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Pneumococcal DiseasePhase 1/2NCT06182124

A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults

A Phase 1/2 study testing Multivalent Pneumococcal Vaccine - Formulation 1, Multivalent Pneumococcal Vaccine - Formulation 2 and 20-valent pneumococcal conjugate vaccine (20vPnC) in people with Pneumococcal Disease, run by Pfizer at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pneumococcal Disease
What is being tested?
Multivalent Pneumococcal Vaccine - Formulation 1, Multivalent Pneumococcal Vaccine - Formulation 2 and 20-valent pneumococcal conjugate vaccine (20vPnC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,710 participants
Where
20 sitesUnited States
Study dates
20 Dec 2023to 12 May 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Headlands Horizons LLC

    Brownsville, Texas, 78526

  • Alliance for Multispecialty Research, LLC

    Doral, Florida, 33172

  • Indago Research & Health Center, Inc

    Hialeah, Florida, 33012

  • DM Clinical Research- Cyfair

    Houston, Texas, 77065

  • AMR Clinical

    Knoxville, Tennessee, 37909

  • AMR Clinical

    Knoxville, Tennessee, 37920

  • Alliance for Multispecialty Research, LLC

    New Orleans, Louisiana, 70119

  • Optimal Research

    Peoria, Illinois, 61614

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609

  • J. Lewis Research, Inc. / Foothill Family Clinic

    Salt Lake City, Utah, 84109

  • J. Lewis Research, Inc.

    Salt Lake City, Utah, 84109

  • Clinical Trials of Texas, LLC dba Flourish Research

    San Antonio, Texas, 78229

  • IMA Clinical Research San Antonio

    San Antonio, Texas, 78229

  • Headlands Research - Detroit

    Southfield, Michigan, 48034

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Dynamed Clinical Research, LP d/b/a DM Clinical Research

    Sugarland, Texas, 77478

  • IMA Evaluations, LLC dba IMA Clinical Research

    Tarrytown, New York, 10591

  • DM Clinical Research

    Tomball, Texas, 77375

  • Dynamed Clinical Research, LP d/b/a DM Clinical Research

    Tomball, Texas, 77375

  • Accellacare - Wilmington

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: 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

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.

Read more

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.

Being tested
Multivalent Pneumococcal Vaccine - Formulation 1, Multivalent Pneumococcal Vaccine - Formulation 2, 20-valent pneumococcal conjugate vaccine (20vPnC), Licensed pneumococcal comparator vaccine, Multivalent Pneumococcal Vaccine - Formulation 3
Medical subject headings
Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multivalent Pneumococcal Vaccine - Formulation 1Biological

    Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4).

  • Multivalent Pneumococcal Vaccine - Formulation 2Biological

    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)Biological

    Also called Prevnar 20

    20-valent pneumococcal conjugate vaccine (20vPnC)

  • Licensed pneumococcal comparator vaccineBiological

    A licensed pneumococcal comparator vaccine

  • Multivalent Pneumococcal Vaccine - Formulation 3Biological

    Multivalent pneumococcal conjugate vaccine

  • Multivalent Pneumococcal Vaccine - Formulation 4Biological

    Multivalent pneumococcal conjugate vaccine

Study groups in NCT06182124
Study groupRoleWhat they receive
Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 3ExperimentalParticipants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 3.
Receives: Biological: Multivalent Pneumococcal Vaccine - Formulation 3
Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 1ExperimentalParticipants 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).
Receives: Biological: Multivalent Pneumococcal Vaccine - Formulation 1
Phase 1 (Stage 1) and Phase 2 (Stage 2): 20-valent pneumococcal conjugate vaccine (20vPnC)Active comparatorParticipants to receive a single injection of 20vPnC.
Receives: Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)
Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 2ExperimentalParticipants 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).
Receives: Biological: Multivalent Pneumococcal Vaccine - Formulation 2
Phase 2 (Stage 3): a licensed pneumococcal comparator vaccineActive comparatorParticipants to receive a single injection of a licensed pneumococcal comparator vaccine.
Receives: Biological: Licensed pneumococcal comparator vaccine
Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 4ExperimentalParticipants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 4.
Receives: Biological: Multivalent Pneumococcal Vaccine - Formulation 4

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 7 days

  2. 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

    Measured: 7 days

  3. Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination

    Adverse events occurring within 1 month after vaccination

    Measured: 1 month

  4. Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination

    SAEs occurring within 6 months after vaccination

    Measured: 6 months

  5. 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

    Measured: 12 months

Secondary outcomes (1)

  1. Phase 1 (Stage 1) and Phase 2 (Stage 2) Only: Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)

    Pneumococcal OPA GMTs 1 month after vaccination

    Measured: 1 month after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2023
  2. Study start20 Dec 2023
  3. Primary completion12 May 2026
  4. Study completion12 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,710 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06182124
Sponsor's protocol ID
C4931001
Other IDs
NCT06182124
Status last verified
Sep 2026
First submitted
8 Dec 2023
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Multivalent Pneumococcal Vaccine - Formulation 1, Multivalent Pneumococcal Vaccine - Formulation 2 and 20-valent pneumococcal conjugate vaccine (20vPnC) in people with Pneumococcal Disease, run by Pfizer at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants reporting prespecified local reactions within 7 days after vaccination (time frame: 7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06182124.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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