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CompletedNCT03301051Updated Aug 14, 2023Results posted

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

A Phase 3 interventional study of Quadrivalent VLP Vaccine and Placebo in Virus Diseases, RNA Virus Infections and Respiratory Tract Diseases, sponsored by Medicago. Completed at 73 sites in 7 countries. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.

Primary conditionInfluenza, HumanRegistry: Virus DiseasesReclassifiedWhy we changed it
Registry
Virus Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Influenza, Human
Why
  1. The study's listed conditions name Influenza, Human, a narrower term within Virus Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Medicago (part of Tanabe Pharma Corporation) · Phase 3, Interventional, and Prevention

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Phase
Phase 3
Study type
Interventional
Enrollment
10,160
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 12 studies in Influenza, Human by Tanabe Pharma Corporation — none open to participants now, none under way, none of them phase 3. Influenza, Human · Tanabe Pharma Corporation.

Enrollment
Largest of 12
10,160 · median 345
Started
2017
with 1 other
Phase 3
2 of 12
none open now
Registered
10th of 12
by date

Among the 12 studies in Influenza, Human by Tanabe Pharma Corporation, this one has the largest enrollment, is one of 2 that started in 2017, is one of 2 in phase 3, and was the 10th registered.

Influenza, Human

2,358 studies on the registry are indexed under Influenza, Human; 185 are open to participants now.

Browse Influenza, Human studies →

Open to participants now

None of the 12 studies in Influenza, Human by Tanabe Pharma Corporation is open now. The open studies under Influenza, Human, anywhere →

Who these studies take

Of the 120 Influenza, Human studies recruiting now, 64 (53%) set no upper age limit and 46 (38%) stop at 75 or younger; 33 take children under 18; 66 take healthy volunteers.

This study: 18 Years to 64 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 12 studies in Influenza, Human by Tanabe Pharma Corporation as a file.
02

Study 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 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.

03

Conditions studied

  • Virus Diseases
  • RNA Virus Infections
  • Respiratory Tract Diseases
  • Respiratory Tract Infections
  • Influenza

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
04

In context

Influenza, Human Reclassified

2,358 studies on the registry are indexed under Influenza, Human; 185 are open to participants now.

This study's enrollment of 10,160 is above the median of 227 across 1,957 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Medicago is the lead sponsor of 18 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.

First submitted after Medicago became part of Tanabe Pharma Corporation.

Browse Medicago studies →All Tanabe Pharma Corporation studies →

Compared within Influenza, Human, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Virus Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Participants must meet all of the following inclusion criteria to be eligible for participation in this study; no protocol waivers are allowed:

  1. Participants must have a (BMI) below 40 kg/m\^2;
  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;
  3. Participants must be in good general health prior to study participation, with no 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.
  4. Female participants must have a negative urine pregnancy test result at the Screening/Vaccination visit (Visit 1).

  5. Female participants of must use an effective method of 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:

    • 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;

  6. 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
    • (absence of menses for 24 consecutive months and age consistent with natural cessation of ovulation).

Exclusion criteria

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from participating in this study; no protocol waivers are allowed:

  1. 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;

  2. 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.
  3. 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 or unable to provide valid safety observations and reporting;
  4. Any 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 condition or immunodeficiency including known or suspected (HIV), or C infection, the presence of lymphoproliferative disease;
  5. 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);
  6. 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]).
  7. 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;
  8. Administration of any adjuvanted or influenza vaccine within one year prior to randomization or planned administration prior to the completion of the study;
  9. 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;
  10. 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;
  11. Treatment with systemic 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;
  12. Any significant disorder of coagulation including, but not limited to, treatment with warfarin derivatives or heparin. Persons receiving prophylactic anti- 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;
  13. History of allergy to any of the constituents of the Quadrivalent VLP Influenza Vaccine or tobacco;
  14. History of anaphylactic allergic reactions to plants or plants components;
  15. 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);
  16. 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;
  17. Planned use of influenza antiviral treatment medication before the collection of nasopharyngeal swabs (e.g. oseltamivir, zanamivir, rapivab);
  18. Have a rash, dermatological condition, tattoos, muscle mass, or any other abnormalities at the injection site that may interfere with injection site reaction rating;
  19. Participants who have received a blood transfusion within 90 days prior to study vaccination;
  20. Any female participant who has a positive or doubtful pregnancy test result prior to vaccination or who is lactating;
  21. 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 . 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);
  22. 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;

  23. 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;

  24. 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;
  25. Participants with a history of Guillain-Barré Syndrome.
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

06

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
10,160 participants (actual)

Study arms

  • Experimental
    Quadrivalent VLP Vaccine

    Participants received one intramuscular (IM) injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.

