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COVID-19Phase 2COVID-19NCT05519839

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

A Phase 2 study testing qNIV Vaccine with Matrix-M Adjuvant, Influenza Vaccine and CIC Vaccine with Matrix-M Adjuvant in people with COVID-19 and Influenza, run by Novavax at 35 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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™… Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19, Influenza
What is being tested?
qNIV Vaccine with Matrix-M Adjuvant, Influenza Vaccine and CIC Vaccine with Matrix-M Adjuvant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,579 participants
Where
35 sitesin 2 countries
Study dates
30 Dec 2022to 24 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • To be included in this study, each individual must satisfy all the following criteria:
  • Medically stable adult male or females ≥ 50 to ≤ 80 years of age at screening.
  • Participants may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by:
  • Absence of changes in medical therapy in the past 2 months due to treatment failure or toxicity;
  • Absence of medical events qualifying as SAEs within 3 months; and
  • Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the investigator.
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  • The participant has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at screening.
  • Willing and able to give informed consent prior to study enrollment.
  • Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.
  • 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).
  • 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
  • Condoms (male or female) with spermicide (if acceptable in country)
  • Diaphragm with spermicide
  • Cervical cap with spermicide
  • Intrauterine device
  • Oral or patch contraceptives
  • Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy
  • Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle
  • 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.
  • 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.

Who cannot join

  • If an individual meets any of the following criteria, he or she is ineligible for this study:
  • 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)
  • 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.
  • Serious chronic diseases inclusive of:
  • Uncontrolled hypertension (NOTE: well controlled hypertension ≤ grade 2 in NOT exclusionary);
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  • 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);
  • 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);
  • 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);
  • 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).
  • Type 1 or type 2 diabetes (adult onset) requiring insulin (NOTE: non-insulin dependent type 2 diabetes is NOT exclusionary);
  • Chronic kidney disease/renal insufficiency;
  • Chronic gastrointestinal and hepatic diseases; or
  • 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).
  • Participation in research involving an investigational product (drug/biologic/device) within 90 days before planned date of vaccination.
  • Use of COVID-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to planned date of vaccination.
  • 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.
  • Any history of anaphylaxis to any prior vaccine.
  • History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine.
  • 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.
  • 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).
  • 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.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
  • 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).
  • Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study (EoS).
  • Known disturbance of coagulation.
  • 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.
  • 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).
  • History of myocarditis or pericarditis.
  • 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).
  • 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.

Trial locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

Australia25 sites

  • CMAX

    Adelaide, South Australia

  • Paratus Clinical Research - Brisbane Clinic

    Albion, Queensland

  • Paratus Clinical Research - Western Sydney

    Blacktown, New South Wales, 2148

  • Emeritus Research - Sydney

    Botany, New South Wales

  • Mater Adult Hospital

    Brisbane, Queensland

  • Genesis Central Coast

    Broadmeadow, New South Wales

  • Northern Beaches Clinical Research

    Brookvale, New South Wales

  • Paratus Clinical Research - Canberra

    Bruce, Australian Capital Territory

  • Emeritus Research

    Camberwell, Victoria

  • Northside Health

    Coffs Harbour, New South Whales, 2450

  • East Sydney Doctors

    Darlinghurst, New South Wales

  • Holdsworth House Medical Brisbane

    Darlinghurst, New South Wales

  • Oztrials Clinical Research

    Drummoyne, New South Wales

  • Nucleus Network Pty Ltd

    Herston, Queensland

  • Paratus Clinical Research - Central Coast

    Kanwal, New South Wales

  • Novatrials

    Kotara, New South Whales, 2289

  • Australian Clinical Research Network

    Maroubra, New South Wales

  • Nucleus Network Limited

    Melbourne, Victoria

  • Hunter Diabetes Centre

    Merewether, New South Wales

  • Core Research Group

    Milton, Queensland

  • Sutherland Clinical Trials

    Miranda, New South Wales

  • Austrials Pty Ltd - Taringa

    Taringa, Queensland

  • AusTrials (Wellers Hill)

    Tarragindi, Queensland

  • Menzies Darwin

    Tiwi, Norther Territory

  • Illawarra Health and Medical Research Institute

    Wollongong, New South Wales

Other trials in Australia

New Zealand10 sites

  • Middlemore Clinical Trials

    Auckland

  • Optimal Clinical Trials Ltd

    Auckland

  • New Zealand Clinical Research - Christchurch

    Christchurch

  • P3 Research - Dunedin

    Dunedin

  • P3 Reseach - Hawkes Bay

    Havelock North, Hawkes Bay

  • P3 Research - Lower Hutt

    Palmerston, Wellington Region

  • P3 Research - Palmerston North

    Palmerston North, Manawatu-Wanganui, 4414

  • P3 Research Kapiti

    Paraparaumu, Wellington Region

  • P3 Research - Tauranga

    Tauranga

  • P3 Research - Wellington

    Wellington

Other trials in New Zealand

About this study

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

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.

