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Novavax vaccine trial for kids under 12 shows promise

NCT ID NCT05468736

Vaccine Sponsor: Novavax Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested Novavax's COVID-19 vaccine in 3,600 children aged 6 months to 12 years. The goal was to see if the vaccine is safe and triggers a strong immune response. Children received two doses 21 days apart, with some getting a placebo. The trial is complete, and results will help decide if the vaccine can be used in young kids.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Novavax COVID-19 vaccine (NVX-CoV2373) with Matrix-M adjuvant
What this could lead to
If successful, this could provide a safe and effective COVID-19 vaccine option for children as young as 6 months, helping protect them from severe illness.
What could go wrong
This is a completed phase 2/3 trial, but results are not yet published. Side effects like fever or injection site pain are possible, and rare risks like heart inflammation need monitoring.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

3,600 people

The number who actually took part.

Started

Jul 2022

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 11 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: To be included in this study, each individual must satisfy all of the following criteria: 1. Pediatric participants 6 months to \< 12 years of age at randomization, determined to be healthy or medically stable by the investigator (based on review of health status, vital signs \[to include body temperature\], medical history, and targeted physical examination \[to include body weight\]). Vital signs must be within the normal range prior to the first vaccination, according to the child's age, sex, weight, and height/length. 2. For children from 6 months to \< 12 months of age: born at full-term (≥ 37 weeks gestation) with a minimum birth weight of 2.5 kilograms (kg). 3. Participant and parent(s)/caregiver(s) or legally acceptable representative willing and able to give informed consent and assent, as required, prior to study enrollment and to comply with study procedures. 4. Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through 3 months after the last vaccination OR agree to consistently use a highly effective contraception method from at least 28 days prior to enrollment and through 3 months after the last vaccination. 5. Agree not to participate in another SARS-CoV-2 prevention trial for the duration of the study. Exclusion Criteria: If an individual meets any of the following criteria, he or she is ineligible for this study: 1. Any acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F \[≥ 38.0°C\]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided. 2. Unstable acute or chronic illness. Criteria for unstable medical conditions include: 1. Substantive changes in chronic prescribed medication (change in class or significant change in dose) in the past 2 months. 2. Currently undergoing workup of undiagnosed illness that could lead to a diagnosis of a new condition. NOTE: Well-controlled human immunodeficiency virus \[HIV\] infection with undetectable HIV ribonucleic acid \[RNA \< 50 copies/mL\] and CD4 count \> 200 cells/µL for at least 1 year, documented within the last 6 months, is NOT considered an unstable chronic illness. Participant's or parent's/caregiver's verbal report will suffice as documentation. 3. Participation in research involving an investigational product (drug/biologic/device) administered within 45 days prior to the first study vaccination. 4. History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19. 5. Prior administration of an investigational, authorized, or approved Coronavirus vaccine (ie, against either SARS-CoV, SARS-CoV-2, or MERS CoV) or expected receipt during the period of study follow-up. 6. Previous or current diagnosis of MIS-C. 7. Receipt of medications intended to prevent or treat COVID-19. 8. Received any vaccine within 14 days prior to first study vaccination or planned receipt of any vaccine before Day 49 (ie, 28 days after the second vaccination), except for influenza vaccination, which may be received \> 14 days prior to or \> 14 days after any study vaccination. 9. Known or suspected congenital or acquired immunodeficiency or autoimmune disease/condition; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for \> 14 continuous days) within 90 days prior to first study vaccination. NOTE: An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 20 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporin are permitted. Stable autoimmune endocrine disorders (eg, thyroiditis, pancreatitis), including stable diabetes mellitus type 1, or participants with a history of Kawasaki disease are NOT excluded. 10. Received immunoglobulin or blood-derived products within 90 days prior to first study vaccination. 11. Active cancer (malignancy) on chemotherapy within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator). 12. Any known allergies to products contained in the investigational product. 13. Participants who are breastfeeding a child, pregnant or who plan to become pregnant within 3 months following the last study vaccination. 14. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with the evaluation of the trial vaccine or interpretation of study results. 15. Study team member or first-degree relative of any study team member (inclusive of Sponsor, and study site personnel involved in the study). 16. Current participation in any other COVID-19 prevention clinical trial. 17. Participants with a history of myocarditis or pericarditis.

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19

Contacts and locations

Locations

  • ARS-Nona Pediatric Center

    Orlando, Florida, 32829, United States

  • Advanced Research Center

    Anaheim, California, 92805, United States

  • Alliance for Multispecialty Research

    Layton, Utah, 84041, United States

  • Alliance for Multispecialty Research c/o Wee Care Pediatrics - Roy

    Roy, Utah, 84067, United States

  • Apex Research Group

    Fair Oaks, California, 95628, United States

  • Ark Clinical Research

    Long Beach, California, 90815, United States

  • Bay Colony Pediatrics

    Dickinson, Texas, 77539, United States

  • Be Part Yoluntu Centre - Paarl

    Paarl, Western Cape, 7655, South Africa

  • Be Well Clinical Studies, LLC

    Lincoln, Nebraska, 68516, United States

  • Bluegrass Clinical Research, Inc./All Children Pediatrics

    Louisville, Kentucky, 40243, United States

  • Boeson Research

    Missoula, Montana, 59804, United States

  • CECLISA

    Guatemala City, 01009, Guatemala

  • California Research Foundation

    San Diego, California, 92123, United States

  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S.C.P.

    Mérida, Yucatán, 97130, Mexico

  • Centro de Atencion e Investigacion Medica - CAIMED

    Yopal, Casanare Department, 850007, Colombia

  • Centro de Atencion e Investigacion Medica S.A.S-CAIMED

    Puente Aranda, Bogota D.C., 111011, Colombia

  • Centro de Estudios en Infectologia Pediatrica S.A.S.CEIP

    Cali, Valle del Cauca Department, 760042, Colombia

  • Centro de Investigaciones Pediátricas (CIP)

    Guatemala City, 01001, Guatemala

  • Clinica de la costa

    Barranquilla, Atlántico, 80002, Colombia

  • Clinical Research Associates, Inc.

    Nashville, Tennessee, 37203, United States

  • Clinical Research Institute S.C.

    Tlalnepantla, 54055, Mexico

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226, United States

  • Clinical Research of California

    Walnut Creek, California, 94598, United States

  • Coast Clinical Research, LLC

    Bellflower, California, 90706, United States

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, A Coruña, 15706, Spain

  • Cordova Research Institute, LLC

    Miami, Florida, 33155, United States

  • Corning Center for Clinical Research

    Horseheads, New York, 14845, United States

  • Craig A. Spiegel, M.D.

    Bridgeton, Missouri, 63044, United States

  • DEMEDICA

    San Pedro Sula, Cortés Department, 21104, Honduras

  • Dayton Clinical Research

    Dayton, Ohio, 45409, United States

  • FAICIC S. de R.L. de C.V.

    Veracruz, 91900, Mexico

  • FEU-NRMF

    Quezon City, National Capital Region, 1118, Philippines

  • Fundacion Centro de Investigacion Clinica - CIC

    Medellín, Antioquia, 50021, Colombia

  • Fundacion Oftalmologica de Santander - FOSCAL

    Floridablanca, Santander Department, 681004, Colombia

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Severo Ochoa

    Leganés, Madrid, 28911, Spain

  • Hospital Universitario de Torrejon

    Torrejón de Ardoz, Madrid, 28850, Spain

  • Imagine Research of Palm Beach County

    Boynton Beach, Florida, 33435, United States

  • Innovacion y Desarrollo en Ciencias de la Salud (IDeCSa)

    Tlalpan, Mexico City, 14090, Mexico

  • Instituto Dermatologico y Cirugia de Piel Dr. Huberto Bogaert Diaz IDCP

    Santo Domingo, Nacional, 10306, Dominican Republic

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Tlalpan, Mexico City, 14080, Mexico

  • Inverime S.A.

    Tegucigalpa, Francisco Morazán Department, 11101, Honduras

  • Investigacion Sin Limites

    Tegucigalpa, Francisco Morazán Department, 11101, Honduras

  • Lakeside Healthcare Research

    Corby, Northamptonshire, NN17 2UR, United Kingdom

  • Leavitt Clinical Research

    Idaho Falls, Idaho, 83404, United States

  • Limpopo Clinical Research Initiative

    Thabazimbi, Limpopo, 0380, South Africa

  • Lynn Institute of Tulsa

    Tulsa, Oklahoma, 74135, United States

  • MEDYVAC INTERNACIONAL SRL en Clinica Cruz Jiminian

    Santo Domingo, Nacional, 10601, Dominican Republic

  • Manila Doctors Hospital

    Manila, National Capital Region, 1000, Philippines

  • Medical Mission Group Hospital-Lucban and Southern Luzon State University

    Lucena City, Quezon, 4328, Philippines

  • Mercury Clinical Research

    Houston, Texas, 77087, United States

  • Mercury Clinical Research - Pediatric Center

    Richmond, Texas, 77469, United States

  • Meridian Clinical Research

    Lincoln, Nebraska, 68510, United States

  • Michael W. Simon, M.D., PSC

    Lexington, Kentucky, 40517, United States

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310, United States

  • National Children's Hospital

    Quezon City, National Capital Region, 1102, Philippines

  • Orange County Research Institute

    Ontario, California, 91762, United States

  • PROBEBE en Hospital Universitario Maternidad Nuestra Senora de la Altagracia

    Santo Domingo, Nacional, 10205, Dominican Republic

  • Palm Harbor Dermatology PA

    Brandon, Florida, 33511, United States

  • PanAmerican Clinical Research

    Brownsville, Texas, 78520, United States

  • Panamerican Clinical Research Mexico S.A. de C.V. (Queretaro Site)

    Querétaro, 76100, Mexico

  • Panamerican Clinical Research S.A de C.V.

    Guadalajara, Jalisco, 44670, Mexico

  • Panamerican Clinical Research, Mexico S.A de C.V.

    Cuernavaca, Morelos, 62290, Mexico

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas, 72211, United States

  • REIMED Riger Park

    Boksburg, Gauteng, 1459, South Africa

  • Registrum Group (Hospital Materno Infantil San Lorenzo de Los Mina)

    Santo Domingo, Nacional, 11901, Dominican Republic

  • Registrum Group (Hospital Regional Marcelino Velez)

    Santo Domingo, Nacional, 11005, Dominican Republic

  • Research Your Health

    Plano, Texas, 75093, United States

  • SMI (Servicios Medicos Integrales)

    Guatemala City, 01007, Guatemala

  • Senders Pediatrics

    South Euclid, Ohio, 44121, United States

  • Setshaba Research Centre

    Ga-Tshwene, Gauteng, 0152, South Africa

  • South Texas Clinical Research

    Corpus Christi, Texas, 78404, United States

  • Soweto Clinical Trials Centre

    Johannesburg, Gauteng, 1818, South Africa

  • St Georges Hospital

    London, SW17 0QT, United Kingdom

  • Stellenbosch University Worcester

    Worcester, Western Cape, 6850, South Africa

  • Tekton Research

    San Antonio, Texas, 78244, United States

  • Tekton Research - Atlanta

    Chamblee, Georgia, 30341, United States

  • Tekton Research Beaumont

    Beaumont, Texas, 77706, United States

  • Tiervlei Trial Centre

    Bellville, Western Cape, 7530, South Africa

  • Tribe Clinical Research

    Greenville, South Carolina, 29607, United States

  • Trio Clinical Trials

    Houston, Texas, 77008, United States

  • University of the Philippines - Philippine General Hospital

    Manila, National Capital Region, 1000, Philippines

  • University of the Philippines Manila - National Institutes of Health (NIH) - Institute of

    San Juan City, Batangas, 4226, Philippines

  • Velocity Clinical Research

    Beachwood, Ohio, 44122, United States

  • Velocity Clinical Research - Covington

    Covington, Louisiana, 70433, United States

  • Velocity Clinical Research - Covington, LA

    Covington, Louisiana, 70433, United States

  • Velocity Clinical Research - Lafayette LA

    Lafayette, Louisiana, 70508, United States

  • Velocity Clinical Research - West Jordan

    West Jordan, Utah, 84088, United States

  • Velocity Clinical Research Grants Pass

    Grants Pass, Oregon, 97527, United States

  • WR - ClinSearch, LLC

    Chattanooga, Tennessee, 37421, United States

  • Westside Center for Clinical Research

    Jacksonville, Florida, 32205, United States

  • WiWits RHI - Shandukani Research Centre

    Johannesburg, Gauteng, 2001, South Africa

  • Wits Vida Nkanyezi Site- Rahima Moosa Mother and Child Hospital

    Johannesburg, Gauteng, 2093, South Africa

  • Wits Vida- Chris Hani Baragwanath Hospital

    Soweto, Gauteng, 1862, South Africa

More trials for these conditions

Other studies related to the condition(s) this trial covers.