Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines
NCT ID: NCT05372588
Last Updated: 2024-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1340 participants
INTERVENTIONAL
2022-05-25
2024-04-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group A (NVX-CoV2515 )
1 intramuscular (IM) injection of NVX-CoV2515 of 0.5 mL injection volume on Day 0.
NVX-CoV2515
Intramuscular (deltoid) injection of co-formulated Omicron BA.1 SARS-CoV-2 rS vaccine with Matrix-M adjuvant (0.5 mL).
Group B (NVX-CoV2373 )
1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 0.
NVX-Cov2373
Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL).
Group C (NVX-CoV2515 )
1 intramuscular (IM) injection of NVX-CoV2515 of 0.5 mL injection volume on Day 0.
NVX-CoV2515
Intramuscular (deltoid) injection of co-formulated Omicron BA.1 SARS-CoV-2 rS vaccine with Matrix-M adjuvant (0.5 mL).
Group D (NVX-CoV2373)
1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 0.
NVX-Cov2373
Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL).
Group E (BA.1 Bivalent Vaccine)
1 intramuscular (IM) injection of Bivalent Vaccine (NVX-CoV2373 + NVX-CoV2515) of 0.5 mL injection volume on Day 0.
NVX-CoV2373 + NVX-CoV2515
Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2515) with 50 µg Matrix-M adjuvant.
Group F (NVX-CoV2540)
2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90.
NVX-CoV2540
Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL).
Group G (NVX-CoV2373)
2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90.
NVX-Cov2373
Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL).
Group H (NVX-CoV2373 + NVX-CoV2540)
2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90.
NVX-CoV2373 + NVX-CoV2540
Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2515) with 50 µg Matrix-M adjuvant.
Interventions
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NVX-CoV2515
Intramuscular (deltoid) injection of co-formulated Omicron BA.1 SARS-CoV-2 rS vaccine with Matrix-M adjuvant (0.5 mL).
NVX-Cov2373
Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL).
NVX-CoV2373 + NVX-CoV2515
Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2515) with 50 µg Matrix-M adjuvant.
NVX-CoV2540
Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL).
NVX-CoV2373 + NVX-CoV2540
Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2515) with 50 µg Matrix-M adjuvant.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Adults ≥ 18 and ≤ 64 years of age at screening.
2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
3. Female participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea ≥ 12 consecutive months\]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from ≥ 28 days prior to and through the end of the study.
4. Is medically stable, as determined by the investigator (based on a 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 medically acceptable ranges prior to the vaccination.
5. Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
6. Have previously received 2 doses of the Moderna and/or Pfizer-BioNTech COVID-19 prototype vaccines with the last dose having been given ≥ 180 days prior to study vaccination or 3 doses of the Moderna and/or Pfizer-BioNTech COVID-19 prototype vaccines with the last dose having been given ≥ 90 days previously prior to the study vaccination.
To be included in this study, each individual must satisfy all of the following criteria:
1. Adults and adolescents ≥ 18 years of age at screening.
2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
3. Female participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea ≥ 12 consecutive months\]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from ≥ 28 days prior to enrollment and through the end of the study.
4. Is medically stable, as determined 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 medically acceptable ranges prior to the first vaccination.
5. Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
6. Have previously received ≥ 3 doses of the Moderna and/or Pfizer-BioNTech monovalent and/or bivalent COVID-19 vaccines with the last dose having been given ≥ 90 days previously prior to first study booster.
Exclusion Criteria
1. Received COVID-19 vaccines other than Moderna and/or Pfizer-BioNTech in the past, inclusive of clinical trial COVID- 19 vaccines.
2. Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to study vaccination.
3. Received any vaccine ≤ 90 days prior to study vaccination, except for influenza vaccination which may be received \> 14 days prior to study vaccination, or rabies vaccine which may be given if medically indicated.
4. Any known allergies to products contained in the investigational product.
5. Any history of anaphylaxis to any prior vaccine.
6. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
7. Chronic administration (defined as \> 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to study vaccination.
8. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to the first study vaccination, except for rabies immunoglobulin which may be given if medically indicated.
9. Active cancer (malignancy) on therapy within 3 years prior to study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).
10. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of the study.
11. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to the study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.
12. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).