Read the detailed description

The study will enroll approximately 2300 (1520 in Part 1 and 800 in Part 2) healthy (based on history and physical examination) adult male and female participants 50 to 80 years of age, inclusive, targeting participants, who 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]) ≥ 3 months prior to enrollment. Randomization will be stratified by age ≥ 50 to < 65 or ≥ 65 to ≤ 80 years to distribute the proportions of each age stratum evenly across vaccine groups.

Conditions
COVID-19, Influenza
Being tested
qNIV Vaccine with Matrix-M Adjuvant, Influenza Vaccine, CIC Vaccine with Matrix-M Adjuvant, Placebo Comparator, SARS-CoV-2 rS Vaccine with Matrix-M Adjuvant
Keywords
Coronavirus, Influenza
Medical subject headings
COVID-19, Influenza, Human, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • qNIV Vaccine with Matrix-M AdjuvantDrug

    Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV vaccine given on Day 0 and Day 70 .

  • Influenza VaccineDrug

    Intramuscular (deltoid) injections of Comparator influenza vaccine given on Day 0 and Day 70 (if applicable).

  • CIC Vaccine with Matrix-M AdjuvantDrug

    Intramuscular (deltoid) injections of co-formulated mix of various doses and formulations of CIC Vaccine given on Day 0 and Day 70

  • Placebo ComparatorOther

    Intramuscular (deltoid) injection of placebo given on Day 70.

  • SARS-CoV-2 rS Vaccine with Matrix-M AdjuvantDrug

    Intramuscular (deltoid) injections of in-clinic mix of various doses of SARS-CoV-2 rS vaccine given on Day 0 and Day 70 .

Study groups in NCT05519839
Study groupRoleWhat they receive
Group A (Part 1)ExperimentalCIC Vaccine Formulation1. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: CIC Vaccine with Matrix-M Adjuvant
Group B (Part 1)ExperimentalCIC Vaccine Formulation 2. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: CIC Vaccine with Matrix-M Adjuvant
Group C (Part 1)ExperimentalCIC Vaccine Formulation 3. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: CIC Vaccine with Matrix-M Adjuvant
Group D (Part 1)ExperimentalCIC Vaccine Formulation 3. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: CIC Vaccine with Matrix-M Adjuvant
Group E (Part 1)ExperimentalCIC Vaccine Formulation 1. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: CIC Vaccine with Matrix-M Adjuvant
Group F (Part 1)ExperimentalCIC Vaccine Formulation 2. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: CIC Vaccine with Matrix-M Adjuvant
Group G (Part 1)ExperimentalCIC Vaccine Formulation 3. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: CIC Vaccine with Matrix-M Adjuvant
Group H (Part 1)ExperimentalCIC Vaccine Formulation 4. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: CIC Vaccine with Matrix-M Adjuvant
Group I (Part 1)ExperimentalCIC Vaccine Formulation 5. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: CIC Vaccine with Matrix-M Adjuvant
Group J (Part 1)ExperimentalCIC Vaccine Formulation 6. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: CIC Vaccine with Matrix-M Adjuvant
Group K (Part 1)ExperimentalCIC Vaccine Formulation 7. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: CIC Vaccine with Matrix-M Adjuvant
Group L (Part 1)ExperimentalqNIV Vaccine Formulation 1. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: qNIV Vaccine with Matrix-M Adjuvant
Group M (Part 1)ExperimentalqNIV Vaccine Formulation 2. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: qNIV Vaccine with Matrix-M Adjuvant
Group N (Part 1)ExperimentalqNIV Vaccine Formulation 3 . 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: qNIV Vaccine with Matrix-M Adjuvant
Group O (Part 1)ExperimentalSARS-CoV-2 rS Vaccine Formulation 1. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: SARS-CoV-2 rS Vaccine with Matrix-M Adjuvant
Group P (Part 1)ExperimentalSARS-CoV-2 rS Vaccine Formulation 2. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: SARS-CoV-2 rS Vaccine with Matrix-M Adjuvant
Group Q (Part 1)ExperimentalSARS-CoV-2 rS Vaccine Formulation 3. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: SARS-CoV-2 rS Vaccine with Matrix-M Adjuvant
Group R (Part 1)ExperimentalSARS-CoV-2 rS Vaccine Formulation 4. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Receives: Drug: SARS-CoV-2 rS Vaccine with Matrix-M Adjuvant
Group S (Part 1)ExperimentalInfluenza Vaccine Formulation 1. 1 intramuscular (IM) doses of vaccine, on Day 0.
Receives: Drug: Influenza Vaccine
Group T (Part 2)ExperimentalCIC Vaccine Formulation 8. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 (if applicable).
Receives: Drug: CIC Vaccine with Matrix-M Adjuvant
Group U (Part 2)ExperimentalCIC Vaccine Formulation 9. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 (if applicable).
Receives: Drug: CIC Vaccine with Matrix-M Adjuvant
Group S (Part 1)-PlaceboPlacebo comparator1 intramuscular (IM) doses of placebo, on Day 70.
Receives: Other: Placebo Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 and Part 2 : Number of participants with solicited local and systemic Adverse Events (AEs)

