NCT06672055

Brief Summary

The primary objective of the study is to determine the relative efficacy of the investigational oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine tablet VXA-CoV2-3.3 compared to a currently recommended vaccine for the prevention of symptomatic Coronavirus Disease 2019 (COVID-19). In order to represent a more recently circulating SARS-CoV-2 variant, the main study endpoints will now evaluate the VXA-CoV2-3.3 (KP.2 strain) vaccine, and not the VXA-CoV2-3.1 (XBB.1.5 strain) vaccine.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,400

participants targeted

Target at P75+ for phase_2

Timeline
6mo left

Started Oct 2024

Geographic Reach
1 country

145 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Oct 2024Nov 2026

Study Start

First participant enrolled

October 8, 2024

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

2.1 years

First QC Date

November 1, 2024

Last Update Submit

October 20, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic Polymerase Chain Reaction (PCR)-Positive COVID-19 at 14 Days Post-vaccination

    Up to approximately Day 14

  • KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 at 12 Months Post-vaccination

    Up to approximately 12 months

  • XBB Sentinel Cohorts: Percentage of Participants who Experience any Solicited Local Reactogenicity Through 7 Days Post-vaccination

    Up to approximately Day 7

  • XBB Sentinel Cohorts: Percentage of Participants who Experience any Solicited Systemic Reactogenicity Through 7 Days Post-vaccination

    Up to approximately Day 7

  • XBB Sentinel Cohorts: Percentage of Participants who Experience Unsolicited Adverse Events (AEs) Through 30 Days Post-vaccination

    Up to approximately Day 30

  • XBB Sentinel Cohorts: Percentage of Participants who Experience Treatment-emergent Adverse Events (TEAEs) Through 12 Months Post-vaccination

    An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. An AE of special interest (AESI) is an AE (serious or non-serious) of scientific and medical concern specific to the sponsor's product or program. Medically attended AEs (MAAEs) are defined as AEs with medically attended visits including hospital, emergency room, urgent care clinic. A serious TEAE (SAE) is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.

    Up to approximately 12 months

  • XBB Sentinel Cohorts: Percentage of Participants With any Clinically Significant Abnormal Safety Laboratory Results Within 7 Days Pots-vaccination

    Up to approximately Day 7

Secondary Outcomes (23)

  • KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 Within 14 Days and 12 Months Post-vaccination in Participants with Specified Body Mass Index (BMI)

    Up to approximately 12 months

  • KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 within 0 and 6 Months Post-vaccination

    Up to approximately 6 months

  • KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 within 6 and 12 Months Post-vaccination

    Up to approximately 12 months

  • KP.2 Cohorts: Number of Participants with First Occurrence of Asymptomatic PCR-Positive COVID-19 within 14 Days and 12 Months Post-vaccination

    Up to approximately 12 months

  • KP.2 Cohorts: Number of Participants with First Occurrence of Severe PCR-Positive COVID-19 within 14 Days and 12 Months Post-vaccination

    Up to approximately 12 months

  • +18 more secondary outcomes

Study Arms (4)

VXA-CoV2-3.1 Safety Sentinel Cohort

EXPERIMENTAL

Participants previously immunized against COVID-19 infection will be randomized to receive VXA-CoV2-3.1 (XBB.1.5 vaccine) tablet oral vaccine.

Biological: VXA-CoV2-3.1

COMIRNATY® Safety Sentinel Cohort

ACTIVE COMPARATOR

Participants previously immunized against COVID-19 infection will be randomized to receive COMIRNATY® (variant matched vaccine 2023-2024 formula) injectable COVID-19 vaccine.

Biological: COMIRNATY®

VXA-CoV2-3.3

EXPERIMENTAL

If no dose-related toxicities are observed, and upon the recommendation of the Data and Safety Monitoring Board following review of Day 31 safety data in the initial safety cohorts (and possibly immunogenicity data), enrollment will continue with the remaining participants who will be randomized to receive a single dose of VXA-CoV2-3.3 (KP.2 vaccine).

Biological: VXA-CoV2-3.3

COMIRNATY®

ACTIVE COMPARATOR

If no dose-related toxicities are observed, and upon the recommendation of the Data and Safety Monitoring Board following review of Day 31 safety data in the initial safety cohorts (and possibly immunogenicity data), enrollment will continue with the remaining participants who will be randomized to receive a single dose of 2024-2025 formula of COMIRNATY® mRNA COVID-19 injectable vaccine.

Biological: COMIRNATY®

Interventions

VXA-CoV2-3.1BIOLOGICAL

Tablets for oral use.

VXA-CoV2-3.1 Safety Sentinel Cohort
COMIRNATY®BIOLOGICAL

Intramuscular (IM) injection.

Also known as: Pfizer-BioNTech mRNA Vaccine
COMIRNATY®COMIRNATY® Safety Sentinel Cohort
VXA-CoV2-3.3BIOLOGICAL

Tablets for oral use.

VXA-CoV2-3.3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 years of age and above, at time of screening.
  • Completed primary approved/authorized COVID-19 vaccination series with ≥ 2 mRNA vaccine doses.
  • Last COVID-19 vaccine received ≥6 months prior to study vaccination.
  • Male and female participants of childbearing potential must agree to consistently use a highly effective method of contraception from at least 30 days prior to enrollment and through 3 months after the study vaccination.
  • Male participants must refrain from sperm donation from the day of study vaccination through the end of the study. Female participants must refrain from egg donation at least 30 days prior to study vaccination through the end of the study.
  • Is medically stable, as determined by the site investigator (based on review of health status, vital signs, medical history, and physical examination) with screening lab values within normal limits or abnormalities assessed as not clinically significant. Screening platelet count must be \>140,000/μL.
  • Agree to not participate in any other SARS-CoV-2 infection prevention trial (vaccine, drug, biologic, PrEP) during participation in the study.
  • Willing and able to provide informed consent prior to initiation of study procedures.
  • Available for all study visits, willing to participate in all study procedures, and not planning to relocate from the area for the duration of the study.
  • Negative rapid molecular Covid test at the screening visit and on Day 1 prior to vaccine dosing.

You may not qualify if:

  • Participant has an acute illness as defined by any of the following (note: assessment may be repeated once during screening period) as determined by the site investigator, within 72 hours prior to vaccination as follows:
  • An acute illness that is nearly resolved, with only minor residual symptoms remaining, is allowable if, in the opinion of the site investigator, the residual symptoms will not interfere with the ability of study staff to assess safety parameters as required by the protocol.
  • Presence of a fever ≥ 38.0°C (100.4°F) measured orally at baseline, on Day 1 prior to vaccination.
  • Receipt of antipyretic/analgesic medications within 24 hours prior to vaccine administration.
  • Participant has had a positive COVID test within 90 days prior to screening.
  • Current or planned participation in any other interventional clinical trial.
  • Participation in research involving any investigational product within 45 days prior to study vaccination.
  • Receipt of any approved or authorized products intended to prevent SARS-CoV2 infection within 6 months prior to study vaccination.
  • Receipt or donation of blood products or immunoglobulins within 60 days prior to enrollment or planned administration during the study.
  • Received influenza vaccination within 14 days prior to study vaccination, or any other vaccine within 30 days prior to study vaccination.
  • Any autoimmune or immunodeficiency disease/condition (including and not limited to untreated or advanced HIV infection with CD4 counts \<200 cells/mm\^3, history of AIDS defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV, severe combined immunodeficiency (SCID), hypogammaglobulinemia, asplenia or functional asplenia).
  • Unstable medical or psychiatric illness (acute or chronic illness) requiring significant medical monitoring and intervention during the 90 days prior to enrollment. Note: diabetes mellitus (Types 1 \& 2) are not excluded if assessed by the principal investigator (PI) as well-controlled.
  • Administration of immunosuppressants, systemic glucocorticoids, or other immune-modifying drugs within the following timeframes:
  • B-cell therapies within the 6 months prior to first study vaccination
  • Prednisone, ≥20 mg for more than 2 weeks, within the 30 days prior to study vaccination
  • +45 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (145)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

Core Clinical Trials - Central Alabama Research LLC

Birmingham, Alabama, 35209-8401, United States

Location

Coastal Clinical Research

Mobile, Alabama, 36608, United States

Location

Avacare - Lenzmeier Family Medicine

Glendale, Arizona, 85308, United States

Location

Desert Clinical Research

Mesa, Arizona, 85213, United States

Location

Velocity Clinical Research - MedPharmics - Phoenix

Phoenix, Arizona, 85020, United States

Location

Foothills Research Center

Phoenix, Arizona, 85044, United States

Location

Avacare (CCT) - Fiel Family & Sports Medicine

Tempe, Arizona, 85283, United States

Location

Baptist Health Center for Clinical Research - Little Rock

Little Rock, Arkansas, 72205, United States

Location

Elligo Health Research (BTC/ClinEdge) - Core Healthcare Group

Cerritos, California, 90703, United States

Location

Velocity Clinical Research - Chula Vista (eStudySite - Chula Vista)

