Clinical trial NCT05489328: Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age
Official title: A PHASE 1, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF PNEUMOCOCCAL CONJUGATE FORMULATIONS IN HEALTHY ADULTS 18 THROUGH 49 YEARS OF AGE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-08-05
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to describe the safety and immunogenicity of Pneumococcal Conjugate Formulations in healthy adults 18 through 49 years of age.


Eligibility criteria: Inclusion Criteria:

* Male or female participants ≥18 and ≤49 years of age at the time of consent
* Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention
* Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children

Exclusion Criteria:

* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine
* Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
* Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study
* Known or suspected immunodeficiency or other conditions associated with immunosuppression
* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
* Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine within 28 days before administration of study intervention

Primary outcomes:
measure: Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention
timeFrame: Within 7 days after study intervention
measure: Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
timeFrame: Within 7 days after study intervention
measure: Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention
timeFrame: Within 1 month after study intervention
measure: Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention
timeFrame: Within 1 month after study intervention
Secondary outcomes:
measure: Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group
timeFrame: 1 month after study intervention
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Milford
country: United States
facility: Clinical Research Consulting
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Proactive Clinical Research,LLC
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc
state: Florida
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Saint Paul
country: United States
facility: Prism Research LLC dba Nucleus Network
state: Minnesota
city: Somers Point
country: United States
facility: South Jersey Infectious Disease
state: New Jersey
city: Wilmington
country: United States
facility: Accellacare - Wilmington
state: North Carolina
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: San Antonio
country: United States
facility: IMA Clinical Research San Antonio
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
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: Norfolk
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: