AzTrials
AzTrials

Virus DiseasesPhase 3NCT03301051

Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in Adults

A Phase 3 study testing Quadrivalent VLP Vaccine in people with Virus Diseases and RNA Virus Infections, run by Medicago at 73 sites in 7 countries.

Completed

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

Official record
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Trial summary

This Phase 3 study is intended to assess the efficacy of the Quadrivalent VLP Influenza Vaccine during the 2017-2018 influenza season in healthy adults 18 to 64 years of age. One dose of Quadrivalent VLP Influenza Vaccine (30 μg/strain) or of placebo will be administered to approximately 10,000 participants Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
What is being tested?
Quadrivalent VLP Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10,160 participants
Where
73 sitesin 7 countries
Study dates
31 Aug 2017to 9 May 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants must meet all of the following inclusion criteria to be eligible for participation in this study; no protocol waivers are allowed:
  • Participants must have a body mass index (BMI) below 40 kg/m^2;
  • Participants are considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study;
  • Participants must be in good general health prior to study participation, with no clinically relevant abnormalities that could jeopardize participant safety or interfere with study assessments, as assessed by the Principal Investigator or sub-Investigator (thereafter referred as Investigator) and determined by medical history, physical examination, and vital signs; Note: Participants with a pre-existing chronic disease will be allowed to participate if the disease is stable and, according to the Investigator's judgment, the condition is unlikely to confound the results of the study or pose additional risk to the participant by participating in the study. Stable disease is generally defined as no new onset or exacerbation of pre-existing chronic disease three months prior to vaccination. Based on the Investigator's judgment, a participant with more recent stabilization of a disease could also be eligible.
  • Female participants must have a negative urine pregnancy test result at the Screening/Vaccination visit (Visit 1).
  • Female participants of childbearing potential must use an effective method of contraception for one month prior to vaccination and agree to continue employing adequate birth control measures for at least 60 days post-vaccination. Moreover, female participants must have no plan to become pregnant for at least two months post-vaccination. Abstinent participants should be asked what method(s) they would use should their circumstances change, and participants without a well-defined plan should be excluded. The following relationship or methods of contraception are considered to be effective:
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  • Hormonal contraceptives (e.g. oral, injectable, topical [patch], or estrogenic vaginal ring);
  • Intra-uterine device with or without hormonal release;
  • Male partner using a condom plus spermicide or sterilized partner (at least one year prior to vaccination);
  • Credible self-reported history of heterosexual vaginal intercourse abstinence until at least 60 days post-vaccination;
  • Female partner;
  • Non-childbearing females are defined as:
  • Surgically-sterile (defined as bilateral tubal ligation, hysterectomy or bilateral oophorectomy performed more than one month prior to vaccination); or
  • Post-menopausal (absence of menses for 24 consecutive months and age consistent with natural cessation of ovulation).

Who cannot join

  • Participants who meet any of the following criteria will be excluded from participating in this study; no protocol waivers are allowed:
  • Any participant whose medical condition(s) is sufficiently severe that annual influenza vaccination would be routinely recommended in the jurisdiction of recruitment, as per the Investigator's judgement;
  • According to the Investigator's opinion, history of significant acute or chronic, uncontrolled medical or neuropsychiatric illness. 'Uncontrolled' is defined as:
  • Requiring a new medical or surgical treatment during the three months prior to study vaccine administration unless the criteria outlined in inclusion criterion no. 5 can be met (i.e. the Investigator can justify inclusion based upon the innocuous nature of medical/surgical events and/or treatments);
  • Requiring any significant change in a chronic medication (i.e. drug, dose, frequency) during the three months prior to study vaccine administration due to uncontrolled symptoms or drug toxicity unless the innocuous nature of the medication change meets the criteria outlined in inclusion criterion no. 5 and is appropriately justified by the Investigator.
  • Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug abuse which, in the Investigator's opinion, would render the participant unable to provide informed consent or unable to provide valid safety observations and reporting;
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  • Any autoimmune disease other than hypothyroidism on stable replacement therapy (including, but not limited to rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease, and inflammatory bowel disease) or any confirmed or suspected immunosuppressive condition or immunodeficiency including known or suspected human immunodeficiency virus (HIV), Hepatitis B or C infection, the presence of lymphoproliferative disease;
  • History of chronic pulmonary (including asthma, bronchopulmonary dysplasia, and cystic fibrosis) or cardiovascular (except isolated hypertension), renal, hepatic, neurologic, hematologic (including anemia and hemoglobinopathy), or metabolic disorders (including diabetes mellitus);
  • Because this is a placebo-controlled study, any participants in close contact with individuals considered to be at high risk for developing influenza-related complications (individuals considered at high risk for complications include adults and children who have chronic pulmonary or cardiovascular [except isolated hypertension], renal, hepatic, neurologic, hematologic, or metabolic disorders [including diabetes mellitus]).
  • Administration or planned administration of any non-influenza vaccine within 30 days prior to randomization up to blood sampling on Day 21. Immunization on an emergency basis will be evaluated case-by-case by the Investigator;
  • Administration of any adjuvanted or investigational influenza vaccine within one year prior to randomization or planned administration prior to the completion of the study;
  • Administration of any 'standard', non-adjuvanted influenza vaccine (e.g. live attenuated trivalent/quadrivalent inactivated influenza vaccine or split trivalent/quadrivalent inactivated influenza vaccine administered by intranasal, intradermal, or intramuscular route) within six months prior to randomization and up to completion of the study;
  • Use of any investigational or non-registered product within 30 days or five half-lives, whichever is longer, prior to randomization or planned use during the study period. Participants may not participate in any other investigational or marketed drug study while participating in this study until after the study;
  • Treatment with systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than seven consecutive days or for 10 or more days in total, within one month of study vaccine administration; any other cytotoxic or immunosuppressant drug, or any immunoglobulin preparation within three months of vaccination and until the completion of the study. Low doses of nasal or inhaled glucocorticoids are allowed. Topical steroids are permitted;
  • Any significant disorder of coagulation including, but not limited to, treatment with warfarin derivatives or heparin. Persons receiving prophylactic anti-platelet medications (e.g. low-dose aspirin [no more than 325 mg/day]), and without a clinically apparent bleeding tendency are eligible. Participants treated with new generation drugs that do not increase the risk of intramuscular bleeding (e.g. clopidogrel) are also eligible;
  • History of allergy to any of the constituents of the Quadrivalent VLP Influenza Vaccine or tobacco;
  • History of anaphylactic allergic reactions to plants or plants components;
  • Use of antihistamines with systemic absorption for more than 14 days in the four weeks prior to vaccination or use of antihistamines 48 hours prior to study vaccination (the use of topical antihistamines and nasal or inhaled steroids is acceptable);
  • Use of prophylactic medications (e.g. acetaminophen/paracetamol, aspirin, naproxen, or ibuprofen) within 24 hours of randomization to prevent or pre-empt symptoms due to vaccination. Any participant discovered to have taken a prophylactic medication to prevent or pre-empt symptoms due to vaccination within the 24 hours prior to planned randomization must be delayed until at least the 24 hours period is met;
  • Planned use of influenza antiviral treatment medication before the collection of nasopharyngeal swabs (e.g. oseltamivir, zanamivir, rapivab);
  • Have a rash, dermatological condition, tattoos, muscle mass, or any other abnormalities at the injection site that may interfere with injection site reaction rating;
  • Participants who have received a blood transfusion within 90 days prior to study vaccination;
  • Any female participant who has a positive or doubtful pregnancy test result prior to vaccination or who is lactating;
  • Participants with abnormal vital signs (systolic blood pressure [BP] > 140 mmHg and/or diastolic BP ≥ 90 mmHg, heart rate ≤ 45 beats/min and ≥ 100 beats/min) evaluated by an Investigator to be clinically significant. A participant with abnormal vital signs results may be included in the study based on Investigator's judgment (e.g. a resting hear rate ≤ 45 in highly trained athletes);
  • Presence of any febrile illness (including an oral temperature ≥ 38.0 ˚C within 24 hours prior to vaccination. Such participants may be re-evaluated for enrolment after resolution of illness;
  • Cancer or treatment for cancer within three years prior to study vaccine administration.
  • Persons with a history of cancer who are disease-free without treatment for three years or more are eligible. However, individuals with conditions such as treated and uncomplicated basal cell carcinoma of the skin or non-treated, non-disseminated local prostate cancer may be eligible;
  • Participants identified as an Investigator or employee of the Investigator or clinical site with direct involvement in the proposed study, or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study or any employee of Medicago;
  • Participants with a history of Guillain-Barré Syndrome.

Trial locations and contacts

73 sites in 7 countries.

73 sites in 7 countries

United States29 sites

  • Site 210

    Anaheim, California, 92801

  • Site 204

    Austin, Texas, 78705

  • Site 229

    Austin, Texas, 78745

  • Site 205

    Binghamton, New York, 13901

  • Site 209

    Bristol, Tennessee, 37260

  • Site 216

    Charlotte, North Carolina, 28209

  • Site 221

    Charlotte, North Carolina, 28277

  • Site 201

    Columbus, Ohio, 43123

  • Site 217

    Coral Gables, Florida, 33134

  • Site 207

    Dakota Dunes, South Dakota, 57049

  • Site 228

    Endwell, New York, 13760

  • Site 226

    Fort Worth, Texas, 76104

  • Site 219

    Fort Worth, Texas, 76135

  • Site 220

    Hollywood, Florida, 33024

  • Site 213

    Las Vegas, Nevada, 89104

  • Site 202

    Metairie, Louisiana, 70006

  • Site 223

    Milford, Connecticut, 06460

  • Site 222

    Mobile, Alabama, 36608

  • Site 224

    Norfolk, Nebraska, 68701

  • Site 230

    Norfolk, Virginia, 23507

  • Site 208

    Omaha, Nebraska, 63134

  • Site 214

    Salt Lake City, Utah, 84124

  • Site 203

    Savannah, Georgia, 31406

  • Site 212

    South Miami, Florida, 33143

  • Site 225

    St Louis, Missouri, 63141

  • Site 218

    Stockbridge, Georgia, 30281

  • Site 211

    West Jordan, Utah, 84088

  • Site 206

    Wichita, Kansas, 67025

  • Site 227

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada10 sites

  • Site 107

    Brampton, Ontario

  • Site 110

    Greater Sudbury, Ontario

  • Site 105

    Halifax, Nova Scotia

  • Site 109

    Mirabel, Quebec

  • Site 103

    Pierrefonds, Quebec

  • Site 101

    Québec, Quebec

  • Site 102

    Québec, Quebec

  • Site 104

    Sherbrooke, Quebec

  • Site 108

    Toronto, Ontario

  • Site 106

    Truro, Nova Scotia

Other trials in Canada

Finland10 sites

  • Site 306

    Espoo

  • Site 305

    Helsinki

  • Site 310

    Helsinki

  • Site 304

    Jarvenpaa

  • Site 309

    Kokkola

  • Site 307

    Oulu

  • Site 303

    Pori

  • Site 308

    Seinäjoki

  • Site 301

    Tampere

  • Site 302

    Turku

Other trials in Finland

Thailand7 sites

  • Site 601

    Bangkok

  • Site 603

    Bangkok

  • Site 604

    Bangkok

  • Site 606

    Bangkok

  • Site 607

    Bangkok

  • Site 605

    Bangkok Noi

  • Site 602

    Chiang Mai

Other trials in Thailand

Germany6 sites

  • Site 402

    Berlin

  • Site 403

    Berlin

  • Site 406

    Berlin

  • Site 401

    Essen

  • Site 404

    Essen

  • Site 405

    Hamburg

Other trials in Germany

Philippines6 sites

  • Site 702

    City of Muntinlupa

  • Site 704

    City of Muntinlupa

  • Site 705

    City of Muntinlupa

  • Site 701

    Manila

  • Site 703

    Manila

  • Site 706

    Pasay

Other trials in Philippines

United Kingdom5 sites

  • Site 510

    Corby

  • Site 507

    Gillingham

  • Site 506

    Northwood

  • Site 508

    Romford

  • Site 509

    Shipley

Other trials in United Kingdom

About this study

Official title: A Randomized, Observer-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Adults 18-64 Years of Age

This Phase 3 study is intended to assess the efficacy of the Quadrivalent VLP Influenza Vaccine during the 2017-2018 influenza season in healthy adults 18 to 64 years of age. One dose of Quadrivalent VLP Influenza Vaccine (30 μg/strain) or of placebo will be administered to approximately 10,000 participants

Read the detailed description

This randomized, observer-blind, placebo-controlled multicenter, Phase 3 study will be conducted at multiple sites. The composition of the Quadrivalent VLP Influenza Vaccine to be used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins expressed as VLPs for the 2017-2018 influenza virus strains.

Approximately 10,000 healthy male and female participants aged 18 to 64 years will be randomized in a 1:1 ratio into one of two parallel treatment groups, such that approximately 5,000 participants will receive the Quadrivalent VLP Influenza Vaccine at a dose of 30 μg/strain and approximately 5,000 participants will receive the placebo. Within the two treatment groups, participants will be stratified by site and two age groups (18-49 years of age and 50-64 years of age in a 1:1 ratio).

Participants will participate in this study for approximately eight to ten months, during which a first visit will be scheduled on Day 0 for screening and vaccine administration.

Being tested
Quadrivalent VLP Vaccine, Placebo
Keywords
Influenza, Human, RNA Virus Infections, Efficacy, Immunologic, Immunogenic Factors, Physiological Effects of Drug, Virus Diseases, Orthomyxoviridae Infections, Infection, Vaccine, Safety, Plant-made, Virus-like Particle, Hemagglutinin, Quadrivalent Influenza Vaccine
Medical subject headings
Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections, Influenza, Human, Orthomyxoviridae Infections, Infections

What participants receive

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

  • Quadrivalent VLP VaccineBiological

    Single dose of a 30 µg/strain of Quadrivalent VLP Vaccine

  • PlaceboBiological

    Single dose of a Placebo

Study groups in NCT03301051
Study groupRoleWhat they receive
Quadrivalent VLP VaccineExperimentalParticipants received one intramuscular (IM) injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
Receives: Biological: Quadrivalent VLP Vaccine
PlaceboPlacebo comparatorParticipants received one IM injection of 0.5 mL of placebo on Day 0.
Receives: Biological: Placebo

What is being measured

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

  1. Number of Occurrences of Protocol-Defined Respiratory Illness Caused by Vaccine-Matched Influenza Strains

    Occurrences of protocol-defined respiratory illness caused by vaccine-matched influenza strains were assessed. The vaccine-matched strains included: H1N1 (A/Michigan/45/2015); H3N2 (A/Hong Kong/4801/2014); B/Brisbane (B/Brisbane/60/2008); and B/Phuket (B/Phuket/3073/2013A). The protocol-defined respiratory illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sneezing, stuffy nose, sore throat, cough, sputum production, wheezing, or difficulty breathing. Occurrences of all matched strains are reported.

    Measured: Day 14 (post-vaccination) up to ~8 months

Secondary outcomes (26)

  1. Number of Occurrences of Protocol-Defined Respiratory Illness Cases Caused by Any Laboratory Confirmed Influenza Strain

    Occurrences of protocol-defined respiratory illness due to laboratory-confirmed influenza strain (matched, mismatched, and un-typed) were assessed. A protocol-defined respiratory illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sneezing, stuffy nose, sore throat, cough, sputum production, wheezing, or difficulty breathing.

    Measured: Day 14 (post-vaccination) up to ~8 months

  2. Number of Occurrences of Laboratory-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Vaccine-Matched Influenza Strains

    Occurrences of protocol-defined ILI due to laboratory-confirmed influenza caused by influenza viral types/subtypes that are matched (and/or antigenically similar) to the strains covered in the vaccine formulation were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature > 37.2 °C or > 99.0 °F), chills, tiredness, headache or myalgia.

    Measured: Day 14 (post-vaccination) up to ~8 months

  3. Number of Occurrences of Laboratory-Confirmed ILI Caused by Any Influenza Strain

    Occurrences of laboratory-confirmed ILI caused by any influenza viral strains were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature > 37.2 °C or > 99.0 °F), chills, tiredness, headache or myalgia.

    Measured: Day 14 (post-vaccination) up to ~8 months

  4. Number of Occurrences of Protocol-Defined ILI Cases

    Occurrences of protocol-defined ILI cases (confirmed or not) were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature > 37.2 °C or > 99.0 °F), chills, tiredness, headache or myalgia.

    Measured: Day 14 (post-vaccination) up to ~8 months

  5. Number of Participants With at Least One Immediate Complaint

    Immediate complaints were defined as any solicited local or systemic reactions. Solicited local reactions included: erythema, swelling, and pain at the injection site and solicited systemic reactions included: fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck.

