CompletedNCT05468736COVID-19Updated May 22, 2026

Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years

A Phase 2/3 interventional study of SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period) and Placebo in COVID-19, sponsored by Novavax. Completed at 94 sites in 10 countries. Open to participants aged 6 Months to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Novavax · Phase 2/3, Interventional, and Prevention

From the registry’s dates

Primary completion was Jan 2024, 2 years 9 months ago, and no results have been posted to the registry; the sponsor requested a delay in submitting them in Dec 2024.

Phase: Phase 2/3
Study type: Interventional
Enrollment: 3,600
Allocation: Randomized
Ages: 6 Months to 11 Years
Sex: All

Study summary

This is a Phase 2/3 randomized, observer-blinded, placebo-controlled, age de-escalation trial to evaluate the safety and immunogenicity of 2 primary doses of SARS-CoV-2 rS with Matrix-M™ adjuvant (NVX-CoV2373) given 21 days apart and NVX CoV2373 or a variant-based vaccine given as a booster dose or at crossover in pediatric participants (3 age cohorts; 6 to \< 12 years, 2 to \< 6 years, and 6 to \< 24 months of age). Each age cohort will be conducted in 2 parts starting with the oldest age cohort (6 to \< 12 years of age).

Read the detailed description

Each age cohort will be conducted in 2 parts starting with the oldest age cohort (6 to \< 12 years of age).

Part 1 will enroll approximately 120 healthy or medically stable sentinel participants per age cohort (10% of the intended enrollment population per age cohort, for a total of 360 sentinel participants overall) who will be randomized in a 1:1 ratio to receive 2 doses of NVX-CoV2373 or placebo with doses given 21 days apart.

Part 2 will enroll a larger number of healthy or medically stable participants (N= approximately 1,080 per age cohort), for a total of approximately 3,240 pediatric participants enrolled in Part 2, and a total of approximately 3,600 participants enrolled in the entire trial). Initial randomization in Part 2 will be in a 2:1 ratio, and the safety and effectiveness of 2 doses of NVX-CoV2373 given 21 days apart will be assessed.

Conditions studied

COVID-19

Browse trials for

COVID-19 7,990

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 3,600 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Novavax is the lead sponsor of 47 studies on the registry; none are open to participants now.

Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.

Browse Novavax studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Months to 11 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

To be included in this study, each individual must satisfy all of the following criteria:

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.
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).
Participant and parent(s)/caregiver(s) or legally acceptable representative willing and able to give and assent, as required, prior to study enrollment and to comply with study procedures.
Participants of (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 method from at least 28 days prior to enrollment and through 3 months after the last vaccination.
Agree not to participate in another SARS-CoV-2 prevention trial for the duration of the study.

Exclusion criteria

Exclusion Criteria:

If an individual meets any of the following criteria, he or she is ineligible for this study:

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.
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 [HIV] infection with undetectable HIV ribonucleic acid [RNA \< 50 copies/mL] and > 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.
Participation in research involving an product (drug/biologic/device) administered within 45 days prior to the first study vaccination.
History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.
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.
Previous or current diagnosis of MIS-C.
Receipt of medications intended to prevent or treat COVID-19.
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.
Known or suspected congenital or acquired immunodeficiency or disease/condition; or receipt of therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic 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.
Received immunoglobulin or blood-derived products within 90 days prior to first study vaccination.
Active cancer () on chemotherapy within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator).
Any known allergies to products contained in the investigational product.
Participants who are breastfeeding a child, pregnant or who plan to become pregnant within 3 months following the last study vaccination.
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.
Study team member or first-degree relative of any study team member (inclusive of Sponsor, and study site personnel involved in the study).
Current participation in any other COVID-19 prevention clinical trial.
Participants with a history of myocarditis or pericarditis.

Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 3,600 participants (actual)

Study arms

Experimental
Cohort-1(6 to < 12 y)-Part-1(Active Vaccine)
NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)
Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
Placebo comparator
Cohort-1(6 to < 12 y)-Part-1(Placebo)
Placebo (normal saline)
Other: Placebo
Experimental
Cohort-1(6 to < 12 y)-Part-2(Active Vaccine)
NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)
Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
Placebo comparator
Cohort-1(6 to < 12 y)-Part-2(Placebo)
Placebo (normal saline)
Other: Placebo
Experimental
Cohort-2(2 to < 6 y)-Part-1(Active Vaccine)
NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)
Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
Placebo comparator
Cohort-2(2 to < 6 y)-Part-1(Placebo)
Placebo (normal saline)
Other: Placebo
Experimental
Cohort-2(2 to < 6 y)-Part-2(Active Vaccine)
NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)
Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
Placebo comparator
Cohort-2(2 to < 6 y)-Part-2(Placebo)
Placebo (normal saline)
Other: Placebo
Experimental
Cohort-3(6 to < 24 m)-Part-1(Active Vaccine)
NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)
Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
Placebo comparator
Cohort-3(6 to < 24 m)-Part-1(Placebo)
Placebo (normal saline)
Other: Placebo
Experimental
Cohort-3(6 to < 24 m)-Part-2
NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)
Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
Placebo comparator
Cohort-3(6 to < 24 m)-Part-2(Placebo)
Placebo (normal saline)
Other: Placebo

Interventions

BiologicalSARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
Drug page: NVX-CoV2373 adjuvated lipid nanoparticle
Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) (or fractional dose if necessary) on Days 0 and 21 in the Initial Vaccination Period.
Also known as: NVX-CoV2373
OtherPlacebo
Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21 in the Initial Vaccination Period or on Days 201 or Day 229 in the Booster Vaccination Period
Also known as: Sodium chloride 0.9% (BP, sterile)

What researchers measure

Primary outcomes

Reactogenicity Incidence and Severity
Reactogenicity incidence, duration, and severity (mild, moderate, severe, or potentially life-threatening) recorded by parent(s)/caregiver(s) on an electronic patient-reported outcome diary application (eDiary) on days of vaccination and subsequent 6 days (total 7 days after each vaccine injection).
Time frame: Day 0 to Day 7
Incidence and Severity of Medically Attended Adverse Events (MAAEs)
Incidence and severity of MAAEs through 28 days after second injection of each set of vaccinations (initial and crossover), and after a booster dose.
Time frame: Day 0 to Day 28
Incidence and Severity of Unsolicited Adverse Events (AEs)
Incidence and severity of unsolicited AEs through 28 days after second injection of each set of vaccinations (initial and crossover), and after a booster dose.
Time frame: Day 0 to Day 28
Incidence and Severity of MAAEs Attributed to Study Vaccine
Incidence and severity of MAAEs attributed to study vaccine after initial vaccination at Day 0 through Month 24 or the EoS.
Time frame: Day 0 to Day 730
Incidence and Severity of Serious Adverse Events (SAEs)
Incidence and severity of SAEs after initial vaccination at Day 0 through Month 24 or the EoS.
Time frame: Day 0 to Day 730
Incidence and Severity of Adverse Events of Special Interest (AESIs)
Incidence and severity of AESIs (including multisystem inflammatory syndrome in children \[MIS-C\], and myocarditis and/or pericarditis) after initial vaccination at Day 0 through Month 24 or the EoS.
Time frame: Day 0 to Day 730
Death due to any cause
Death due to any cause occurring from Day 0 to EoS.
Time frame: Day 0 to Day 730

Secondary outcomes

Participants with PCR positive mild, moderate or severe COVID-19 after the primary series of 2 doses
Incidence rate of participants with first episode of PCR-positive mild, moderate, or severe COVID-19 overall and per age cohort, with or without positive anti-NP serology at baseline after the primary series of 2 doses.
Time frame: Day 0 to Day 730
Participants with PCR positive moderate or severe COVID-19 after the primary series of 2 doses
Incidence rate of participants with first episode of PCR-positive moderate or severe COVID-19 overall and per age cohort, with or without positive anti-NP serology at baseline, and by risk factors to develop severe COVID-19 after the primary series of 2 doses.
Time frame: Day 0 to Day 730
Participants with diagnostic test - positive asymptomatic, mild, moderate or severe COVID-19 after the primary series of 2 doses
Incidence rate of participants with first episode of diagnostic test-positive asymptomatic, mild, moderate, or severe COVID-19 (regardless of confirmatory test used, ie, PCR or rapid antigen test, and of testing location, ie, central or externally tested) overall and per age cohort, with or without positive anti-NP serology at baseline after the primary series of 2 doses.
Time frame: Day 0 to Day 730
Participants with diagnostic test - positive moderate or severe COVID-19 after the primary series of 2 doses
Incidence rate of participants with first episode of diagnostic test-positive moderate or severe COVID-19 (regardless of confirmatory test used, ie, PCR or rapid antigen test, and of testing location, ie, central or externally tested) overall and per age cohort, with or without positive anti NP serology at baseline, and by risk factors to develop severe COVID-19 after the primary series of 2 doses.
Time frame: Day 0 to Day 730
Participants with PCR positive mild, moderate or severe COVID-19 after the booster dose
Incidence rate of participants with first episode of PCR-positive mild, moderate, or severe COVID-19 overall and per age cohort, with or without positive anti-NP serology at baseline after the booster dose.
Time frame: Day 0 to Day 730
Participants with PCR positive moderate or severe COVID-19 after the booster dose
Incidence rate of participants with first episode of PCR-positive moderate or severe COVID-19 overall and per age cohort, with or without positive anti-NP serology at baseline, and by risk factors to develop severe COVID-19 after the booster dose.
Time frame: Day 0 to Day 730
Participants with diagnostic test - positive asymptomatic, mild, moderate or severe COVID-19 after the booster dose
Incidence rate of participants with first episode of diagnostic test-positive asymptomatic, mild, moderate, or severe COVID-19 (regardless of confirmatory test used, ie, PCR or rapid antigen test, and of testing location, ie, central or externally tested) overall and per age cohort, with or without positive anti-NP serology at baseline after the booster dose.
Time frame: Day 0 to Day 730
Participants with diagnostic test moderate or severe COVID-19 after the booster dose
Incidence rate of participants with first episode of diagnostic test-positive moderate or severe COVID-19 (regardless of confirmatory test used, ie, PCR or rapid antigen test, and of testing location, ie, central or externally tested) overall and per age cohort, with or without positive anti-NP serology at baseline after the booster dose, and by risk factors to develop severe COVID-19.
Time frame: Day 0 to Day 730
Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specified Time Points
Antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic. Antibodies to SARS-CoV-2 NP at Days 0 and 35, at Crossover Visit 1, at Booster vaccination visit, and at Months 12 and 24 will be used to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.
Time frame: Day 0 to Day 730
Neutralizing antibody response, post-booster, by age cohort,seronegative to anti-SARS-CoV-2 NP antibodies at baseline and pre-booster
Neutralizing antibody response at 28 days post booster for pediatric participants in the Immunogenicity Population overall and by age cohort, seronegative to anti-SARS-CoV-2 NP antibodies at baseline and pre-booster, compared with that observed at 28 days post-booster vaccination in young adult participants 18 to \< 26 years of age.
Time frame: Day 0 to Day 28
Neutralizing antibody response, by age cohort, regardless of serostatus at baseline and pre-booster
Neutralizing antibody response at 28 days post-booster for pediatric participants in the Immunogenicity Population overall and by age cohort, regardless of serostatus at baseline and pre-booster, compared with that observed in pediatric participants at baseline (Day 0).
Time frame: Day 0 to Day 28
Serum IgG levels to SARS-CoV-2 S protein, post-booster, by age cohort, regardless of serostatus at baseline and pre-booster vaccination
Serum IgG levels to SARS-CoV-2 S protein at 28 days post-booster vaccination for pediatric participants in the Immunogenicity Population overall and by age cohort, regardless of serostatus at baseline and pre-booster vaccination, compared with that observed at 28 days post-booster vaccination in young adult participants 18 to \< 26 years of age.
Time frame: Day 0 to Day 28
Serum IgG levels to SARS-CoV-2 S protein, post booster, by age cohort, regardless of serostatus at baseline and pre-booster
Serum IgG levels to SARS-CoV-2 S protein at 28 days post-booster for pediatric participants in the Immunogenicity Population overall and by age cohort, regardless of serostatus at baseline and pre-booster, compared with that observed in pediatric participants at baseline (Day 0).
Time frame: Day 0 to Day 28
Serum IgG levels to SARS-CoV-2 S protein , post booster, by age cohort, regardless of serostatus at baseline and pre-booster
Serum IgG levels to SARS-CoV-2 S protein at 28 days post-booster for pediatric participants in the Immunogenicity Population overall and by age cohort, regardless of serostatus at baseline and pre-booster, compared with that observed in pediatric participants at Day 35,
Time frame: Day 0 to Day 35
Neutralizing antibody response for pediatric participants and adult participants expressed as Geometric Mean Titers (GMT)
Neutralizing antibody response for pediatric participants compared with adult participants 18 to \< 26 years of age from the Adult Main Study at Day 35
Time frame: Day 35
Neutralizing antibody response for pediatric participants and adult participants expressed as Sero response (SRR)
Neutralizing antibody response for pediatric participants compared with adult participants 18 to \< 26 years of age from the Adult Main Study at Day 35
Time frame: Day 35
Serum IgG levels to SARS-CoV-2 S protein after second injection of the initial vaccination series
Serum IgG levels to SARS-CoV-2 S protein 14 days after second injection of the initial vaccination series (Day 35) in pediatric participants in the Immunogenicity Population by age cohort and subsets with and without anti-NP antibodies at baseline.
Time frame: Day 35
Treatment and severity of COVID 19 after a PCR-confirmed case
Description of course, treatment and severity of COVID 19 reported after a PCR-confirmed case via the Case Form.
Time frame: Day 0 to Day 730
Antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic.
Antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic. Antibodies to SARS-CoV-2 NP at Days 0 and 35, at Crossover Visit 1, at Booster vaccination visit, and at Months 12 and 24 will be used to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.
Time frame: Day 0 to Day 730
Serum IgG levels to SARS-CoV-2 S protein expressed as GMT
Serum IgG levels to SARS-CoV-2 S protein at Months 6 (pre- booster), 7/8 (1-month post-booster), 12, and 24 post-vaccination with NVXCoV2373.
Time frame: Day 180 to Day 730
MN titers to SARS-CoV-2 S protein expressed as GMT
MN titers at Months 6 (pre- booster), 7/8 (1-month post-booster), 12, and 24 post-vaccination with NVXCoV2373.
Time frame: Day 180 to Day 730

Study locations

94 sites

Preferred Research Partners, Inc.
Little Rock, Arkansas 72211, United States
Advanced Research Center
Anaheim, California 92805, United States
Coast Clinical Research, LLC
Bellflower, California 90706, United States
Apex Research Group
Fair Oaks, California 95628, United States
Ark Clinical Research
Long Beach, California 90815, United States
Orange County Research Institute
Ontario, California 91762, United States
California Research Foundation
San Diego, California 92123, United States
Clinical Research of California
Walnut Creek, California 94598, United States
Imagine Research of Palm Beach County
Boynton Beach, Florida 33435, United States
Palm Harbor Dermatology PA
Brandon, Florida 33511, United States
Westside Center for Clinical Research
Jacksonville, Florida 32205, United States
Cordova Research Institute, LLC
Miami, Florida 33155, United States
ARS-Nona Pediatric Center
Orlando, Florida 32829, United States
Morehouse School of Medicine
Atlanta, Georgia 30310, United States
Tekton Research - Atlanta
Chamblee, Georgia 30341, United States
Leavitt Clinical Research
Idaho Falls, Idaho 83404, United States
Michael W. Simon, M.D., PSC
Lexington, Kentucky 40517, United States
Bluegrass Clinical Research, Inc./All Children Pediatrics
Louisville, Kentucky 40243, United States
Velocity Clinical Research - Covington, LA
Covington, Louisiana 70433, United States
Velocity Clinical Research - Covington
Covington, Louisiana 70433, United States
Velocity Clinical Research - Lafayette LA
Lafayette, Louisiana 70508, United States
Craig A. Spiegel, M.D.
Bridgeton, Missouri 63044, United States
Boeson Research
Missoula, Montana 59804, United States
Meridian Clinical Research
Lincoln, Nebraska 68510, United States
Be Well Clinical Studies, LLC
Lincoln, Nebraska 68516, United States
Corning Center for Clinical Research
Horseheads, New York 14845, United States
Velocity Clinical Research
Beachwood, Ohio 44122, United States
Dayton Clinical Research
Dayton, Ohio 45409, United States
Senders Pediatrics
South Euclid, Ohio 44121, United States
Lynn Institute of Tulsa
Tulsa, Oklahoma 74135, United States
Velocity Clinical Research Grants Pass
Grants Pass, Oregon 97527, United States
Tribe Clinical Research
Greenville, South Carolina 29607, United States
WR - ClinSearch, LLC
Chattanooga, Tennessee 37421, United States
Clinical Research Associates, Inc.
Nashville, Tennessee 37203, United States
Tekton Research Beaumont
Beaumont, Texas 77706, United States
PanAmerican Clinical Research
Brownsville, Texas 78520, United States
South Texas Clinical Research
Corpus Christi, Texas 78404, United States
Bay Colony Pediatrics
Dickinson, Texas 77539, United States
Trio Clinical Trials
Houston, Texas 77008, United States
Mercury Clinical Research
Houston, Texas 77087, United States
Research Your Health
Plano, Texas 75093, United States
Mercury Clinical Research - Pediatric Center
Richmond, Texas 77469, United States
Tekton Research
San Antonio, Texas 78244, 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
Velocity Clinical Research - West Jordan
West Jordan, Utah 84088, United States
Clinical Research Partners, LLC
Richmond, Virginia 23226, United States
Fundacion Centro de Investigacion Clinica - CIC
Medellín, Antioquia 50021, Colombia
Clinica de la costa
Barranquilla, Atlántico 80002, Colombia
Centro de Atencion e Investigacion Medica S.A.S-CAIMED
Puente Aranda, Bogota D.C. 111011, Colombia
Centro de Atencion e Investigacion Medica - CAIMED
Yopal, Casanare Department 850007, Colombia
Fundacion Oftalmologica de Santander - FOSCAL
Floridablanca, Santander Department 681004, Colombia
Centro de Estudios en Infectologia Pediatrica S.A.S.CEIP
Cali, Valle del Cauca Department 760042, Colombia
PROBEBE en Hospital Universitario Maternidad Nuestra Senora de la Altagracia
Santo Domingo, Nacional 10205, Dominican Republic
Instituto Dermatologico y Cirugia de Piel Dr. Huberto Bogaert Diaz IDCP
Santo Domingo, Nacional 10306, Dominican Republic
MEDYVAC INTERNACIONAL SRL en Clinica Cruz Jiminian
Santo Domingo, Nacional 10601, Dominican Republic
Registrum Group (Hospital Regional Marcelino Velez)
Santo Domingo, Nacional 11005, Dominican Republic
Registrum Group (Hospital Materno Infantil San Lorenzo de Los Mina)
Santo Domingo, Nacional 11901, Dominican Republic
Centro de Investigaciones Pediátricas (CIP)
Guatemala City, 01001, Guatemala
SMI (Servicios Medicos Integrales)
Guatemala City, 01007, Guatemala
CECLISA
Guatemala City, 01009, Guatemala
DEMEDICA
San Pedro Sula, Cortés Department 21104, Honduras
Inverime S.A.
Tegucigalpa, Francisco Morazán Department 11101, Honduras
Investigacion Sin Limites
Tegucigalpa, Francisco Morazán Department 11101, Honduras
Panamerican Clinical Research S.A de C.V.
Guadalajara, Jalisco 44670, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Tlalpan, Mexico City 14080, Mexico
Innovacion y Desarrollo en Ciencias de la Salud (IDeCSa)
Tlalpan, Mexico City 14090, Mexico
Panamerican Clinical Research, Mexico S.A de C.V.
Cuernavaca, Morelos 62290, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S.C.P.
Mérida, Yucatán 97130, Mexico
Panamerican Clinical Research Mexico S.A. de C.V. (Queretaro Site)
Querétaro, 76100, Mexico
Clinical Research Institute S.C.
Tlalnepantla, 54055, Mexico
FAICIC S. de R.L. de C.V.
Veracruz, 91900, Mexico
University of the Philippines Manila - National Institutes of Health (NIH) - Institute of
San Juan City, Batangas 4226, Philippines
Manila Doctors Hospital
Manila, National Capital Region 1000, Philippines
University of the Philippines - Philippine General Hospital
Manila, National Capital Region 1000, Philippines
National Children's Hospital
Quezon City, National Capital Region 1102, Philippines
FEU-NRMF
Quezon City, National Capital Region 1118, Philippines
Medical Mission Group Hospital-Lucban and Southern Luzon State University
Lucena City, Quezon 4328, Philippines
REIMED Riger Park
Boksburg, Gauteng 1459, South Africa
Setshaba Research Centre
Ga-Tshwene, Gauteng 0152, South Africa
Soweto Clinical Trials Centre
Johannesburg, Gauteng 1818, South Africa
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
Limpopo Clinical Research Initiative
Thabazimbi, Limpopo 0380, South Africa
Tiervlei Trial Centre
Bellville, Western Cape 7530, South Africa
Be Part Yoluntu Centre - Paarl
Paarl, Western Cape 7655, South Africa
Stellenbosch University Worcester
Worcester, Western Cape 6850, South Africa
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña 15706, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid 28911, Spain
Hospital Universitario de Torrejon
Torrejón de Ardoz, Madrid 28850, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Lakeside Healthcare Research
Corby, Northamptonshire NN17 2UR, United Kingdom
St Georges Hospital
London, SW17 0QT, United Kingdom

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05468736
Lead sponsor: Novavax
Responsible party: Sponsor
First posted: Jul 21, 2022
Start date: Jul 22, 2022
Primary completion: Jan 16, 2024
Completion: Oct 25, 2025
Last update: May 22, 2026

Study contacts

Clinical Development

study director · Novavax, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: NVX-CoV2373 adjuvated lipid nanoparticle

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