Chula Vista, California, 91911, United States

Location

Avacare - Benchmark Research - SOCAL-Colton

Colton, California, 92324, United States

Location

Altasciences Los Angeles (Formerly WCCT Global)

Cypress, California, 90630, United States

Location

Ark Clinical Research - Fountain Valley, CA

Fountain Valley, California, 92708, United States

Location

Velocity Clinical Research - San Diego (eStudySite - La Mesa)

La Mesa, California, 91942, United States

Location

Ark Clinical Research - Long Beach, CA

Long Beach, California, 90815, United States

Location

Velocity Clinical Research (National Research Institute) - Panorama City

Los Angeles, California, 90057, United States

Location

Northern California Research

Sacramento, California, 95821, United States

Location

Avacare - Benchmark Research - Sacramento

Sacramento, California, 95864, United States

Location

Velocity Clinical Research - Gardena

Santa Ana, California, 92704, United States

Location

Elite Research Network (ERN) - Legacy Clinical Trials

Colorado Springs, Colorado, 80909, United States

Location

Tekton Research - Fort Collins

Fort Collins, Colorado, 80528, United States

Location

Avacare - Critical Care, Pulmonary and Sleep Associates

Lakewood, Colorado, 80228, United States

Location

Tekton Research - Colorado - Longmont

Longmont, Colorado, 80501, United States

Location

Paradigm Clinical Research - Wheat Ridge

Wheat Ridge, Colorado, 80033, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

Chase Medical Research

Waterbury, Connecticut, 06708, United States

Location

Velocity Clinical Research - Washington DC

Washington D.C., District of Columbia, 20016, United States

Location

AMR - Miami (Clinical Research of South Florida)

Coral Gables, Florida, 33134, United States

Location

Universal Axon Clinical Research

Doral, Florida, 33166, United States

Location

Velocity Clinical Research - New Smyrna Beach

Edgewater, Florida, 32132, United States

Location

Fleming Island Center For Clinical Research

Fleming Island, Florida, 32003, United States

Location

AMR - Fort Myers - Clinical Physiology Associates

Fort Myers, Florida, 33912, United States

Location

Velocity Clinical Research - Hallandale Beach (MD Clinical)

Hallandale, Florida, 33009, United States

Location

ENCORE - Nature Coast Clinical Research Inverness

Inverness, Florida, 34452, United States

Location

ENCORE - Westside Center for Clinical Research

Jacksonville, Florida, 32205, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Headlands Research - JEM Research - Lake Worth

Lake Worth, Florida, 33462, United States

Location

Accel Research Sites - Lakeland

Lakeland, Florida, 33803, United States

Location

Accel Research Sites (ARS) - St. Petersburg - Largo

Largo, Florida, 33777, United States

Location

Accel Research Sites - Maitland

Maitland, Florida, 32751, United States

Location

K2 Medical Research - Maitland

Maitland, Florida, 32751, United States

Location

SRA Trials LLC - Miami Clinical Trials at Suncoast Research Associates

Miami, Florida, 33173, United States

Location

Atlas Clinical Research - Suncoast Clinical Research - Pasco County

New Port Richey, Florida, 34652, United States

Location

Biscayne Clinical Research

North Miami Beach, Florida, 33169, United States

Location

K2 Medical Research - South Orlando

Orlando, Florida, 32806, United States

Location

Boca Raton Clinical Research (BRCR) Global - Weston

Plantation, Florida, 33322, United States

Location

ENCORE - St. Johns Center for Clinical Research

Saint Augustine, Florida, 32086, United States

Location

IMA Clinical Research - St. Petersburg

St. Petersburg, Florida, 33704, United States

Location

hyperCORE - Centricity Research Columbus

Columbus, Georgia, 31904, United States

Location

Javara Research - Privia Medical Group Georgia

Fayetteville, Georgia, 30214, United States

Location

Privia Health - SouthCoast Health

Fayetteville, Georgia, 30214, United States

Location

Avacare (CCT) - Lifeline Primary Care

Lilburn, Georgia, 30047, United States

Location

hyperCORE - Centricity Research (IACT Health) - Rincon

Rincon, Georgia, 31326, United States

Location

Velocity Clinical Research - Savannah

Savannah, Georgia, 31406, United States

Location

Velocity Clinical Research - Boise (Meridian)

