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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 0, 28, 90, and 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 below
Select...
I am between 12 and 17 years old.

COVID-19 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, 28, 90, and 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, 28, 90, and 180 for reporting.

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 more
Secondary 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 more

Side effects data

From 2012 Phase 3 trial • 6104 Patients • NCT01346592
27%
Injection site pain
25%
Pyrexia
14%
Decreased appetite
14%
Upper respiratory tract infection
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Myalgia
7%
Hypersomnia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)

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
46 Previous Clinical Trials
106,164 Total Patients Enrolled
17 Trials studying COVID-19
70,995 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

NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05973006 — Phase 3
COVID-19 Research Study Groups: Group-A NVX-CoV2601, Group-B Bivalent NVX CoV2373 + NVX CoV2601
COVID-19 Clinical Trial 2023: NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine Highlights & Side Effects. Trial Name: NCT05973006 — Phase 3
NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05973006 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age eligibility for this experiment limited to individuals under 30 years old?

"This medical trial's entry requirements set the minimum age to 12 years of age and mandate that participants must not exceed 18."

Answered by AI

What kind of risks do individuals run by being exposed to Group-A NVX-CoV2601?

"There is existing clinical data attesting to the safety of Group-A NVX-CoV2601, which earned it a rating of 3 on our company's scale. This score was attributed due to the numerous rounds of research demonstrating its efficacy and safety."

Answered by AI

Are there any opportunities for enrollment in this research study at the present time?

"This medical trial, posted on August 16th 2023 and last updated on the 11th of August that same year, is no longer seeking participants. However, there are 751 other clinical trials actively recruiting patients at present."

Answered by AI

How many venues are currently facilitating this investigation?

"Currently, Westside Center for Clinical Research in Jacksonville, ITB Research in Miami and Velocity Clinical Research Meridian are amongst the 20 medical centres recruiting participants."

Answered by AI

What demographic would be most advantageous for this research?

"This clinical trial is recruiting 400 participants aged 12 to 18 who are infected with coronavirus. To be eligible, applicants need to have an intrauterine device or use oral/patch contraceptives and must give informed consent along with their parent/caregiver (where applicable). Furthermore, people of childbearing potential must agree to remain heterosexually inactive for the duration of the study or consistently employ a medically accepted preventive measure such as condoms, diaphragms etc., while abstinence is acceptable if it fits in with their lifestyle."

Answered by AI

What is the precise aim of this research project?

"Over the course of 28 days, this trial will evaluate the safety profile (incidence, duration and severity) of solicited local and systemic adverse effects for a week after vaccination. Secondary assessments include neutralizing antibody titers and IgG GMEUs levels in response to ancestral Wuhan strain at Days 0, 28, 90 and 180; NVX CoV2601's NAb GMTs against Omicron XBB.1.5 strain at Days 0, 90 and 180; as well as IgG ELISA units towards Omicron XBB.1.5 S protein over time from Day 0 to Day180 post"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines
2023. "Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05973006.
~240 spots leftby Apr 2025
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