A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults
NCT ID: NCT06182124
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
558 participants
INTERVENTIONAL
2023-12-20
2026-05-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Learn About a Type of Pneumococcal Vaccine With a New Ingredient (PF-07872411) Intended to Enhance the Effects of the Vaccine Which is Given to Adults
NCT05831124
A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age
NCT03313050
Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age
NCT05489328
Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults
NCT03760146
Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.
NCT02124161
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 1
Participants 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).
Multivalent Pneumococcal Vaccine - Formulation 1
Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4).
Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 2
Participants 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).
Multivalent Pneumococcal Vaccine - Formulation 2
Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4).
Phase 1 (Stage 1) and Phase 2 (Stage 2): 20-valent pneumococcal conjugate vaccine (20vPnC)
Participants to receive a single injection of 20vPnC.
20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
Phase 2 (Stage 3): a licensed pneumococcal comparator vaccine
Participants to receive a single injection of a licensed pneumococcal comparator vaccine.
Licensed pneumococcal comparator vaccine
A licensed pneumococcal comparator vaccine
Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 3
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 3.
Multivalent Pneumococcal Vaccine - Formulation 3
Multivalent pneumococcal conjugate vaccine
Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 4
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 4.
Multivalent Pneumococcal Vaccine - Formulation 4
Multivalent pneumococcal conjugate vaccine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Multivalent Pneumococcal Vaccine - Formulation 1
Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4).
Multivalent Pneumococcal Vaccine - Formulation 2
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)
20-valent pneumococcal conjugate vaccine (20vPnC)
Licensed pneumococcal comparator vaccine
A licensed pneumococcal comparator vaccine
Multivalent Pneumococcal Vaccine - Formulation 3
Multivalent pneumococcal conjugate vaccine
Multivalent Pneumococcal Vaccine - Formulation 4
Multivalent pneumococcal conjugate vaccine
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alliance for Multispecialty Research, LLC
Doral, Florida, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Optimal Research
Peoria, Illinois, United States
Alliance for Multispecialty Research, LLC
New Orleans, Louisiana, United States
Headlands Research - Detroit
Southfield, Michigan, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
AMR Clinical
Knoxville, Tennessee, United States
AMR Clinical
Knoxville, Tennessee, United States
Headlands Horizons LLC
Brownsville, Texas, United States
DM Clinical Research- Cyfair
Houston, Texas, United States
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas, United States
IMA Clinical Research San Antonio
San Antonio, Texas, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Sugar Land, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCT06182124
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4931001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.