Pneumococcal DiseasePhase 3NCT07284654
Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49
A Phase 3 study testing 31 valent pneumococcal conjugate vaccine, PCV20 and PCV21 in people with Pneumococcal Disease, run by Vaxcyte, Inc. at 30 sites in United States.
Trial summary
The primary objectives of this study are to evaluate the safety, tolerability, immunologic noninferiority (for shared serotypes) and immunologic superiority (for novel serotypes) of VAX-31 compared to PCV21 and PCV20 in adults ≥50 years of age, and to bridge the immune responses induced by VAX-31 in adults 50-64 years… 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?
- 31 valent pneumococcal conjugate vaccine, PCV20 and PCV21
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,049 participants
- Where
- 30 sitesUnited States
- Study dates
- 1 Dec 2025to 17 Sep 2026
- Phase
- Phase 3
- 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 ≥18 years of age (inclusive) at the time of randomization into the study.
- Able and willing to complete the informed consent process.
- Available for clinical follow-up through the last study visit.
- In good general health or with stable underlying chronic condition(s), as determined by medical history, oral temperature, physical examination, and clinical judgment of the Investigator (ongoing chronic conditions must be documented as stable per Investigator).
- Willing to have blood samples collected and used for research purposes.
- Able to provide proof of identity to the satisfaction of the site personnel completing the enrollment process.
- Female participants of childbearing potential, defined as premenopausal females capable of becoming pregnant, must have a negative urine pregnancy test immediately prior to randomization and agree to use acceptable contraception. Male subjects with partners of childbearing potential must agree to practice an acceptable contraception method.
- Able to access and use a device connected to Wi-Fi or cellular network for completion of an electronic diary (eDiary).
Who cannot join
- History of invasive pneumococcal disease (IPD) or pneumococcal pneumonia (either confirmed or self-reported) at any age.
- Previous receipt of any licensed or investigational pneumococcal vaccine at any age.
- Receipt of any investigational product within 30 days prior to Day 1, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
- Receipt of any live vaccine within 30 days prior to Day 1, or receipt of any non-live (including inactivated) vaccine within 14 days prior to Day 1.
- Body temperature >38.0°C (>100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescreened).
- Current diagnosis of human immunodeficiency virus, Hepatitis B, or Hepatitis C.
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- History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any previous vaccination.
- Individual who is pregnant, breastfeeding, or planning to become pregnant during study participation.
- Has a known or suspected immunocompromising condition, including, but not limited to, leukemia, lymphoma, chronic renal failure, or congenital or acquired immunodeficiency.
- Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in clinically significant bruising or bleeding difficulties with IM injections or blood draws.
- Receipt of blood or blood product (including polyclonal intravenous immunoglobulin) within 60 days prior to enrollment into the study.
- Is currently receiving immunosuppressive or immune-modifying therapy, including systemic corticosteroids (this includes ≥3 months of prednisone equivalent from 5 to <10 mg/day and ≥2 weeks of prednisone equivalent ≥10 mg/day).
- Received any part of a ≥14-day course of systemic corticosteroids (prednisone equivalent >10 mg/day) within 14 days of study vaccination.
- History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Any medical, psychiatric, or social condition that in the judgment of the Investigator is a contraindication to protocol participation or impairs a subject's ability to give informed consent.
- Employee of, or first-degree relative of, any person employed by the Sponsor, the contract research organization (CRO), the Investigator, site personnel, or site.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Accel Research Site - Achieve - Birmingham - ERN
Birmingham, Alabama, 35216
Charlottesville Medical Research Center - Alcanza - HyperCore
Charlottesville, Virginia, 22911
Center for Indigenous Health - Chinle - Johns Hopkins Project
Chinle, Arizona, 86503
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Center for Indigineous Health - Gallup - John Hopkins Project
Gallup, New Mexico, 87301
DelRicht Research, LLC - Gulfport
Gulfport, Mississippi, 39503
Research Centers of America - Hollywood - CenExel
Hollywood, Florida, 33024
Health Awareness - Jupiter - ERN
Jupiter, Florida, 33458
