Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly

NCT03739112 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CP-PRO-QVLP-014
• Study Type: interventional
• Target: 12,794
• Locations: 5 countries
• Sites: 104

Brief Summary

This Phase 3 study was intended to assess the relative efficacy of the Quadrivalent VLP Influenza Vaccine during the 2018-2019 influenza season compared to a licensed vaccine in elderly adults 65 years of age and older. One dose of VLP Influenza Vaccine (30 μg/strain) or of Comparator (15 μg/strain) was to be administered to 12,738 participants.

Conditions

Virus Diseases; RNA Virus Infections; Respiratory Tract Diseases; Respiratory Tract Infections

Keywords

vaccine; safety; efficacy; plant-made; virus-like particle; hemagglutinin

Outcome Measures

Primary Outcomes (1)

• Number of Occurrences of Protocol-Defined Influenza-Like Illness (ILI) Due to Any Laboratory-Confirmed Influenza Strains

  Occurrences of laboratory-confirmed ILI caused by any influenza viral strains was measured by reverse transcriptase polymerase chain reaction (RT-PCR). A participant was 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. The number of laboratory-confirmed ILI cases caused by any influenza strains are reported.

  Day 14 (post-vaccination) up to ~9 months

Secondary Outcomes (26)

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

  Day 14 (post-vaccination) up to ~9 months

• Number of Occurrences of Protocol-Defined Respiratory Illness Due to Any Laboratory-Confirmed Influenza Strains

  Day 14 (post-vaccination) up to ~9 months

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

  Day 14 (post-vaccination) up to ~9 months

• Number of Occurrences of Protocol-Defined ILI

  Day 14 (post-vaccination) up to ~9 months

• Number of Participants With at Least One Immediate Complaints

  15 minutes post vaccination

Study Arms (2)

Quadrivalent VLP Vaccine

EXPERIMENTAL

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

Fluarix Quadrivalent® Comparator Vaccine

ACTIVE COMPARATOR

Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Biological: Fluarix Quadrivalent® Comparator Vaccine

Interventions

Quadrivalent VLP Vaccine BIOLOGICAL

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

Quadrivalent VLP Vaccine

Fluarix Quadrivalent® Comparator Vaccine BIOLOGICAL

Single dose of a 15 μg/strain of Fluarix Quadrivalent® Comparator Vaccine

Fluarix Quadrivalent® Comparator Vaccine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Participants must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; participants must also complete study-related procedures and communicate with the study staff at visits and by phone during the study;
• Participants must have a body mass index (BMI) ≤35 kg/m\^2;
• Participants are considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study;
• Male and female participants must be 65 years of age and older at the Screening/Vaccination visit (Visit 1);
• Participants must be non-institutionalized (e.g. not living in rehabilitation centres or old-age homes; living in an elderly community is acceptable) and have no acute or evolving medical problems prior to study participation and no clinically relevant abnormalities that could jeopardize participant safety or interfere with study assessments, as assessed by the Principal Investigator or sub-Investigator (thereafter referred as Investigator) and determined by medical history, physical examination, and vital signs;
• Note: Participants with a pre-existing chronic disease are 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.

You may not qualify if:

