Back to resultsStudy to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Taiwanese Adults 65 Years of Age and Older
Primary Purpose
Influenza (Healthy Volunteers)
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
High-Dose Quadrivalent Influenza Vaccine
Standard-Dose Quadrivalent Influenza Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza (Healthy Volunteers) focused on measuring Influenza
Eligibility Criteria
Inclusion criteria :
- 65 years and older on the day of inclusion.
- Able to attend all scheduled visits and complied with all study procedures.
Exclusion criteria:
- Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccine in the 4 weeks (28 days) preceding the study vaccination or planned receipt of any vaccine prior to Visit 2.
- Previous vaccination against influenza (in the preceding 6 months) with either the study vaccine or another vaccine.
- Receipt of immune globulins, blood or blood-derived products in the past 3 months.
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the study or to a vaccine containing any of the same substances.
- Thrombocytopenia, bleeding disorder, or receipt of anticoagulants that based on Investigator's judgment contraindicate intramuscular vaccination.
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
- Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion.
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature greater than or equal to [>=] 38.0 degree Celsius). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- Personal or family history of Guillain-Barré syndrome.
- Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that was stable at the time of vaccination in the absence of therapy and participants who had a history of neoplastic disease and had been disease free for >=5 years).
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse) of the Investigator or employee with direct involvement in the proposed study.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number 1580004
- Investigational Site Number 1580001
- Investigational Site Number 1580002
- Investigational Site Number 1580003
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Arm Description
Participants received a single injection of 0.7 milliliters (mL) QIV-HD, intramuscularly (IM) at Day 0.
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Outcomes
Primary Outcome Measures
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria Lineage), and B2 (B Yamagata Lineage). Titers were expressed in terms of 1/dilution.
Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution.
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
GMTRs of anti-influenza antibodies were measured by using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (<) 10 (1/dilution) at Day 0 and a post-vaccination titer greater than or equal to (>=) 40 (1/dilution) at Day 28 or a pre-vaccination titer >=10 (1/dilution) at Day 0 and a >= four-fold increase in post-vaccination titer at Day 28.
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0
Antibody titer was measured by using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28
Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Number of Participants With Solicited Injection Site and Systemic Reactions
A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to the product administered. Solicited injection site reactions included pain, erythema, swelling, induration, and bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.
Number of Participants With Unsolicited Adverse Events
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination.
Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs)
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.
Secondary Outcome Measures
Full Information
NCT ID
NCT04537234
First Posted
August 26, 2020
Last Updated
March 24, 2022
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT04537234
Brief Title
Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Taiwanese Adults 65 Years of Age and Older
Official Title
Immunogenicity and Safety of a High-Dose Quadrivalent Influenza Vaccine in Subjects 65 Years of Age and Older in Taiwan
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
February 9, 2021 (Actual)
Study Completion Date
February 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary Objective:
Immunogenicity: To describe the immune response induced by high-dose quadrivalent influenza vaccine (QIV-HD) and AdimFlu-S (QIS) by hemagglutinin inhibition (HAI) measurement method in all participants.
Safety: To describe the safety profile of all participants in each study groups.
Detailed Description
The duration of each participant's participation was approximately 28 days (Day 0 through Day 28 [+ 7 days]).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza (Healthy Volunteers)
Keywords
Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study was modified double-blind. The designated vaccine prepare(s)/administrator(s) would be unblinded given that the QIV-HD and QIV-SD vaccines had different dose volumes. Neither the participant nor the investigator nor the study staff in charge of vaccination was aware of which vaccine was administered (the syringes was masked to maintained the blinding of the participants and other members of the clinical site). The unblinded designated vaccine preparer(s)/administrator(s) was not involved in any of the blinded study assessments (eg, immunogenicity, safety).
Allocation
Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)
Arm Type
Experimental
Arm Description
Participants received a single injection of 0.7 milliliters (mL) QIV-HD, intramuscularly (IM) at Day 0.
Arm Title
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Arm Type
Active Comparator
Arm Description
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Intervention Type
Biological
Intervention Name(s)
High-Dose Quadrivalent Influenza Vaccine
Other Intervention Name(s)
Fluzone® High Dose, Efluelda™
Intervention Description
Pharmaceutical form: Suspension for injection in pre-filled syringe,
Route of administration: IM
Intervention Type
Biological
Intervention Name(s)
Standard-Dose Quadrivalent Influenza Vaccine
Other Intervention Name(s)
AdimFlu-S (QIS)
Intervention Description
Pharmaceutical form: Suspension for injection in pre-filled syringe,
Route of administration: IM
Primary Outcome Measure Information:
Title
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0
Description
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria Lineage), and B2 (B Yamagata Lineage). Titers were expressed in terms of 1/dilution.
Time Frame
Day 0 (pre-vaccination)
Title
Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28
Description
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution.
Time Frame
Day 28 (post-vaccination)
Title
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
Description
GMTRs of anti-influenza antibodies were measured by using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).
Time Frame
Day 0 (pre-vaccination), Day 28 (post-vaccination)
Title
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
Description
Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (<) 10 (1/dilution) at Day 0 and a post-vaccination titer greater than or equal to (>=) 40 (1/dilution) at Day 28 or a pre-vaccination titer >=10 (1/dilution) at Day 0 and a >= four-fold increase in post-vaccination titer at Day 28.
Time Frame
Day 28 (post-vaccination)
Title
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0
Description
Antibody titer was measured by using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).
Time Frame
Day 0 (pre-vaccination)
Title
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28
Description
Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).
Time Frame
Day 28 (post-vaccination)
Title
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
Description
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Time Frame
Within 30 minutes post-vaccination
Title
Number of Participants With Solicited Injection Site and Systemic Reactions
Description
A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to the product administered. Solicited injection site reactions included pain, erythema, swelling, induration, and bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.
Time Frame
Within 7 days post-vaccination
Title
Number of Participants With Unsolicited Adverse Events
Description
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination.
Time Frame
Within 28 days post-vaccination
Title
Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs)
Description
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.
Time Frame
From Day 0 up to 28 days post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria :
65 years and older on the day of inclusion.
Able to attend all scheduled visits and complied with all study procedures.
Exclusion criteria:
Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
Receipt of any vaccine in the 4 weeks (28 days) preceding the study vaccination or planned receipt of any vaccine prior to Visit 2.
Previous vaccination against influenza (in the preceding 6 months) with either the study vaccine or another vaccine.
Receipt of immune globulins, blood or blood-derived products in the past 3 months.
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the study or to a vaccine containing any of the same substances.
Thrombocytopenia, bleeding disorder, or receipt of anticoagulants that based on Investigator's judgment contraindicate intramuscular vaccination.
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion.
Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature greater than or equal to [>=] 38.0 degree Celsius). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
Personal or family history of Guillain-Barré syndrome.
Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that was stable at the time of vaccination in the absence of therapy and participants who had a history of neoplastic disease and had been disease free for >=5 years).
Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse) of the Investigator or employee with direct involvement in the proposed study.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 1580004
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Investigational Site Number 1580001
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Investigational Site Number 1580002
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Investigational Site Number 1580003
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Citations:
PubMed Identifier
36216650
Citation
Chen JY, Hsieh SM, Hwang SJ, Liu CS, Li X, Fournier M, Yeh TY, Yin JK, Samson SI. Immunogenicity and safety of high-dose quadrivalent influenza vaccine in older adults in Taiwan: A phase III, randomized, multi-center study. Vaccine. 2022 Oct 26;40(45):6450-6454. doi: 10.1016/j.vaccine.2022.09.078. Epub 2022 Oct 7.
Results Reference
derived
Learn more about this trial
Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Taiwanese Adults 65 Years of Age and Older
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