    Measured: 15 minutes post vaccination

  6. Number of Participants With at Least One Solicited Local and Systemic Reactions

    Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). Any solicited local or systemic immediate complaint was also included.

    Measured: Day 0 (post-vaccination) up to Day 7

  7. Number of Participants With ≥ Severe Solicited Local and Systemic Reactions

    Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). Any solicited local or systemic immediate complaint was also included. The intensity of the solicited reactions was graded as mild (1)-easily tolerated and does not interfere with usual activity; moderate (2)-interferes with daily activity, but the participant is still able to function; severe (3)-incapacitating and the participant is unable to work or complete usual activity or potentially life threatening; (4)-likely to be life-threatening if not treated in a timely manner, according to the Food and Drug Administration (FDA) Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.

    Measured: Day 0 (post-vaccination) up to Day 7

  8. Number of Participants With ≥ Severe Related Solicited Reactions

    Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). The intensity of the solicited reactions was graded according to the FDA Toxicity Grading Scale: mild (1), moderate (2), severe (3) or potentially life threatening (4). The causal relationship with the study vaccine was assessed as "definitely not related" (clearly not related), "probably not related" (no medical evidence), "possibly related" (reasonable possibility of cause and effect), "probably related" (plausible biologic mechanism and temporal relationship) or "definitely related" (direct cause and effect relationship). The ≥ severe events included "severe" and "potentially life-threatening" and the related category included "possibly related", "probably related", and "definitely related."

    Measured: Day 0 (post-vaccination) up to Day 7

  9. Number of Participants With Unsolicited Treatment-Emergent Adverse Events (TEAEs)

    Participants were monitored for unsolicited TEAEs (e.g., nasopharyngitis, upper respiratory tract infection, headache, and oropharyngeal pain). An adverse event (AE) or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An AE was considered treatment-emergent if it began on or after the date and time of Study Day 0 vaccination.

    Measured: Day 0 (post-vaccination) up to Day 21

  10. Number of Participants With ≥ Severe Unsolicited TEAEs

    The intensity of the unsolicited TEAEs was graded as mild (1)-easily tolerated and does not interfere with usual activity; moderate (2)-interferes with daily activity, but the participant is still able to function; severe (3)-incapacitating and the participant is unable to work or complete usual activity or potentially life threatening; (4)-likely to be life-threatening if not treated in a timely manner, according to the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. The ≥ Severe events included severe and potentially life-threatening events. AE and TEAEs are defined in outcome measure #10.

    Measured: Day 0 (post-vaccination) up to Day 21

  11. Number of Participants With ≥ Severe Related Unsolicited Reactions

    The intensity of the solicited local and systemic reactions was graded as: mild (1), moderate (2), severe (3) or potentially life threatening (4). The causal relationship with the study vaccine was assessed as "definitely not related" (clearly not related), "probably not related" (no medical evidence), "possibly related" (reasonable possibility of cause and effect), "probably related" (plausible biologic mechanism and temporal relationship) or "definitely related" (direct cause and effect relationship). The ≥ severe events included "severe" and "potentially life-threatening" and the related category included "possibly related", "probably related", and "definitely related." AE and TEAEs are defined in outcome measure #10.

    Measured: Day 0 (post-vaccination) up to Day 21

  12. Number of Participants With an Occurrence of Death

    The number of participants in each treatment group with an occurrence of death was assessed.

    Measured: Day 0 up to ~8 months

  13. Number of Participants With at Least One Serious TEAE

    A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. An SAE was considered treatment-emergent if it was aggravated in severity or frequency following the administration of the study vaccine, up to and including the last visit of the study. AE is defined in outcome measure #10.

    Measured: Day 0 up to ~8 months

  14. Number of Participants With at Least One AE Leading to Withdrawal

    An AE or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The number of participants with at least one adverse event leading to withdrawal was assessed.

    Measured: Day 0 up to ~8 months

  15. Number of Participants With at Least One New Onset Chronic Diseases (NOCDs)

    All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility should be interpreted broadly; the only clear exceptions are degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases In this context, most cancers, cardiac conditions and kidney diseases should be reported.

    Measured: Day 0 up to ~8 months

  16. Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain

    The GMTs in each treatment group were measured using a HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.

    Measured: Day 0 (pre-vaccination), Day 21

  17. Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous and Heterologous Strain

    Seroconversion rate: the percentage of participants in a given treatment group with either a ≥ 4-fold increase in reciprocal HI titers between Day 0 and Day 21 or a rise of undetectable HI titer (i.e. < 10) pre-vaccination (Day 0) to an HI titer of ≥ 40 on Day 21 was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.

    Measured: Day 0 (pre-vaccination) up to Day 21

  18. Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain

    Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥ 40 on Day 21 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.

    Measured: Day 0 (pre-vaccination) up to Day 21

  19. Geometric Mean Fold Ratio (GMFR) of HI Antibody Response for Each Homologous and Heterologous Strain

    GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) in each treatment group was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.

    Measured: Day 0 (pre-vaccination), Day 21

  20. GMTs of Microneutralization (MN) Antibody Response for Each Homologous Strain

    The GMTs in each treatment group were measured using an MN assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.

    Measured: Day 0 (pre-vaccination), Day 21

  21. Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Strain

    Seroconversion rate: the percentage of participants in a given treatment group with either a ≥ 4-fold increase in reciprocal MN titers between Day 0 and Day 21 or a rise of undetectable MN titer (i.e. 7.1) pre-vaccination (Day 0) to an MN titer of ≥ 28.3 at Day 21 post-vaccination were measured using an MN assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.

    Measured: Day 0 (pre-vaccination) up to Day 21

  22. GMFR of MN Antibody Response for Each Homologous Strain

    GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) was measured in each treatment group using an MN assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, and B/Phuket/3073/2013.

    Measured: Day 0 (pre-vaccination), Day 21

  23. Geometric Mean Area (GMA) of Single Radial Hemolysis (SRH) Antibody Response for Each Homologous Strain

    The GMA in each treatment group were measured using an SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013. The GMA calculations were performed by taking the anti-log of the mean of the log titer transformations.

    Measured: Day 0 (pre-vaccination), Day 21

  24. Percentage of Participants With Seroconversion Measured by SRH Antibody Response for Each Homologous Strain

    Seroconversion rate: the percentage of participants in a given treatment group showing at least 50 % increase in GMA between Days 0 and 21 were measured using a SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.

    Measured: Day 0 (pre-vaccination) up to Day 21

  25. Percentage of Participants With Seroprotection Measured by SRH Antibody Response for Each Homologous Strain

    Seroprotection rate: the percentage of participants in a given treatment group attaining an area ≥ 25 mm^2 following vaccination (Day 21) were measured using an SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.

    Measured: Day 0 (pre-vaccination) up to Day 21

  26. GMFR of SRH Antibody Response for Each Homologous Strain

    GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) was measured in each treatment group using an SRH assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, and B/Phuket/3073/2013.

    Measured: Day 0 (pre-vaccination), Day 21

Timeline

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

  1. First posted4 Oct 2017
  2. Study start31 Aug 2017
  3. Primary completion2 May 2018
  4. Study completion9 May 2018

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
10,160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03301051
Sponsor's protocol ID
CP-PRO-QVLP-012
Status last verified
Jul 2023
First submitted
21 Sep 2017
Last updated
14 Aug 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ward BJ, Makarkov A, Seguin A, Pillet S, Trepanier S, Dhaliwall J, Libman MD, Vesikari T, Landry N. Efficacy, immunogenicity, and safety of a plant-derived, quadrivalent, virus-like particle influenza vaccine in adults (18-64 years) and older adults (>/=65 years): two multicentre, randomised phase 3 trials. Lancet. 2020 Nov 7;396(10261):1491-1503. doi: 10.1016/S0140-6736(20)32014-6. Epub 2020 Oct 13.

    PubMed 33065035

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quadrivalent VLP Vaccine in people with Virus Diseases and RNA Virus Infections, run by Medicago at 73 sites in 7 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 14 inclusion and 29 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Canada, Finland, Thailand, Germany and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Occurrences of Protocol-Defined Respiratory Illness Caused by Vaccine-Matched Influenza Strains (time frame: Day 14 (post-vaccination) up to ~8 months). 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 NCT03301051, which also lists 1 linked publication.

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 14 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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