    Numbers of participants with solicited local and systemic AEs over the 7 days post-vaccination.

    Measured: Day 0 to Day 7

  2. Part 1 and Part 2 : Percentage of participants with all AEs

    Proportions of participants reporting all AEs, solicited and unsolicited, over 21 days post-vaccination.

    Measured: Day 0 to Day 21

  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)

    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

    Measured: Day 0 to Day 182

Secondary outcomes (17)

  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)

    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

    Measured: Day 0 to Day 84

  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)

    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.

    Measured: Day 0 to Day 84

  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)

    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

    Measured: Day 0 to Day 84

  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)

    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.

    Measured: Day 0 to Day 84

  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)

    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).

    Measured: Day 0 to Day 84

  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

    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.

    Measured: Day 0 to Day 84

  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

    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

    Measured: Day 0 to Day 84

  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

    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.

    Measured: Day 0 to Day 84

  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

    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.

    Measured: Day 0 to Day 84

  10. Part 1 and Part 2: Serum Immunoglobulin G (IgG) to the SARS-CoV-2 spike protein expressed as GMEU

    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.

    Measured: Day 0 to Day 84

  11. Part 1 and Part 2: Serum IgG to the SARS-CoV-2 spike protein expressed as GMFR

    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.

    Measured: Day 0 to Day 84

  12. Part 1 and Part 2: Serum IgG to the SARS-CoV-2 spike protein expressed as SCR

    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.

    Measured: Day 0 to Day 84

  13. Part 1 and Part 2: Serum IgG to the SARS-CoV-2 spike protein expressed as Geometric Mean ELISA Unit Ratio (GMEUR)

    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.

    Measured: Day 0 to Day 84

  14. Part 1 and Part 2: Microneutralization assay (MN) 50 GMTs to the SARS-CoV-2 expressed as GMTs

    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.

    Measured: Day 0 to Day 84

  15. Part 1 and Part 2: MN50 GMTs to the SARS-CoV-2 expressed as GMFR

    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.

    Measured: Day 0 to Day 84

  16. Part 1 and Part 2: MN50 GMTs to the SARS-CoV-2 expressed as SCR

    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.

    Measured: Day 0 to Day 84

  17. Part 1 and Part 2: MN50 GMTs to the SARS-CoV-2 expressed as GMTR

    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

    Measured: Day 0 to Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2022
  2. Study start30 Dec 2022
  3. Primary completion25 Jul 2023
  4. Study completion24 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,579 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05519839
Sponsor's protocol ID
2019nCoV-CIC-E-201
Acronym
COVID-19
Status last verified
Jul 2024
First submitted
26 Aug 2022
Last updated
16 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing qNIV Vaccine with Matrix-M Adjuvant, Influenza Vaccine and CIC Vaccine with Matrix-M Adjuvant in people with COVID-19 and Influenza, run by Novavax at 35 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 and Part 2 : Number of participants with solicited local and systemic Adverse Events (AEs) (time frame: Day 0 to Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05519839.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.

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