• According to the Investigator's opinion, history of an ongoing acute or evolving medical or neuropsychiatric illness. 'Evolving' was defined as:
• Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug abuse that would render the participant unable to provide informed consent or unable to provide valid safety observations and reporting, including methadone (methadone as treatment for opioid dependence may be acceptable if the participant has been otherwise opioid-free for at least three years);
• Any autoimmune disease other than hypothyroidism on stable replacement therapy (including, but not limited to rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease, type 1 diabetes, and inflammatory bowel disease) or any confirmed or suspected immunosuppressive condition or immunodeficiency including known or suspected human immunodeficiency virus (HIV), Hepatitis B or C infection, the presence of lymphoproliferative disease;
• Any history of status asthmaticus or ongoing serious problems with asthma, hospitalization for asthma control, or recurrent asthma episodes requiring medical attention in the last three years (one or more episodes per year);
• 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 was evaluated case-by-case by the Investigator;
• Administration of any adjuvanted or investigational influenza vaccine within one year prior to randomization or planned administration prior to the completion of the study;
• Administration of any 'standard', non-adjuvanted influenza vaccine (e.g. live attenuated trivalent/quadrivalent inactivated influenza vaccine or split trivalent/quadrivalent inactivated influenza vaccine administered by intranasal, intradermal, or IM route) within six months prior to randomization and up to completion of the study;
• Use of any investigational or non-registered product within 30 days or five half-lives, whichever is longer, prior to randomization or planned use during the study period. Participants may not participate in any other investigational or marketed drug study while participating in this study until after the study;
• Treatment with systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than seven consecutive days or for ten or more days in total, within one month of study vaccine administration; any other cytotoxic or immunosuppressant drug, or any immunoglobulin preparation within three months of vaccination and until the completion of the study. Low doses of nasal or inhaled glucocorticoids are allowed. Topical steroids are permitted;
• Any significant disorder of coagulation including, but not limited to, treatment with warfarin derivatives or heparin. Persons receiving prophylactic anti-platelet medications (e.g. low-dose aspirin \[no more than 100 mg/day\]), 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;
• History of allergy to any of the constituents of the Quadrivalent VLP Influenza Vaccine, any components of the active comparator quadrivalent vaccine, or tobacco;
• History of anaphylactic allergic reactions to plants or plants components (including fruits and nuts);
• Use of antihistamines within 48 hours prior to study vaccination;
• 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;
• Planned use of influenza antiviral treatment medication before the collection of nasopharyngeal (NP) swabs (e.g. oseltamivir, zanamivir, rapivab);

Sponsors & Collaborators

• Medicago: lead

Study Sites (104)

