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A Study to Evaluate the Safety and Immunogenicity of COVID-19 and Influenza Combination Vaccine (COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05519839
Recruitment Status : Active, not recruiting
First Posted : August 29, 2022
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
Novavax

Study Description
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Brief Summary:
This is a randomized, observer-blinded, Phase 2 study evaluating the safety and immunogenicity of a severe acute respiratory syndrome coronavirus 2 (SARSCoV2) recombinant spike (rS) (SARS-CoV-2 rS) nanoparticle and quadrivalent hemagglutinin (HA) nanoparticle influenza vaccine (qNIV) combination vaccine with Matrix-M™ adjuvant; this combination vaccine.

Condition or disease Intervention/treatment Phase
COVID-19 Influenza Drug: CIC Vaccine Drug: qNIV Vaccine Drug: SARS-CoV-2 rS Vaccine Drug: Influenza Vaccine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1579 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 rS Nanoparticle and Quadrivalent Hemagglutinin Nanoparticle Influenza Combination Vaccine With Matrix-M™ Adjuvant in Healthy Participants ≥ 50 to ≤ 80 Years of Age
Actual Study Start Date : December 30, 2022
Estimated Primary Completion Date : July 25, 2023
Estimated Study Completion Date : December 24, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A (Part 1)
CIC Vaccine Formulation 1 doses of Formulation 1. 1 dose on Days 0.
 Drug: CIC Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (CIC Vaccine) on Day 0.
Experimental: Group B (Part 1)
CIC Vaccine Formulation 1 doses of Formulation 2. 1 dose on Days 0.
 Drug: CIC Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV, SARS-CoV-2 rS, and 75 μg Matrix-M1 Adjuvant (CIC Vaccine) on Day 0.
Experimental: Group C (Part 1)
CIC Vaccine Formulation 1 doses of Formulation 3. 1 dose on Days 0.
 Drug: CIC Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (CIC Vaccine) on Day 0.
Experimental: Group D (Part 1)
CIC Vaccine Formulation1 doses of Formulation 4. 1 dose on Days 0.
 Drug: CIC Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV, SARS-CoV-2 rS, and 75 μg Matrix-M1 Adjuvant (CIC Vaccine) on Day 0.
Experimental: Group E (Part 1)
CIC Vaccine Formulation 1 doses of Formulation 5. 1 dose on Days 0.
 Drug: CIC Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (CIC Vaccine) on Day 0.
Experimental: Group F (Part 1)
CIC Vaccine Formulation 1 doses of Formulation 6. 1 dose on Days 0.
 Drug: CIC Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV, SARS-CoV-2 rS, and 75 μg Matrix-M1 Adjuvant (CIC Vaccine) on Day 0.
Experimental: Group G (Part 1)
CIC Vaccine Formulation 1 doses of Formulation 7. 1 dose on Days 0.
 Drug: CIC Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (CIC Vaccine) on Day 0.
Experimental: Group H (Part 1)
CIC Vaccine Formulation 1 doses of Formulation 8. 1 dose on Days 0.
 Drug: CIC Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV, SARS-CoV-2 rS, and 75 μg Matrix-M1 Adjuvant (CIC Vaccine) on Day 0.
Experimental: Group I (Part 1)
CIC Vaccine Formulation 1 doses of Formulation 9. 1 dose on Days 0.
 Drug: CIC Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (CIC Vaccine) on Day 0.
Experimental: Group J (Part 1)
CIC Vaccine Formulation 1 doses of Formulation 10. 1 dose on Days 0.
 Drug: CIC Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV, SARS-CoV-2 rS, and 75 μg Matrix-M1 Adjuvant (CIC Vaccine) on Day 0.
Experimental: Group K (Part 1)
CIC Vaccine Formulation 1 doses of Formulation 11. 1 dose on Days 0.
 Drug: CIC Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (CIC Vaccine) on Day 0.
Experimental: Group L (Part 1)
qNIV Vaccine Formulation 1 doses of Formulation 12. 1 dose on Days 0.
 Drug: qNIV Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV and 75 μg Matrix-M1 Adjuvant (Influenza Vaccine) on Day 0.
Experimental: Group M (Part 1)
qNIV Vaccine Formulation 1 doses of Formulation 13. 1 dose on Days 0.
 Drug: qNIV Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV and 75 μg Matrix-M1 Adjuvant (Influenza Vaccine) on Day 0.
Experimental: Group N (Part 1)
CIC Vaccine Formulation 1 doses of Formulation 14. 1 dose on Days 0.
 Drug: qNIV Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV and 75 μg Matrix-M1 Adjuvant (Influenza Vaccine) on Day 0.
Experimental: Group O (Part 1)
SARS-CoV-2 rS Vaccine Formulation 1 doses of Formulation 15. 1 dose on Days 0.
 Drug: SARS-CoV-2 rS Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of SARS-CoV-2 rS, Diluent, and 50 μg Matrix-M1 Adjuvant (SARS-CoV-2 rS Vaccine) on Day 0.
Experimental: Group P (Part 1)
Reference Vaccine Formulation 1 doses of Formulation 16. 1 dose on Days 0.
 Drug: SARS-CoV-2 rS Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of SARS-CoV-2 rS, Diluent, and 50 μg Matrix-M1 Adjuvant (SARS-CoV-2 rS Vaccine) on Day 0.
Experimental: Group Q (Part 1)
Reference Vaccine Formulation 1 doses of Formulation 17. 1 dose on Days 0.
 Drug: SARS-CoV-2 rS Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of SARS-CoV-2 rS, Diluent, and 50 μg Matrix-M1 Adjuvant (SARS-CoV-2 rS Vaccine) on Day 0.
Experimental: Group R (Part 1)
Reference Vaccine Formulation 1 doses of Formulation 18. 1 dose on Days 0.
 Drug: SARS-CoV-2 rS Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of SARS-CoV-2 rS, Diluent, and 50 μg Matrix-M1 Adjuvant (SARS-CoV-2 rS Vaccine) on Day 0.
Experimental: Group S (Part 1)
Comparator Influenza Vaccine Formulation 1 doses of Formulation 19. 1 dose on Days 0.
 Drug: Influenza Vaccine
Intramuscular (deltoid) injections of Comparator influenza on Day 0.
Experimental: Group T (Part 1)
Comparator Influenza Vaccine Formulation 1 doses of Formulation 20. 1 dose on Days 0.
 Drug: Influenza Vaccine
Intramuscular (deltoid) injections of Comparator influenza on Day 0.
Experimental: Group U (Part 2)
CIC Vaccine Formulation 1 doses of Formulation 1. 1 dose on Days 0.
 Drug: CIC Vaccine
Intramuscular (deltoid) injections of co-formulated mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (CIC Vaccine) on Day 0.
Experimental: Group V (Part 2)
CIC Vaccine Formulation 1 doses of Formulation 2. 1 dose on Days 0.
 Drug: CIC Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (CIC Vaccine) on Day 0.