Meridian, Idaho, 83642, United States

Location

IMA Clinical Research - Chicago

Chicago, Illinois, 60602, United States

Location

Accellacare - Duly Health and Care

Lombard, Illinois, 60148, United States

Location

Velocity Clinical Research - Valparaiso (Buynak Clinical Research)

Valparaiso, Indiana, 46383, United States

Location

Accellacare - McFarland Clinic

Ames, Iowa, 50010, United States

Location

Velocity (Meridian) Clinical Research - Sioux City

Sioux City, Iowa, 51106, United States

Location

AMR - El Dorado - Heartland Research Associates

El Dorado, Kansas, 67042, United States

Location

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

AMR - Newton (Heartland Research Associates)

Newton, Kansas, 67114, United States

Location

AMR - Wichita West - Heartland Research Associates

Wichita, Kansas, 67205, United States

Location

AMR - Wichita East - Heartland Research Associates

Wichita, Kansas, 67207, United States

Location

AMR - Lexington (Central Kentucky Research Associates)

Lexington, Kentucky, 40509, United States

Location

Velocity (Meridian) Clinical Research - Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

Avacare - Benchmark Research - New Orleans-North Shore

Covington, Louisiana, 70433, United States

Location

Velocity Clinical Research - MedPharmics - Covington

Covington, Louisiana, 70433, United States

Location

Boca Raton Clinical Research (BRCR) Global USA - New Orleans

Gretna, Louisiana, 70053, United States

Location

Velocity Clinical Research - MedPharmics - Lafayette

Lafayette, Louisiana, 70508, United States

Location

Avacare - Benchmark Research - Metairie

Metairie, Louisiana, 70006, United States

Location

AMR - New Orleans - Center for Clinical Research

New Orleans, Louisiana, 70119, United States

Location

Javara Research - Privia Medical Group Mid-Atlantic - Annapolis

Annapolis, Maryland, 21401, United States

Location

Pharmaron

Baltimore, Maryland, 21201, United States

Location

Avacare (CCT) - Advanced Primary and Geriatric Care

Rockville, Maryland, 20850, United States

Location

Velocity (Meridian) Clinical Research - Rockville

Rockville, Maryland, 20854, United States

Location

Javara Research - Mankato Clinic

Mankato, Minnesota, 56001, United States

Location

Velocity Clinical Research - MedPharmics - Gulfport

Gulfport, Mississippi, 39503, United States

Location

Avacare (CCT) - Clay Platte Family Medicine Clinic

Kansas City, Missouri, 64151, United States

Location

Avacare (CCT) - Skyline Medical Center

Elkhorn, Nebraska, 68022, United States

Location

Velocity (Meridian) Clinical Research - Grand Island

Grand Island, Nebraska, 68803, United States

Location

Be Well Clinical Studies - Nebraska

Lincoln, Nebraska, 68516, United States

Location

Velocity (Meridian) Clinical Research - Omaha

Omaha, Nebraska, 68134, United States

Location

hyperCORE - ActivMed Practices and Research - Portsmouth

Portsmouth, New Hampshire, 03801, United States

Location

DM Clinical Research - Jersey City

Jersey City, New Jersey, 07306, United States

Location

Velocity Clinical Research - Alburquerque

Albuquerque, New Mexico, 87107, United States

Location

AXCES Research & Health - Santa Fe

Santa Fe, New Mexico, 87505, United States

Location

IMA Clinical Research - Albany, Suite 202

Albany, New York, 12205, United States

Location

Velocity Clinical Research - Syracuse

East Syracuse, New York, 13057, United States

Location

IMA Clinical Research - Manhattan

New York, New York, 10036, United States

Location

Atlas Clinical Research - Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Cary Medical Group

Cary, North Carolina, 27518, United States

Location

Velocity Clinical Research - Durham

Durham, North Carolina, 27701, United States

Location

Accellacare - Hickory

Hickory, North Carolina, 28601, United States

Location

Accellacare - Raleigh

Raleigh, North Carolina, 27609, United States

Location

Accellacare - Rocky Mount

Rocky Mount, North Carolina, 27804, United States

Location

Accellacare - Salisbury

Salisbury, North Carolina, 28144, United States

Location

Accellacare - Piedmont Healthcare

Statesville, North Carolina, 28625, United States

Location

Accellacare - Tradd Court

Wilmington, North Carolina, 28401, United States

Location

Accellacare - Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Atrium Health Wake Forest Baptist - Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

