COVID-19 Vaccines for Adolescents with Prior mRNA Vaccine
(COVID-19 Trial)

Recruiting in Palo Alto (17 mi)

+19 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novavax

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clinical Development

Principal Investigator

Novavax

Eligibility Criteria

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.

Inclusion Criteria

Participants of childbearing potential 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

I am between 12 and 17 years old.

Is medically stable, as determined by the investigator

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Exclusion 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.

Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study

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

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Treatment Details

Interventions

NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine (Virus Therapy)
Prototype/XBB.1.5 Bivalent Vaccine (5 µg) (Virus Therapy)

Trial OverviewThis 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.

Participant Groups

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