Pneumococcal VaccinesPhase 2NCT06720038
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants
A Phase 2 study testing 0.5 mL of the low dose VAX-31, 0.5 mL of the mid dose VAX-31 and 0.5 mL of the high dose VAX-31 in people with Pneumococcal Vaccines, run by Vaxcyte, Inc. at 48 sites in 2 countries.
Trial summary
The objective of the study is to evaluate the safety, tolerability, and immunogenicity of 4 injections of VAX-31 (at 4 dose levels) compared to PCV20 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Read more about this study
- Who is it for?
- Ages 42 to 89 daysHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Vaccines
- What is being tested?
- 0.5 mL of the low dose VAX-31, 0.5 mL of the mid dose VAX-31 and 0.5 mL of the high dose VAX-31
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 48 sitesin 2 countries
- Study dates
- 25 Nov 2024to Dec 2027
- Phase
- Phase 2
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 42 to 89 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male or female infant ≥42 days to ≤89 days.
- Full-term infant at least 37 weeks gestational age at birth.
- Afebrile for ≥72 hours with an tympanic or rectal temperature <38.0°C (<100.4°F) before receipt of study vaccine.*Criterion applies to each vaccination. If not met, visit may be rescheduled for a time when no longer febrile for ≥72 hours.
- Able to attend all scheduled visits and comply with the study procedures.
- Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent.
- Subject's parent/legal guardian is able to fill out an eDiary of solicited AE and take daily tympanic temperature and measurements of local injection site reactions for the 7 days after each study vaccination.
- Subject's parent/legal guardian has an email address and access to a computer or smartphone with internet to complete the eDiary.
Who cannot join
- History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
- Previous receipt of a licensed or investigational vaccine (excluding 1 dose of hepatitis B vaccine).
- Known hypersensitivity to any vaccine.
- Known or suspected impairment of immunological function (e.g., asplenia, human immunodeficiency virus, primary immunodeficiency).
- Use of any immunosuppressive therapy or planned use through the last blood draw (Visit 6). Receipt of a <14-day course of systemic corticosteroids is not exclusionary if completed ≥1 month prior to first study vaccination. Topical and inhaled/nebulized steroids are also permitted.
- History of failure to thrive or prior hospitalization for any chronic condition.
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- Subject has a bleeding disorder contraindicating IM vaccination.
- Subject or his/her mother has documented hepatitis B surface antigen-positive test.
- Subject has a known neurologic or cognitive behavioral disorder.
- Subject has a known clinically significant congenital malformation or serious chronic disorder.
- Receipt of a blood transfusion or blood products, including immunoglobulins.
- Receipt of any investigational study product since birth, currently participating in another interventional investigational study, or plans to receive another investigational product while on study.
- Any infant who cannot be adequately followed for safety according to the protocol plan.
- Any other reason that in the opinion of the Investigator may interfere with the evaluation required by the study.
Trial locations and contacts
48 sites in 2 countries.
48 sites in 2 countries
United States45 sites
Children's Hospital of Colorado - Dept. of Infectious Disease
Aurora, Colorado, 80045
Kentucky Pediatrics/Adult Research
Bardstown, Kentucky, 40004
Proactive RGV LLC
Brownsville, Texas, 78520
Tribe Clinical Research, LLC dba Neighbors Clinical Research
Charleston, South Carolina, 29407
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902
UPMC Children's Community Pediatrics - Bass Wolfson, Cranberry
Cranberry Township, Pennsylvania, 16066
Javara Inc. /Texas Health Care, PLLC
Dallas, Texas, 75001-
Oak Cliff Research Company
Dallas, Texas, 75287
Ohio Pediatric Research Association
Dayton, Ohio, 45414
Allegheny Health & Wellness Pavilion West
Erie, Pennsylvania, 16506
Matrix Clinical Research
Gardena, California, 90237
Pediatric Research of Charlottesville, LLC
Gordonsville, Virginia, 22942
Cyn3rgy Research
Gresham, Oregon, 97030
ACC Pediatric Research
Haughton, Louisiana, 71037
Kool Kids Pediatrics (Dynamed)
Houston, Texas, 77065
Sunrise Pediatrics
Houston, Texas, 77077
Mercury Clinical Research - Pediatric Associates
Houston, Texas, 77087
Clinical Research Prime, LLP
Idaho Falls, Idaho, 83404
The Children's Clinic of Jonesboro, P.A
Jonesboro, Arkansas, 72401
AMR - Layton
Layton, Utah, 84041
University of Texas Medical Branch - Sealy Institute for Vaccine Sciences, Clinical Trials Program
League City, Texas, 77573
Complete Children's Health
Lincoln, Nebraska, 68504
Complete Children's Health
Lincoln, Nebraska, 68505
Be Well Clinical Studies Nebraska
Lincoln, Nebraska, 68516
Complete Children's Health
Lincoln, Nebraska, 68516
Complete Children's Health
Lincoln, Nebraska, 68522
Matrix Clinical Research
Los Angeles, California, 90057
AMR - Cottonwood
Murray, Utah, 84107
UPMC Children's Community Pediatrics - Norwin
N. Huntingdon, Pennsylvania, 15642
Orange County Research Institute
Ontario, California, 91762
SEC Clinical Research
Pensacola, Florida, 32503
UPMC Children's Community Pediatrics South Hills-Jefferson Hills
Pittsburgh, Pennsylvania, 15025
UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics (GAP)
Pittsburgh, Pennsylvania, 15213
UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill
Pittsburgh, Pennsylvania, 15217
UPMC Children's Community Pediatrics-Castle Shannon
Pittsburgh, Pennsylvania, 15234
Clinical Research Prime - Rexburg
Rexburg, Idaho, 83440
Pediatric Center/Neutra Life Sciences
Richmond, Texas, 77469
Clinical Research Partners, LLC.
