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

NCT05973006 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 2019nCoV-314
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 20

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (5)

• Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination

  Participants with solicited local and systemic adverse events (AEs) To assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) for 7 days following vaccination

  Day 7

• Participants With Unsolicited AEs Through 28 Days After Vaccination

  Participants with unsolicited AEs to assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) through 28 days after vaccination.

  Day 28

• Participants With (MAAEs) Attributed to Study Vaccine, (AESIs) (PIMMCs), Myocarditis and/or Pericarditis, and Complications Specific to COVID-19), and Serious Adverse Events (SAEs)

  Participants with medically attended adverse events (MAAEs) attributed to study vaccine, adverse events of special interest (AESIs) (predefined list including potential immune-mediated medical conditions (PIMMCs), myocarditis and/or pericarditis, and complications specific to COVID-19), and serious adverse events (SAEs) o assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601)through day 180 or end of study (EOS).

  Day 180

• Immunogenicity Index- Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain.

  The neutralizing antibody (NAb) response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain assessed at Day 28 following initial study vaccination.

  Day 0 and Day 28

• Immunogenicity Index- The Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain.

  the neutralizing antibody (NAb) response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain, assessed at Day 28

  Day 28

Secondary Outcomes (5)

• Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain.

  Day 0 to Day 180

• Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain.

  Day 28 to Day 180

• IgG Geometric Mean ELISA (Enzyme-linked Immunosorbent Assay) Units (GMEUs) to the Omicron XBB.1.5 S Protein.

  Day 0 to Day 180

• NAb(Neutralizing Antibody Titers) Levels Are Measured to the Ancestral (Wuhan) Strain .

  Day 0 to 180

• Serum IgG GMEUs Levels Are Measured to the Ancestral (Wuhan) Strain .

  Day 0 to Day 180

Study Arms (2)

Group-A NVX-CoV2601

EXPERIMENTAL

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

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

Group-B Bivalent NVX CoV2373 + NVX CoV2601

ACTIVE COMPARATOR

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

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

Interventions

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

Also known as: NVX-CoV2601

Group-A NVX-CoV2601

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

Also known as: Omicron XBB.1.5 (sub-variant)SARS-CoV-2 rS /Matrix-M Adjuvant

Group-B Bivalent NVX CoV2373 + NVX CoV2601

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents ≥ 12 to \< 18 years of age at screening
• 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.
• 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.
• 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.
• Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
• 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.

You may not qualify if:

• Received COVID-19 vaccines other than Moderna and/or Pfizer-BioNTech in the past, inclusive of clinical trial COVID-19 vaccines.
• Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to study vaccination.
• Received influenza vaccination within 14 days prior to study vaccination.
• 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.
• Any known allergies to products contained in the investigational product.
• Any history of anaphylaxis to any prior vaccine.
• Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
• 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.
• 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.
• 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).
• Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
• 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.
• 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).
• 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).

Sponsors & Collaborators

• Novavax: lead

Study Sites (20)

Alfa Medical Research

Davie, Florida, 33024, United States

Location

Westside Center for Clinical Research

Jacksonville, Florida, 32205, United States

Location

ITB Research

Miami, Florida, 33173, United States

Location

Velocity Clinical Research

Meridian, Idaho, 83642, United States

Location

DM Clinical Research - Chicago

River Forest, Illinois, 60305, United States

Location

Johnson County Clinical Trials

Lenexa, Kansas, 66219, United States

Location

Alliance for Multispecialty Research, LLC (AMR)

Newton, Kansas, 67114, United States

Location

AMR

Wichita, Kansas, 67207, United States

Location

Velocity Clinical Research

Lafayette, Louisiana, 70508, United States

Location

Velocity Clinical Research

Vestal, New York, 13850, United States

Location

Velocity Clinical Research

Cincinnati, Ohio, 45246, United States

Location

Tekton Research

Tulsa, Oklahoma, 74137, United States

Location

Clinical Research Associates, Inc

Nashville, Tennessee, 37203, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

South Texas Clinical Research

Corpus Christi, Texas, 78404, United States

Location

DM Clinical Research

Houston, Texas, 77065, United States

Location

Medical Colleagues of Texas, LLP

Katy, Texas, 77450, United States

Location

Research Your Health

Plano, Texas, 75093, United States

Location

Tekton Research

San Antonio, Texas, 78244, United States

Location

Mountain View CCT Research

Pleasant View, Utah, 84404, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Novavax Customer Service Center
• Organization: Novavax Inc.

Clinicaltrials@novavax.com

1-844-Novavax (668-2829)

Study Officials

• Clinical Development

  Novavax

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 2, 2023
• Study Start: August 16, 2023
• Primary Completion: April 1, 2024
• Study Completion: September 30, 2024
• Last Updated: July 15, 2025
• Results First Posted: July 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)