Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 3INTERVENTIONAL

Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Prior Pneumococcal Vaccination

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 Prior Pneumococcal Vaccination

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The study will evaluate the safety, tolerability, and immunogenicity of VAX-31 in adults ≥50 years of age.

Who May Be Eligible (Plain English)

Who May Qualify: - Male or female ≥50 years of age (inclusive) at the time of randomization into the study. - Previous receipt of a licensed pneumococcal vaccine or combination of licensed vaccines, with most recent vaccination ≥1 year prior to randomization; the exception is PCV21, which may have been received ≥6 months prior to randomization (confirmed). - Able and willing to complete the willing to sign a consent form 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 Should NOT Join This Trial: - Previous invasive pneumococcal disease (IPD) or pneumococcal pneumonia (either confirmed or self-reported) at any age. - Previous receipt of an 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Male or female ≥50 years of age (inclusive) at the time of randomization into the study. * Previous receipt of a licensed pneumococcal vaccine or combination of licensed vaccines, with most recent vaccination ≥1 year prior to randomization; the exception is PCV21, which may have been received ≥6 months prior to randomization (confirmed). * 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). Exclusion Criteria: * Previous invasive pneumococcal disease (IPD) or pneumococcal pneumonia (either confirmed or self-reported) at any age. * Previous receipt of an 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. * 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

Treatments Being Tested

BIOLOGICAL

31-valent pneumococcal conjugate vaccine

0.5 mL of VAX-31 will be administered into the deltoid muscle

BIOLOGICAL

PCV20

0.5 mL of the 20-valent pneumococcal conjugate vaccine will be administered into the deltoid muscle

Locations (20)

Chinle Center for Indigenous Health
Chinle, Arizona, United States
Avacare (CCT Research)
Phoenix, Arizona, United States
Whiteriver Center for Indigenous Health
Whiteriver, Arizona, United States
Chase Medical Research
Waterbury, Connecticut, United States
CenExel (RCA)
Hollywood, Florida, United States
Eximia (Health Awareness)
Jupiter, Florida, United States
Eximia (Health Awareness)
Port Saint Lucie, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
The Villages
The Villages, Florida, United States
DelRicht Clinical Research
Stockbridge, Georgia, United States
Velocity Clinical Valparaiso
Valparaiso, Indiana, United States
Johnson County Clin-Trials, LLC
Lenexa, Kansas, United States
DelRicht Clinical Research
New Orleans, Louisiana, United States
Velocity (Meridian Clinical Research)
Rockville, Maryland, United States
DM Clinical Research-Detroit
Southfield, Michigan, United States
AMR
Kansas City, Missouri, United States
DelRicht Research (Command Family Medicine)
Springfield, Missouri, United States
Quality Clinical Research
Omaha, Nebraska, United States
Center of American Indian Health
Gallup, New Mexico, United States
Shiprock Center for Indigenous Health
Shiprock, New Mexico, United States