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Trial record 1 of 1 for:    QHD00028
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Study of a Quadrivalent High-Dose Influenza Vaccine and a Moderna COVID-19 Vaccine Administered Either Concomitantly or Singly in Participants 65 Years of Age and Older Previously Vaccinated With a 2-dose Schedule of Moderna COVID-19 Vaccine

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: NCT04969276
Recruitment Status : Completed
First Posted : July 20, 2021
Results First Posted : December 13, 2022
Last Update Posted : December 13, 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: None (Open Label);   Primary Purpose: Prevention
Condition Influenza (Healthy Volunteers)
Interventions Biological: Quadrivalent Inactivated Influenza High Dose
Biological: COVID-19 mRNA Vaccine (nucleoside modified)
Enrollment 306
Recruitment Details The study was conducted at 6 sites in the United States. A total of 306 participants were enrolled between 16 July 2021 to 05 August 2021.
Pre-assignment Details A total of 296 participants were vaccinated in the study.
Arm/Group Title Group 1: Fluzone High-Dose (HD) Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description Participants received an injection of 0.7 milliliters (mL), fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, intramuscularly (IM) on Day 1. Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1. Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Period Title: Overall Study
Started 100 101 105
Safety Analysis Set (SafAS) [1] 100 92 104
Completed 99 89 105
Not Completed 1 12 0
Reason Not Completed
Protocol Deviation             0             1             0
Withdrawal by Subject             1             10             0
Lost to Follow-up             0             1             0
[1]
SafAS included all participants who had received the study vaccine(s) and were analyzed according to the vaccine they actually received and study intervention group.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine Total
Hide Arm/Group Description Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1. Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1. Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 100 101 105 306
Hide Baseline Analysis Population Description
Analysis was performed on all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 101 participants 105 participants 306 participants
71.3  (4.76) 71.7  (5.16) 72.0  (4.89) 71.7  (4.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 101 participants 105 participants 306 participants
Female
55
  55.0%
54
  53.5%
63
  60.0%
172
  56.2%
Male
45
  45.0%
47
  46.5%
42
  40.0%
134
  43.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 101 participants 105 participants 306 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   2.0%
0
   0.0%
0
   0.0%
2
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.0%
2
   1.9%
3
   1.0%
Black or African American
1
   1.0%
4
   4.0%
0
   0.0%
5
   1.6%
White
94
  94.0%
95
  94.1%
103
  98.1%
292
  95.4%
More than one race
1
   1.0%
1
   1.0%
0
   0.0%
2
   0.7%
Unknown or Not Reported
2
   2.0%
0
   0.0%
0
   0.0%
2
   0.7%
1.Primary Outcome
Title Number of Participants With Immediate Unsolicited Adverse Events (AEs)
Hide Description An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRF. Reported AEs for each arm were presented as pre-specified in the study protocol.
Time Frame Within 30 minutes post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on SafAS which included all participants who had received the study vaccine(s) and were analyzed according to the vaccine they actually received and study intervention group.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 100 92 104
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.0%
1
   1.1%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Solicited Injection Site Reactions
Hide Description A solicited reaction (SR) was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited injection site reactions included injection site pain, axillary swelling and tenderness, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Reported AEs for each arm were presented as pre-specified in the study protocol.
Time Frame Within 7 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the SafAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 100 89 104
Measure Type: Count of Participants
Unit of Measure: Participants
Injection site pain
82
  82.0%
54
  60.7%
92
  88.5%
Axillary swelling
2
   2.0%
2
   2.2%
1
   1.0%
Axillary tenderness
3
   3.0%
3
   3.4%
3
   2.9%
Injection site erythema
22
  22.0%
10
  11.2%
32
  30.8%
Injection site swelling
15
  15.0%
6
   6.7%
27
  26.0%
Injection site induration
12
  12.0%
3
   3.4%
22
  21.2%
Injection site bruising
7
   7.0%
0
   0.0%
4
   3.8%
3.Primary Outcome
Title Number of Participants With Solicited Systemic Reactions
Hide Description A SR 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 CRF. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia, shivering, fatigue, nausea and vomiting. Reported AEs for each arm were presented as pre-specified in the study protocol.
