← Back to Search

Virus Vaccine

COVID-19 Vaccine for Children (COVID-19 Trial)

Phase 2 & 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

For children from 6 months to < 12 months of age: born at full-term (≥ 37 weeks gestation) with a minimum birth weight of 2.5 kilograms (kg).

For children from 6 months to < 12 months of age: born at full-term (≥ 37 weeks gestation) with a minimum birth weight of 2.5 kilograms (kg)

Must not have

Received any vaccine within 14 days prior to first study vaccination or planned receipt of any vaccine before Day 49 (ie, 28 days after the second vaccination), except for influenza vaccination

Prior administration of an investigational, authorized, or approved Coronavirus vaccine or expected receipt during the period of study follow-up

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 180 to day 730

Summary

This trial will test how safe and effective a new vaccine is for children. It will start with the oldest age group (6-12 years old) and move down to the youngest (6-24 months old).

Who is the study for?

This trial is for healthy or medically stable children aged 6 months to less than 12 years. They must have normal vital signs and not be part of any other COVID-19 prevention trials. Children under a year old should be born full-term with adequate birth weight. Participants capable of childbearing must abstain from sex or use contraception.

What is being tested?

The study tests the safety and immune response to NVX CoV2373, a COVID-19 vaccine candidate, in kids. It involves two initial doses plus a booster, given three weeks apart in different age groups starting with the oldest children.

What are the potential side effects?

Possible side effects may include typical vaccine reactions like soreness at injection site, fever, fatigue, headaches and possibly allergic reactions. The exact side effects are being studied as part of this trial.

Eligibility Criteria

Inclusion Criteria

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

Select...

My child was born full-term, weighing at least 2.5 kg and is between 6 to 12 months old.

Select...

My child was born full-term and weighed at least 2.5 kg.

Exclusion Criteria

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

Select...

I haven't had any vaccines in the last 14 days and won't get any before Day 49, except for the flu shot.

Select...

I have received or will receive a COVID-19 vaccine during the study.

Select...

I am taking medication to prevent or treat COVID-19.

Select...

I have been diagnosed with MIS-C before or currently.

Select...

I have an immune system disorder or have been on drugs that weaken my immune system.

Select...

I have had myocarditis or pericarditis in the past.

Select...

I do not have a fever or any acute illness today.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 180 to day 730

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 180 to day 730

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 180 to day 730 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Death due to any cause

Incidence and Severity of Adverse Events of Special Interest (AESIs)

Incidence and Severity of MAAEs Attributed to Study Vaccine

+4 more

Secondary study objectives

Antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic.

Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specified Time Points

MN titers to SARS-CoV-2 S protein expressed as GMT

+18 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Originally Randomized to Vaccine, Immediate Booster GroupExperimental Treatment2 Interventions

2 doses of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21 in Initial Vaccination Period.One dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 201 in the Booster Vaccination Period.

Group II: Originally Randomized to Vaccine, Delayed Booster GroupExperimental Treatment2 Interventions

2 doses of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21 in the Initial Vaccination Period. 1 dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 201 or Day 229 and 1 dose of Placebo (Saline) on Day 201 or Day 229 in the Booster Vaccination Period.

Group III: Originally Randomized to PlaceboExperimental Treatment3 Interventions

2 doses of Placebo (Saline),1 dose each on Days 0 and 21 in the Initial Vaccination Period. 2 doses of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) 1 dose each on Day 201 and Day 229 in Open-Label Crossover Vaccination Period. One dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 409 in the Booster Vaccination Period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)

2020

Completed Phase 3

~33000

0 / 9Eligibility criteria met