Alliance for Multispecialty Research, LLC - Kansas City
Kansas City, Missouri, 64114
Johnson County Clin-Trials - JCCT
Lenexa, Kansas, 66219
Suncoast Research Group LLC
Miami, Florida, 33135
DelRicht Clinical Research, LLC - New Orleans
New Orleans, Louisiana, 70115
Lynn Institute of Norman
Norman, Oklahoma, 73072
Coastal Carolina Research Center - Alcanza - HyperCore
North Charleston, South Carolina, 29405
Velocity Clinical Research
Omaha, Nebraska, 68134
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, 19107
Sky Integrative Medical Center - SKYCRNG
Ridgeland, Mississippi, 39157
Clinical Innovations Trials - Riverside - CenExel
Riverside, California, 92506
Rochester Clinical Research - ATLAS - Rochester
Rochester, New York, 14609
JBR Clinical Research - CenExel JBR
Salt Lake City, Utah, 84107
Flourish Research - San Antonio
San Antonio, Texas, 78229
Center for Indigineous Health - Shiprock - John Hopkins Project
Shiprock, New Mexico, 87420
Headlands Research - Detroit - Headlands
Southfield, Michigan, 48034
Clinical Research Atlanta - Headlands
Stockbridge, Georgia, 30281
DM Clinical Research - Sugarland
Sugar Land, Texas, 77478
Precision Clinical Research - Sunrise
Sunrise, Florida, 33351
Advanced Memory Research Institute - CenExe
Toms River, New Jersey, 08755
Velocity Clinical Research - Valparaiso (Buynak Clinical Research)
Valparaiso, Indiana, 46383
Center for Indigineous Health - Whiteriver - John Hopkins Project
Whiteriver, Arizona, 85941
Alliance for Multispecialty Research, LLC - West Wichita
Wichita, Kansas, 67207
About this study
Official title: A Phase 3, Randomized, Double-Blind, Active-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Subjects 50 Years of Age and Older With Immunobridging to Subjects 18-49 Years of Age
The primary objectives of this study are to evaluate the safety, tolerability, immunologic noninferiority (for shared serotypes) and immunologic superiority (for novel serotypes) of VAX-31 compared to PCV21 and PCV20 in adults ≥50 years of age, and to bridge the immune responses induced by VAX-31 in adults 50-64 years of age to adults 18-49 years of age.
- Conditions
- Pneumococcal Disease
- Being tested
- 31 valent pneumococcal conjugate vaccine, PCV20, PCV21
- Keywords
- 31 Valent PCV, Pneumonia, Pneumococcal Infection
- Medical subject headings
- Pneumococcal Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
31 valent pneumococcal conjugate vaccineBiological
0.5 mL of VAX-31 will be administered into the deltoid muscle
PCV20Biological
Also called Prevnar 20
0.5 mL of the 20 valent pneumococcal conjugate vaccine will be administered into the deltoid muscle
PCV21Biological
Also called Capvaxive
0.5 mL of the 21 valent pneumococcal conjugate vaccine will be administered into the deltoid muscle
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (VAX-31), participant ≥ 50 years of age | Experimental | Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 Receives: Biological: 31 valent pneumococcal conjugate vaccine |
| Cohort 1 (PCV21), participant ≥ 50 years of age | Active comparator | Participants will receive a single dose of PCV21 (Capvaxive) administered via intramuscular injection at Day 1 Receives: Biological: PCV21 |
| Cohort 1 (PCV20), participant ≥ 50 years of age | Active comparator | Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 Receives: Biological: PCV20 |
| Cohort 2 (VAX-31), participant 18-49 years of age | Experimental | Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 Receives: Biological: 31 valent pneumococcal conjugate vaccine |
| Cohort 2 (PCV20), participant 18-49 years of age | Active comparator | Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 Receives: Biological: PCV20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serotype-specific OPA geometric mean titers (GMT) in 50 year olds and above
Measured: 1 month after vaccination
Percentage of subjects reporting solicited local adverse events (AE) (redness, swelling, and pain at injection site)
Measured: up to 7 days after vaccination
Percentage of subjects reporting solicited systemic AE (fever, headache, fatigue, muscle pain, and joint pain)
Measured: up to 7 days after vaccination
Percentage of subjects reporting unsolicited AE
Measured: up to 31 days after vaccination
Percentage of subjects reporting serious adverse events (SAE), new onset of chronic illness (NOCI), and medically attended adverse events (MAAE)
Measured: up to 6 Months after vaccination
Serotype-specific OPA geometric mean titers (GMT) in 18 to 49 year olds and 50 to 64 year olds
Measured: 1 month after vaccination
Secondary outcomes (2)
Serotype-specific IgG geometric mean concentrations (GMC) in 50 year olds and above
Measured: 1 month after vaccination
Serotype-specific IgG GMC in 18 to 49 year olds and 50 to 64 year olds
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.
