A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults
A Phase 1/2, Randomized, Double-Blind Trial of the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 18 Years of Age and Older
2 other identifiers
interventional
558
1 country
18
Brief Summary
The purpose of this study is to learn about the safety and immune effects of a pneumococcal vaccine in adults. This vaccine can possibly provide protection against further pneumococcal disease. This study will happen in 4 stages: Stage 1 is seeking participants who are between 18 years to 49 years of age. The participants will receive 1 of 2 pneumococcal vaccine candidates (different formulations) or 20vPnC (Prevnar 20) as a single shot given into the upper arm muscle. Stage 2 will begin after participants have completed Stage 1, and a pneumococcal vaccine candidate has been decided. Stage 2 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or 20vPnC (Prevnar 20). The vaccines will be given as a single shot into the upper arm muscle. Stage 3 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or a licensed pneumococcal comparator vaccine. The vaccines will be given as a single shot into the upper arm muscle. Stage 4 is seeking participants who are adults 50 years of age and older. The participants will receive either one of three pneumococcal vaccine candidates or one of two licensed pneumococcal comparator vaccines. The vaccines will be given as a single shot into the upper arm muscle. Participants will take part in this study for about 6 months for Stage 1, Stage 3, and Stage 4 and 12 months for Stage 2. During this time participants will have from 2 to 4 clinic visits and 1 phone visit. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during these clinic visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2023
Typical duration 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
December 8, 2023
CompletedStudy Start
First participant enrolled
December 20, 2023
CompletedFirst Posted
Study publicly available on registry
December 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 23, 2026
October 14, 2025
October 1, 2025
2.4 years
December 8, 2023
October 9, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Percentage of participants reporting prespecified local reactions within 7 days after vaccination
Prespecified local reactions (redness, swelling, and pain at the injection site) after vaccination
7 days
Percentage of participants reporting prespecified systemic events within 7 days after vaccination
Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain) after vaccination
7 days
Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination
Adverse events occurring within 1 month after vaccination
1 month
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
SAEs occurring within 6 months after vaccination
6 months
Phase 2 (Stage 2) Only: Percentage of participants reporting related Serious Adverse Events (SAEs) through 12 months after vaccination
Related SAEs occurring through 12 months after vaccination
12 months
Secondary Outcomes (1)
Phase 1 (Stage 1) and Phase 2 (Stage 2) Only: Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)
1 month after vaccination
Study Arms (6)
Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 1
EXPERIMENTALParticipants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 1. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4).
Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 2
EXPERIMENTALParticipants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 2. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4).
Phase 1 (Stage 1) and Phase 2 (Stage 2): 20-valent pneumococcal conjugate vaccine (20vPnC)
ACTIVE COMPARATORParticipants to receive a single injection of 20vPnC.
Phase 2 (Stage 3): a licensed pneumococcal comparator vaccine
ACTIVE COMPARATORParticipants to receive a single injection of a licensed pneumococcal comparator vaccine.
Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 3
EXPERIMENTALParticipants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 3.
Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 4
EXPERIMENTALParticipants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 4.
Interventions
Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4).
Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4).
20-valent pneumococcal conjugate vaccine (20vPnC)
A licensed pneumococcal comparator vaccine
Multivalent pneumococcal conjugate vaccine
Multivalent pneumococcal conjugate vaccine
Eligibility Criteria
You may qualify if:
- Male or female participants ≥18 to\<50 years of age (Stage 1) and ≥50 years of age (Stage 2, Stage 3, and Stage 4) 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
- Phase 1 (Stage 1): Adults 18 through 49 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve)
- Phase 2 (Stages 2, 3, and 4): Adults ≥50 through 64 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve) and adults 65 years of age and older with either no history of ever receiving a pneumococcal vaccine or who received PPSV23 \>5 years prior to the first vaccination in this study (ie, experienced)
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
- Planned receipt of 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)
Alliance for Multispecialty Research, LLC
Doral, Florida, 33172, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Optimal Research
Peoria, Illinois, 61614, United States
Alliance for Multispecialty Research, LLC
New Orleans, Louisiana, 70119, United States
Headlands Research - Detroit
Southfield, Michigan, 48034, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Accellacare - Wilmington
Wilmington, North Carolina, 28401, United States
AMR Clinical
Knoxville, Tennessee, 37909, United States
AMR Clinical
Knoxville, Tennessee, 37920, United States
Headlands Horizons LLC
Brownsville, Texas, 78526, United States
DM Clinical Research- Cyfair
Houston, Texas, 77065, United States
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas, 78229, United States
IMA Clinical Research San Antonio
San Antonio, Texas, 78229, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Sugar Land, Texas, 77478, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball, Texas, 77375, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2023
First Posted
December 26, 2023
Study Start
December 20, 2023
Primary Completion (Estimated)
May 23, 2026
Study Completion (Estimated)
May 23, 2026
Last Updated
October 14, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will 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.