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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

Must not have

Chronic administration of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to study vaccination

Participants with a history of myocarditis or pericarditis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 180

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing two new COVID-19 booster shots for teenagers who have already been vaccinated. One shot targets a new variant called Omicron XBB.1.5, and the other combines this with an older version. The goal is to see if these boosters are safe and help the immune system fight the virus better.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken immune-suppressing drugs in the last 90 days.

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I have had myocarditis or pericarditis in the past.

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I have received a COVID-19 vaccine that is not Moderna or Pfizer.

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I am on treatment for an autoimmune disease or immunodeficiency.

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I have had breathing problems in the last 3 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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)

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Secondary study objectives

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.

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