Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age
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
1 other identifier
interventional
394
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2022
Shorter than P25 for phase_1
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2022
CompletedFirst Posted
Study publicly available on registry
August 5, 2022
CompletedStudy Start
First participant enrolled
August 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2022
CompletedResults Posted
Study results publicly available
April 18, 2024
CompletedApril 18, 2024
April 1, 2024
2 months
August 3, 2022
October 3, 2023
April 16, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention
Local reactions included redness, swelling and pain at the injection site collected in an electronic diary (e-diary) or case report form(CRF). Redness and swelling were measured and recorded in measuring device units. One measuring device unit=0.5 centimeter (cm). Redness and swelling reported in e-diary were graded as mild: greater than (\>) 2.0 cm to 5.0 cm, moderate: \>5.0 cm to 10.0 cm and severe \> 10 cm. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; and severe: prevented daily activity. Severity definition from CRF: mild (does not interfere)/moderate (interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% confidence interval (CI) was based on the Clopper and Pearson method.
Within 7 days after study intervention
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were collected in an e-diary or CRF. Fever was defined as temperature greater than or equal to (\>=) 38.0 degrees Celsius (C) and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild: did not interfere with activity; moderate: some interference with activity and severe: prevented daily routine activities. Severity definition from the CRF: mild (does not interfere)/moderate(interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Within 7 days after study intervention
Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Within 1 month after study intervention
Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Within 1 month after study intervention
Secondary Outcomes (1)
Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group
1 month after study intervention
Study Arms (9)
Candidate-1
EXPERIMENTALParticipants to receive a single injection of Candidate-1.
Candidate-2
EXPERIMENTALParticipants to receive a single injection of Candidate-2.
Candidate-3
EXPERIMENTALParticipants to receive a single injection of Candidate-3.
Candidate-4
EXPERIMENTALParticipants to receive a single injection of Candidate-4.
Candidate-5
EXPERIMENTALParticipants to receive a single injection of Candidate-5.
Candidate-6
EXPERIMENTALParticipants to receive a single injection of Candidate-6.
Candidate Control
ACTIVE COMPARATORParticipants to receive a single injection of Candidate Control.
13-valent pneumococcal conjugate vaccine (13vPnC)
OTHERParticipants to receive a single injection of 13vPnC.
15-valent pneumococcal conjugate vaccine (PCV15)
OTHERParticipants to receive a single injection of PCV15.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (18)
Orange County Research Center
Tustin, California, 92780, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Clinical Research Consulting
Milford, Connecticut, 06460, United States
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, 33308, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012, United States
Qps-Mra, Llc
South Miami, Florida, 33143, United States
Centennial Medical Group
Elkridge, Maryland, 21075, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, 55114, United States
South Jersey Infectious Disease
Somers Point, New Jersey, 08244, United States
Accellacare - Wilmington
Wilmington, North Carolina, 28401, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
IMA Clinical Research San Antonio
San Antonio, Texas, 78229, United States
DM Clinical Research
Tomball, Texas, 77375, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
Alliance for Multispecialty Research, LLC
Norfolk, Virginia, 23502, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2022
First Posted
August 5, 2022
Study Start
August 15, 2022
Primary Completion
October 7, 2022
Study Completion
October 7, 2022
Last Updated
April 18, 2024
Results First Posted
April 18, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.