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Virus Therapy
COVID-19 Vaccines for Adolescents with Prior mRNA Vaccine (COVID-19 Trial)
Phase 3
Waitlist Available
Research Sponsored by Novavax
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adolescents ≥ 12 to < 18 years of age at screening
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 180
Awards & highlights
COVID-19 Trial Summary
This trial tests two new COVID-19 vaccines to see if they're safe and effective in teens who already got an mRNA vaccine.
Who is the study for?
Adolescents aged 12 to under 18 who are medically stable and have had at least two doses of Moderna or Pfizer-BioNTech COVID-19 vaccines can join. They must not be pregnant, planning pregnancy, or breastfeeding, agree to contraception if applicable, and avoid other COVID trials.Check my eligibility
What is being tested?
This study tests the safety and immune response of a new Omicron XBB.1.5 variant vaccine in teens previously vaccinated with mRNA COVID-19 vaccines. It's randomized and double-blinded, meaning participants don't know which vaccine they receive.See study design
What are the potential side effects?
Potential side effects may include typical reactions seen with vaccines such as soreness at injection site, fever, fatigue, headache or allergic reactions but specific side effects for this new vaccine will be closely monitored.
COVID-19 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 12 and 17 years old.
COVID-19 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 180
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immunogenicity index- Neutralizing antibody (NAb) expressed as geometric mean titers (GMTs) to the Omicron XBB.1.5 strain.
Immunogenicity index- The Neutralizing antibody (NAb) expressed as geometric mean fold rise (GMFR) to the Omicron XBB.1.5 strain.
Safety: Incidence and severity of (MAAEs) attributed to study vaccine, (AESIs) (PIMMCs), myocarditis and/or pericarditis, and complications specific to COVID-19), and serious adverse events (SAEs)
+2 moreSecondary outcome measures
IgG geometric mean ELISA (enzyme-linked immunosorbent assay) units (GMEUs) to the Omicron XBB.1.5 S protein.
NAb(neutralizing antibody titers) and IgG GMEUs levels are measured to the ancestral (Wuhan) strain .
Neutralizing antibody (NAb) expressed as geometric mean fold rise (GMFR) to the Omicron XBB.1.5 strain.
+2 moreSide effects data
From 2023 Phase 4 trial • 267 Patients • NCT050070418%
COVID-19 Infection
7%
Upper Respiratory Infection
1%
Cardiovascular Accident (CVA), Unspecified Mechanism
1%
Acute pulmonary embolism and acute deep vein thrombosis
1%
Left partial cranial nerve III palsy
1%
Acute Hyperkalemia
1%
Shortness of Breath
100%
80%
60%
40%
20%
0%
Study treatment Arm
Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine
Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
COVID-19 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group-A NVX-CoV2601Experimental Treatment1 Intervention
The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant
Group II: Group-B Bivalent NVX CoV2373 + NVX CoV2601Active Control1 Intervention
The Bivalent NVX CoV2373 + NVX CoV2601 of 5 μg of each antigen with a total of 50 μg of Matrix-M adjuvant
Find a Location
Who is running the clinical trial?
NovavaxLead Sponsor
47 Previous Clinical Trials
106,264 Total Patients Enrolled
18 Trials studying COVID-19
71,095 Patients Enrolled for COVID-19
Clinical DevelopmentStudy DirectorNovavax
35 Previous Clinical Trials
88,515 Total Patients Enrolled
15 Trials studying COVID-19
65,797 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have had a fever of more than 38°C (100.4°F) within 24 hours before the scheduled study vaccination, you cannot participate.I haven't taken immune-suppressing drugs in the last 90 days.I got a flu shot within the last 14 days.I am between 12 and 17 years old.I have had myocarditis or pericarditis in the past.I haven't received any vaccines in the last 45 days, except for medically necessary ones.I haven't taken immunosuppressants or blood products in the last 90 days, except for rabies treatment if needed.I have received a COVID-19 vaccine that is not Moderna or Pfizer.Your blood pressure is higher than 160 over 100.I am on treatment for an autoimmune disease or immunodeficiency.I have been treated for cancer within the last 3 years.I've had at least 2 doses of Moderna or Pfizer COVID-19 vaccines, with the last dose over 90 days ago.You have had a severe allergic reaction to a vaccine before.I have had breathing problems in the last 3 days.You have had a problem with drinking too much alcohol or using drugs in the past 2 years before the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group-A NVX-CoV2601
- Group 2: Group-B Bivalent NVX CoV2373 + NVX CoV2601
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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