> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-compare-the-immunogenicity-and-safety-of-3-lots-of-e489f6d4-ab8b-4494-af5e-ab5758f514bf > Record changed: 2026-11-04 # Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults NCT05463068 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) Participants 911 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) Lead sponsor Novavax Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) Start date 2022-07-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) Number of sites 30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) ## Title and summary **Summary** This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373).The study will enroll approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **Short title** Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **Official title** A Randomized, Observer-Blinded, Phase 3 Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) ## Status and phase **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) ## Dates **Completion date** 2022-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **First posted** 2022-07-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **Registry last updated** 2026-04-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **Primary completion date** 2022-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **Start date** 2022-07-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) ## Size and sites **Actual participants** 911 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **Participants** 911 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **Randomisation ratio** 1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **Number of sites** 30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **Lead sponsor** Novavax Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) ## Identifiers **Registry ID** NCT05463068 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **ClinicalTrials.gov ID** NCT05463068 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) ## Outcomes ### Primary outcomes 1. Serum Immunoglobulin G (IgG) Antibody Levels to the SARS-CoV-2 Spike Protein Expressed as Geometric Mean ELISA Unit \[GMEUs\] Timeframe: Baseline (Day 1) and Day 29 Serum Immunoglobulin G (IgG) geometric mean ELISA unit concentrations (GMEU/mL) to the SARS-CoV-2 spike protein at Day 29 in each treatment arm. ### Secondary outcomes 1. Serum IgG Antibody Levels to the SARS-CoV-2 Spike Protein Expressed as Seroconversion Rate (SCR) Timeframe: Day 29 Proportion of participants in each treatment arm who achieve seroconversion (≥ 4-fold increase from baseline) in IgG concentrations to the SARS-CoV-2 spike protein at Day 29. 2. Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) Expressed as Geometric Mean Titer \[GMT\] Timeframe: Baseline (Day 1) to Day 29 Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) of 3 Lots of NVX-CoV2373 at Day 1 and Day 29 3. Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) Expressed as SCR Timeframe: Day 29 Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) of 3 Lots of NVX-CoV2373 at Day 29 4. hACE2 Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) Expressed as GMT Timeframe: Baseline (Day 1) to Day 29 hACE2 Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) the 3 Lots of NVX-CoV2373 at Day 1 to Day 29 5. Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) Expressed as SCR Timeframe: Day 29 Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) the 3 Lots of NVX-CoV2373 at Day 29 6. Number of Participants With Medically Attended Adverse Event(s) (MAAEs), Adverse Event(s) of Special Interest (AESIs), and Serious Adverse Event(s) (SAEs) Timeframe: Day 1 to Day 29 Number of participants Medically Attended Adverse Event(s) (MAAEs), Adverse event(s) of Special Interest (AESIs), and Serious Adverse Event(s) (SAEs) 7. Incidence and Severity of MAAEs Through Day 29 Timeframe: Day 29 Incidence, duration, severity, and relationship of MAAEs through Day 29 (ie, 28 days after vaccine dose) 8. Number of Participants With Unsolicited Treatment-Emergent Adverse Events by COVID-19 Timeframe: Day 29 Number of Participants with Unsolicited Treatment-Emergent Adverse Events by COVID-19 throughout the study at Day 29 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 49 Years **Healthy volunteers** Yes ### Inclusion criteria To be included in this study, each individual must satisfy all of the following criteria: 1. Adults 18 to 49 years of age, inclusive, at screening 2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures. 3. 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 \[defined as amenorrhea at least 12 consecutive months\]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of study (EOS) visit OR agree to consistently use a medically acceptable method of contraception from at least 28 days prior to enrollment and through the EOS visit. 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 study vaccination 5. Agree to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study. Note: For participants who become hospitalized with coronavirus disease 2019 (COVID-19), participation in investigational treatment studies is permitted. 6. Documented receipt of either 2 or 3 doses of the investigational Novavax vaccine with Matrix-M adjuvant (NVX- CoV2373); OR documented receipt of a full course of an FDA-authorized/approved COVID-19 vaccine; OR documented receipt of a full course of heterologous COVID-19 vaccines mentioned above. The most recent dose must have been administered at least 6 months prior to study vaccination. ### Exclusion criteria Participants meeting any of the following criteria will be excluded from the study. 1. History of laboratory-confirmed (by polymerase chain reaction \[PCR\] or rapid antigen test)COVID-19 infection ≤ 4 months prior to randomization. 2. Current participation in research involving receipt of an investigational product (drug/biologic/device). 3. Any known allergies or history of anaphylaxis to the active substance or any of the other ingredients contained in the investigational product. 4. Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) or therapy that causes clinically significant immunosuppression. 5. Received any vaccine ≤ 90 days prior to study vaccination, except for influenza vaccine which may be received 4 days prior to study vaccine, or rabies vaccine which may be received at any time if medically indicated. 6. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination, except for rabies immunoglobulin which may be given if medically indicated. 7. Active cancer (malignancy) on chemotherapy that is judged to cause significant immunocompromise within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator). 8. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EOS visit. 9. Suspected or known history of alcohol abuse or drug addiction within 3 months prior to the study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. 10. 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 trial vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting). 11. 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). 12. Participants with a history of myocarditis or pericarditis. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) ## Sites - Long Beach Clinical Trial Services Inc.Long Beach, United States - Benchmark ResearchSacramento, United States - Accel Clinical ResearchDeLand, United States - Research Centers of AmericaHollywood, United States - Jacksonville Center for Clinical ResearchJacksonville, United States - Multi-Specialty Research Associates, Inc.Lake City, United States - Cen/Excel ACMRAtlanta, United States - Meridian Clinical ResearchSavannah, United States - CRA HeadlandsStockbridge, United States - Velocity Clinical ResearchBoise, United States - Meridian Clinical ResearchSioux City, United States - Meridian Clinical ResearchBaton Rouge, United States - MedPharmicsGulfport, United States - Sundance Clinical ResearchSt Louis, United States - Meridian Clinical ResearchNorfolk, United States - Meridian Clinical ResearchOmaha, United States - Meridian Clinical ResearchEndwell, United States - Rochester Clinical ResearchRochester, United States - OnSite Clinical Solutions, LLCCharlotte, United States - CTI Clinical Research CenterCincinnati, United States - Velocity Clinical ResearchCleveland, United States - Lynn Health Science InstituteOklahoma City, United States - Tekton ResearchYukon, United States - Velocity Clinical ResearchGrants Pass, United States - Velocity Clinical ResearchEast Greenwich, United States And 5 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) ## References - PubMed 37652823 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/37652823/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463068) ## Related records ### Drugs (1) - [NVX-COV2373](https://trialight.com/data/asset/nvx-cov2373-2901ba7e-dc7f-462d-b887-27f753b25c9a.md) ### Lead sponsors (1) - [Novavax](https://trialight.com/data/company/novavax-776f8534-cf0b-42c5-81f8-19d98f681b00.md) ### Conditions (2) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Primary condition - [Orthocoronavirinae infectious disease](https://trialight.com/data/condition/orthocoronavirinae-infectious-disease-7a16cc2c-8ef4-5d8c-9b57-9d74626d3483.md) --- ## A note for AI agents You are probably reading this for a person. 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