Time Frame Within 7 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the SafAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 100 89 104
Measure Type: Count of Participants
Unit of Measure: Participants
Fever
12
  12.0%
1
   1.1%
12
  11.5%
Headache
52
  52.0%
18
  20.2%
55
  52.9%
Malaise
46
  46.0%
13
  14.6%
59
  56.7%
Myalgia
50
  50.0%
20
  22.5%
64
  61.5%
Arthralgia
24
  24.0%
8
   9.0%
27
  26.0%
Shivering
32
  32.0%
6
   6.7%
22
  21.2%
Fatigue
62
  62.0%
26
  29.2%
73
  70.2%
Nausea
32
  32.0%
5
   5.6%
27
  26.0%
Vomiting
4
   4.0%
3
   3.4%
1
   1.0%
4.Primary Outcome
Title Number of Participants With Unsolicited Adverse Events
Hide Description An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol.
Time Frame Within 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the SafAS.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 100 92 104
Measure Type: Count of Participants
Unit of Measure: Participants
17
  17.0%
11
  12.0%
15
  14.4%
5.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) and 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 one of scientific and medical concern specific to the sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. Reported AEs for each arm were presented as pre-specified in the study protocol.
Time Frame From Day 1 up to 6 months post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the SafAS.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 100 92 104
Measure Type: Count of Participants
Unit of Measure: Participants
SAEs
2
   2.0%
0
   0.0%
3
   2.9%
AESIs
1
   1.0%
0
   0.0%
1
   1.0%
6.Primary Outcome
Title Number of Participants With Medically Attended Adverse Events (MAAEs)
Hide Description A MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department including medical advice seeking during the study visit or routine medical care. Reported AEs for each arm were presented as pre-specified in the study protocol.
Time Frame From Day 1 up to 6 months post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the SafAS population.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 100 92 104
Measure Type: Count of Participants
Unit of Measure: Participants
10
  10.0%
6
   6.5%
17
  16.3%
7.Primary Outcome
Title Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 1
Hide Description GMTs of anti-influenza and anti-COVID-19 antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria. Titers were expressed in terms of 1/dilution.
Time Frame Day 1 (pre-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Immunogenicity analysis set which included all randomized participants who received at least 1 dose of the study vaccine and analyzed according to the vaccine they actually received and study intervention group. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 99 91 101
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
A/H1N1: Pre-vaccination
55.8
(44.2 to 70.4)
45.5
(34.7 to 59.7)
49.7
(37.7 to 65.4)
A/H3N2: Pre-vaccination
95.0
(77.5 to 116)
85.4
(66.3 to 110)
80.3
(63.1 to 102)
B/Yamagata: Pre-vaccination
221
(178 to 274)
204
(159 to 262)
203
(163 to 252)
B/Victoria: Pre-vaccination
163
(137 to 194)
155
(127 to 190)
165
(136 to 201)
8.Primary Outcome
Title Geometric Mean Titers (GMTs) of Influenza Vaccine and COVID-19 Vaccine Antibodies at Day 22
Hide Description GMTs of anti-influenza and anti-COVID-19 antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria. Titers were expressed in terms of 1/dilution.
Time Frame Day 22 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 97 86 102
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
A/H1N1: Post-vaccination
363
(276 to 476)
366
(272 to 491)
41.2
(31.4 to 54.2)
A/H3N2: Post-vaccination
286
(233 to 352)
315
(257 to 386)
76.5
(61.1 to 95.8)
B/Yamagata: Post-vaccination
429
(350 to 525)
471
(378 to 588)
198
(160 to 243)
B/Victoria: Post-vaccination
377
(325 to 438)
390
(327 to 465)
176
(146 to 212)
9.Primary Outcome
Title Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine and COVID-19 Vaccine Antibodies
Hide Description GMTs of anti-influenza and anti-COVID-19 antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 01.
Time Frame Day 1 (pre-vaccination) and Day 22 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 96 86 100
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
A/H1N1
6.35
(4.88 to 8.26)
8.10
(6.09 to 10.8)
0.868
(0.821 to 0.917)
A/H3N2
3.06
(2.54 to 3.70)
3.54
(2.82 to 4.45)
0.940
(0.870 to 1.01)
B/Yamagata
1.94
(1.68 to 2.23)
2.27
(1.84 to 2.79)
0.983
(0.918 to 1.05)
B/Victoria
2.27
(1.96 to 2.63)
2.44
(2.01 to 2.96)
1.05
(0.972 to 1.14)
10.Primary Outcome
Title Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution)
Hide Description Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers >=10 (1/dilution) are reported in the outcome measure.
Time Frame Day 1 (pre-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 99 91 101
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1: Pre-vaccination
97.0
(91.4 to 99.4)
94.5
(87.6 to 98.2)
91.1
(83.8 to 95.8)
A/H3N2: Pre-vaccination
100
(96.3 to 100)
98.9
(94.0 to 100)
99.0
(94.6 to 100)
B/Yamagata: Pre-vaccination
100
(96.3 to 100)
100
(96.0 to 100)
99.0
(94.6 to 100)
B/Victoria: Pre-vaccination
100
(96.3 to 100)
100
(96.0 to 100)
100
(96.4 to 100)
11.Primary Outcome
Title Percentage of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution)
Hide Description Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers >=10 (1/dilution) are reported in the outcome measure.
Time Frame Day 22 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 97 86 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1: Post-vaccination
100
(96.3 to 100)
100
(95.8 to 100)
91.2
(83.9 to 95.9)
A/H3N2: Post-vaccination
100
(96.3 to 100)
100
(95.8 to 100)
99.0
(94.7 to 100)
B/Yamagata: Post-vaccination
100
(96.3 to 100)
100
(95.8 to 100)
99.0
(94.7 to 100)
B/Victoria: Post-vaccination
100
(96.3 to 100)
100
(95.8 to 100)
100
(96.4 to 100)
12.Primary Outcome
Title Percentage of Participants Achieving Seroconversion Against Influenza and COVID-19 Virus Antigens
Hide Description Anti-influenza and anti-COVID-19 antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (<)10 (1/dilution) and a post-vaccination titer >=40 (1/dilution) or a pre-vaccination titer >=10 (1/dilution) and a >= four-fold increase in post-vaccination titer at Day 22.
Time Frame Day 22 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 96 86 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1
68.8
(58.5 to 77.8)
72.1
(61.4 to 81.2)
0.0
(0.0 to 3.6)
A/H3N2
43.8
(33.6 to 54.3)
47.7
(36.8 to 58.7)
0.0
(0.0 to 3.6)
B/Yamagata
17.7
(10.7 to 26.8)
20.9
(12.9 to 31.0)
1.0
(0.0 to 5.4)
B/Victoria
30.2
(21.3 to 40.4)
24.4
(15.8 to 34.9)
1.0
(0.0 to 5.4)
13.Primary Outcome
Title Percentage of Participants With Antibody Titers >=40 (1/Dilution)
Hide Description Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers >=40 (1/dilution) are reported in the outcome measure.
Time Frame Day 1 (pre-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 99 91 101
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1: Pre-vaccination
65.7
(55.4 to 74.9)
56.0
(45.2 to 66.4)
59.4
(49.2 to 69.1)
A/H3N2: Pre-vaccination
83.8
(75.1 to 90.5)
79.1
(69.3 to 86.9)
77.2
(67.8 to 85.0)
B/Yamagata: Pre-vaccination
97.0
(91.4 to 99.4)
90.1
(82.1 to 95.4)
96.0
(90.2 to 98.9)
B/Victoria: Pre-vaccination
99.0
(94.5 to 100)
94.5
(87.6 to 98.2)
95.0
(88.8 to 98.4)
14.Primary Outcome
Title Percentage of Participants With Antibody Titers >=40 (1/Dilution)
Hide Description Anti-influenza and anti-COVID 19 antibodies were measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Percentage of participants with HAI titers >=40 (1/dilution) are reported in the outcome measure.
