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Trial record 1 of 1 for:    QHD00023
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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

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: NCT04537234
Recruitment Status : Completed
First Posted : September 3, 2020
Results First Posted : November 8, 2021
Last Update Posted : April 7, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza (Healthy Volunteers)
Interventions Biological: High-Dose Quadrivalent Influenza Vaccine
Biological: Standard-Dose Quadrivalent Influenza Vaccine
Enrollment 165
Recruitment Details The study was conducted at 4 active centers in Taiwan. A total of 165 participants were enrolled and randomized between 10 November 2020 to 12 January 2021.
Pre-assignment Details A total of 165 participants were vaccinated in the study.
Arm/Group Title Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Hide Arm/Group 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.
Period Title: Overall Study
Started 82 83
Completed 80 83
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             2             0
Arm/Group Title Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) Total
Hide Arm/Group Description Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0. Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0. Total of all reporting groups
Overall Number of Baseline Participants 82 83 165
Hide Baseline Analysis Population Description
Analysis was performed on all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 83 participants 165 participants
71.5  (5.37) 71.4  (5.71) 71.4  (5.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 83 participants 165 participants
Female
47
  57.3%
46
  55.4%
93
  56.4%
Male
35
  42.7%
37
  44.6%
72
  43.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 83 participants 165 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
82
 100.0%
83
 100.0%
165
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the full analysis set (FAS) that included randomized participants who received one of the study vaccine and had a post-vaccination blood sample. Participants were analyzed according to the vaccine group to which they were randomized.
Arm/Group Title Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Overall Number of Participants Analyzed 80 83
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
A/H1N1
23.6
(18.1 to 30.6)
24.1
(18.5 to 31.5)
A/H3N2
111
(78.4 to 156)
169
(120 to 238)
B1
88.0
(66.7 to 116)
98.2
(76.6 to 126)
B2
149
(111 to 199)
160
(121 to 211)
2.Primary Outcome
Title Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS.
Arm/Group Title Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Overall Number of Participants Analyzed 80 83
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
A/H1N1
283
(221 to 364)
109
(78.2 to 151)
A/H3N2
643
(522 to 791)
427
(324 to 563)
B1
812
(645 to 1023)
324
(253 to 414)
B2
707
(595 to 840)
361
(290 to 450)
3.Primary Outcome
Title Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS.
Arm/Group Title Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Overall Number of Participants Analyzed 80 83
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
A/H1N1
12.0
(9.09 to 15.9)
4.50
(3.47 to 5.82)
A/H3N2
5.81
(4.28 to 7.87)
2.53
(1.87 to 3.41)
B1
9.23
(7.00 to 12.2)
3.30
(2.48 to 4.39)
B2
4.76
(3.65 to 6.21)
2.26
(1.76 to 2.89)
4.Primary Outcome
Title Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS.
Arm/Group Title Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Overall Number of Participants Analyzed 80 83
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1
86.3
(76.7 to 92.9)
50.6
(39.4 to 61.8)
A/H3N2
61.3
(49.7 to 71.9)
28.9
(19.5 to 39.9)
B1
78.8
(68.2 to 87.1)
37.3
(27.0 to 48.7)
B2
50.0
(38.6 to 61.4)
24.1
(15.4 to 34.7)
5.Primary Outcome
Title Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS.
Arm/Group Title Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Overall Number of Participants Analyzed 80 83
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1
33.8
(23.6 to 45.2)
36.1
(25.9 to 47.4)
A/H3N2
76.3
(65.4 to 85.1)
84.3
(74.7 to 91.4)
B1
81.3
(71.0 to 89.1)
85.5
(76.1 to 92.3)
B2
85.0
(75.3 to 92.0)
86.7
(77.5 to 93.2)
6.Primary Outcome
Title Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS.
Arm/Group Title Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Overall Number of Participants Analyzed 80 83
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1
97.5
(91.3 to 99.7)
79.5
(69.2 to 87.6)
A/H3N2
100
(95.5 to 100)
96.4
(89.8 to 99.2)
B1
98.8
(93.2 to 100)
98.8
(93.5 to 100)
B2
100
(95.5 to 100)
100
(95.7 to 100)
7.Primary Outcome
Title Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the safety analysis set (SafAS) that included participants who had received one of the study vaccines and had any safety data available; and were analyzed according to the vaccine they actually received.
Arm/Group Title Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Overall Number of Participants Analyzed 82 83
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
8.Primary Outcome
Title Number of Participants With Solicited Injection Site and Systemic Reactions
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the SafAS. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Overall Number of Participants Analyzed 82 83
Measure Type: Count of Participants
Unit of Measure: Participants
Injection site Pain Number Analyzed 82 participants 83 participants
37
  45.1%
30
  36.1%
Injection site Erythema Number Analyzed 82 participants 83 participants
8
   9.8%
7
   8.4%
Injection site Swelling Number Analyzed 82 participants 83 participants
8
   9.8%
2
   2.4%
Injection site Induration Number Analyzed 82 participants 83 participants
8
   9.8%
2
   2.4%
Injection site Bruising Number Analyzed 82 participants 83 participants
0
   0.0%
0
   0.0%
Fever Number Analyzed 80 participants 83 participants
1
   1.3%
0
   0.0%
Headache Number Analyzed 82 participants 83 participants
9
  11.0%
4
   4.8%
Malaise Number Analyzed 82 participants 83 participants
9
  11.0%
7
   8.4%
Myalgia Number Analyzed 82 participants 83 participants
22
  26.8%
10
  12.0%
Shivering Number Analyzed 82 participants 83 participants
3
   3.7%
3
   3.6%
9.Primary Outcome
Title Number of Participants With Unsolicited Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the SafAS.
Arm/Group Title Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Overall Number of Participants Analyzed 82 83
Measure Type: Count of Participants
Unit of Measure: Participants
8
   9.8%
12
  14.5%
10.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the SafAS.
Arm/Group Title Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Overall Number of Participants Analyzed 82 83
Measure Type: Count of Participants
Unit of Measure: Participants
SAE
0
   0.0%
0
   0.0%
AESIs
0
   0.0%
0
   0.0%
Time Frame Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 (post-vaccination) up to 28 days post-vaccination.
Adverse Event Reporting 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. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on SafAS.
 
Arm/Group Title Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Hide Arm/Group Description Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0. Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
All-Cause Mortality
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)      0/83 (0.00%)    
Hide Serious Adverse Events
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/82 (0.00%)      0/83 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/82 (56.10%)      35/83 (42.17%)    
General disorders     
Injection Site Erythema  1  8/82 (9.76%)  8 7/83 (8.43%)  7
Injection Site Induration  1  8/82 (9.76%)  8 2/83 (2.41%)  2
Injection Site Pain  1  37/82 (45.12%)  37 30/83 (36.14%)  30
Injection Site Swelling  1  8/82 (9.76%)  8 2/83 (2.41%)  2
Malaise  1  9/82 (10.98%)  9 7/83 (8.43%)  7
Musculoskeletal and connective tissue disorders     
Myalgia  1  22/82 (26.83%)  22 10/83 (12.05%)  10
Nervous system disorders     
Headache  1 [1]  9/82 (10.98%)  9 5/83 (6.02%)  5
1
Term from vocabulary, MedDRA 23.1
Indicates events were collected by systematic assessment
[1]
Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi Pasteur
Phone: 800-633-1610 ext 6#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT04537234    
Other Study ID Numbers: QHD00023
U1111-1238-1970 ( Other Identifier: UTN )
First Submitted: August 26, 2020
First Posted: September 3, 2020
Results First Submitted: October 8, 2021
Results First Posted: November 8, 2021
Last Update Posted: April 7, 2022