    Biological: Quadrivalent VLP Vaccine

  • Placebo comparator
    Placebo

    Participants received one IM injection of 0.5 mL of placebo on Day 0.

    Biological: Placebo

Interventions

  • BiologicalQuadrivalent VLP Vaccine

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

  • BiologicalPlacebo

    Single dose of a Placebo

07

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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."

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Day 0 (pre-vaccination), Day 21

08

Results

Posted Aug 14, 2023

Participant flow

Participants were randomized in a 1:1 ratio to receive the Quadrivalent virus-like particle (VLP) Influenza Vaccine at a dose of 30 μg/strain or the placebo.

Participant flow — Overall Study
MilestoneQuadrivalent VLP VaccinePlacebo
Started50775083
Safety analysis set50645072
Vaccinated50655072
Completed47314711
Not completed346372
Withdrew: Adverse event04
Withdrew: Withdrawal by subject5965
Withdrew: Lost to follow-up263282
Withdrew: Protocol violation13
Withdrew: Physician decision13
Withdrew: Death11
Withdrew: Miscellaneous84
Withdrew: Randomized, not vaccinated1310

Outcome measures

PrimaryNumber 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.

Time frame:
Day 14 (post-vaccination) up to ~8 months
Reported as:
Number · Number of cases
Number of Occurrences of Protocol-Defined Respiratory Illness Caused by Vaccine-Matched Influenza Strains
Number of casesQuadrivalent VLP VaccinePlacebo
Number of Occurrences of Protocol-Defined Respiratory Illness Caused by Vaccine-Matched Influenza Strains110169
Statistical analysis
  • Quadrivalent VLP Vaccine vs Placebo · Vaccine efficacy: 34.9 · 95% CI 17.6 to 48.6The VE success criterion is defined as a \>40% lower limit of the two-sided 95% confidence interval (CI).
SecondaryNumber 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.

Time frame:
Day 14 (post-vaccination) up to ~8 months
Reported as:
Number · Number of cases
Number of Occurrences of Protocol-Defined Respiratory Illness Cases Caused by Any Laboratory Confirmed Influenza Strain
Number of casesQuadrivalent VLP VaccinePlacebo
Number of Occurrences of Protocol-Defined Respiratory Illness Cases Caused by Any Laboratory Confirmed Influenza Strain213347
Statistical analysis
  • Quadrivalent VLP Vaccine vs Placebo · Vaccine efficacy: 38.6 · 95% CI 27.6 to 48.0The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.
SecondaryNumber 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.

Time frame:
Day 14 (post-vaccination) up to ~8 months
Reported as:
Number · Number of cases
Number of Occurrences of Laboratory-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Vaccine-Matched Influenza Strains
Number of casesQuadrivalent VLP VaccinePlacebo
Number of Occurrences of Laboratory-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Vaccine-Matched Influenza Strains98148
Statistical analysis
  • Quadrivalent VLP Vaccine vs Placebo · Vaccine efficacy: 33.8 · 95% CI 14.9 to 48.5The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.
SecondaryNumber 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.

Time frame:
Day 14 (post-vaccination) up to ~8 months
Reported as:
Number · Number of cases
Number of Occurrences of Laboratory-Confirmed ILI Caused by Any Influenza Strain
Number of casesQuadrivalent VLP VaccinePlacebo
Number of Occurrences of Laboratory-Confirmed ILI Caused by Any Influenza Strain178285
Statistical analysis
  • Quadrivalent VLP Vaccine vs Placebo · Vaccine efficacy: 37.6 · 95% CI 25.1 to 48.0The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.
SecondaryNumber 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.

Time frame:
Day 14 (post-vaccination) up to ~8 months
Reported as:
Number · Number of cases
Number of Occurrences of Protocol-Defined ILI Cases
Number of casesQuadrivalent VLP VaccinePlacebo
Number of Occurrences of Protocol-Defined ILI Cases15761679
Statistical analysis
  • Quadrivalent VLP Vaccine vs Placebo · Vaccine efficacy: 6.2 · 95% CI 0.8 to 11.3The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.
SecondaryNumber 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.

Time frame:
15 minutes post vaccination
Reported as:
Number · Participants
Number of Participants With at Least One Immediate Complaint
ParticipantsQuadrivalent VLP VaccinePlacebo
Number of Participants With at Least One Immediate Complaint441377
SecondaryNumber 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.

Time frame:
Day 0 (post-vaccination) up to Day 7
Reported as:
Number · Participants
Number of Participants With at Least One Solicited Local and Systemic Reactions
ParticipantsQuadrivalent VLP VaccinePlacebo
Number of Participants With at Least One Solicited Local and Systemic Reactions27761723
SecondaryNumber 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.

Time frame:
Day 0 (post-vaccination) up to Day 7
Reported as:
Number · Participants
Number of Participants With ≥ Severe Solicited Local and Systemic Reactions
ParticipantsQuadrivalent VLP VaccinePlacebo
Number of Participants With ≥ Severe Solicited Local and Systemic Reactions7585
SecondaryNumber 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."

Time frame:
Day 0 (post-vaccination) up to Day 7
Reported as:
Number · Participants
Number of Participants With ≥ Severe Related Solicited Reactions
ParticipantsQuadrivalent VLP VaccinePlacebo
Number of Participants With ≥ Severe Related Solicited Reactions5662
SecondaryNumber 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.

Time frame:
Day 0 (post-vaccination) up to Day 21
Reported as:
Number · Participants
Number of Participants With Unsolicited Treatment-Emergent Adverse Events (TEAEs)
ParticipantsQuadrivalent VLP VaccinePlacebo
Number of Participants With Unsolicited Treatment-Emergent Adverse Events (TEAEs)661639
SecondaryNumber 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.

Time frame:
Day 0 (post-vaccination) up to Day 21
Reported as:
Number · Participants
Number of Participants With ≥ Severe Unsolicited TEAEs
ParticipantsQuadrivalent VLP VaccinePlacebo
Number of Participants With ≥ Severe Unsolicited TEAEs1325
SecondaryNumber 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.

Time frame:
Day 0 (post-vaccination) up to Day 21
Reported as:
Number · Participants
Number of Participants With ≥ Severe Related Unsolicited Reactions
ParticipantsQuadrivalent VLP VaccinePlacebo
Number of Participants With ≥ Severe Related Unsolicited Reactions46
SecondaryNumber of Participants With an Occurrence of Death

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

Time frame:
Day 0 up to ~8 months
Reported as:
Number · Participants
Number of Participants With an Occurrence of Death
ParticipantsQuadrivalent VLP VaccinePlacebo
Number of Participants With an Occurrence of Death12
SecondaryNumber 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.

Time frame:
Day 0 up to ~8 months
Reported as:
Number · Participants
Number of Participants With at Least One Serious TEAE
ParticipantsQuadrivalent VLP VaccinePlacebo
Number of Participants With at Least One Serious TEAE5551
SecondaryNumber 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.

Time frame:
Day 0 up to ~8 months
Reported as:
Number · Participants
Number of Participants With at Least One AE Leading to Withdrawal
ParticipantsQuadrivalent VLP VaccinePlacebo
Number of Participants With at Least One AE Leading to Withdrawal05
SecondaryNumber 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.

Time frame:
Day 0 up to ~8 months
Reported as:
Number · Participants
Number of Participants With at Least One New Onset Chronic Diseases (NOCDs)
ParticipantsQuadrivalent VLP VaccinePlacebo
Number of Participants With at Least One New Onset Chronic Diseases (NOCDs)5441
SecondaryGeometric 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.