Velocity Clinical Research - Cleveland (Rapid Medical Research)

Beachwood, Ohio, 44122, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Velocity Clinical Research - Cincinnati (New Horizons Clinical Research - Blue Ash)

Cincinnati, Ohio, 45242, United States

Location

Tekton Research - Oklahoma - Magnolia Court

Moore, Oklahoma, 73160, United States

Location

Tekton Research - Delaware Pointe

Tulsa, Oklahoma, 74137, United States

Location

Tekton Research - Oklahoma - Primary Health Partners

Yukon, Oklahoma, 73099, United States

Location

Velocity Clinical Research - Grants Pass

Grants Pass, Oregon, 97527, United States

Location

Avacare (CCT) - Hatboro Medical Associates

Hatboro, Pennsylvania, 19040, United States

Location

Atlas Clinical Research - Suburban Research Associates - Media Office

Media, Pennsylvania, 19063, United States

Location

Velocity Clinical Research - Providence (East Greenwich)

East Greenwich, Rhode Island, 02818, United States

Location

Velocity Clinical Research - Anderson

Anderson, South Carolina, 29621, United States

Location

Velocity Clinical Research - Charleston

Charleston, South Carolina, 29414, United States

Location

Velocity Clinical Research - Columbia (VitaLink)

Columbia, South Carolina, 29204, United States

Location

Accellacare - Charleston

Mt. Pleasant, South Carolina, 29464, United States

Location

Trial Management Associates - Myrtle Beach

Myrtle Beach, South Carolina, 29572, United States

Location

hyperCORE International - Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Velocity Clinical Research - Union (Vitalink)

Union, South Carolina, 29379, United States

Location

Accellacare - PMG Research of Bristol

Bristol, Tennessee, 37620, United States

Location

Alliance for Multispecialty Research (AMR) - Corporate

Knoxville, Tennessee, 37909, United States

Location

Accellacare of Knoxville

Knoxville, Tennessee, 37912, United States

Location

Velocity Clinical Research - Abilene

Abilene, Texas, 79606, United States

Location

IMA Clinical Research - Austin

Austin, Texas, 78745, United States

Location

Tekton Research - Austin

Austin, Texas, 78745, United States

Location

Orion Clinical Research

Austin, Texas, 78759, United States

Location

Velocity Clinical Research - Austin

Austin, Texas, 78759, United States

Location

Tekton Research - Beaumont

Beaumont, Texas, 77706, United States

Location

PanAmerican Clinical Research - Brownsville, Levee Street

Brownsville, Texas, 78520, United States

Location

Cedar Health Research - Arlington/Euless

Euless, Texas, 76040, United States

Location

EmVenio Research - Fort Worth, TX

Fort Worth, Texas, 76134, United States

Location

Avacare - Benchmark Research Fort Worth

Fort Worth, Texas, 76135, United States

Location

DM Clinical Research - CyFair Clinical Research Center

Houston, Texas, 77065, United States

Location

Tekton Research - Fredericksburg Road

San Antonio, Texas, 78229, United States

Location

DM Clinical Research - Tomball - Multiple Specialties

Tomball, Texas, 77375, United States

Location

Velocity Clinical Research - Waco (formerly: Impact Research Institute)

Waco, Texas, 76710, United States

Location

Avacare (CCT) - Ogden Clinic - Grand View

Roy, Utah, 84067, United States

Location

Avacare (CCT) - Olympus Family Medicine

Salt Lake City, Utah, 84117, United States

Location

South Ogden Family Medicine

South Ogden, Utah, 84405, United States

Location

Health Research of Hampton Roads

Newport News, Virginia, 23606, United States

Location

AMR - Norfolk (Clinical Research Associates of Tidewater)

Norfolk, Virginia, 23502, United States

Location

Centricity Research (IACT Health) - Suffolk Primary Care

Suffolk, Virginia, 23435, United States

Location

Velocity Clinical Research - Medford

Spokane, Washington, 99204, United States

Location

Velocity Clinical Research - Spokane

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA VaccinesNucleic Acid-Based VaccinesVaccines, SyntheticRecombinant ProteinsProteinsAmino Acids, Peptides, and ProteinsVaccinesBiological ProductsComplex MixturesCOVID-19 VaccinesViral VaccinesAntigensBiological Factors

Study Officials

  • James Cummings, MD

    Vaxart, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2024

First Posted

November 4, 2024

Study Start

October 8, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

October 22, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations