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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 180 to day 730
Awards & highlights

COVID-19 Trial 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.Check my eligibility
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.See study design
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.

COVID-19 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.

COVID-19 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

COVID-19 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

Find a Location

Who is running the clinical trial?

NovavaxLead Sponsor
46 Previous Clinical Trials
102,964 Total Patients Enrolled
Clinical DevelopmentStudy DirectorNovavax, Inc.
34 Previous Clinical Trials
85,044 Total Patients Enrolled

Media Library

NVX CoV2373 (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05468736 — Phase 2 & 3
Coronavirus Research Study Groups: Originally Randomized to Vaccine, Delayed Booster Group, Originally Randomized to Vaccine, Immediate Booster Group, Originally Randomized to Placebo
Coronavirus Clinical Trial 2023: NVX CoV2373 Highlights & Side Effects. Trial Name: NCT05468736 — Phase 2 & 3
NVX CoV2373 (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05468736 — Phase 2 & 3
Coronavirus Patient Testimony for trial: Trial Name: NCT05468736 — Phase 2 & 3

Frequently Asked Questions

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

How many distinct facilities are overseeing this clinical trial?

"There are 42 different locations at which this trial is accepting patients, three of which are MedPharmics in Lafayette, Louisiana, Wee Care Pediatrics - Roy in Roy, Utah, and PanAmerican Clinical Research in Brownsville, Texas."

Answered by AI

Are there vacancies in this experiment for test subjects?

"That is correct. The information on clinicaltrials.gov does show that the study is still recruiting patients. This trial was originally posted on 7/22/2022 and was most recently edited on 10/14/2022. 3600 patients are needed for this study, which will be conducted at 39 different locations."

Answered by AI

Does this research require participants to be of a certain age?

"The age bracket that this trial is recruiting from are those who have not yet turned 12, and are at least 6 months old."

Answered by AI

How many patients will be enrolled in this clinical trial?

"The clinical trial is still actively recruiting patients, as of 10/14/2022. According to the original posting on clinicaltrials.gov from 7/22/2022, 3600 participants are needed for the study which will be taking place at 39 locations."

Answered by AI

By the end of this research, what do scientists hope to have accomplished?

"The primary outcome of this study will be the incidence and severity of medically attended adverse events (MAAEs) over a period of 730 days. Secondary outcomes include the incidence rate of participants with first episode of diagnostic test-positive moderate or severe COVID-19, the incidence rate of participants with first episode of PCR-positive mild, moderate, or severe COVID-19, and antibodies to SARS-CoV-2 nucleoprotein at specified time points."

Answered by AI

Who meets the requirements to take part in this clinical trial?

"This clinical trial is looking for 3600 participants aged between 6 months and 11 years who currently have covid-19. The following additional criteria must be met: Pediatric participants 6 months to < 12 years of age at randomization, determined to be healthy or medically stable by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Vital signs must be within normal range prior to the first vaccination, according to the child's age, sex, and height., Participant and parent(s)/caregiver(s) or legally"

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
Texas
California
Other
How old are they?
18 - 65
What site did they apply to?
Cordova Research InstituteLLC
Be Well Clinical Studies, LLC
Lynn Institute of Tulsa
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm hoping to find a solution to this problem. Seemed like something to do when you got nothing to do all day.
PatientReceived no prior treatments
Because I am broke most of the time and caring for 8 people isn't cheap.
PatientReceived 1 prior treatment
~1309 spots leftby Apr 2025