Official Title
A Phase 3, Randomized, Double-Blinded Study to Evaluate the Safety and Immunogenicity of Omicron Subvariant and Bivalent SARS-CoV-2 rS Vaccines in Adolescents Previously Vaccinated With mRNA COVID-19 Vaccines
Brief Summary

This study is a large-scale investigation (Phase 3) into a new booster shot designedspecifically for teenagers. The booster targets a particular variant of COVID-19, OmicronXBB.1.5. The main focus is on safety: researchers want to see if this new booster is safefor teenagers who have already received two doses of the Pfizer or Moderna mRNA COVID-19vaccines. To ensure a fair comparison, the study will use a double-blind approach. Thismeans two groups of teenagers will receive booster shots, but neither the teenagers northe researchers giving the shots will know beforehand which version of the booster eachperson gets. The study will also assess how well the body fights the virus after thebooster shot.

Detailed Description

This is a Phase 3, randomized, double-blinded study to evaluate the safety and
immunogenicity of booster doses of Omicron subvariant severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccines
(SARS-CoV-2 rS) adjuvanted with Matrix-M™ adjuvant (NVX-CoV2601 [Omicron XBB.1.5]) and
bivalent (NVX-CoV2373 [prototype] + NVX CoV2601) in previously vaccinated adolescent
participants ≥ 12 to < 18 years of age.

Approximately 400 adolescents who have received a regimen of ≥ 2 doses of the Moderna
and/or Pfizer-BioNTech monovalent and/or bivalent COVID-19 vaccines ≥ 90 days previously
will be randomized 1:1 to Group A or Group B:

- Group A: 1 dose of NVX-CoV2601 (1 on Day 0)

- Group B: 1 dose of bivalent NVX-CoV2373 + NVX-CoV2601 (1 on Day 0) All participants
will remain on study for immunogenicity and safety data collection through Day 180.

Completed
COVID-19

Biological: NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine

Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a
solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg
adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a
dose of 5 µg antigen with 50 µg Matrix-M adjuvant.
Other Name: NVX-CoV2601

Biological: Prototype/XBB.1.5 Bivalent Vaccine (5 µg)

A site-mixed bivalent vaccine prepared by combining 0.25 mL of NVX-CoV2373 and 0.25 mL
NVX-CoV2601. All injections will be administered in a 0.5 mL injection volume at a dose
of 5 µg total antigen (2.5 µg prototype antigen + 2.5 µg Omicron XBB.1.5 antigen) with 50
µg Matrix-M adjuvant.
Other Name: Omicron XBB.1.5 (sub-variant)SARS-CoV-2 rS /Matrix-M Adjuvant

Eligibility Criteria

Inclusion Criteria:

1. Adolescents ≥ 12 to < 18 years of age at screening

2. Participant and parent(s)/caregiver(s) or legally acceptable representative willing
and able to give in-formed consent and assent, as required, prior to study
enrollment and to comply with study procedures.

3. 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] or post-menopausal [defined as amenorrhea
≥ 12 consecutive months]) must agree to be heterosexually inactive from at least 28
days prior to enrollment and through the end of the study OR agree to consistently
use a medically acceptable method of contraception listed below from ≥ 28 days prior
to enrollment and through the end of the study.

4. Is medically stable, as determined 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 medically
acceptable ranges prior to the vaccination.

5. Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for
the duration of the study.

6. Have previously received ≥ 2 doses of the Moderna and/or Pfizer-BioNTech monovalent
and/or bivalent COVID-19 vaccines with the last dose having been given ≥ 90 days
previously prior to study vaccination.

Exclusion Criteria:

1. Received COVID-19 vaccines other than Moderna and/or Pfizer-BioNTech in the past,
inclusive of clinical trial COVID-19 vaccines.

2. Participation in research involving receipt of investigational products
(drug/biologic/device) within 90 days prior to study vaccination.

3. Received influenza vaccination within 14 days prior to study vaccination.

4. Received any vaccine ≤ 45 days prior to study vaccination, except for rabies, human
papilloma virus (HPV), tetanus-diphtheria (Td), tetanus, diphtheria, and pertussis
(TDaP/DTap), hepatitis B virus (HBV), and meningococcal vaccines which may be given
as medically indicated.

5. Any known allergies to products contained in the investigational product.

6. Any history of anaphylaxis to any prior vaccine.

7. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital)
requiring ongoing immunomodulatory therapy.

8. Chronic administration (defined as > 14 continuous days) of immunosuppressant,
systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to
study vaccination.

An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of
prednisone per day or equivalent. The use of topical or intranasal glucocorticoids
is permitted. Topical tacrolimus and ocular cyclosporin are permitted.

9. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within
90 days prior to study vaccination, except for rabies immunoglobulin which may be
given if medically indicated.

10. Active cancer (malignancy) on therapy within 3 years prior to study vaccination
(with the exception of adequately treated non-melanomatous skin carcinoma or lentigo
maligna and uterine cervical carcinoma in situ without evidence of disease, at the
discretion of the investigator).

11. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior
to the end of study.

12. Suspected or known history of alcohol abuse or drug addiction within 2 years prior
to the study vaccine dose that, in the opinion of the investigator, might interfere
with protocol compliance.

13. Any other condition that, in the opinion of the investigator, would pose a health
risk to the participant if enrolled or could interfere with evaluation of the study
vaccine or interpretation of study results (including neurologic or psychiatric
conditions likely to impair the quality of safety reporting).

14. Study team member or immediate family member of any study team member (inclusive of
Sponsor, clinical research organization [CRO], and study site personnel involved in
the conduct or planning of the study).

15. Participants with a history of myocarditis or pericarditis.

16. Respiratory symptoms in the past 3 days (ie, cough, sore throat, difficulty
breathing).

17. Temperature of > 38°C within 24 hours of planned study vaccination (site measured or
participant measured).

18. Blood pressure of ≥ 160/100 mmHg.

Eligibility Gender
All
Eligibility Age
Minimum: 11 Years ~ Maximum: 18 Years
Countries
United States
Locations

Alfa Medical Research
Davie 4152820, Florida 4155751, United States

Westside Center for Clinical Research
Jacksonville 4160021, Florida 4155751, United States

ITB Research
Miami 4164138, Florida 4155751, United States

Velocity Clinical Research
Meridian 5600685, Idaho 5596512, United States

DM Clinical Research - Chicago
River Forest 4907637, Illinois 4896861, United States

Johnson County Clinical Trials
Lenexa 4274356, Kansas 4273857, United States

Alliance for Multispecialty Research, LLC (AMR)
Newton 4276248, Kansas 4273857, United States

AMR
Wichita 4281730, Kansas 4273857, United States

Velocity Clinical Research
Lafayette 4330145, Louisiana 4331987, United States

Velocity Clinical Research
Vestal 5142296, New York 5128638, United States

Velocity Clinical Research
Cincinnati 4508722, Ohio 5165418, United States

Tekton Research
Tulsa 4553433, Oklahoma 4544379, United States

Clinical Research Associates, Inc
Nashville 4644585, Tennessee 4662168, United States

Benchmark Research
Austin 4671654, Texas 4736286, United States

South Texas Clinical Research
Corpus Christi 4683416, Texas 4736286, United States

DM Clinical Research
Houston 4699066, Texas 4736286, United States

Medical Colleagues of Texas, LLP
Katy 4702732, Texas 4736286, United States

Research Your Health
Plano 4719457, Texas 4736286, United States

Tekton Research
San Antonio 4726206, Texas 4736286, United States

Mountain View CCT Research
Pleasant View 5779833, Utah 5549030, United States

Clinical Development, Study Director
Novavax

NCT Number
MeSH Terms
COVID-19