Outcome Measures
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Primary Outcome Measures :
  1. Part 1 and Part 2 : Number of participants with solicited local and systemic Adverse Events (AEs) [ Time Frame: Day 0 to Day 7 ]
    Numbers of participants with solicited local and systemic AEs over the 7 days post-vaccination.

  2. Part 1 and Part 2 : Percentage of participants with all AEs [ Time Frame: Day 0 to Day 21 ]
    Proportions of participants reporting all AEs, solicited and unsolicited, over 21 days post-vaccination.

  3. Part 1 and Part 2 : Percentage of participants with Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs) [ Time Frame: Day 0 to Day 182 ]
    Proportions of participants with MAAEs, AESIs (including PIMMCs and myocarditis and/or pericarditis), SAEs, will be collected for 6 months (approximately 182 days) post-vaccination


Secondary Outcome Measures :
  1. Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Geometric Mean Titer (GMT) [ Time Frame: Day 0 to Day 84 ]
    HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s), and antigenically drifted influenza strains. Derived/calculated endpoints based on GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 0, 7, 21, 84, and other follow-up time points

  2. Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Geometric Mean Fold Rise (GMFR) [ Time Frame: Day 0 to Day 84 ]
    HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s), and antigenically drifted influenza strains. Derived/calculated endpoints based on Geometric mean fold rise (GMFRPost/Pre) - defined as the within group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 7, 21, 84, and other follow-up time points.

  3. Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Seroconversion Rate (SCR) [ Time Frame: Day 0 to Day 84 ]
    HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s), and antigenically drifted influenza strains. Derived/calculated endpoints based on Seroconversion rate (SCR) - defined as proportion of participants in a given Vaccine Group with either a baseline reciprocal (Day 0) titer of < 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 7, 21, 84, and other follow-up time points

  4. Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Seroprotection Rate (SPR) [ Time Frame: Day 0 to Day 84 ]
    HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s), and antigenically drifted influenza strains. Derived/calculated endpoints based on Seroprotection rate (SPR) - defined as the proportion of participants with a reciprocal HAI titer ≥ 40 on Days 7, 21, 84, and other follow-up time points.

  5. Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Geometric Mean Titer Ratio (GMTR) [ Time Frame: Day 0 to Day 84 ]
    HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s), and antigenically drifted influenza strains. Derived/calculated endpoints based on GMTR between select treatment arms at Days 7, 21, 84, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline [pre-vaccination] titers).

  6. Part 1 and Part 2: Neutralizing Antibody Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and/or Antigenically Drifted Influenza Strains Expressed as GMTs [ Time Frame: Day 0 to Day 84 ]
    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B strain(s) and/or antigenically drifted influenza strains, as measured by a MN assay expressed as GMTs.

  7. Part 1 and Part 2 : Neutralizing Antibody Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and/or Antigenically Drifted Influenza Strains Expressed as GMFR [ Time Frame: Day 0 to Day 84 ]
    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B strain(s) and/or antigenically drifted influenza strains, as measured by a MN assay expressed as GMFR

  8. Part 1 and Part 2: Neutralizing Antibody Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and/or Antigenically Drifted Influenza Strains Expressed as SCR [ Time Frame: Day 0 to Day 84 ]
    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B strain(s) and/or antigenically drifted influenza strains, as measured by a MN assay expressed as SCR.

  9. Part 1 and Part 2: Neutralizing Antibody Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and/or Antigenically Drifted Influenza Strains Expressed as GMTR [ Time Frame: Day 0 to Day 84 ]
    Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B strain(s) and/or antigenically drifted influenza strains, as measured by a MN assay expressed as GMTR.

  10. Part 1 and Part 2: Serum Immunoglobulin G (IgG) to the SARS-CoV-2 spike protein expressed as GMEU [ Time Frame: Day 0 to Day 84 ]
    IgG geometric mean enzyme-linked immunosorbent assay (ELISA) unit (GMEU) concentrations (EU/mL) to the SARS-CoV-2 S protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points, expressed as GMEU.

  11. Part 1 and Part 2: Serum IgG to the SARS-CoV-2 spike protein expressed as GMFR [ Time Frame: Day 0 to Day 84 ]
    IgG geometric mean enzyme-linked immunosorbent assay (ELISA) unit (GMEU) concentrations (EU/mL) to the SARS-CoV-2 S protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points, expressed as GMFR.

  12. Part 1 and Part 2: Serum IgG to the SARS-CoV-2 spike protein expressed as SCR [ Time Frame: Day 0 to Day 84 ]
    IgG geometric mean enzyme-linked immunosorbent assay (ELISA) unit (GMEU) concentrations (EU/mL) to the SARS-CoV-2 S protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points expressed as SCR.

  13. Part 1 and Part 2: Serum IgG to the SARS-CoV-2 spike protein expressed as Geometric Mean ELISA Unit Ratio (GMEUR) [ Time Frame: Day 0 to Day 84 ]
    IgG geometric mean enzyme-linked immunosorbent assay (ELISA) unit (GMEU) concentrations (EU/mL) to the SARS-CoV-2 S protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points, expressed as GMEUR.

  14. Part 1 and Part 2: Microneutralization assay (MN) 50 GMTs to the SARS-CoV-2 expressed as GMTs [ Time Frame: Day 0 to Day 84 ]
    MN50 GMTs to the SARS-CoV-2 from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points, expressed as GMTs.

  15. Part 1 and Part 2: MN50 GMTs to the SARS-CoV-2 expressed as GMFR [ Time Frame: Day 0 to Day 84 ]
    MN50 GMTs to the SARS-CoV-2 from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points expressed as GMFR.

  16. Part 1 and Part 2: MN50 GMTs to the SARS-CoV-2 expressed as SCR [ Time Frame: Day 0 to Day 84 ]
    MN50 GMTs to the SARS-CoV-2 from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points expressed as SCR.

  17. Part 1 and Part 2: MN50 GMTs to the SARS-CoV-2 expressed as GMTR [ Time Frame: Day 0 to Day 84 ]
    MN50 GMTs to the SARS-CoV-2 from the matched vaccine construct (and mismatched variant if available), at Days 0, 7, 21, 84, and other follow-up time points expressed as GMTR


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

  1. Medically stable adult male or females ≥ 50 to ≤ 80 years of age at screening.

  2. Participants may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by:

    1. Absence of changes in medical therapy in the past 2 months due to treatment failure or toxicity;
    2. Absence of medical events qualifying as SAEs within 3 months; and
    3. Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the investigator.
  3. The participant has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at screening.
  4. Willing and able to give informed consent prior to study enrollment.
  5. Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.
  6. Participants must have completed a primary vaccination series against SARS-CoV-2 with an authorized COVID 19 vaccine (and fulfill national recommendations for his/her age and morbidity category) with receipt of second/last dose of authorized vaccine (with or without boosters[s]) ≥ 8 weeks prior to enrollment (first study vaccination).

  7. Women of childbearing potential (defined as any female participant 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 the study OR agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study

    1. Condoms (male or female) with spermicide (if acceptable in country)
    2. Diaphragm with spermicide
    3. Cervical cap with spermicide
    4. Intrauterine device
    5. Oral or patch contraceptives
    6. Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy
    7. Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle
  8. Participants must be healthy and 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 vaccination.
  9. Participants must agree to not participate in any other SARS-CoV-2 or influenza prevention or treatment studies for the duration of the study. Note: For participants who become hospitalized with COVID-19, participation in investigational treatment studies is permitted.

Exclusion Criteria:

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

  1. History of laboratory-confirmed (by Polymerase Chain Reaction (PCR) or rapid antigen test) COVID-19 or asymptomatic SARS-CoV-2 infection ≤ 8 weeks prior to enrollment.

    (NOTE: Symptomatic COVID-19 or asymptomatic SARS-CoV-2 infection > 8 weeks prior to enrollment is NOT exclusionary)

  2. Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator). This includes any current workup of undiagnosed illness that could lead to a new condition.

  3. Serious chronic diseases inclusive of:

    1. Uncontrolled hypertension (NOTE: well controlled hypertension ≤ grade 2 in NOT exclusionary);

    2. Congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years (NOTE:

      mild well-controlled congestive heart failure is NOT exclusionary);

    3. Chronic obstructive pulmonary disease (COPD) with a history of an acute exacerbation of any severity in the prior 2 years (NOTE: mild well-controlled COPD is NOT exclusionary);
    4. In the past 3 months, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass grafting [CABG]) surgery, new cardiac medications for control of symptoms, or unstable angina (NOTE: stable coronary heart disease is NOT exclusionary);
    5. Asthma with a history of exacerbation in the prior 2 years or worsening of asthma symptoms or requiring changes in asthma control medications in the past 2 months (NOTE: well-controlled asthma is NOT exclusionary).
    6. Type 1 or type 2 diabetes (adult onset) requiring insulin (NOTE: non-insulin dependent type 2 diabetes is NOT exclusionary);
    7. Chronic kidney disease/renal insufficiency;
    8. Chronic gastrointestinal and hepatic diseases; or
    9. Chronic neurological diseases (such as multiple sclerosis, dementia, Parkinson's disease, degenerative neurological conditions, neuropathy, or epilepsy), history of stroke within 12 months with residual symptoms, or previous neurological disorder within 12 months with residual symptoms (NOTE: history of migraine or chronic headaches or nerve root compression that have been stable on treatment for the last 4 weeks are NOT exclusionary).
  4. Participation in research involving an investigational product (drug/biologic/device) within 90 days before planned date of vaccination.
  5. Use of COVID-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to planned date of vaccination.
  6. History of a serious reaction to prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product.
  7. Any history of anaphylaxis to any prior vaccine.
  8. History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine.
  9. Receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 8 weeks preceding the study vaccination. Note: Routine vaccinations will not be allowed until after study Day 21 and COVID and influenza vaccination will not be allowed until after Day 84.
  10. Any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination (NOTE: mild psoriasis is not exclusionary).
  11. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune- modifying drugs within 6 months prior to the administration of the study vaccines. An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids is permitted.
  12. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
  13. Active cancer (malignancy) 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).
  14. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study (EoS).
  15. Known disturbance of coagulation.
  16. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to study vaccination, which in the opinion of the investigator, might interfere with protocol compliance.
  17. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature > 38.0°C, on the planned day of vaccine administration).
  18. History of myocarditis or pericarditis.
  19. Any 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 vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
  20. Study team member or immediate family member of any study team member (inclusive of Sponsor, Contract Research Organization, and study site personnel involved in the conduct or planning of the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05519839


Locations
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Sponsors and Collaborators
Novavax
Investigators
Layout table for investigator information
Study Director: Clinical Development Novavax, Inc.
More Information
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Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT05519839    
Other Study ID Numbers: 2019nCoV-CIC-E-201
First Posted: August 29, 2022    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Novavax:
Coronavirus
Influenza
Additional relevant MeSH terms:
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COVID-19
Influenza, Human
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Orthomyxoviridae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs