Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 39 of 112 for:    mf59

Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03314662
Recruitment Status : Completed
First Posted : October 19, 2017
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Seqirus

Brief Summary:
This phase 3 study is a randomized, double-blinded, comparator controlled, parallel-group, multicenter study of aQIV versus the US-licensed 2017-2018 adjuvanted trivalent influenza vaccine (aTIV-1, Fluad), and versus an adjuvanted trivalent influenza vaccine (aTIV-2), containing the alternate B strain.

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) Biological: Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) Biological: MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1778 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The trial is designed as a double-blind study
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Double-Blind, Controlled, Multicenter, Clinical Study to Evaluate Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Influenza Vaccine in Comparison With an MF59-Adjuvanted Trivalent Subunit Influenza Vaccine and an MF59-Adjuvanted Trivalent Subunit Influenza Vaccine Containing the Alternate B Strain, in Adults Aged 65 Years and Above
Actual Study Start Date : October 17, 2017
Actual Primary Completion Date : December 11, 2017
Actual Study Completion Date : May 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: aQIV
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine.
Biological: MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)
The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.

Experimental: aTIV-1
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine.
Biological: Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1)
The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.

Experimental: aTIV-2
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine.
Biological: MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2)
The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).




Primary Outcome Measures :
  1. Immunogenicity Endpoint: The Geometric Mean Titer (GMT) ratio for the four strains included in the vaccines. [ Time Frame: Day 22 ]
    The GMT ratio is defined as the geometric mean of the post-vaccination HI titer for aTIV-1 (or aTIV-2) over the geometric mean of postvaccination HI titer for aQIV.

  2. Immunogenicity Endpoint: The difference between the seroconversion rate (SCR) for the four strains included in the vaccines. [ Time Frame: Day 22 ]
    The SCR is defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a post-vaccination HI titer ≥ 1: 40 or a prevaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI titer.

  3. Immunogenicity Endpoint: The percent of subjects achieving seroconversion for HI antibody for the four strains included in the vaccines. [ Time Frame: Day 22 ]
  4. Immunogenicity Endpoint: The percent of subjects achieving an HI antibody titer ≥ 1:40 for the four strains included in the vaccines. [ Time Frame: Day 22 ]

Secondary Outcome Measures :
  1. Immunogenicity Endpoint: Geometric mean of HI titers against homologous strains [ Time Frame: Day 1 and Day 22 ]
  2. Immunogenicity Endpoint: Geometric mean ratio (GMR) of post vaccination HI titer over the pre-vaccination HI titer against homologous strains [ Time Frame: Day 22/Day 1 ]
  3. Immunogenicity Endpoint: The percentage of subjects with a titer ≥1:40 against homologous strains [ Time Frame: Day 1 and Day 22 ]
  4. Immunogenicity Endpoint: The percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination titer ≥ 1:10 and a ≥ 4- fold increase in postvaccination titer against homologous strains [ Time Frame: Day 22 ]
  5. Immunogenicity Endpoint: GMT ratio for each B virus strain [ Time Frame: Day 22 ]
    The immunologic superiority of HI antibody responses for the alternate B strain in aQIV will be assessed for each aTIV separately

  6. Immunogenicity Endpoint: Difference in SCR for each B virus strain [ Time Frame: Day 22 ]
    The immunologic superiority of HI antibody responses for the alternate B strain in aQIV will be assessed for each aTIV separately

  7. Safety Endpoint: Number of subjects with solicited local and systemic adverse events (AEs) following vaccination [ Time Frame: Day 1 through Day 7 ]
  8. Safety Endpoint: Number of subjects with Unsolicited AEs [ Time Frame: Day 1 through Day 21 ]
  9. Safety Endpoint: Number of subjects with Serious AEs (SAEs), AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs) and AEs of special interest (AESIs) [ Time Frame: Day 1 through Day 181 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females ≥ 65 years old who are healthy or have co-morbidities
  • Individuals who or whose legal representative(s) have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
  • Ability to attend all scheduled visits and to comply with study procedures including Diary card completion and follow-up

Exclusion Criteria:

  • History of behavioral or cognitive impairment or psychiatric condition
  • Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
  • Abnormal function of the immune system
  • Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or plan to receive influenza vaccine prior to the Day 22 blood collection
  • Any other clinical condition that, in the opinion of the Investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study

Additional eligibility criteria may be discussed by contacting the site.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314662


Locations
Layout table for location information
United States, Alabama
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
Paradigm clinical Research Centers, Inc
Redding, California, United States, 96001
United States, Florida
Clinical Research of South Florida, an AMR Company
Coral Gables, Florida, United States, 33134
United States, Georgia
Meridan Clinical Research, LLC
Savannah, Georgia, United States, 31406
United States, Idaho
Advanced Clinical Research
Meridian, Idaho, United States, 83642
United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
Heartland Research Associates, LLC - An AMR Company
Newton, Kansas, United States, 67114
Heartland Research Associates, LLC - An AMR Company
Wichita, Kansas, United States, 67207
United States, Missouri
Center for Pharmaceutical Research, LLC
Kansas City, Missouri, United States, 64114
Sundance Clinical Research, LLC
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Meridian Clinical Research, LLC
Omaha, Nebraska, United States, 68134
United States, New York
United Medical Associates
Binghamton, New York, United States, 13901
United States, Ohio
Rapid Medical Research, Inc.
Cleveland, Ohio, United States, 44122
United States, South Carolina
Medical Research South
Charleston, South Carolina, United States, 29407
United States, Tennessee
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 37920
United States, Texas
Benchmark Research
Fort Worth, Texas, United States, 76135
Benchmark Research
San Angelo, Texas, United States, 76904
Martin Diagnostic Clinic
Tomball, Texas, United States, 77375
United States, Utah
Advanced Clinical Research
West Jordan, Utah, United States, 84088
Sponsors and Collaborators
Seqirus
Investigators
Layout table for investigator information
Study Director: Clinical Scientist Seqirus

Layout table for additonal information
Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT03314662     History of Changes
Other Study ID Numbers: V118_20
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
MF59 oil emulsion
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic