COVID-19 Vaccine for Children

(COVID-19 Trial)

Recruiting at 146 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

3600 Participants Needed

Trial Summary

What is the purpose of this trial?

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 of SARS-CoV-2 rS with Matrix-M™ adjuvant (NVX-CoV2373) given 21 days apart and NVX CoV2373 or a variant-based vaccine given as a booster dose or at crossover in pediatric participants (3 age cohorts; 6 to \< 12 years, 2 to \< 6 years, and 6 to \< 24 months of age). Each age cohort will be conducted in 2 parts starting with the oldest age cohort (6 to \< 12 years of age).

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.

What data supports the effectiveness of the COVID-19 vaccine NVX-CoV2373 for children?

The NVX-CoV2373 vaccine has shown about 90% effectiveness in adults and has been tested for safety and effectiveness in adolescents, suggesting it could be effective for children as well. ^{1 2 3 4 5}

Is the NVX-CoV2373 COVID-19 vaccine safe for children?

The NVX-CoV2373 vaccine has been tested in over 31,000 adults and adolescents, showing it is generally well-tolerated with common side effects like injection site pain and fatigue. While specific safety data for children is not yet available, the vaccine has an acceptable safety profile in older age groups. ^{1 4 6 7 8}

How is the NVX-CoV2373 vaccine different from other COVID-19 vaccines?

The NVX-CoV2373 vaccine is unique because it uses a recombinant spike protein nanoparticle combined with an adjuvant (a substance that enhances the body's immune response) called Matrix-M, which is different from the mRNA technology used in other vaccines like Pfizer and Moderna. This approach aims to stimulate a strong immune response by presenting the spike protein directly to the immune system. ^{1 3 4 7 9}

Research Team

Clinical Development

Principal Investigator

Novavax, Inc.

Eligibility Criteria

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.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of SARS-CoV-2 Recombinant Spike Protein Vaccine in Children and Adolescents in India: A Phase 2-3 Randomized Clinical Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Safety, Immunogenicity and Efficacy of NVX-CoV2373 in Adolescents in PREVENT-19: A Randomized, Phase 3 Trial. [2023]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2023]

6. Netherlands 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. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

NVX-CoV2373-induced cellular and humoral immunity towards parental SARS-CoV-2 and VOCs compared to BNT162b2 and mRNA-1273-regimens. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of the NVX-CoV2373 COVID-19 vaccine in randomized placebo-controlled clinical trials. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico. [2023]