Time frame:
Day 0 (pre-vaccination), Day 21
Reported as:
Geometric mean · Titers
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain
TitersQuadrivalent VLP VaccinePlacebo
Homologous (HIN1): Day 024.2 (20.7 to 28.3)30.0 (22.9 to 39.3)
Homologous (HIN1): Day 2184.8 (71.4 to 100.8)27.8 (21.6 to 35.9)
Homologous (H3N2): Day 026.2 (21.8 to 31.4)29.0 (21.9 to 38.4)
Homologous (H3N2): Day 21144.9 (121.9 to 172.4)28.0 (20.9 to 37.4)
Homologous (B/Brisbane/60/2008): Day 012.8 (11.3 to 14.4)12.9 (10.6 to 15.7)
Homologous (B/Brisbane/60/2008): Day 2128.1 (24.8 to 31.9)12.1 (10.0 to 14.8)
Homologous (B/Phuket/3073/2013): Day 028.8 (24.5 to 33.9)28.1 (21.7 to 36.5)
Homologous (B/Phuket/3073/2013): Day 2187.8 (74.3 to 103.9)26.4 (20.4 to 34.1)
Heterologous (HIN1): Day 014.5 (12.7 to 16.6)14.5 (12.0 to 17.5)
Heterologous (HIN1): Day 2116.4 (14.4 to 18.8)14.4 (11.8 to 17.6)
Heterologous (H3N2): Day 017.2 (14.7 to 20.2)19.7 (15.4 to 25.3)
Heterologous (H3N2): Day 2144.1 (37.1 to 52.3)17.7 (13.9 to 22.6)
Heterologous (B/Florida/4/2006): Day 026.8 (22.8 to 31.6)31.5 (24.2 to 41.1)
Heterologous (B/Florida/4/2006): Day 2165.3 (55.8 to 76.5)26.0 (20.1 to 33.7)
Heterologous (B/Malaysia/2506/2004): Day 011.5 (10.2 to 12.9)10.7 (8.8 to 13.0)
Heterologous (B/Malaysia/2506/2004): Day 2124.6 (21.6 to 27.9)10.6 (8.7 to 12.9)
SecondaryPercentage 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.

Time frame:
Day 0 (pre-vaccination) up to Day 21
Reported as:
Number · Percentage of Participants
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous and Heterologous Strain
Percentage of ParticipantsQuadrivalent VLP VaccinePlacebo
Homologous (HIN1)37.1 (31.4 to 43.0)0 (0 to 0)
Homologous (H3N2)46.4 (40.4 to 52.5)0 (0 to 0)
Homologous (B/Brisbane/60/2008)17.6 (13.3 to 22.6)0 (0 to 0)
Homologous (B/Phuket/3073/2013)31.7 (26.2 to 37.5)0 (0 to 0)
Heterologous (HIN1)2.5 (1.0 to 5.1)0 (0 to 0)
Heterologous (H3N2)23.0 (18.2 to 28.4)0 (0 to 0)
Heterologous (B/Florida/4/2006)27.0 (21.9 to 32.6)0 (0 to 0)
Heterologous (B/Malaysia/2506/2004)18.3 (14.0 to 23.4)0 (0 to 0)
SecondaryPercentage 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.