- First posted16 Dec 2025
- Study start1 Dec 2025
- Primary completion17 Sep 2026
- Study completion17 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,049 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaxcyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284654
- Sponsor's protocol ID
- VAX31-103
- Status last verified
- Oct 2026
- First submitted
- 8 Dec 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Vaxcyte is committed to providing access to anonymized data from the company's clinical trials for the purpose of legitimate scientific research. Requests for data may be addressed to datasharing@vaxcyte.com. Requests must be accompanied by a detailed analysis plan and will be reviewed for scientific validity. Data will be made available after initial product approval. Sharing of data may require execution of a data-sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Active-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Subjects 50 Years of Age and Older With Immunobridging to Subjects 18-49 Years of Age
- ClinicalTrials.gov ID
- NCT07284654
- Acronym / sponsor ID
- VAX31-103
- Conditions
- Pneumococcal Disease
- Keywords
- 31 Valent PCV, Pneumonia, Pneumococcal Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,049 participants (actual)
- Lead sponsor
- Vaxcyte, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 17 Sep 2026 (actual)
- Study completion
- 17 Sep 2026 (actual)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to evaluate the safety, tolerability, immunologic noninferiority (for shared serotypes) and immunologic superiority (for novel serotypes) of VAX-31 compared to PCV21 and PCV20 in adults ≥50 years of age, and to bridge the immune responses induced by VAX-31 in adults 50-64 years of age to adults 18-49 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (VAX-31), participant ≥ 50 years of age | Experimental | Biological: 31 valent pneumococcal conjugate vaccineParticipants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
| Cohort 1 (PCV21), participant ≥ 50 years of age | Active comparator | Biological: PCV21Participants will receive a single dose of PCV21 (Capvaxive) administered via intramuscular injection at Day 1 |
| Cohort 1 (PCV20), participant ≥ 50 years of age | Active comparator | Biological: PCV20Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
| Cohort 2 (VAX-31), participant 18-49 years of age | Experimental | Biological: 31 valent pneumococcal conjugate vaccineParticipants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
| Cohort 2 (PCV20), participant 18-49 years of age | Active comparator | Biological: PCV20Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female ≥18 years of age (inclusive) at the time of randomization into the study.
- Able and willing to complete the informed consent process.
- Available for clinical follow-up through the last study visit.
- In good general health or with stable underlying chronic condition(s), as determined by medical history, oral temperature, physical examination, and clinical judgment of the Investigator (ongoing chronic conditions must be documented as stable per Investigator).
- Willing to have blood samples collected and used for research purposes.
Key exclusion criteria (16 listed)
- History of invasive pneumococcal disease (IPD) or pneumococcal pneumonia (either confirmed or self-reported) at any age.
- Previous receipt of any licensed or investigational pneumococcal vaccine at any age.
- Receipt of any investigational product within 30 days prior to Day 1, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
- Receipt of any live vaccine within 30 days prior to Day 1, or receipt of any non-live (including inactivated) vaccine within 14 days prior to Day 1.
- Body temperature >38.0°C (>100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescreened).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 31 valent pneumococcal conjugate vaccine0.5 mL of VAX-31 will be administered into the deltoid muscle | Biological | Cohort 1 (VAX-31), participant ≥ 50 years of age, Cohort 2 (VAX-31), participant 18-49 years of age |
| PCV20Also: Prevnar 200.5 mL of the 20 valent pneumococcal conjugate vaccine will be administered into the deltoid muscle | Biological | Cohort 1 (PCV20), participant ≥ 50 years of age, Cohort 2 (PCV20), participant 18-49 years of age |
| PCV21Also: Capvaxive0.5 mL of the 21 valent pneumococcal conjugate vaccine will be administered into the deltoid muscle | Biological | Cohort 1 (PCV21), participant ≥ 50 years of age |
Primary outcome
Serotype-specific OPA geometric mean titers (GMT) in 50 year olds and above
Time frame: 1 month after vaccination
Percentage of subjects reporting solicited local adverse events (AE) (redness, swelling, and pain at injection site)
Time frame: up to 7 days after vaccination
Percentage of subjects reporting solicited systemic AE (fever, headache, fatigue, muscle pain, and joint pain)
Time frame: up to 7 days after vaccination
Percentage of subjects reporting unsolicited AE
Time frame: up to 31 days after vaccination
Percentage of subjects reporting serious adverse events (SAE), new onset of chronic illness (NOCI), and medically attended adverse events (MAAE)
Time frame: up to 6 Months after vaccination
Serotype-specific OPA geometric mean titers (GMT) in 18 to 49 year olds and 50 to 64 year olds
Time frame: 1 month after vaccination
2 secondary outcomes
Serotype-specific IgG geometric mean concentrations (GMC) in 50 year olds and above
Time frame: 1 month after vaccination
Serotype-specific IgG GMC in 18 to 49 year olds and 50 to 64 year olds
Time frame: 1 month after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. Vaxcyte is committed to providing access to anonymized data from the company's clinical trials for the purpose of legitimate scientific research. Requests for data may be addressed to datasharing@vaxcyte.com. Requests must be accompanied by a detailed analysis plan and will be reviewed for scientific validity. Data will be made available after initial product approval. Sharing of data may require execution of a data-sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 31 valent pneumococcal conjugate vaccine, PCV20 and PCV21 in people with Pneumococcal Disease, run by Vaxcyte, Inc. at 30 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 8 inclusion and 16 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Serotype-specific OPA geometric mean titers (GMT) in 50 year olds and above (time frame: 1 month after vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.