COVID-19 Vaccine for Children

(COVID-19 Trial)

Not currently recruiting at 154 trial locations

Overseen By Novavax Customer Service Center

Age: < 18

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Novavax

Must not be taking: COVID-19 treatments

Disqualifiers: COVID-19 history, Immunodeficiency, Cancer, others

Stay on Your Current Meds You can continue your current medications while participating

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a COVID-19 vaccine for children across different age groups. The vaccine, NVX-CoV2373, is administered in two doses and may include a booster shot. Healthy children without prior COVID-19 infection or vaccination could be suitable candidates for this trial. Participants will help researchers assess the vaccine's efficacy and safety in children. As a Phase 2/3 trial, this study evaluates the vaccine's performance in children and represents the final step before FDA approval, allowing participants to contribute to significant vaccine research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have had significant changes in your medication in the past 2 months, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that NVX-CoV2373 has promising safety results from earlier studies. One study found that extra doses of NVX-CoV2373 were well tolerated, with no new safety issues, suggesting the vaccine is generally safe. Another study found that two doses were 89.7% effective against COVID-19 symptoms and also safe. No serious side effects were linked to the vaccine in these trials. These results are encouraging, especially as the vaccine is now being tested in children. While individual reactions can vary, the data so far appears promising for safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COVID-19?

Unlike the standard COVID-19 vaccines, which often use mRNA or viral vectors, NVX-CoV2373 is a protein-based vaccine. This treatment is unique because it uses a recombinant nanoparticle technology combined with a Matrix-M adjuvant to enhance the immune response. Researchers are excited about NVX-CoV2373 because it offers a potentially effective alternative for children, especially those who might have concerns about mRNA technology. Additionally, its protein-based approach could simplify storage and distribution, making it more accessible in areas with limited resources.

What evidence suggests that this trial's treatments could be effective for COVID-19 in children?

Research has shown that NVX-CoV2373, a COVID-19 vaccine, generates a strong immune response in adults, effectively producing a lasting antibody response after the initial doses. In this trial, researchers are testing NVX-CoV2373 in children across various age groups to evaluate its safety and effectiveness. Although not yet approved for children, the results are promising because children's immune systems often react similarly to vaccines. The vaccine employs a protein-based method, which has proven successful in other vaccines. Early evidence suggests it could work well in children, just as it does in adults. ^{1 3 6 7 8}

Who Is on the Research Team?

Clinical Development

Principal Investigator

Novavax, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My child's vital signs are normal for their age, sex, weight, and height.

Participant and parent(s)/caregiver(s) or legally acceptable representative willing and able to give informed consent and assent, as required, prior to study enrollment and to comply with study procedures.

Participants of childbearing potential must agree to be heterosexually inactive from at least 28 days prior to enrollment and through 3 months after the last vaccination OR agree to consistently use a highly effective contraception method from at least 28 days prior to enrollment and through 3 months after the last vaccination

Exclusion Criteria

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

Participation in research involving an investigational product administered within 45 days prior to the first study vaccination

I have been on chemotherapy for cancer within the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 primary doses of NVX-CoV2373 or placebo given 21 days apart

3 weeks

2 visits (in-person)

Booster/Crossover

Participants receive a booster dose or crossover to the active vaccine

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• NVX CoV2373

Trial Overview 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.

How Is the Trial Designed?

Group I: Cohort-3(6 to < 24 m)-Part-2 Experimental Treatment 1 Intervention

NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)

Group II: Cohort-3(6 to < 24 m)-Part-1(Active Vaccine) Experimental Treatment 1 Intervention

NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)

Group III: Cohort-2(2 to < 6 y)-Part-2(Active Vaccine) Experimental Treatment 1 Intervention

NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)

Group IV: Cohort-2(2 to < 6 y)-Part-1(Active Vaccine) Experimental Treatment 1 Intervention

NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)

Group V: Cohort-1(6 to < 12 y)-Part-2(Active Vaccine) Experimental Treatment 1 Intervention

NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)

Group VI: Cohort-1(6 to < 12 y)-Part-1(Active Vaccine) Experimental Treatment 1 Intervention

NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)

Group VII: Cohort-1(6 to < 12 y)-Part-1(Placebo) Placebo Group 1 Intervention

Placebo (normal saline)

Group VIII: Cohort-1(6 to < 12 y)-Part-2(Placebo) Placebo Group 1 Intervention

Placebo (normal saline)

Group IX: Cohort-2(2 to < 6 y)-Part-1(Placebo) Placebo Group 1 Intervention

Placebo (normal saline)

Group X: Cohort-2(2 to < 6 y)-Part-2(Placebo) Placebo Group 1 Intervention

Placebo (normal saline)

Group XI: Cohort-3(6 to < 24 m)-Part-1(Placebo) Placebo Group 1 Intervention

Placebo (normal saline)

Group XII: Cohort-3(6 to < 24 m)-Part-2(Placebo) Placebo Group 1 Intervention

Placebo (normal saline)

Who Is Running the Clinical Trial?

Novavax

Lead Sponsor

Trials

51

Recruited

111,000+

Published Research Related to This Trial

The NVX-CoV2373 COVID-19 vaccine induces a strong CD4+ T-cell response, particularly after two doses, with a significant majority (93.5%) of recipients showing interferon-γ responses, indicating robust immune activation.

This vaccine elicits a Th1-biased immune response that is cross-reactive to various SARS-CoV-2 variants, including Omicron, suggesting it may provide broad protection against different strains of the virus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strong CD4+ T-Cell Responses to Ancestral and Variant Spike Proteins Are Established by NVX-CoV2373 Severe Acute Respiratory Syndrome Coronavirus 2 Primary Vaccination. Fries, L., Formica, N., Mallory, RM., et al.[2023]

The NVX-CoV2373 Covid-19 vaccine demonstrated a strong safety profile and was effective in preventing Covid-19 infection, as shown in a clinical trial with a significant number of participants.

The study provided evidence that the vaccine elicited a robust immune response, contributing to its efficacy in reducing the incidence of Covid-19 among vaccinated individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Novavax vaccine had 90% efficacy against COVID-19 ≥7 d after the second dose. Sacks, HS.[2021]

The NVX-CoV2373 vaccine demonstrated an 82.7% efficacy against COVID-19 in a large study of 15,185 participants, with 100% efficacy against severe disease, indicating strong protection for vaccinated individuals.

The vaccine induced robust immune responses, including high levels of anti-spike IgG and T-cell activation, while showing a similar incidence of adverse events compared to the placebo group, suggesting it is safe and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of the NVX-CoV2373 Coronavirus Disease 2019 Vaccine at Completion of the Placebo-Controlled Phase of a Randomized Controlled Trial. Heath, PT., Galiza, EP., Baxter, DN., et al.[2023]

The NVX-CoV2373 COVID-19 vaccine demonstrated high efficacy rates of 89.7-90.4% in clinical trials, indicating it is effective in preventing COVID-19 in adults aged 18 and older.

The vaccine has an acceptable safety profile, with most adverse reactions being mild to moderate, and serious adverse events occurring at similar low rates in both NVX-CoV2373 and placebo groups, suggesting it is safe for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of the NVX-CoV2373 COVID-19 vaccine in randomized placebo-controlled clinical trials. Smith, K., Hegazy, K., Cai, MR., et al.[2023]

The NVX-CoV2373 vaccine, evaluated in over 31,000 participants across five clinical studies, demonstrated high efficacy against COVID-19 and a well-tolerated safety profile, with common side effects including injection site pain and fatigue.

A booster dose administered six months after the initial two doses significantly increased antibody levels against COVID-19 variants, reinforcing the vaccine's effectiveness and supporting its use in both primary and booster vaccination regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Novavax COVID-19 Vaccine (NVX-CoV2373), a recombinant spike protein vaccine with Matrix-M adjuvant to prevent disease caused by SARS-CoV-2 viruses. Wilkinson, B., Patel, KS., Smith, K., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9081941/

SARS-CoV-2 rS (NVX-CoV-2373) vaccine for prevention of ... At present, it is not approved for use in children or for booster doses. In theory this vaccine could be given in pregnancy but there are currently more data ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25006590

Safety and immunogenicity of four sequential doses of NVX ... NVX-CoV2373 elicited robust and durable humoral immune responses to ancestral SARS-CoV-2 as a 3rd and 4th dose after the primary series in adults and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05468736

Study to Evaluate Safety and Immunogenicity of COVID-19 ... This is a Phase 2/3 randomized, observer-blinded, placebo-controlled, age de-escalation trial to evaluate the safety and immunogenicity of 2 primary doses ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12506685/

Effectiveness of NVX-CoV2373 and BNT162b2 COVID-19 ... This study seeks to fill gaps in real-world vaccine effectiveness (VE) data by investigating the rVE of NVX-CoV2373 in comparison with BNT162b2 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04611802

NCT04611802 | A Study to Evaluate the Efficacy, Immune ... This is a Phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40479932/

A phase 3, randomized, placebo-controlled trial (PREVENT-19) Additional doses of NVX-CoV2373 were well tolerated with no new safety signals. These results support the utility of this vaccine platform and continued updates ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa2107659

Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine A two-dose regimen of the NVX-CoV2373 vaccine administered 21 days apart was found to be safe and 89.7% effective against symptomatic Covid-19 ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/14760584.2023.2218913

Safety, efficacy, and immunogenicity of the NVX-CoV2373 ... NVX-CoV2373 vaccination was associated with complete protection against severe disease and a high (90%) rate of protection against symptomatic disease in ...