Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines

NCT ID: NCT05973006

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-16
• Study Completion Date: 2024-09-30

Brief Summary

This study is a large-scale investigation (Phase 3) into a new booster shot designed specifically for teenagers. The booster targets a particular variant of COVID-19, Omicron XBB.1.5. The main focus is on safety: researchers want to see if this new booster is safe for teenagers who have already received two doses of the Pfizer or Moderna mRNA COVID-19 vaccines. To ensure a fair comparison, the study will use a double-blind approach. This means two groups of teenagers will receive booster shots, but neither the teenagers nor the researchers giving the shots will know beforehand which version of the booster each person gets. The study will also assess how well the body fights the virus after the booster 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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group-A NVX-CoV2601

The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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.

Group-B Bivalent NVX CoV2373 + NVX CoV2601

The Bivalent NVX CoV2373 + NVX CoV2601 of 5 μg of each antigen with a total of 50 μg of Matrix-M adjuvant

Group Type: ACTIVE_COMPARATOR

Prototype/XBB.1.5 Bivalent Vaccine (5 µg)

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

NVX-CoV2601; 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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novavax

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development

Role: STUDY_DIRECTOR

Novavax

Locations

Alfa Medical Research

Davie, Florida, United States

Westside Center for Clinical Research

Jacksonville, Florida, United States

ITB Research

Miami, Florida, United States

Velocity Clinical Research

Meridian, Idaho, United States

DM Clinical Research - Chicago

River Forest, Illinois, United States

Johnson County Clinical Trials

Lenexa, Kansas, United States

Alliance for Multispecialty Research, LLC (AMR)

Newton, Kansas, United States

AMR

Wichita, Kansas, United States

Velocity Clinical Research

Lafayette, Louisiana, United States

Velocity Clinical Research

Vestal, New York, United States

Velocity Clinical Research

Cincinnati, Ohio, United States

Tekton Research

Tulsa, Oklahoma, United States

Clinical Research Associates, Inc

Nashville, Tennessee, United States

Benchmark Research

Austin, Texas, United States

South Texas Clinical Research

Corpus Christi, Texas, United States

DM Clinical Research

Houston, Texas, United States

Medical Colleagues of Texas, LLP

Katy, Texas, United States

Research Your Health

Plano, Texas, United States

Tekton Research

San Antonio, Texas, United States

Mountain View CCT Research

Pleasant View, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019nCoV-314

Identifier Type: -

Identifier Source: org_study_id