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

Completed · Phase 3

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT05973006

Run by

Novavax

People needed

400

Starts

2023-08-16

Expected to finish

2024-09-30

Last updated by the study team

2025-07-15

Who can join

Age: 11 and older, up to 18. Sex: any. Healthy volunteers: accepted.

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).
• Participants with a history of myocarditis or pericarditis.
• Respiratory symptoms in the past 3 days (ie, cough, sore throat, difficulty breathing).
• Temperature of > 38°C within 24 hours of planned study vaccination (site measured or participant measured).
• Blood pressure of ≥ 160/100 mmHg.

Where it is running

• 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

Full record on ClinicalTrials.gov

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