(Site 225) Coastal Clinical Research

Mobile, Alabama, 36608, United States

Location

(Site 201) Clinical Research Consortium

Tempe, Arizona, 85003, United States

Location

(Site 213) Advanced Clinical Research

Banning, California, 92220, United States

Location

(Site 246) Paradigm Clinical Research / Pharmaseek

Redding, California, 96001, United States

Location

(Site 212) Benckmark Research

Sacramento, California, 95864, United States

Location

(Site 244) Paradigm Clinical Research Center Inc

San Diego, California, 92117, United States

Location

(Site 242) Paradigm Clinical Research Centers Inc

Wheat Ridge, Colorado, 80033, United States

Location

(Site 239) Alliance for Multispeciality Research

Coral Gables, Florida, 33134, United States

Location

(Site 222) Research Centers of America

Hollywood, Florida, 33024, United States

Location

(Site 221) St-Johns Center for Clinical Research

Ponte Vedra, Florida, 32081, United States

Location

(Site 231) QPS-MRA LLC

South Miami, Florida, 33143, United States

Location

(Site 251) Meridian Clinical Research

Richmond Hill, Georgia, 31324, United States

Location

(Site 240) Meridian Clinical Research LLC

Savannah, Georgia, 31406, United States

Location

(Site 223) Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

(Site 249) Advanced Clinical Research

Meridian, Idaho, 83642, United States

Location

(Site 219) Heartland Research Associates LLC

Augusta, Kansas, 67010, United States

Location

(Site 234) Heartland Research Associates LLC

Newton, Kansas, 67114, United States

Location

(Site 215) Heartland Research Associates LLC

Wichita, Kansas, 67205, United States

Location

(Site 235) Heartland Research Associates LLC

Wichita, Kansas, 67207, United States

Location

(Site 241) Central Kentucky Reserach Associates

Lexington, Kentucky, 40509, United States

Location

(Site 203) Benchmark Research

Metairie, Louisiana, 70006, United States

Location

(Site 227) Sundande Clinical Research

St Louis, Missouri, 63141, United States

Location

(Site 226) Meridian Clinical Research LLC

Norfolk, Nebraska, 68701, United States

Location

(Site 211) Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

(Site 209) United Medical Associates

Binghamton, New York, 13901, United States

Location

(Site 217) Regional Clinical Research inc

Endwell, New York, 13760, United States

Location

(Site 237) PMG Research of Cary LLC

Cary, North Carolina, 27518, United States

Location

(Site 230) PMG Research of Charlotte LLC

Charlotte, North Carolina, 28209, United States

Location

(Site 205) PMG Research of Rocky Mount LLC

Rocky Mount, North Carolina, 27804, United States

Location

(Site 236) PMG Research

Statesville, North Carolina, 28625, United States

Location

(Site 228) Research of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

(Site 233) Sterling Research Group

Cincinnati, Ohio, 45219, United States

Location

(Site 208) Sterling Research Group

Cincinnati, Ohio, 45246, United States

Location

(Site 245) Rapid Medical Research

Cleveland, Ohio, 44122, United States

Location

(Site 202) Aventiv Research Inc

Columbus, Ohio, 43213, United States

Location

(Site 207) Lynn Institute of Norman

Norman, Oklahoma, 73069, United States

Location

(Site 238) Tekton Research

Oklahoma City, Oklahoma, 73114, United States

Location

(Site 216) PMG Research of Charleston LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

(Site 248) Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

(Site 201) Meridian Clinical Research

Dakota Dunes, South Dakota, 57049, United States

Location

(Site 247) New orleans Center for Clinical Research

Knoxville, Tennessee, 37920, United States

Location

(Site 206) Benchmark Research

Austin, Texas, 78705, United States

Location

(Site 218) Tekton Research Inc

Austin, Texas, 78745, United States

Location

(Site 214) Ventavia Research Group LLC

Fort Worth, Texas, 76104, United States

Location

(Site 224) Benchmark Research

Fort Worth, Texas, 76135, United States

Location

(Site 232) Benchmark Research

San Angelo, Texas, 76904, United States

Location

(Site 250) Clinical Trials of Texas Inc

San Antonio, Texas, 78229, United States

Location

(Site 204) Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

(Site 220) Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

(Site 229) Clinical Research Associates of Tidewater

Norfolk, Virginia, 23507, United States

Location

(Site 106) Colchester Research Group

Truro, Nova Scotia, B2N 1L2, Canada

Location

(Site 113) Dawson Road Family Medical Clinic

Guelph, Ontario, N1H 1B1, Canada

Location

(Site 110) Manna Research Inc.

Toronto, Ontario, M9W 4L6, Canada

Location

(Site 103) Q & T Recherche Chicoutimi

Chicoutimi, Quebec, G7H 7Y8, Canada

Location

(Site 105) Q & T Outaouais

Gatineau, Quebec, J8Y 6S8, Canada

Location

(Site 107) Manna Research Inc.

Lévis, Quebec, G6W 0M6, Canada

Location

(Site 109) Manna Research Inc. (Mirabel)

Mirabel, Quebec, J7J 2K8, Canada

Location

(Site 108) Manna Research

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

(Site 102) CHU de Québec - Université Laval

Québec, Quebec, G1E 7G9, Canada

Location

(site 101) Centre de Recherche St-Louis

Québec, Quebec, G1W 4R4, Canada

Location

(Site 110) Alpha Recherche Clinique

Québec, Quebec, G3K 2P8, Canada

Location

(Site 104) Q & T Recherche Sherbrooke

Sherbrooke, Quebec, J1J 2G2, Canada

Location

(Site 112) Medexa Recherche

Victoriaville, Quebec, G6P 6P6, Canada

Location

(Site 309) Espoo Vaccine Research Clinic

Espoo, 02230, Finland

Location

(Site 303) Helsinki South Vaccine Research Clinic

Helsinki, 00100, Finland

Location

(Site 308) Helsinki East Vaccine Research Center

Helsinki, 00930, Finland

Location

(Site 301) Jarvenpaa Vaccine Research Clinic

Jarvenpaa, 04400, Finland

Location

(Site 306) Kokkola Vaccine Research Clinic

Kokkola, 67100, Finland

Location

(Site 304) Oulu Vaccine Research Clinic

Oulu, 90220, Finland

Location

(Site 302) Tampere University Vaccine Research Center

Pori, 28100, Finland

Location

(Site 305) Seinaejoki Vaccine Research Clinic

Seinäjoki, 60100, Finland

Location

(Site 310) Tampere Vaccine Research Clinic

Tampere, 33100, Finland

Location

(Site 307) Turku Vaccine Research Center

Turku, 20520, Finland

Location

(Site 410) Emovis GmbH

Berlin, 10629, Germany

Location

(Site 418) Klinische Forschung Berlin GbR

Berlin, 10787, Germany

Location

(Site 422) Synexus Clinical Research GmbH

Berlin, 12627, Germany

Location

(Site 402) Synexus Clinical research GmbH

Bochum, 44787, Germany

Location

(Site 409) Gemeinschaftspraxis Dr. med Kleinecke-Pohl

Cologne, 51069, Germany

Location

(Site 401) Cardiologicum Dresden & Pirna

Dresden, 01277, Germany

Location

(Site 406) Diabetologische Germeinschafts praxis Faulman

Dresden, 1279, Germany

Location

(Site 405) Doktor Markus Faghih

Essen, 45355, Germany

Location

(Site 407) Klinisches Forschungszentrum Dr. Hagemann am Hausarztzer

Essen, 45355, Germany

Location

(Site 417) Medizentrum Essen-Borbeck

Essen, 45355, Germany

Location

(Site 414) Unterfrintroper Hausarztzentrum Klinische Forschung

Essen, 45359, Germany

Location

(SIte 404) Synexus Clinical Reserach GmbH

Frankfurt, 60313, Germany

Location

(Site 411) MedicoKIT GmbH

Goch, 47574, Germany

Location

(Site 425) Clinical Research Hamburg

Hamburg, 22143, Germany

Location

(Site 403) Praxis Dr. Med Cornelia Brauer

Hamburg, 22415, Germany

Location

(Site 408) Germeinsschaftspraxis Dr. med Christiane Klein/Minnich

Künzing, 94550, Germany

Location

(Site 421) SIBAmed Studienzentrum GmbH

Leipzig, 01403, Germany

Location

(Site 420) Synexus Clinical Research GmbH

Leipzig, 04103, Germany

Location

(Site 423) centrum fuer Diagnostik und Gesundheit

Munich, 80809, Germany

Location

(Site 413) Dr. Ingomar F.K. Naudts MD Office

Rodgau, 63110, Germany

Location

(Site 415) Praxisgemeinschaft Stuhr-Brinkum

Stuhr, 28816, Germany

Location

(Site 416) Praxis Dr. med Joachim Sauter

Wangen, 88239, Germany

Location

(Site 412) MALU-Medizinische Studien GmbH

Wardenburg, 26203, Germany

Location

(Site 424) Medislim GmbH

Weinheim, 69469, Germany

Location

(Site 603) Ramathibodi Hospital, Mahid - Division of Infectious Disease

Bangkok, 10160, Thailand

Location

(Site 606) Faculty of Tropical Medicine, Mahidol University

Bangkok, 10400, Thailand

Location

(Site 608) Phramongkutklao Hospital

Bangkok, 10400, Thailand

Location

(Site 609) Division of Tropical Pediatrics

Bangkok, 10400, Thailand

Location

(Site 601) Faculty of Medicine, Chiang Mai University

Chiang Mai, 50200, Thailand

Location

(Site 607) Srinagarind Hospital Khon Kaen University

Khon Kaen, 40002, Thailand

Location

(Site 605) Golden Jubilee Medical Center

Nakhon Pathom, Thailand

Location

Related Publications (1)

• 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.

  PMID: 33065035 RESULT

MeSH Terms

Conditions

Virus Diseases; RNA Virus Infections; Respiratory Tract Diseases; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections

Results Point of Contact

• Title: Medical Director
• Organization: Medicago

clinicaltrialinquiries@medicago.com

+1 418-658-9393

Study Officials

• Medical Director

  Medicago

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Surveillance personnel is blinded from investigational product injection
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, observer-blind, active comparator-controlled, multicenter, Phase 3 efficacy study.

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: September 18, 2018
• Primary Completion: May 17, 2019
• Study Completion: July 16, 2019
• Last Updated: June 23, 2023
• Results First Posted: June 23, 2023

Record last verified: 2023-05

Locations

TH (7); CA (13); FI (10); DE (24); US (50)