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ACTIVE NOT RECRUITING

NCT05468736

PHASE2/PHASE3

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

Sponsor: Novavax

View on ClinicalTrials.gov

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).

Official title: A Phase 2/3 Age De-escalating Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Vaccine (SARS-CoV-2 rS) With Matrix-M™ Adjuvant in Children 6 Months to < 12 Years of Age

Key Details

Gender

All

Age Range

6 Months - 11 Years

Study Type

INTERVENTIONAL

Enrollment

3600

Start Date

2022-07-22

Completion Date

2025-10-25

Last Updated

2024-12-20

Healthy Volunteers

Yes

Conditions

COVID-19

Interventions

BIOLOGICAL

SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)

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.

OTHER

Placebo

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

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.

Locations (94)

Preferred Research Partners, Inc.

Little Rock, Arkansas, United States

Advanced Research Center

Anaheim, California, United States

Coast Clinical Research, LLC

Bellflower, California, United States

Apex Research Group

Fair Oaks, California, United States

Ark Clinical Research

Long Beach, California, United States

Orange County Research Institute

Ontario, California, United States

California Research Foundation

San Diego, California, United States

Clinical Research of California

Walnut Creek, California, United States

Imagine Research of Palm Beach County

Boynton Beach, Florida, United States

Palm Harbor Dermatology PA

Brandon, Florida, United States

Westside Center for Clinical Research

Jacksonville, Florida, United States

Cordova Research Institute, LLC

Miami, Florida, United States

ARS-Nona Pediatric Center

Orlando, Florida, United States

Morehouse School of Medicine

Atlanta, Georgia, United States

Tekton Research - Atlanta

Chamblee, Georgia, United States

Leavitt Clinical Research

Idaho Falls, Idaho, United States

Michael W. Simon, M.D., PSC

Lexington, Kentucky, United States

Bluegrass Clinical Research, Inc./All Children Pediatrics

Louisville, Kentucky, United States

Velocity Clinical Research - Covington, LA

Covington, Louisiana, United States

Velocity Clinical Research - Covington

Covington, Louisiana, United States

Velocity Clinical Research - Lafayette LA

Lafayette, Louisiana, United States

Craig A. Spiegel, M.D.

Bridgeton, Missouri, United States

Boeson Research

Missoula, Montana, United States

Meridian Clinical Research

Lincoln, Nebraska, United States

Be Well Clinical Studies, LLC

Lincoln, Nebraska, United States

Corning Center for Clinical Research

Horseheads, New York, United States

Velocity Clinical Research

Beachwood, Ohio, United States

Dayton Clinical Research

Dayton, Ohio, United States

Senders Pediatrics

South Euclid, Ohio, United States

Lynn Institute of Tulsa

Tulsa, Oklahoma, United States

Velocity Clinical Research Grants Pass

Grants Pass, Oregon, United States

Tribe Clinical Research

Greenville, South Carolina, United States

WR - ClinSearch, LLC

Chattanooga, Tennessee, United States

Clinical Research Associates, Inc.

Nashville, Tennessee, United States

Tekton Research Beaumont

Beaumont, Texas, United States

PanAmerican Clinical Research

Brownsville, Texas, United States

South Texas Clinical Research

Corpus Christi, Texas, United States

Bay Colony Pediatrics

Dickinson, Texas, United States

Trio Clinical Trials

Houston, Texas, United States

Mercury Clinical Research

Houston, Texas, United States

Research Your Health

Plano, Texas, United States

Mercury Clinical Research - Pediatric Center

Richmond, Texas, United States

Tekton Research

San Antonio, Texas, United States

Alliance for Multispecialty Research

Layton, Utah, United States

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

Roy, Utah, United States

Velocity Clinical Research - West Jordan

West Jordan, Utah, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

Fundacion Centro de Investigacion Clinica - CIC

Medellín, Antioquia, Colombia

Clinica de la costa

Barranquilla, Atlántico, Colombia

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

Puente Aranda, Bogota D.C., Colombia

Centro de Atencion e Investigacion Medica - CAIMED

Yopal, Casanare Department, Colombia

Fundacion Oftalmologica de Santander - FOSCAL

Floridablanca, Santander Department, Colombia

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

Cali, Valle del Cauca Department, Colombia

PROBEBE en Hospital Universitario Maternidad Nuestra Senora de la Altagracia