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Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age

Primary Purpose

Pneumococcal Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Candidate-1
Candidate-2
Candidate-3
Candidate-4
Candidate-5
Candidate-6
Candidate Control
13vPnC
PCV15
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Disease

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Orange County Research Center
  • Diablo Clinical Research, Inc.
  • Clinical Research Consulting
  • Proactive Clinical Research,LLC
  • Indago Research & Health Center, Inc
  • Qps-Mra, Llc
  • Centennial Medical Group
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
  • Prism Research LLC dba Nucleus Network
  • South Jersey Infectious Disease
  • Accellacare - Wilmington
  • Clinical Trials of Texas, LLC
  • Diagnostics Research Group
  • IMA Clinical Research San Antonio
  • DM Clinical Research
  • J. Lewis Research, Inc. / Foothill Family Clinic
  • J. Lewis Research, Inc. / Foothill Family Clinic South
  • Alliance for Multispecialty Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Other

Other

Arm Label

Candidate-1

Candidate-2

Candidate-3

Candidate-4

Candidate-5

Candidate-6

Candidate Control

13-valent pneumococcal conjugate vaccine (13vPnC)

15-valent pneumococcal conjugate vaccine (PCV15)

Arm Description

Participants to receive a single injection of Candidate-1.

Participants to receive a single injection of Candidate-2.

Participants to receive a single injection of Candidate-3.

Participants to receive a single injection of Candidate-4.

Participants to receive a single injection of Candidate-5.

Participants to receive a single injection of Candidate-6.

Participants to receive a single injection of Candidate Control.

Participants to receive a single injection of 13vPnC.

Participants to receive a single injection of PCV15.

Outcomes

Primary Outcome Measures

Percentage of participants reporting prompted local reactions within 7 days after study intervention administration
Prompted local reactions (redness, swelling, pain at the injection site) after study intervention administration
Percentage of participants reporting prompted systemic events within 7 days after study intervention administration
Prompted systemic events (fever, headache, fatigue, muscle pain, joint pain) after study intervention administration
Percentage of participants reporting Adverse Events (AEs) within 1 month after study intervention administration
Adverse events occurring within 1 month after study intervention administration
Percentage of participants reporting Serious Adverse Events (SAEs) within 1 month after study intervention administration
SAEs occurring within 1 month after study intervention administration

Secondary Outcome Measures

Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)
Pneumococcal OPA GMTs 1 month after study intervention administration

Full Information

First Posted
August 3, 2022
Last Updated
October 24, 2022
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05489328
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
October 7, 2022 (Actual)
Study Completion Date
October 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
394 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Candidate-1
Arm Type
Experimental
Arm Description
Participants to receive a single injection of Candidate-1.
Arm Title
Candidate-2
Arm Type
Experimental
Arm Description
Participants to receive a single injection of Candidate-2.
Arm Title
Candidate-3
Arm Type
Experimental
Arm Description
Participants to receive a single injection of Candidate-3.
Arm Title
Candidate-4
Arm Type
Experimental
Arm Description
Participants to receive a single injection of Candidate-4.
Arm Title
Candidate-5
Arm Type
Experimental
Arm Description
Participants to receive a single injection of Candidate-5.
Arm Title
Candidate-6
Arm Type
Experimental
Arm Description
Participants to receive a single injection of Candidate-6.
Arm Title
Candidate Control
Arm Type
Active Comparator
Arm Description
Participants to receive a single injection of Candidate Control.
Arm Title
13-valent pneumococcal conjugate vaccine (13vPnC)
Arm Type
Other
Arm Description
Participants to receive a single injection of 13vPnC.
Arm Title
15-valent pneumococcal conjugate vaccine (PCV15)
Arm Type
Other
Arm Description
Participants to receive a single injection of PCV15.
Intervention Type
Other
Intervention Name(s)
Candidate-1
Intervention Description
Biological
Intervention Type
Other
Intervention Name(s)
Candidate-2
Intervention Description
Biological
Intervention Type
Other
Intervention Name(s)
Candidate-3
Intervention Description
Biological
Intervention Type
Other
Intervention Name(s)
Candidate-4
Intervention Description
Biological
Intervention Type
Other
Intervention Name(s)
Candidate-5
Intervention Description
Biological
Intervention Type
Other
Intervention Name(s)
Candidate-6
Intervention Description
Biological
Intervention Type
Other
Intervention Name(s)
Candidate Control
Intervention Description
Biological
Intervention Type
Biological
Intervention Name(s)
13vPnC
Intervention Description
13-valent pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
PCV15
Intervention Description
15-valent pneumococcal conjugate vaccine
Primary Outcome Measure Information:
Title
Percentage of participants reporting prompted local reactions within 7 days after study intervention administration
Description
Prompted local reactions (redness, swelling, pain at the injection site) after study intervention administration
Time Frame
7 days
Title
Percentage of participants reporting prompted systemic events within 7 days after study intervention administration
Description
Prompted systemic events (fever, headache, fatigue, muscle pain, joint pain) after study intervention administration
Time Frame
7 days
Title
Percentage of participants reporting Adverse Events (AEs) within 1 month after study intervention administration
Description
Adverse events occurring within 1 month after study intervention administration
Time Frame
1 month
Title
Percentage of participants reporting Serious Adverse Events (SAEs) within 1 month after study intervention administration
Description
SAEs occurring within 1 month after study intervention administration
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)
Description
Pneumococcal OPA GMTs 1 month after study intervention administration
Time Frame
1 month after study intervention administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Clinical Research Consulting
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Proactive Clinical Research,LLC
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Indago Research & Health Center, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Qps-Mra, Llc
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Prism Research LLC dba Nucleus Network
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
South Jersey Infectious Disease
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
Accellacare - Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Clinical Trials of Texas, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
IMA Clinical Research San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
J. Lewis Research, Inc. / Foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research, Inc. / Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4801001
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age

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