Status:
COMPLETED
Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines
Lead Sponsor:
Novavax
Conditions:
COVID-19
Eligibility:
All Genders
11-18 years
Phase:
PHASE3
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 i...
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) recomb...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05973006
Start Date
August 16 2023
End Date
September 30 2024
Last Update
July 15 2025
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Alfa Medical Research
Davie, Florida, United States, 33024
2
Westside Center for Clinical Research
Jacksonville, Florida, United States, 32205
3
ITB Research
Miami, Florida, United States, 33173
4
Velocity Clinical Research
Meridian, Idaho, United States, 83642