Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years

NCT05468736
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Phase
Phase 2/Phase 3
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Recruitment status
Completed
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Participants
3,600
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Lead sponsor
Novavax
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Start date
2022-07-22
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Number of sites
94
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Summary
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).
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Acronym
COVID-19
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Short title
Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years
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Official title
A Phase 2/3 Age De-escalating Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Vaccine (SARS-CoV-2 rS) With Matrix-M™ Adjuvant in Children 6 Months to < 12 Years of Age
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2/Phase 3
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Study type
Interventional
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Completion date
2025-10-25
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First posted
2022-07-21
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Registry last updated
2026-05-22
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Primary completion date
2024-01-16
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Start date
2022-07-22
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Actual participants
3,600
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Participants
3,600
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Participant count basis
Actual
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Protocol amendments
6
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Randomisation ratio
1:1
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Number of sites
94
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Novavax
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05468736
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ClinicalTrials.gov ID
NCT05468736
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Registry record
Open registry record
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Allocation
Randomised
Model
Crossover
Purpose
Prevention
Masking
Triple masking
Masked roles
Participants, Care providers, Investigators
Sources for study design
clinicaltrials.gov

  1. Reactogenicity Incidence and Severity

    Timeframe: Day 0 to Day 7

    Reactogenicity incidence, duration, and severity (mild, moderate, severe, or potentially life-threatening) recorded by parent(s)/caregiver(s) on an electronic patient-reported outcome diary application (eDiary) on days of vaccination and subsequent 6 days (total 7 days after each vaccine injection).

  2. Incidence and Severity of Medically Attended Adverse Events (MAAEs)

    Timeframe: Day 0 to Day 28

    Incidence and severity of MAAEs through 28 days after second injection of each set of vaccinations (initial and crossover), and after a booster dose.

  3. Incidence and Severity of Unsolicited Adverse Events (AEs)

    Timeframe: Day 0 to Day 28

    Incidence and severity of unsolicited AEs through 28 days after second injection of each set of vaccinations (initial and crossover), and after a booster dose.

  4. Incidence and Severity of MAAEs Attributed to Study Vaccine

    Timeframe: Day 0 to Day 730

    Incidence and severity of MAAEs attributed to study vaccine after initial vaccination at Day 0 through Month 24 or the EoS.

  5. Incidence and Severity of Serious Adverse Events (SAEs)

    Timeframe: Day 0 to Day 730

    Incidence and severity of SAEs after initial vaccination at Day 0 through Month 24 or the EoS.

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

    Timeframe: Day 0 to Day 730

    Incidence and severity of AESIs (including multisystem inflammatory syndrome in children \[MIS-C\], and myocarditis and/or pericarditis) after initial vaccination at Day 0 through Month 24 or the EoS.

  7. Death due to any cause

    Timeframe: Day 0 to Day 730

    Death due to any cause occurring from Day 0 to EoS.

  1. Participants with PCR positive mild, moderate or severe COVID-19 after the primary series of 2 doses

    Timeframe: Day 0 to Day 730

    Incidence rate of participants with first episode of PCR-positive mild, moderate, or severe COVID-19 overall and per age cohort, with or without positive anti-NP serology at baseline after the primary series of 2 doses.

  2. Participants with PCR positive moderate or severe COVID-19 after the primary series of 2 doses

    Timeframe: Day 0 to Day 730

    Incidence rate of participants with first episode of PCR-positive moderate or severe COVID-19 overall and per age cohort, with or without positive anti-NP serology at baseline, and by risk factors to develop severe COVID-19 after the primary series of 2 doses.

  3. Participants with diagnostic test - positive asymptomatic, mild, moderate or severe COVID-19 after the primary series of 2 doses

    Timeframe: Day 0 to Day 730

    Incidence rate of participants with first episode of diagnostic test-positive asymptomatic, mild, moderate, or severe COVID-19 (regardless of confirmatory test used, ie, PCR or rapid antigen test, and of testing location, ie, central or externally tested) overall and per age cohort, with or without positive anti-NP serology at baseline after the primary series of 2 doses.

  4. Participants with diagnostic test - positive moderate or severe COVID-19 after the primary series of 2 doses

    Timeframe: Day 0 to Day 730

    Incidence rate of participants with first episode of diagnostic test-positive moderate or severe COVID-19 (regardless of confirmatory test used, ie, PCR or rapid antigen test, and of testing location, ie, central or externally tested) overall and per age cohort, with or without positive anti NP serology at baseline, and by risk factors to develop severe COVID-19 after the primary series of 2 doses.

  5. Participants with PCR positive mild, moderate or severe COVID-19 after the booster dose

    Timeframe: Day 0 to Day 730

    Incidence rate of participants with first episode of PCR-positive mild, moderate, or severe COVID-19 overall and per age cohort, with or without positive anti-NP serology at baseline after the booster dose.

  6. Participants with PCR positive moderate or severe COVID-19 after the booster dose

    Timeframe: Day 0 to Day 730

    Incidence rate of participants with first episode of PCR-positive moderate or severe COVID-19 overall and per age cohort, with or without positive anti-NP serology at baseline, and by risk factors to develop severe COVID-19 after the booster dose.

  7. Participants with diagnostic test - positive asymptomatic, mild, moderate or severe COVID-19 after the booster dose

    Timeframe: Day 0 to Day 730

    Incidence rate of participants with first episode of diagnostic test-positive asymptomatic, mild, moderate, or severe COVID-19 (regardless of confirmatory test used, ie, PCR or rapid antigen test, and of testing location, ie, central or externally tested) overall and per age cohort, with or without positive anti-NP serology at baseline after the booster dose.

  8. Participants with diagnostic test moderate or severe COVID-19 after the booster dose

    Timeframe: Day 0 to Day 730

    Incidence rate of participants with first episode of diagnostic test-positive moderate or severe COVID-19 (regardless of confirmatory test used, ie, PCR or rapid antigen test, and of testing location, ie, central or externally tested) overall and per age cohort, with or without positive anti-NP serology at baseline after the booster dose, and by risk factors to develop severe COVID-19.

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

    Timeframe: Day 0 to Day 730

    Antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic. Antibodies to SARS-CoV-2 NP at Days 0 and 35, at Crossover Visit 1, at Booster vaccination visit, and at Months 12 and 24 will be used to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.

  10. Neutralizing antibody response, post-booster, by age cohort,seronegative to anti-SARS-CoV-2 NP antibodies at baseline and pre-booster

    Timeframe: Day 0 to Day 28

    Neutralizing antibody response at 28 days post booster for pediatric participants in the Immunogenicity Population overall and by age cohort, seronegative to anti-SARS-CoV-2 NP antibodies at baseline and pre-booster, compared with that observed at 28 days post-booster vaccination in young adult participants 18 to \< 26 years of age.

  11. Neutralizing antibody response, by age cohort, regardless of serostatus at baseline and pre-booster

    Timeframe: Day 0 to Day 28

    Neutralizing antibody response at 28 days post-booster for pediatric participants in the Immunogenicity Population overall and by age cohort, regardless of serostatus at baseline and pre-booster, compared with that observed in pediatric participants at baseline (Day 0).

  12. Serum IgG levels to SARS-CoV-2 S protein, post-booster, by age cohort, regardless of serostatus at baseline and pre-booster vaccination

    Timeframe: Day 0 to Day 28

    Serum IgG levels to SARS-CoV-2 S protein at 28 days post-booster vaccination for pediatric participants in the Immunogenicity Population overall and by age cohort, regardless of serostatus at baseline and pre-booster vaccination, compared with that observed at 28 days post-booster vaccination in young adult participants 18 to \< 26 years of age.

  13. Serum IgG levels to SARS-CoV-2 S protein, post booster, by age cohort, regardless of serostatus at baseline and pre-booster

    Timeframe: Day 0 to Day 28

    Serum IgG levels to SARS-CoV-2 S protein at 28 days post-booster for pediatric participants in the Immunogenicity Population overall and by age cohort, regardless of serostatus at baseline and pre-booster, compared with that observed in pediatric participants at baseline (Day 0).

  14. Serum IgG levels to SARS-CoV-2 S protein , post booster, by age cohort, regardless of serostatus at baseline and pre-booster

    Timeframe: Day 0 to Day 35

    Serum IgG levels to SARS-CoV-2 S protein at 28 days post-booster for pediatric participants in the Immunogenicity Population overall and by age cohort, regardless of serostatus at baseline and pre-booster, compared with that observed in pediatric participants at Day 35,

  15. Neutralizing antibody response for pediatric participants and adult participants expressed as Geometric Mean Titers (GMT)

    Timeframe: Day 35

    Neutralizing antibody response for pediatric participants compared with adult participants 18 to \< 26 years of age from the Adult Main Study at Day 35

  16. Neutralizing antibody response for pediatric participants and adult participants expressed as Sero response (SRR)

    Timeframe: Day 35

    Neutralizing antibody response for pediatric participants compared with adult participants 18 to \< 26 years of age from the Adult Main Study at Day 35

  17. Serum IgG levels to SARS-CoV-2 S protein after second injection of the initial vaccination series

    Timeframe: Day 35

    Serum IgG levels to SARS-CoV-2 S protein 14 days after second injection of the initial vaccination series (Day 35) in pediatric participants in the Immunogenicity Population by age cohort and subsets with and without anti-NP antibodies at baseline.

  18. Treatment and severity of COVID 19 after a PCR-confirmed case

    Timeframe: Day 0 to Day 730

    Description of course, treatment and severity of COVID 19 reported after a PCR-confirmed case via the Case Form.

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

    Timeframe: Day 0 to Day 730

    Antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic. Antibodies to SARS-CoV-2 NP at Days 0 and 35, at Crossover Visit 1, at Booster vaccination visit, and at Months 12 and 24 will be used to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.

  20. Serum IgG levels to SARS-CoV-2 S protein expressed as GMT

    Timeframe: Day 180 to Day 730

    Serum IgG levels to SARS-CoV-2 S protein at Months 6 (pre- booster), 7/8 (1-month post-booster), 12, and 24 post-vaccination with NVXCoV2373.

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

    Timeframe: Day 180 to Day 730

    MN titers at Months 6 (pre- booster), 7/8 (1-month post-booster), 12, and 24 post-vaccination with NVXCoV2373.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children
Minimum age
6 Months
Maximum age
11 Years
Healthy volunteers
Yes

To be included in this study, each individual must satisfy all of the following criteria:

  1. 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 the normal range prior to the first vaccination, according to the child's age, sex, weight, and height/length.
  2. 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).
  3. 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.
  4. Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy]) 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.
  5. Agree not to participate in another SARS-CoV-2 prevention trial for the duration of the study.

If an individual meets any of the following criteria, he or she is ineligible for this study:

  1. Any acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.

  2. Unstable acute or chronic illness. Criteria for unstable medical conditions include:

    1. Substantive changes in chronic prescribed medication (change in class or significant change in dose) in the past 2 months.
    2. Currently undergoing workup of undiagnosed illness that could lead to a diagnosis of a new condition.

    NOTE: Well-controlled human immunodeficiency virus [HIV] infection with undetectable HIV ribonucleic acid [RNA < 50 copies/mL] and CD4 count > 200 cells/µL for at least 1 year, documented within the last 6 months, is NOT considered an unstable chronic illness. Participant's or parent's/caregiver's verbal report will suffice as documentation.

  3. Participation in research involving an investigational product (drug/biologic/device) administered within 45 days prior to the first study vaccination.

  4. History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.

  5. Prior administration of an investigational, authorized, or approved Coronavirus vaccine (ie, against either SARS-CoV, SARS-CoV-2, or MERS CoV) or expected receipt during the period of study follow-up.

  6. Previous or current diagnosis of MIS-C.

  7. Receipt of medications intended to prevent or treat COVID-19.

  8. 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, which may be received > 14 days prior to or > 14 days after any study vaccination.

  9. Known or suspected congenital or acquired immunodeficiency or autoimmune disease/condition; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for > 14 continuous days) within 90 days prior to first study vaccination. NOTE: An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 20 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporin are permitted. Stable autoimmune endocrine disorders (eg, thyroiditis, pancreatitis), including stable diabetes mellitus type 1, or participants with a history of Kawasaki disease are NOT excluded.

  10. Received immunoglobulin or blood-derived products within 90 days prior to first study vaccination.

  11. Active cancer (malignancy) on chemotherapy within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator).

  12. Any known allergies to products contained in the investigational product.

  13. Participants who are breastfeeding a child, pregnant or who plan to become pregnant within 3 months following the last study vaccination.

  14. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with the evaluation of the trial vaccine or interpretation of study results.

  15. Study team member or first-degree relative of any study team member (inclusive of Sponsor, and study site personnel involved in the study).

  16. Current participation in any other COVID-19 prevention clinical trial.

  17. Participants with a history of myocarditis or pericarditis.

Sources for eligibility
clinicaltrials.gov

  • Preferred Research Partners, Inc.Little Rock, United States
  • Advanced Research CenterAnaheim, United States
  • Coast Clinical Research, LLCBellflower, United States
  • Apex Research GroupFair Oaks, United States
  • Ark Clinical ResearchLong Beach, United States
  • Orange County Research InstituteOntario, United States
  • California Research FoundationSan Diego, United States
  • Clinical Research of CaliforniaWalnut Creek, United States
  • Imagine Research of Palm Beach CountyBoynton Beach, United States
  • Palm Harbor Dermatology PABrandon, United States
  • Westside Center for Clinical ResearchJacksonville, United States
  • Cordova Research Institute, LLCMiami, United States
  • ARS-Nona Pediatric CenterOrlando, United States
  • Morehouse School of MedicineAtlanta, United States
  • Tekton Research - AtlantaChamblee, United States
  • Leavitt Clinical ResearchIdaho Falls, United States
  • Michael W. Simon, M.D., PSCLexington, United States
  • Bluegrass Clinical Research, Inc./All Children PediatricsLouisville, United States
  • Velocity Clinical Research - Covington, LACovington, United States
  • Velocity Clinical Research - CovingtonCovington, United States
  • Velocity Clinical Research - Lafayette LALafayette, United States
  • Craig A. Spiegel, M.D.Bridgeton, United States
  • Boeson ResearchMissoula, United States
  • Meridian Clinical ResearchLincoln, United States
  • Be Well Clinical Studies, LLCLincoln, United States

And 69 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)