13. Study team member or immediate family member of any study team member (inclusive of Sponsor, clinical research organization (CRO), and study site personnel involved in the conduct or planning of the study).
Part 2
If an individual meets any of the following criteria, he or she is ineligible for this study:
1. Received COVID-19 vaccines other than Moderna and/or Pfizer-BioNTech in the past, inclusive of clinical trial COVID-19 vaccines.
2. Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to first study vaccination.
3. Received any vaccine ≤ 90 days prior to study vaccination, except for influenza vaccination which may be received \> 14 days prior to first study vaccination, or rabies vaccine which may be given if medically indicated.
4. Any known allergies to products contained in the investigational product.
5. Any history of anaphylaxis to any prior vaccine.
6. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
7. Chronic administration (defined as \> 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination.
8. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to first study vaccination, except for rabies immunoglobulin which may be given if medically indicated.
9. Active cancer (malignancy) on therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).
10. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
11. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.
12. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).
13. Study team member or immediate family member of any study team member (inclusive of Sponsor, clinical research organization \[CRO\], and study site personnel involved in the conduct or planning of the study).
14. Participants with a history of myocarditis or pericarditis
18 Years
64 Years
ALL
Yes
Sponsors
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Novavax
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development
Role: STUDY_DIRECTOR
Novavax, Inc.
Locations
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Paratus Clinical Research Canberra
Bruce, Australian Capital Territory, Australia
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, Australia
Emeritus Research
Botany, New South Wales, Australia
Northern Beaches Clinical Research
Brookvale, New South Wales, Australia
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia
Australian Clinical Research Network (ACRN)
Maroubra, New South Wales, Australia
AIM Centre (Hunter Diabetes Centre)
Merewether, New South Wales, Australia
Novatrials
Newcastle, New South Wales, Australia
Holdsworth House Medical Practice
Sydney, New South Whales, Australia
Paratus Clinical Research Brisbane
Albion, Queensland, Australia
Core Research Group Pty Ltd
Milton, Queensland, Australia
Griffith University Clinical Trial Unit
Southport, Queensland, Australia
Data Health Australia PTY Ltd t/a Austrials
Taringa, Queensland, Australia
AusTrials Wellers Hill
Wellers Hill, Queensland, Australia
Clinical Medical and Analytical Excellence (CMAX)
Adelaide, South Australia, Australia
Eastern Health-Box Hill Hospital
Box Hill, Victoria, Australia
Emeritus Research
Camberwell, Victoria, Australia
University Hospital Geelong-Barwon Health
Geelong, Victoria, Australia
Monash Health -Monash Medical Centre
Melbourne, Victoria, Australia
Countries
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References
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Bennett C, Rivers EJ, Woo W, Bloch M, Cheung K, Griffin P, Mohan R, Deshmukh S, Arya M, Cumming O, Neville AM, Pardey TM, Plested JS, Cloney-Clark S, Zhu M, Kalkeri R, Patel N, Buchanan A, Marcheschi A, Swan J, Smith G, Cho I, Glenn GM, Walker R, Mallory RM. Immunogenicity and Safety of Heterologous Omicron BA.1 and Bivalent SARS-CoV-2 Recombinant Spike Protein Booster Vaccines: A Phase 3 Randomized Clinical Trial. J Infect Dis. 2024 Jul 25;230(1):e4-e16. doi: 10.1093/infdis/jiad508.
Bennett C, Woo W, Bloch M, Cheung K, Griffin P, Mohan R, Deshmukh S, Arya M, Cumming O, Neville AM, McCallum Pardey TG, Plested JS, Cloney-Clark S, Zhu M, Kalkeri R, Patel N, Marcheschi A, Swan J, Smith G, Cho I, Glenn GM, Walker R, Mallory RM; Novavax 2019nCoV-311 Study Group. Immunogenicity and safety of a bivalent (omicron BA.5 plus ancestral) SARS-CoV-2 recombinant spike protein vaccine as a heterologous booster dose: interim analysis of a phase 3, non-inferiority, randomised, clinical trial. Lancet Infect Dis. 2024 Jun;24(6):581-593. doi: 10.1016/S1473-3099(24)00077-X. Epub 2024 Mar 6.
Other Identifiers
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2019nCoV- 311
Identifier Type: -
Identifier Source: org_study_id
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