Time frame:
Day 0 (pre-vaccination) up to Day 21
Reported as:
Number · Percentage of Participants
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain
Percentage of ParticipantsQuadrivalent VLP VaccinePlacebo
Homologous (HIN1): Day 040.6 (34.8 to 46.7)47.4 (37.2 to 57.8)
Homologous (HIN1): Day 2174.8 (69.3 to 79.8)39.2 (29.4 to 49.6)
Homologous (H3N2): Day 046.4 (40.4 to 52.5)46.4 (36.2 to 56.8)
Homologous (H3N2): Day 2185.3 (80.5 to 89.2)48.5 (38.2 to 58.8)
Homologous (B/Brisbane/60/2008): Day 019.4 (14.9 to 24.6)20.6 (13.1 to 30.0)
Homologous (B/Brisbane/60/2008: Day 2141.0 (35.2 to 47.0)15.5 (8.9 to 24.2)
Homologous (B/Phuket/3073/2013): Day 047.5 (41.5 to 53.5)46.4 (36.2 to 56.8)
Homologous (B/Phuket/3073/2013): Day 2176.3 (70.8 to 81.1)43.3 (33.3 to 53.7)
Heterologous (HIN1): Day 023.4 (18.5 to 28.8)16.5 (9.7 to 25.4)
Heterologous (HIN1): Day 2127.0 (21.9 to 32.6)16.5 (9.7 to 25.4)
Heterologous (H3N2): Day 031.3 (25.9 to 37.1)34.0 (24.7 to 44.3)
Heterologous (H3N2): Day 2158.6 (52.6 to 64.5)29.9 (21.0 to 40.0)
Heterologous (B/Florida/4/2006): Day 046.8 (40.8 to 52.8)48.5 (38.2 to 58.8)
Heterologous (B/Florida/4/2006): Day 2170.9 (65.1 to 76.1)46.4 (36.2 to 56.8)
Heterologous (B/Malaysia/2506/2004): Day 020.1 (15.6 to 25.3)15.5 (8.9 to 24.2)
Heterologous (B/Malaysia/2506/2004): Day 2143.2 (37.3 to 49.2)13.4 (7.3 to 21.8)
SecondaryGeometric 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.

Time frame:
Day 0 (pre-vaccination), Day 21
Reported as:
Geometric mean · Ratio
Geometric Mean Fold Ratio (GMFR) of HI Antibody Response for Each Homologous and Heterologous Strain
RatioQuadrivalent VLP VaccinePlacebo
Homologous (HIN1)3.4 (3.0 to 3.9)1.0 (0.8 to 1.2)
Homologous (H3N2)5.5 (4.7 to 6.3)1.0 (0.8 to 1.3)
Homologous (B/Brisbane/60/2008)2.2 (2.0 to 2.4)0.9 (0.8 to 1.1)
Homologous (B/Phuket/3073/2013)3.1 (2.7 to 3.4)0.9 (0.8 to 1.1)
Heterologous (HIN1)1.1 (1.1 to 1.2)1.0 (0.9 to 1.1)
Heterologous (H3N2)2.5 (2.3 to 2.9)0.9 (0.8 to 1.1)
Heterologous (B/Florida/4/2006)2.4 (2.2 to 2.7)0.9 (0.7 to 1.0)
Heterologous (B/Malaysia/2506/2004)2.2 (2.0 to 2.4)1.0 (0.8 to 1.1)
SecondaryGMTs 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.

Time frame:
Day 0 (pre-vaccination), Day 21
Reported as:
Geometric mean · Titers
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Strain
TitersQuadrivalent VLP VaccinePlacebo
Homologous (HIN1): Day 088.1 (76.7 to 101.1)112.3 (91.1 to 138.6)
Homologous (HIN1): Day 21366.1 (316.1 to 424.1)135.7 (110.4 to 166.9)
Homologous (H3N2): Day 046.7 (41.9 to 52.1)62.1 (53.1 to 72.6)
Homologous (H3N2): Day 21120.3 (108.9 to 132.9)67.2 (57.0 to 79.1)
Homologous (B/Brisbane/60/2008): Day 015.2 (13.8 to 16.7)14.9 (12.9 to 17.3)
Homologous (B/Brisbane/60/2008): Day 2138.2 (34.3 to 42.7)16.0 (13.7 to 18.6)
Homologous (B/Phuket/3073/2013): Day 018.2 (16.3 to 20.4)18.9 (16.0 to 22.3)
Homologous (B/Phuket/3073/2013): Day 2152.0 (46.1 to 58.6)21.3 (18.0 to 25.2)
SecondaryPercentage 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.

Time frame:
Day 0 (pre-vaccination) up to Day 21
Reported as:
Number · Percentage of Participants
Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Strain
Percentage of ParticipantsQuadrivalent VLP VaccinePlacebo
Homologous (HIN1)41.7 (35.9 to 47.8)2.1 (0.3 to 7.3)
Homologous (H3N2)28.1 (22.9 to 33.7)0 (0 to 0)
Homologous (B/Brisbane/60/2008)30.6 (25.2 to 36.4)0 (0 to 0)
Homologous (B/Phuket/3073/2013)31.3 (25.9 to 37.1)1.0 (0.0 to 5.6)
SecondaryGMFR 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.

