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NCT05973006 | COMPLETED | COVID-19

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

Novavax

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.

Condition or disease

COVID-19

Intervention/treatment

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

Prototype/XBB.1.5 Bivalent Vaccine (5 µg)

Phase

PHASE3

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 400 participants
Masking : DOUBLE
Primary Purpose : PREVENTION
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
Actual Study Start Date : 2023-08-16
Estimated Primary Completion Date : 2024-04-01
Estimated Study Completion Date : 2024-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 11 Years to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.
Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines

Location Details

NCT05973006

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Florida

Alfa Medical Research

Davie, Florida, United States, 33024

Not yet recruiting

United States, Florida

Westside Center for Clinical Research

Jacksonville, Florida, United States, 32205

Not yet recruiting

United States, Florida

ITB Research

Miami, Florida, United States, 33173

Not yet recruiting

United States, Idaho

Velocity Clinical Research

Meridian, Idaho, United States, 83642

Not yet recruiting

United States, Illinois

DM Clinical Research - Chicago

River Forest, Illinois, United States, 60305

Not yet recruiting

United States, Kansas

Johnson County Clinical Trials

Lenexa, Kansas, United States, 66219

Not yet recruiting

United States, Kansas

Alliance for Multispecialty Research, LLC (AMR)

Newton, Kansas, United States, 67114

Not yet recruiting

United States, Kansas

AMR

Wichita, Kansas, United States, 67207

Not yet recruiting

United States, Louisiana

Velocity Clinical Research

Lafayette, Louisiana, United States, 70508

Not yet recruiting

United States, New York

Velocity Clinical Research

Vestal, New York, United States, 13850

Not yet recruiting

United States, Ohio

Velocity Clinical Research

Cincinnati, Ohio, United States, 45246

Not yet recruiting

United States, Oklahola

Tekton Research

Tulsa, Okholohan, United States, 74137

Not yet recruiting

United States, Tennessee

Clinical Research Associates, Inc

Nashville, Tennessee, United States, 37203

Not yet recruiting

United States, Texas

Benchmark Research

Austin, Texas, United States, 78705

Not yet recruiting

United States, Texas

South Texas Clinical Research

Corpus Christi, Texas, United States, 78404

Not yet recruiting

United States, Texas

DM Clinical Research

Houston, Texas, United States, 77065

Not yet recruiting

United States, Texas

Medical Colleagues of Texas, LLP

Katy, Texas, United States, 77450

Not yet recruiting

United States, Texas

Research Your Health

Plano, Texas, United States, 75093

Not yet recruiting

United States, Texas

Tekton Research

San Antonio, Texas, United States, 78244

Not yet recruiting

United States, Utah

Mountain View CCT Research

Pleasant View, Utah, United States, 84404