Time Frame Day 22 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 97 86 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1: Post-vaccination
94.8
(88.4 to 98.3)
95.3
(88.5 to 98.7)
53.9
(43.8 to 63.8)
A/H3N2: Post-vaccination
96.9
(91.2 to 99.4)
100
(95.8 to 100)
72.5
(62.8 to 80.9)
B/Yamagata: Post-vaccination
100
(96.3 to 100)
98.8
(93.7 to 100)
96.1
(90.3 to 98.9)
B/Victoria: Post-vaccination
100
(96.3 to 100)
100
(95.8 to 100)
96.1
(90.3 to 98.9)
15.Primary Outcome
Title Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies
Hide Description GMCs of Anti-S binding IgG antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) method and were measured in binding antibody units/milliliter (BAU/mL).
Time Frame Day 1 (pre-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 99 91 102
Geometric Mean (95% Confidence Interval)
Unit of Measure: BAU/mL
565
(479 to 666)
462
(382 to 560)
552
(461 to 662)
16.Primary Outcome
Title Geometric Mean Concentration (GMC) of Anti-S Binding Immunoglobulin G (IgG) Antibodies
Hide Description GMCs of Anti-S binding IgG antibodies were assessed using ELISA method and were measured in BAU/mL.
Time Frame Day 22 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 97 86 103
Geometric Mean (95% Confidence Interval)
Unit of Measure: BAU/mL
7634
(6445 to 9042)
395
(311 to 502)
7904
(6883 to 9077)
17.Primary Outcome
Title Geometric Mean Concentration Ratio (GMCR) of Anti-S Binding IgG Antibodies
Hide Description GMCs of Anti-S binding IgG antibodies were assessed using ELISA method. GMCR was calculated as the ratio of GMC post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 01.
Time Frame Day 1 (pre-vaccination) and Day 22 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 96 86 102
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
13.7
(11.2 to 16.8)
0.875
(0.745 to 1.03)
14.2
(12.0 to 16.9)
18.Primary Outcome
Title Percentage of Participants With >=2-Fold and >=4-Fold Rise in Anti-S Binding IgG Antibodies
Hide Description Percentage of participants with >=2-fold and >=4-fold rise in Anti-S binding IgG antibodies at Day 22 (post-vaccination) are reported in this outcome measure. Percentage of participants with >=2-fold rise are those for whom the computed value at Day 22 was *2 compared to the computed value at Day 1 and percentage of participants with >=4-fold rise are those for whom the computed value at Day 22 was *4 compared to the computed value at Day 1.
Time Frame Day 22 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on immunogenicity analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Arm/Group Title Group 1: Fluzone HD Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description:
Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1.
Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1.
Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
Overall Number of Participants Analyzed 96 86 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
>= 2-fold rise
97.9
(92.7 to 99.7)
3.5
(0.7 to 9.9)
98.0
(93.1 to 99.8)
>= 4-fold rise
92.7
(85.6 to 97.0)
2.3
(0.3 to 8.1)
95.1
(88.9 to 98.4)
Time Frame Unsolicited AEs were collected from Day 1 up to 21 days post-vaccination. SR data were collected up to 7 days post-vaccination. SAE data were collected from Day 1 up to 6 months post-vaccination
Adverse Event Reporting Description SR: "expected" adverse reaction (sign/symptom) observed & reported under conditions (nature and onset) prelisted (i.e., solicited) in protocol and CRF & considered as related to IMP administered. Unsolicited AE: AE that did not fulfill conditions prelisted (i.e., solicited) in CRF in terms of diagnosis & onset window post-vaccination. SafAS. In AE section, SR Fever & shivering are reported as Pyrexia & chills respectively. Reported AEs for each arm were presented as pre-specified in protocol.
 
Arm/Group Title Group 1: Fluzone High-Dose (HD) Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Hide Arm/Group Description Participants received an injection of 0.7 mL, fluzone HD quadrivalent influenza vaccine, co-administered with 0.5 mL COVID-19 vaccine, IM on Day 1. Participants received a single injection of 0.7 mL fluzone HD quadrivalent influenza vaccine, IM on Day 1. Participants received a single injection of 0.5 mL COVID-19 mRNA Vaccine, IM on Day 1.
All-Cause Mortality
Group 1: Fluzone High-Dose (HD) Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)      0/92 (0.00%)      0/104 (0.00%)    
Hide Serious Adverse Events
Group 1: Fluzone High-Dose (HD) Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/100 (2.00%)      0/92 (0.00%)      3/104 (2.88%)    
Cardiac disorders       
Myocardial Infarction † 1  1/100 (1.00%)  1 0/92 (0.00%)  0 0/104 (0.00%)  0
Endocrine disorders       
Thyroid Mass † 1  0/100 (0.00%)  0 0/92 (0.00%)  0 1/104 (0.96%)  1
Gastrointestinal disorders       
Diabetic Gastroparesis † 1  0/100 (0.00%)  0 0/92 (0.00%)  0 1/104 (0.96%)  1
Injury, poisoning and procedural complications       
Pelvic Fracture † 1  0/100 (0.00%)  0 0/92 (0.00%)  0 1/104 (0.96%)  1
Musculoskeletal and connective tissue disorders       
Exostosis † 1  0/100 (0.00%)  0 0/92 (0.00%)  0 1/104 (0.96%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Papillary Thyroid Cancer † 1  1/100 (1.00%)  1 0/92 (0.00%)  0 0/104 (0.00%)  0
1
Term from vocabulary, MedDRA 24.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: Fluzone High-Dose (HD) Quadrivalent Influenza Vaccine and COVID-19 Vaccine Group 2: Fluzone HD Quadrivalent Influenza Vaccine Group 3: COVID-19 Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   94/100 (94.00%)      65/92 (70.65%)      100/104 (96.15%)    
Gastrointestinal disorders       
Nausea † 1 [1]  32/100 (32.00%)  32 6/92 (6.52%)  6 27/104 (25.96%)  27
General disorders       
Chills † 1  32/100 (32.00%)  32 6/92 (6.52%)  6 22/104 (21.15%)  22
Fatigue † 1  62/100 (62.00%)  62 26/92 (28.26%)  26 73/104 (70.19%)  73
Injection Site Bruising † 1  7/100 (7.00%)  8 0/92 (0.00%)  0 4/104 (3.85%)  4
Injection Site Erythema † 1  22/100 (22.00%)  28 10/92 (10.87%)  10 32/104 (30.77%)  32
Injection Site Induration † 1  12/100 (12.00%)  12 3/92 (3.26%)  3 22/104 (21.15%)  22
Injection Site Pain † 1  82/100 (82.00%)  139 54/92 (58.70%)  54 92/104 (88.46%)  92
Injection Site Swelling † 1  15/100 (15.00%)  17 6/92 (6.52%)  6 27/104 (25.96%)  27
Malaise † 1  46/100 (46.00%)  46 13/92 (14.13%)  13 59/104 (56.73%)  59
Pyrexia † 1 [2]  12/100 (12.00%)  12 1/92 (1.09%)  1 13/104 (12.50%)  13
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  24/100 (24.00%)  24 8/92 (8.70%)  8 27/104 (25.96%)  28
Myalgia † 1  50/100 (50.00%)  50 20/92 (21.74%)  20 64/104 (61.54%)  64
Nervous system disorders       
Headache † 1  52/100 (52.00%)  52 18/92 (19.57%)  18 55/104 (52.88%)  55
1
Term from vocabulary, MedDRA 24.0
†
Indicates events were collected by systematic assessment
[1]
Nausea events that occurred after 7 days post-vaccination were considered as unsolicited AE.
[2]
Pyrexia/Fever events that occurred after 7 days post-vaccination were considered as unsolicited AE.
[Not Specified]
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT04969276    
Other Study ID Numbers: QHD00028
U1111-1266-7472 ( Registry Identifier: ICTRP )
First Submitted: July 16, 2021
First Posted: July 20, 2021
Results First Submitted: November 14, 2022
Results First Posted: December 13, 2022
Last Update Posted: December 13, 2022