Time frame:
Day 0 (pre-vaccination), Day 21
Reported as:
Geometric mean · Ratio
GMFR of MN Antibody Response for Each Homologous Strain
RatioQuadrivalent VLP VaccinePlacebo
Homologous (HIN1)4.0 (3.6 to 4.6)1.3 (1.1 to 1.6)
Homologous (H3N2)2.5 (2.2 to 2.7)1.2 (1.1 to 1.5)
Homologous (B/Brisbane/60/2008)2.5 (2.3 to 2.8)1.1 (0.9 to 1.2)
Homologous (B/Phuket/3073/2013)2.8 (2.6 to 3.1)1.1 (1.0 to 1.3)
SecondaryGeometric 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.

Time frame:
Day 0 (pre-vaccination), Day 21
Reported as:
Geometric mean · mm^2
Geometric Mean Area (GMA) of Single Radial Hemolysis (SRH) Antibody Response for Each Homologous Strain
mm^2Quadrivalent VLP VaccinePlacebo
Homologous (HIN1): Day 010.3 (8.7 to 12.1)15.4 (12.0 to 19.8)
Homologous (HIN1): Day 2131.4 (27.6 to 35.7)20.9 (16.4 to 26.6)
Homologous (H3N2): Day 015.6 (12.9 to 18.8)19.3 (14.2 to 26.1)
Homologous (H3N2): Day 2156.0 (50.2 to 62.5)28.4 (21.2 to 38.1)
Homologous (B/Brisbane/60/2008): Day 08.2 (6.9 to 9.9)6.8 (5.0 to 9.3)
Homologous (B/Brisbane/60/2008): Day 2131.9 (27.4 to 37.1)9.3 (6.7 to 12.9)
Homologous (B/Phuket/3073/2013): Day 011.4 (9.5 to 13.7)11.7 (8.8 to 15.7)
Homologous (B/Phuket/3073/2013): Day 2136.7 (31.9 to 42.1)15.5 (11.5 to 20.8)
SecondaryPercentage 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.

Time frame:
Day 0 (pre-vaccination) up to Day 21
Reported as:
Number · Percentage of Participants
Percentage of Participants With Seroconversion Measured by SRH Antibody Response for Each Homologous Strain
Percentage of ParticipantsQuadrivalent VLP VaccinePlacebo
Homologous (HIN1)53.6 (47.5 to 59.6)14.4 (8.1 to 23.0)
Homologous (H3N2)48.2 (42.2 to 54.2)14.4 (8.1 to 23.0)
Homologous (B/Brisbane/60/2008)45.7 (39.7 to 51.7)9.3 (4.3 to 16.9)
Homologous (B/Phuket/3073/2013)47.1 (41.1 to 53.2)12.4 (6.6 to 20.6)
SecondaryPercentage 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.

Time frame:
Day 0 (pre-vaccination) up to Day 21
Reported as:
Number · Percentage of Participants
Percentage of Participants With Seroprotection Measured by SRH Antibody Response for Each Homologous Strain
Percentage of ParticipantsQuadrivalent VLP VaccinePlacebo
Homologous (HIN1): Day 036.3 (30.7 to 42.3)42.3 (32.3 to 52.7)
Homologous (HIN1): Day 2175.9 (70.4 to 80.8)57.7 (47.3 to 67.7)
Homologous (H3N2): Day 054.7 (48.6 to 60.6)57.7 (47.3 to 67.7)
Homologous (H3N2): Day 2192.1 (88.3 to 95.0)74.2 (64.3 to 82.6)
Homologous (B/Brisbane/60/2008): Day 040.3 (34.5 to 46.3)37.1 (27.5 to 47.5)
Homologous (B/Brisbane/60/2008): Day 2181.3 (76.2 to 85.7)45.4 (35.2 to 55.8)
Homologous (B/Phuket/3073/2013): Day 047.5 (41.5 to 53.5)44.3 (34.2 to 54.8)
Homologous (B/Phuket/3073/2013): Day 2181.7 (76.6 to 86.0)54.6 (44.2 to 64.8)
SecondaryGMFR 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.

Time frame:
Day 0 (pre-vaccination), Day 21
Reported as:
Geometric mean · Ratio
GMFR of SRH Antibody Response for Each Homologous Strain
RatioQuadrivalent VLP VaccinePlacebo
Homologous (HIN1)2.9 (2.6 to 3.2)1.6 (1.3 to 1.9)
Homologous (H3N2)3.5 (3.1 to 3.9)1.6 (1.4 to 2.0)
Homologous (B/Brisbane/60/2008)4.0 (3.5 to 4.5)1.3 (1.0 to 1.6)
Homologous (B/Phuket/3073/2013)3.2 (2.9 to 3.6)1.3 (1.1 to 1.6)

Adverse events

Collected over Day 0 (post-vaccination) up to ~8 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Quadrivalent VLP Vaccine1/5,064 (0%)55/5,064 (1.1%)930/5,064 (18.4%)
Placebo2/5,072 (0%)51/5,072 (1%)918/5,072 (18.1%)
Most frequent serious events
Showing 10 of 100
Most frequent serious events
EventQuadrivalent VLP VaccinePlacebo
PneumoniaInfections and infestations3/50643/5072
AppendicitisInfections and infestations2/50641/5072
InfluenzaInfections and infestations2/50642/5072
Pulmonary embolismRespiratory, thoracic and mediastinal disorders2/50640/5072
VolvulusGastrointestinal disorders2/50640/5072
Radius fractureInjury, poisoning and procedural complications2/50640/5072
BronchitisInfections and infestations0/50642/5072
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/50642/5072
Cerebrovascular accidentNervous system disorders1/50642/5072
ColitisGastrointestinal disorders0/50642/5072
Most frequent other events
Showing 10 of 448
Most frequent other events
EventQuadrivalent VLP VaccinePlacebo
Upper respiratory tract infectionInfections and infestations126/5064117/5072
HeadacheNervous system disorders113/5064111/5072
Influenza like illnessGeneral disorders82/506487/5072
Oropharyngeal painRespiratory, thoracic and mediastinal disorders54/506457/5072
NasopharyngitisInfections and infestations56/506455/5072
Nasal congestionRespiratory, thoracic and mediastinal disorders49/506428/5072
CoughRespiratory, thoracic and mediastinal disorders39/506441/5072
RhinorrhoeaRespiratory, thoracic and mediastinal disorders40/506439/5072
RhinitisInfections and infestations31/506427/5072
Injection site painGeneral disorders29/50648/5072

Baseline characteristics

The Safety Analysis Set (SAS) was defined as all participants who received either the Quadrivalent VLP Influenza Vaccine or the placebo.

Age, Categorical
Age, Categorical(Participants)Quadrivalent VLP VaccinePlaceboTotal
<=18 years000
Between 18 and 65 years5064507210136
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Quadrivalent VLP VaccinePlaceboTotal
Female305130346085
Male201320384051
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Quadrivalent VLP VaccinePlaceboTotal
Hispanic or Latino293326619
Not Hispanic or Latino476947409509
Unknown or Not Reported268
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Quadrivalent VLP VaccinePlaceboTotal
American Indian or Alaska Native201838
Asian119211852377
Native Hawaiian or Other Pacific Islander7613
Black or African American6466201266
White316832146382
More than one race232346
Unknown or Not Reported8614
09

Study locations

73 sites
  • Site 222
    Mobile, Alabama 36608, United States
  • Site 210
    Anaheim, California 92801, United States
  • Site 223
    Milford, Connecticut 06460, United States
  • Site 217
    Coral Gables, Florida 33134, United States
  • Site 220
    Hollywood, Florida 33024, United States
  • Site 212
    South Miami, Florida 33143, United States
  • Site 203
    Savannah, Georgia 31406, United States
  • Site 218
    Stockbridge, Georgia 30281, United States
  • Site 206
    Wichita, Kansas 67025, United States
  • Site 202
    Metairie, Louisiana 70006, United States
  • Site 225
    Saint Louis, Missouri 63141, United States
  • Site 224
    Norfolk, Nebraska 68701, United States
  • Site 208
    Omaha, Nebraska 63134, United States
  • Site 213
    Las Vegas, Nevada 89104, United States
  • Site 205
    Binghamton, New York 13901, United States
  • Site 228
    Endwell, New York 13760, United States
  • Site 216
    Charlotte, North Carolina 28209, United States
  • Site 221
    Charlotte, North Carolina 28277, United States
  • Site 227
    Winston-Salem, North Carolina 27103, United States
  • Site 201
    Columbus, Ohio 43123, United States
  • Site 207
    Dakota Dunes, South Dakota 57049, United States
  • Site 209
    Bristol, Tennessee 37260, United States
  • Site 204
    Austin, Texas 78705, United States
  • Site 229
    Austin, Texas 78745, United States
  • Site 226
    Fort Worth, Texas 76104, United States
  • Site 219
    Fort Worth, Texas 76135, United States
  • Site 214
    Salt Lake City, Utah 84124, United States
  • Site 211
    West Jordan, Utah 84088, United States
  • Site 230
    Norfolk, Virginia 23507, United States
  • Site 105
    Halifax, Nova Scotia, Canada
  • Site 106
    Truro, Nova Scotia, Canada
  • Site 107
    Brampton, Ontario, Canada
  • Site 110
    Sudbury, Ontario, Canada
  • Site 108
    Toronto, Ontario, Canada
  • Site 109
    Mirabel, Quebec, Canada
  • Site 103
    Pierrefonds, Quebec, Canada
  • Site 101
    Quebec City, Quebec, Canada
  • Site 102
    Quebec City, Quebec, Canada
  • Site 104
    Sherbrooke, Quebec, Canada
  • Site 306
    Espoo, Finland
  • Site 305
    Helsinki, Finland
  • Site 310
    Helsinki, Finland
  • Site 304
    Jarvenpaa, Finland
  • Site 309
    Kokkola, Finland
  • Site 307
    Oulu, Finland
  • Site 303
    Pori, Finland
  • Site 308
    Seinäjoki, Finland
  • Site 301
    Tampere, Finland
  • Site 302
    Turku, Finland
  • Site 402
    Berlin, Germany
  • Site 403
    Berlin, Germany
  • Site 406
    Berlin, Germany
  • Site 401
    Essen, Germany
  • Site 404
    Essen, Germany
  • Site 405
    Hamburg, Germany
  • Site 701
    Manila, Philippines
  • Site 703
    Manila, Philippines
  • Site 702
    Muntinlupa, Philippines
  • Site 704
    Muntinlupa, Philippines
  • Site 705
    Muntinlupa, Philippines
  • Site 706
    Pasay, Philippines
  • Site 605
    Bangkok Noi, Thailand
  • Site 601
    Bangkok, Thailand
  • Site 603
    Bangkok, Thailand
  • Site 604
    Bangkok, Thailand
  • Site 606
    Bangkok, Thailand
  • Site 607
    Bangkok, Thailand
  • Site 602
    Chiang Mai, Thailand
  • Site 510
    Corby, United Kingdom
  • Site 507
    Gillingham, United Kingdom
  • Site 506
    Northwood, United Kingdom
  • Site 508
    Romford, United Kingdom
  • Site 509
    Shipley, United Kingdom
10

References and documents

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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

11

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in May 2018, 8 months.

Results were first posted in Aug 2023, 5 years 3 months after primary completion. A results delay was requested in Oct 2019.

Of 118 industry-sponsored phase 3 interventional studies under Influenza, Human, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 14. This study's 8 months is close to that.

Counting every sponsor, half of 153 studies reached it within 8 months; a quarter within 4 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2017
First posted
Oct 4, 2017
StartActual
Aug 31, 2017
Primary completionActual
May 2, 2018
CompletionActual
May 9, 2018
Results delay requested
Oct 31, 2019
Results first posted
Aug 14, 2023
Last update
Aug 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
12

Registry details

Key details

Study ID
NCT03301051
Lead sponsor
Medicago
Responsible party
Sponsor
First posted
Oct 4, 2017
Start date
Aug 31, 2017
Primary completion
May 2, 2018
Completion
May 9, 2018
Results posted
Aug 14, 2023
Last update
Aug 14, 2023

Study contacts

Medical Director
study director · Medicago

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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