Richmond, Virginia, 23226
AMR - Roy
Roy, Utah, 84067
Tribe Clinical Research/Parkside Pediatrics
Simpsonville, South Carolina, 29680
Senders Pediatrics
South Euclid, Ohio, 44121
AMR South Jordan
South Jordan, Utah, 84095
AMR - Syracuse
Syracuse, Utah, 84075
PAS Research
Tampa, Florida, 33613
Center for Clinical Trials of San Gabriel
West Covina, California, 91790
Puerto Rico3 sites
Ponce Medical School Foundation Inc. / CAIMED Center
Ponce, PR 716
BRCR Global Puerto Rico
San Juan, PR 907
Caribbean Medical Research Center
San Juan, PR 918
About this study
Official title: A Phase 2, Randomized, Double-Blind, Active-Controlled, Dose-Finding Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants Given 4 Doses at 2, 4, 6, and 12-15 Months of Age Concomitantly With Routine Pediatric Vaccines
The objective of the study is to evaluate the safety, tolerability, and immunogenicity of 4 injections of VAX-31 (at 4 dose levels) compared to PCV20 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll approximately 352 subjects. Stage 3 of the study will enroll approximately 500 subjects.
- Conditions
- Pneumococcal Vaccines
- Being tested
- 0.5 mL of the low dose VAX-31, 0.5 mL of the mid dose VAX-31, 0.5 mL of the high dose VAX-31, 0.5 mL dose of PCV20, 0.5 mL of the High-PFS dose VAX-31
- Keywords
- 31 Valent PCV, Pneumonia, Pneumococcal Infection
- Medical subject headings
- Pneumonia, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 mL of the low dose VAX-31Biological
31 valent pneumococcal conjugate vaccine
0.5 mL of the mid dose VAX-31Biological
31 valent pneumococcal conjugate vaccine
0.5 mL of the high dose VAX-31Biological
31 valent pneumococcal conjugate vaccine
0.5 mL dose of PCV20Biological
20 valent pneumococcal conjugate vaccine
0.5 mL of the High-PFS dose VAX-31Biological
31 valent pneumococcal conjugate vaccine
| Study group | Role | What they receive |
|---|---|---|
| VAX-31 Low | Experimental | Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels. Receives: Biological: 0.5 mL of the low dose VAX-31 |
| VAX-31 Mid | Experimental | Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels. Receives: Biological: 0.5 mL of the mid dose VAX-31 |
| VAX-31 High | Experimental | Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels. Receives: Biological: 0.5 mL of the high dose VAX-31 |
| PCV20 | Active comparator | Participants will receive 4 doses of PCV20 administered as an intramuscular injection of the standard dose at 2, 4, 6, and 12-15 months of age. Receives: Biological: 0.5 mL dose of PCV20 |
| VAX-31 High-PFS | Experimental | Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels. Receives: Biological: 0.5 mL of the High-PFS dose VAX-31 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with any solicited local injection site adverse events (AE) within 7 days after each vaccination
Solicited local reactions include erythema, edema, and tenderness at the injection site
Measured: 7 days after each vaccination
Percentage of subjects with any solicited systemic AE within 7 days after each vaccination
Solicited systemic reactions include fever, irritability, decreased appetite, decreased sleep, and increased sleep
Measured: 7 days after each vaccination
Percentage of subjects with any unsolicited AE within 1 month after each vaccination
Percentage of subjects with unsolicited AE
Measured: 1 months after each vaccination
Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination
Percentage of subjects with MAAE
Measured: 6 months after last vaccination
Percentage of subjects with any Serious Adverse Events (SAE) within 6 months after last vaccination
Percentage of subjects with SAE
Measured: 6 months after last vaccination
Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination
Percentage of subjects with NOCI
Measured: 6 months after last vaccination
Secondary outcomes (3)
Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL 1 month after Dose 3
Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL
Measured: 1 month after Dose 3
Serotype-specific IgG antibody geometric mean concentration (GMC) 1 month after Dose 3
Antibody geometric mean concentrations as measured by IgG for the 31 pneumococcal serotypes in VAX-31
Measured: 1 month after Dose 3
Serotype-specific IgG antibody GMC 1 month after Dose 4
Antibody geometric mean concentrations as measured by IgG for the 31 pneumococcal serotypes in VAX-31
Measured: 1 month after Dose 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start25 Nov 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal VaccinesStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 900 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
- NCT06720038
- Sponsor's protocol ID
- VAX31-201
- Status last verified
- May 2026
- First submitted
- 2 Dec 2024
- Last updated
- 15 May 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.