Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49
NCT07284654
Phase
Phase 3
Recruitment status
Active, not recruiting
Participants
4,049
Lead sponsor
Vaxcyte, Inc.
Start date
2025-12-01
Number of sites
- 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 of age to adults 18-49 years of age.
- Short title
- Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-01-01
- First posted
- 2025-12-16
- Registry last updated
- 2026-05-15
- Primary completion date
- 2027-01-01
- Start date
- 2025-12-01
- Actual participants
- 4,049
- Participants
- 4,049
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Vaxcyte, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07284654
- ClinicalTrials.gov ID
- NCT07284654
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
Serotype-specific OPA geometric mean titers (GMT) in 50 year olds and above
Timeframe: 1 month after vaccination
Percentage of subjects reporting solicited local adverse events (AE) (redness, swelling, and pain at injection site)
Timeframe: up to 7 days after vaccination
Percentage of subjects reporting solicited systemic AE (fever, headache, fatigue, muscle pain, and joint pain)
Timeframe: up to 7 days after vaccination
Percentage of subjects reporting unsolicited AE
Timeframe: 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)
Timeframe: 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
Timeframe: 1 month after vaccination
Serotype-specific IgG geometric mean concentrations (GMC) in 50 year olds and above
Timeframe: 1 month after vaccination
Serotype-specific IgG GMC in 18 to 49 year olds and 50 to 64 year olds
Timeframe: 1 month after vaccination
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- Yes
- 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).
- 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.
- 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.
Sources for eligibility
- Accel Research Site - Achieve - Birmingham - ERNBirmingham, United States
- Center for Indigenous Health - Chinle - Johns Hopkins ProjectChinle, United States
- Center for Indigineous Health - Whiteriver - John Hopkins ProjectWhiteriver, United States
- Clinical Innovations Trials - Riverside - CenExelRiverside, United States
- Research Centers of America - Hollywood - CenExelHollywood, United States
- Health Awareness - Jupiter - ERNJupiter, United States
- Suncoast Research Group LLCMiami, United States
- Precision Clinical Research - SunriseSunrise, United States
- Clinical Research Atlanta - HeadlandsStockbridge, United States
- Velocity Clinical Research - Valparaiso (Buynak Clinical Research)Valparaiso, United States
- Johnson County Clin-Trials - JCCTLenexa, United States
- Alliance for Multispecialty Research, LLC - West WichitaWichita, United States
- DelRicht Clinical Research, LLC - New OrleansNew Orleans, United States
- Headlands Research - Detroit - HeadlandsSouthfield, United States
- DelRicht Research, LLC - GulfportGulfport, United States
- Sky Integrative Medical Center - SKYCRNGRidgeland, United States
- Alliance for Multispecialty Research, LLC - Kansas CityKansas City, United States
- Velocity Clinical ResearchOmaha, United States
- Advanced Memory Research Institute - CenExeToms River, United States
- Center for Indigineous Health - Gallup - John Hopkins ProjectGallup, United States
- Center for Indigineous Health - Shiprock - John Hopkins ProjectShiprock, United States
- Rochester Clinical Research - ATLAS - RochesterRochester, United States
- CTI Clinical Research CenterCincinnati, United States
- Lynn Institute of NormanNorman, United States
- DM Clinical Research - PhiladelphiaPhiladelphia, United States
And 5 more, listed on the interactive page.
Sources for sites