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CompletedNCT03321968Updated Aug 4, 2023Results posted

Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults

A Phase 3 interventional study of Quadrivalent VLP Influenza Vaccine in Virus Diseases, RNA Virus Infections and Respiratory Tract Infections, sponsored by Medicago. Completed at 10 sites in Canada. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-04.

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 Other

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 3
Study type
Interventional
Enrollment
1,202
Allocation
Randomized
Ages
18 Years to 49 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
2nd of 12
1,202 · median 345
Started
2017
with 1 other
Phase 3
2 of 12
none open now
Registered
11th of 12
by date

Among the 12 studies in Influenza, Human by Tanabe Pharma Corporation, this one is the 2nd largest by enrollment, is one of 2 that started in 2017, is one of 2 in phase 3, and was the 11th 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 49 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.

Was this useful?
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 clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three consecutively manufactured lots of the Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine, during the 2016-2017 influenza season, in healthy adults 18-49 years of age. A single dose of one of three consecutive lots of Quadrivalent VLP Influenza Vaccine (30 µg/strain) will be administered to 1,200 participants.

Read the detailed description

This randomized, observer-blind, multicenter, Phase 3 lot consistency study will be conducted at multiple sites in Canada. The composition of the Quadrivalent VLP Influenza Vaccine used in this study includes two influenza A virus strains and two influenza B virus strains based on the 2016-2017 recommended strains for vaccination in the Northern hemisphere.

1,200 healthy male and female participants aged 18 to 49 years will be randomized in a 1:1:1 ratio to one of three lots of the Quadrivalent VLP Influenza Vaccine (30 μg/strain). Participant will participate in this study for approximately 21 days, during which a first visit will be scheduled on Day 0 for screening, eligibility assessment, and vaccine administration; and on Day 21 for blood sample collection for immunogenicity assessment.

03

Conditions studied

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

Keywords

  • Influenza
  • Human
  • RNA Virus Infections
  • Lot Consistency
  • Immunologic
  • Orthomyxoviridae Infections
  • Infection
  • Virus Diseases
  • Vaccine
  • Safety
  • Plant-made
  • Virus-like particle
  • Hemagglutinin
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 1,202 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 49 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 be considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study;
  2. Participants have a (BMI) ≤ 40.0 kg/m\^2 on Day 0 (pre-vaccination);
  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 six months prior to vaccination. Based on the Investigator's judgment, a participant with a 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 the duration of the study. 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 a sterilized partner (at least one year prior to vaccination);
    • Credible self-reported history of heterosexual vaginal intercourse abstinence until at least the Day 21 visit;
    • 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. 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 six months prior to study vaccine administration unless the criteria outlined in inclusion criterion no. 3 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.
  2. 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;
  3. Any disease other than hypothyroidism with stable replacement therapy; or any confirmed or suspected condition or immunodeficiency including known or suspected (HIV), or C infection, or the presence of lymphoproliferative disease;
  4. Administration or planned administration of any non-influenza vaccine within 30 days prior to randomization and up to blood sampling on Day 21. Immunization on an emergency basis will be evaluated case-by-case by the Investigator;
  5. Administration of any adjuvanted or influenza vaccine within 24 months prior to randomization or planned administration prior to the completion of Day 21;
  6. Administration of any "standard", non-adjuvanted influenza vaccine (e.g. live attenuated trivalent/quadrivalent inactivated influenza vaccine intranasal or split trivalent/quadrivalent inactivated influenza vaccine by either intradermal or IM route) within 24 months prior to randomization and up to completion of the Day 21 visit;
  7. Use of any investigational or non-registered product within 30 days 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 the Day 21 visit. Participation in observational studies is permitted;
  8. Treatment with systemic at a dose exceeding 10 milligrams (mg) of prednisone (or the equivalent) per day for more than seven consecutive days or for ten or more days in total, within one month of study vaccine administration; or any other cytotoxic or immunosuppressant drug, or any immunoglobulin preparation within three months of vaccination and until the completion of the Day 21 visit. Low doses of nasal or inhaled glucocorticoids and topical steroids are permitted;
  9. 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 IM bleeding (e.g. clopidogrel) are also eligible.
  10. History of allergy to any of the constituents of the Quadrivalent VLP Influenza Vaccine or a tobacco allergy;
  11. History of anaphylactic allergic reactions to plants or plants components;
  12. Any history of serious asthma (e.g. status asthmaticus, hospitalization for asthma control) in the last three years;
  13. Use of antihistamines 48 hours prior to study vaccination;
  14. The 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. 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-hour period is met;
  15. Participants who have a dermatological condition at the injection site that may interfere with injection site reaction rating;
  16. Participant who have received a blood transfusion within 90 days prior to study vaccination;
  17. Any female participant who has a positive or doubtful pregnancy test result prior to vaccination or who is lactating;
  18. Presence of any febrile illness (including oral temperature (OT) ≥ 38.0 ˚C within 24 hours prior to vaccination). Such participants may be re-evaluated for enrolment after resolution of illness;
  19. Cancer or treatment for cancer within three years of study vaccine administration. Participants with a history of cancer who are disease-free without treatment for three years or more are eligible. Individuals with treated and uncomplicated basal cell carcinoma of the skin or with non-treated, non-disseminated local prostate cancer are eligible;
  20. 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. Immediate family members of the Investigator or employees of a clinical site can participate in the study at another clinical site, as long as the Investigator or employees are not involved in the study at that site;
  21. Participant 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
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,202 participants (actual)

Study arms

  • Experimental
    Quadrivalent VLP Influenza Vaccine - Lot 1

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

    Biological: Quadrivalent VLP Influenza Vaccine

  • Experimental
    Quadrivalent VLP Influenza Vaccine - Lot 2

    Participants received one IM injection of 0.5 mL of their assigned vaccine lot of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.

    Biological: Quadrivalent VLP Influenza Vaccine

  • Experimental
    Quadrivalent VLP Influenza Vaccine - Lot 3

    Participants received one IM injection of 0.5 mL of their assigned vaccine lot of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.

    Biological: Quadrivalent VLP Influenza Vaccine

Interventions

  • BiologicalQuadrivalent VLP Influenza Vaccine

    Single dose of 30 µg/strain Quadrivalent VLP Influenza Vaccine

07

What researchers measure

Primary outcomes

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

    The GMTs were measured using a HI assay for the homologous strains: A/California/7/2009 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008 (Victoria lineage), and B/Phuket/3073/2013 (Yamagata lineage). Lot-to-lot consistency was based on adjusted GMT ratio for pairwise comparisons of the lots (Lot 1 / Lot 2, Lot 1 / Lot 3, and Lot 2 / Lot 3).

    Time frame: Day 21 (post-vaccination)

Secondary outcomes

  1. Percentage of Participants With Seroconversion (SC) Measured by HI Antibody Response for Each Homologous Influenza Strain

    The SC rate is the percentage of participants 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 post-vaccination. SC rate was measured using an HI assay for the homologous strains: A/California/7/2009 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008 (Victoria lineage), and B/Phuket/3073/2013 (Yamagata lineage).

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

  2. Percentage of Participants With Seroprotection (SP) Measured by HI Antibody Response of for Each Homologous Influenza Strain

    The SP rate is the percentage of participants 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). SP rate was measured using an HI assay for the homologous strains: A/California/7/2009 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008 (Victoria lineage), and B/Phuket/3073/2013 (Yamagata lineage).

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

  3. Geometric Mean of the Ratio of GMTs (Geometric Mean Fold Rise [GMFR]) of HI Antibody Response for Each Homologous Influenza Strain

    GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0), was measured using an HI assay for the homologous strains: A/California/7/2009 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008 (Victoria lineage), and B/Phuket/3073/2013 (Yamagata lineage).

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

  4. 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

  5. Number of Participants With at Least One Solicited Local and/or 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

  6. Number of Participants With ≥ Severe Solicited Local and Systemic Reaction

    Participants were monitored for both solicited local reactions (erythema, swelling, 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, swelling in the neck). Any solicited local or systemic immediate complaint was also included. Intensity of solicited reactions 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.

    Time frame: Day 0 (post-vaccination) up to Day 7

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

    Participants were monitored for both solicited local reactions (erythema, swelling, 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, swelling in the neck). Intensity of solicited reactions was graded according to the FDA toxicity grade: mild (1); moderate (2); severe (3); (4)-likely to be life-threatening if not treated in a timely manner. Causal relationship with 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

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

    Participants were monitored for unsolicited TEAEs. 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 was aggravated in severity or frequency following the administration of the study vaccine, up to and including the last visit of the study.

    Time frame: Day 0 (post-vaccination) up to Day 21

  9. 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#9.

    Time frame: Day 0 (post-vaccination) up to Day 21

  10. Number of Participants With ≥ Severe Related Unsolicited TEAEs

    The intensity of the unsolicited TEAEs 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 #9.

    Time frame: Day 0 (post-vaccination) up to Day 21

  11. Number of Participants With an Occurrence of Death

    The number of participants with an occurrence of death was assessed.

    Time frame: Day 0 (post-vaccination) up to Day 21

  12. Number of Participants With at Least One Serious TEAE

    A serious adverse event (SAE) was considered to be any untoward medical occurrence (whether or not considered to be related to the study vaccine) that, at any dose results in death; is life-threatening (at the time of the event); requires inpatient hospitalization (≥ 24 hours) or prolongation of existing hospitalization (elective hospitalizations/procedures for pre-existing conditions that have not worsened are excluded); results in persistent or significant disability/incapacity; is a congenital abnormality/birth defect; or is another medically important event (e.g. any cases of newly diagnosed cancer). AE and TEAEs is defined in outcome measure #9.

    Time frame: Day 0 (post-vaccination) up to Day 21

  13. 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 (post-vaccination) up to Day 21

  14. 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 reported. Plausibility should be interpreted broadly; however, 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. NOCDs were collected from vaccination on Day 0 to the end of the Day 21 visit.

    Time frame: Day 0 (post-vaccination) up to Day 21

08

Results

Posted Aug 4, 2023

Participant flow

Participants were randomized in a 1:1:1 ratio to receive one of the three lots of the Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine at a dose of 30 μg/strain.

Participant flow — Overall Study
MilestoneQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
Started401399402
Vaccinated401398401
Completed398397399
Not completed323
Withdrew: Withdrawal by subject121
Withdrew: Lost to follow-up201
Withdrew: Other than specified001

Outcome measures

PrimaryGeometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain

The GMTs were measured using a HI assay for the homologous strains: A/California/7/2009 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008 (Victoria lineage), and B/Phuket/3073/2013 (Yamagata lineage). Lot-to-lot consistency was based on adjusted GMT ratio for pairwise comparisons of the lots (Lot 1 / Lot 2, Lot 1 / Lot 3, and Lot 2 / Lot 3).

Time frame:
Day 21 (post-vaccination)
Reported as:
Geometric mean · titers
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain
titersQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
A/H1N1 (California)603.7 (541.4 to 673.2)595.6 (533.9 to 664.4)630.6 (565.6 to 703.0)
A/H3N2 (Hong Kong)96.3 (84.2 to 110.1)103.0 (90.0 to 117.7)88.0 (77.0 to 100.6)
B/Brisbane41.8 (37.8 to 46.1)41.9 (38.0 to 46.3)38.3 (34.7 to 42.3)
B/Phuket215.7 (193.2 to 240.9)231.1 (206.8 to 258.1)235.9 (211.3 to 263.4)
Statistical analysis
  • Quadrivalent VLP Influenza Vaccine - Lot 1 vs Quadrivalent VLP Influenza Vaccine - Lot 2 · Adjusted gmt ratio: 1.01 · 95% CI 0.87 to 1.18Adjusted GMT/GMT Ratio based on analysis of covariance (ANCOVA) model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.
  • Quadrivalent VLP Influenza Vaccine - Lot 1 vs Quadrivalent VLP Influenza Vaccine - Lot 3 · Adjusted gmt ratio: 0.96 · 95% CI 0.82 to 1.12Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.
  • Quadrivalent VLP Influenza Vaccine - Lot 2 vs Quadrivalent VLP Influenza Vaccine - Lot 3 · Adjusted gmt ratio: 0.94 · 95% CI 0.81 to 1.10Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.
  • Quadrivalent VLP Influenza Vaccine - Lot 1 vs Quadrivalent VLP Influenza Vaccine - Lot 2 · Adjusted gmt ratio: 0.94 · 95% CI 0.77 to 1.13Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.
  • Quadrivalent VLP Influenza Vaccine - Lot 1 vs Quadrivalent VLP Influenza Vaccine - Lot 3 · Adjusted gmt ratio: 1.09 · 95% CI 0.91 to 1.32Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.
  • Quadrivalent VLP Influenza Vaccine - Lot 2 vs Quadrivalent VLP Influenza Vaccine - Lot 3 · Adjusted gmt ratio: 1.17 · 95% CI 0.97 to 1.41Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.
  • Quadrivalent VLP Influenza Vaccine - Lot 1 vs Quadrivalent VLP Influenza Vaccine - Lot 2 · Adjusted gmt ratio: 1.00 · 95% CI 0.87 to 1.15Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.
  • Quadrivalent VLP Influenza Vaccine - Lot 1 vs Quadrivalent VLP Influenza Vaccine - Lot 3 · Adjusted gmt ratio: 1.09 · 95% CI 0.95 to 1.26Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.
  • Quadrivalent VLP Influenza Vaccine - Lot 2 vs Quadrivalent VLP Influenza Vaccine - Lot 3 · Adjusted gmt ratio: 1.10 · 95% CI 0.95 to 1.26Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.
  • Quadrivalent VLP Influenza Vaccine - Lot 1 vs Quadrivalent VLP Influenza Vaccine - Lot 2 · Adjusted gmt ratio: 0.93 · 95% CI 0.80 to 1.09Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.
  • Quadrivalent VLP Influenza Vaccine - Lot 1 vs Quadrivalent VLP Influenza Vaccine - Lot 3 · Adjusted gmt ratio: 0.91 · 95% CI 0.78 to 1.07Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.
  • Quadrivalent VLP Influenza Vaccine - Lot 2 vs Quadrivalent VLP Influenza Vaccine - Lot 3 · Adjusted gmt ratio: 0.98 · 95% CI 0.84 to 1.15Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.
SecondaryPercentage of Participants With Seroconversion (SC) Measured by HI Antibody Response for Each Homologous Influenza Strain

The SC rate is the percentage of participants 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 post-vaccination. SC rate was measured using an HI assay for the homologous strains: A/California/7/2009 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008 (Victoria lineage), and B/Phuket/3073/2013 (Yamagata lineage).

Time frame:
Day 0 (pre-vaccination) to Day 21
Reported as:
Number · percentage of participants
Percentage of Participants With Seroconversion (SC) Measured by HI Antibody Response for Each Homologous Influenza Strain
percentage of participantsQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
A/H1N1 (California)73.3 (68.6 to 77.7)68.7 (63.8 to 73.3)73.1 (68.4 to 77.5)
A/H3N2 (Hong Kong)60.9 (55.8 to 65.8)63.2 (58.1 to 68.0)57.4 (52.3 to 62.4)
B/Brisbane41.2 (36.2 to 46.3)42.8 (37.8 to 48.0)39.0 (34.1 to 44.1)
B/Phuket63.2 (58.2 to 68.0)55.4 (50.2 to 60.4)61.2 (56.2 to 66.1)
SecondaryPercentage of Participants With Seroprotection (SP) Measured by HI Antibody Response of for Each Homologous Influenza Strain

The SP rate is the percentage of participants 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). SP rate was measured using an HI assay for the homologous strains: A/California/7/2009 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008 (Victoria lineage), and B/Phuket/3073/2013 (Yamagata lineage).

Time frame:
Day 0 (pre-vaccination), Day 21
Reported as:
Number · percentage of participants
Percentage of Participants With Seroprotection (SP) Measured by HI Antibody Response of for Each Homologous Influenza Strain
percentage of participantsQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
A/H1N1 (California): Day 072.3 (67.5 to 76.7)76.5 (71.9 to 80.7)76.7 (72.2 to 80.9)
A/H1N1 (California): Day 2196.1 (93.7 to 97.8)97.1 (94.9 to 98.6)98.7 (97.0 to 99.6)
A/H3N2 (Hong Kong): Day 020.0 (16.1 to 24.3)19.8 (16.0 to 24.2)18.4 (14.6 to 22.6)
A/H3N2 (Hong Kong): Day 2180.3 (76.0 to 84.2)79.6 (75.3 to 83.6)77.5 (73.0 to 81.6)
B/Brisbane: Day 013.5 (10.2 to 17.3)12.3 (9.2 to 16.0)13.4 (10.2 to 17.2)
B/Brisbane: Day 2160.1 (55.0 to 65.0)59.8 (54.7 to 64.7)55.8 (50.7 to 60.8)
B/Phuket: Day 051.6 (46.4 to 56.6)58.8 (53.6 to 63.7)57.9 (52.8 to 62.9)
B/Phuket: Day 2190.7 (87.3 to 93.4)92.4 (89.3 to 94.9)93.8 (90.9 to 96.0)
SecondaryGeometric Mean of the Ratio of GMTs (Geometric Mean Fold Rise [GMFR]) of HI Antibody Response for Each Homologous Influenza Strain

GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0), was measured using an HI assay for the homologous strains: A/California/7/2009 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008 (Victoria lineage), and B/Phuket/3073/2013 (Yamagata lineage).

Time frame:
Day 0 (pre-vaccination), Day 21
Reported as:
Geometric mean · ratio
Geometric Mean of the Ratio of GMTs (Geometric Mean Fold Rise [GMFR]) of HI Antibody Response for Each Homologous Influenza Strain
ratioQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
A/H1N1 (California)8.55 (7.66 to 9.53)8.43 (7.56 to 9.41)8.93 (8.01 to 9.95)
A/H3N2 (Hong Kong)8.41 (7.36 to 9.61)8.99 (7.86 to 10.28)7.69 (6.73 to 8.78)
B/Brisbane4.08 (3.69 to 4.50)4.09 (3.70 to 4.52)3.73 (3.38 to 4.12)
B/Phuket5.76 (5.16 to 6.44)6.17 (5.53 to 6.90)6.30 (5.64 to 7.04)
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:
Count of participants · Participants
Number of Participants With at Least One Immediate Complaint
ParticipantsQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
Number of Participants With at Least One Immediate Complaint96108106
SecondaryNumber of Participants With at Least One Solicited Local and/or 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:
Count of participants · Participants
Number of Participants With at Least One Solicited Local and/or Systemic Reactions
ParticipantsQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
Number of Participants With at Least One Solicited Local and/or Systemic Reactions314321321
SecondaryNumber of Participants With ≥ Severe Solicited Local and Systemic Reaction

Participants were monitored for both solicited local reactions (erythema, swelling, 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, swelling in the neck). Any solicited local or systemic immediate complaint was also included. Intensity of solicited reactions 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.

Time frame:
Day 0 (post-vaccination) up to Day 7
Reported as:
Count of participants · Participants
Number of Participants With ≥ Severe Solicited Local and Systemic Reaction
ParticipantsQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
Number of Participants With ≥ Severe Solicited Local and Systemic Reaction5116
SecondaryNumber of Participants With ≥ Severe Related Solicited Local and Systemic Reactions

Participants were monitored for both solicited local reactions (erythema, swelling, 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, swelling in the neck). Intensity of solicited reactions was graded according to the FDA toxicity grade: mild (1); moderate (2); severe (3); (4)-likely to be life-threatening if not treated in a timely manner. Causal relationship with 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:
Count of participants · Participants
Number of Participants With ≥ Severe Related Solicited Local and Systemic Reactions
ParticipantsQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
Number of Participants With ≥ Severe Related Solicited Local and Systemic Reactions383
SecondaryNumber of Participants With Unsolicited Treatment-Emergent Adverse Events (TEAEs)

Participants were monitored for unsolicited TEAEs. 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 was aggravated in severity or frequency following the administration of the study vaccine, up to and including the last visit of the study.

Time frame:
Day 0 (post-vaccination) up to Day 21
Reported as:
Count of participants · Participants
Number of Participants With Unsolicited Treatment-Emergent Adverse Events (TEAEs)
ParticipantsQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
Number of Participants With Unsolicited Treatment-Emergent Adverse Events (TEAEs)949295
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#9.

Time frame:
Day 0 (post-vaccination) up to Day 21
Reported as:
Count of participants · Participants
Number of Participants With ≥ Severe Unsolicited TEAEs
ParticipantsQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
Number of Participants With ≥ Severe Unsolicited TEAEs432
SecondaryNumber of Participants With ≥ Severe Related Unsolicited TEAEs

The intensity of the unsolicited TEAEs 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 #9.

Time frame:
Day 0 (post-vaccination) up to Day 21
Reported as:
Count of participants · Participants
Number of Participants With ≥ Severe Related Unsolicited TEAEs
ParticipantsQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
Number of Participants With ≥ Severe Related Unsolicited TEAEs200
SecondaryNumber of Participants With an Occurrence of Death

The number of participants with an occurrence of death was assessed.

Time frame:
Day 0 (post-vaccination) up to Day 21
Reported as:
Count of participants · Participants
Number of Participants With an Occurrence of Death
ParticipantsQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
Number of Participants With an Occurrence of Death000
SecondaryNumber of Participants With at Least One Serious TEAE

A serious adverse event (SAE) was considered to be any untoward medical occurrence (whether or not considered to be related to the study vaccine) that, at any dose results in death; is life-threatening (at the time of the event); requires inpatient hospitalization (≥ 24 hours) or prolongation of existing hospitalization (elective hospitalizations/procedures for pre-existing conditions that have not worsened are excluded); results in persistent or significant disability/incapacity; is a congenital abnormality/birth defect; or is another medically important event (e.g. any cases of newly diagnosed cancer). AE and TEAEs is defined in outcome measure #9.

Time frame:
Day 0 (post-vaccination) up to Day 21
Reported as:
Count of participants · Participants
Number of Participants With at Least One Serious TEAE
ParticipantsQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
Number of Participants With at Least One Serious TEAE010
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 (post-vaccination) up to Day 21
Reported as:
Count of participants · Participants
Number of Participants With at Least One AE Leading to Withdrawal
ParticipantsQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
Number of Participants With at Least One AE Leading to Withdrawal000
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 reported. Plausibility should be interpreted broadly; however, 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. NOCDs were collected from vaccination on Day 0 to the end of the Day 21 visit.

Time frame:
Day 0 (post-vaccination) up to Day 21
Reported as:
Count of participants · Participants
Number of Participants With at Least One New Onset Chronic Diseases (NOCDs)
ParticipantsQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
Number of Participants With at Least One New Onset Chronic Diseases (NOCDs)000

Adverse events

Collected over Day 0 (post-vaccination) up to 21 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Quadrivalent VLP Influenza Vaccine - Lot 10/401 (0%)0/401 (0%)94/401 (23.4%)
Quadrivalent VLP Influenza Vaccine - Lot 20/398 (0%)1/398 (0.3%)92/398 (23.1%)
Quadrivalent VLP Influenza Vaccine - Lot 30/401 (0%)0/401 (0%)95/401 (23.7%)
Most frequent serious events
Most frequent serious events
EventQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
AppendicitisInfections and infestations0/4011/3980/401
Most frequent other events
Showing 10 of 122
Most frequent other events
EventQuadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3
HeadacheNervous system disorders11/40120/39816/401
Viral upper respiratory tract infectionInfections and infestations15/40115/39820/401
Oropharyngeal painRespiratory, thoracic and mediastinal disorders16/40115/3988/401
CoughRespiratory, thoracic and mediastinal disorders5/4013/3988/401
Nasal congestionRespiratory, thoracic and mediastinal disorders5/4015/3988/401
NauseaGastrointestinal disorders4/4017/3987/401
Upper respiratory tract infectionInfections and infestations0/4016/3984/401
FatigueGeneral disorders4/4016/3984/401
RhinorrhoeaRespiratory, thoracic and mediastinal disorders3/4015/3983/401
DiarrhoeaGastrointestinal disorders2/4015/3981/401

Baseline characteristics

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

Age, Continuous
Age, Continuous(years)Quadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3Total
Mean30.5 ± 9.3129.9 ± 8.9029.4 ± 8.8029.9 ± 9.01
Sex: Female, Male
Sex: Female, Male(Participants)Quadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3Total
Female216224217657
Male185174184543
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Quadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3Total
Hispanic or Latino21202768
Not Hispanic or Latino3803773741131
Unknown or Not Reported0101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Quadrivalent VLP Influenza Vaccine - Lot 1Quadrivalent VLP Influenza Vaccine - Lot 2Quadrivalent VLP Influenza Vaccine - Lot 3Total
American Indian or Alaska Native1102
Asian636658187
Native Hawaiian or Other Pacific Islander0123
Black or African American17242869
White318305310933
More than one race2136
Unknown or Not Reported0000
09

Study locations

10 sites
  • Site 205
    Halifax, Nova Scotia, Canada
  • Site 208
    Burlington, Ontario, Canada
  • Site 207
    Guelph, Ontario, Canada
  • Site 202
    Toronto, Ontario, Canada
  • Site 204
    Chicoutimi, Quebec, Canada
  • Site 203
    Gatineau, Quebec, Canada
  • Site 201
    Lévis, Quebec, Canada
  • Site 209
    Pointe-Claire, Quebec, Canada
  • Site 206
    Toronto, Quebec, Canada
  • Site 210
    Victoriaville, Quebec, Canada
10

References and documents

Publications

  • Ward BJ, Seguin A, Couillard J, Trepanier S, Landry N. Phase III: Randomized observer-blind trial to evaluate lot-to-lot consistency of a new plant-derived quadrivalent virus like particle influenza vaccine in adults 18-49 years of age. Vaccine. 2021 Mar 5;39(10):1528-1533. doi: 10.1016/j.vaccine.2021.01.004. Epub 2021 Feb 10. PubMed 33581920 ↗

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 Sep 2017 to primary completion in Dec 2017, 2 months.

Results were first posted in Aug 2023, 5 years 8 months after primary completion.

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 2 months is below 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
Oct 16, 2017
First posted
Oct 26, 2017
StartActual
Sep 29, 2017
Primary completionActual
Dec 1, 2017
CompletionActual
Dec 1, 2017
Results first posted
Aug 4, 2023
Last update
Aug 4, 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 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
12

Registry details

Key details

Study ID
NCT03321968
Lead sponsor
Medicago
Responsible party
Sponsor
First posted
Oct 26, 2017
Start date
Sep 29, 2017
Primary completion
Dec 1, 2017
Completion
Dec 1, 2017
Results posted
Aug 4, 2023
Last update
Aug 4, 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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