccine Development and Global Health
state: Maryland
city: Frederick
country: United States
facility: The Pediatric Center of Frederick, LLC
state: Maryland
city: Gulfport
country: United States
facility: MedPharmics, LLC
state: Mississippi
city: Missoula
country: United States
facility: Boeson Research
state: Montana
city: Hastings
country: United States
facility: Meridian Clinical Research
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: Omaha
country: United States
facility: Children's Physicians Dundee
state: Nebraska
city: Albuquerque
country: United States
facility: Medpharmics
state: New Mexico
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: East Syracuse
country: United States
facility: Child Health Care Associates
state: New York
city: Jackson Heights
country: United States
facility: Smart Medical Research, Inc
state: New York
city: Liverpool
country: United States
facility: Child Health Care Associates
state: New York
city: Greenville
country: United States
facility: ECU Physicians Adult and Pediatric Health Center
state: North Carolina
city: Greenville
country: United States
facility: ECU Physicians Pediatric Outpatient Clinic
state: North Carolina
city: Greenville
country: United States
facility: Leo Jenkins Cancer Center Pharmacy
state: North Carolina
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: Fairfield
country: United States
facility: Pediatric Associates of Fairfield
state: Ohio
city: South Euclid
country: United States
facility: Senders Pediatrics
state: Ohio
city: East Norriton
country: United States
facility: Pediatric Medical Associates
state: Pennsylvania
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: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: North Charleston
country: United States
facility: Palmetto Pediatrics, PA
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Children's Specialty Clinic
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford 69th & Louise Family Medicine
state: South Dakota
city: Bristol
country: United States
facility: Holston Medical Group
state: Tennessee
city: Clarksville
country: United States
facility: Premier Medical Group
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Memphis
country: United States
facility: LeBonheur Children's Hospital
state: Tennessee
city: Corpus Christi
country: United States
facility: Coastal Bend Clinical Research
state: Texas
city: Houston
country: United States
facility: Kool Kids Pediatrics
state: Texas
city: Houston
country: United States
facility: La Providence Pediatrics Clinic
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Associates
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: Longview
country: United States
facility: Diagnostic Clinic of Longview
state: Texas
city: McAllen
country: United States
facility: Ashley Pediatrics Day and Night Clinic
state: Texas
city: McAllen
country: United States
facility: Dr. Ruben Aleman & Associates
state: Texas
city: San Antonio
country: United States
facility: Tekton Research, Inc
state: Texas
city: Kaysville
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Layton
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Murray
country: United States
facility: Wasatch Pediatrics, Cottonwood Office
state: Utah
city: Roy
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Saint George
country: United States
facility: Dixie Pediatrics
state: Utah
city: Syracuse
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Associates of Charlottesville, PLC
state: Virginia
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
city: Vancouver
country: United States
facility: The Vancouver Clinic, Inc
state: Washington
city: Bayamon
country: Puerto Rico
facility: Cooperativa de Facultad Medica Sanacoop DBA Instituto Sanacoop
city: Guayama
country: Puerto Rico
facility: Clinical Research Puerto Rico
city: San Juan
country: Puerto Rico
facility: Hispanic Alliance for Clinical and Translational Research
city: San Juan
country: Puerto Rico
facility: San Juan Hospital
city: Trujillo Alto
country: Puerto Rico
facility: San Miguel Medical
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: