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Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years

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: NCT03233217
Recruitment Status : Completed
First Posted : July 28, 2017
Results First Posted : December 17, 2019
Last Update Posted : December 17, 2019
Sponsor:
Collaborator:
Sanofi K.K.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: QIV-HD by IM
Biological: QIV-SD by SC
Biological: QIV-HD by SC
Enrollment 175
Recruitment Details Study participants were enrolled from 15 September 2017 to 26 October 2017 at 2 centers in Japan.
Pre-assignment Details 10 participants were randomized 1:1 to receive either QIV-HD by intramuscular (IM) route or QIV-HD by subcutaneous (SC) route (Cohort 1). After review of local and systemic AEs for 7 days post-vaccination in Cohort 1, remaining 165 participants were randomized 1:1:1 to receive QIV-HD by IM route, QIV-HD by SC route, or QIV-SD by SC route (Cohort 2)
Arm/Group Title Cohort 1: QIV-HD by IM Cohort 1: QIV-HD by SC Cohort 2: QIV-HD by IM Cohort 2: QIV-HD by SC Cohort 2: QIV-SD by SC
Hide Arm/Group Description Participants were randomized to receive a single 0.7-milliliter (mL) injection of high-dose Quadrivalent influenza vaccine (QIV-HD) by IM route on Day 0. Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0. Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0. Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0. Participants were randomized to receive a single 0.5 mL injection of standard-dose Quadrivalent influenza vaccine (QIV-SD) by SC route on Day 0.
Period Title: Overall Study
Started [1] 5 5 55 55 55
Safety Analysis Set (SafAS) 5 5 55 55 55
Per-protocol Analysis Set (PPAS) [2] 5 5 55 55 54
Completed 5 5 55 55 55
Not Completed 0 0 0 0 0
[1]
Randomized and vaccinated.
[2]
Cohort 1 = 10 participants, and Cohort 2 = 164 participants
Arm/Group Title Cohort 1: QIV-HD by IM Cohort 1: QIV-HD by SC Cohort 2: QIV-HD by IM Cohort 2: QIV-HD by SC Cohort 2: QIV-SD by SC Total
Hide Arm/Group Description Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0. Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0. Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0. Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0. Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 5 5 55 55 55 175
Hide Baseline Analysis Population Description
The baseline characteristics was analyzed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 55 participants 55 participants 55 participants 175 participants
70.8  (2.0) 70.8  (2.3) 70.1  (3.7) 70.5  (3.6) 69.9  (3.8) 70.2  (3.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 55 participants 55 participants 55 participants 175 participants
Female
1
  20.0%
1
  20.0%
27
  49.1%
26
  47.3%
25
  45.5%
80
  45.7%
Male
4
  80.0%
4
  80.0%
28
  50.9%
29
  52.7%
30
  54.5%
95
  54.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 55 participants 55 participants 55 participants 175 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
 100.0%
5
 100.0%
55
 100.0%
55
 100.0%
55
 100.0%
175
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With Immediate Unsolicited Adverse Events (AE) After Vaccination
Hide Description An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Time Frame Within 30 minutes after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).
Arm/Group Title Cohort 1 and 2: QIV-HD by IM Cohort 1 and 2: QIV-HD by SC Cohort 2: QIV-SD by SC
Hide Arm/Group Description:
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
Overall Number of Participants Analyzed 60 60 55
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Solicited Injection Site and Systemic Reactions
Hide Description A solicited reaction was an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions: pain, erythema, swelling, induration, and bruising. Solicited systemic reactions: fever, headache, malaise, myalgia, and shivering.
Time Frame Within 7 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population for Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).
Arm/Group Title Cohort 1 and 2: QIV-HD by IM Cohort 1 and 2: QIV-HD by SC Cohort 2: QIV-SD by SC
Hide Arm/Group Description:
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
Overall Number of Participants Analyzed 60 60 55
Measure Type: Count of Participants
Unit of Measure: Participants
Injection site pain 18 27 15
Injection site erythema 11 19 11
Injection site swelling 9 17 13
Injection site induration 2 7 2
Injection site bruising 0 0 0
Fever 0 1 0
Headache 3 8 1
Malaise 1 4 3
Myalgia 9 16 7
Shivering 0 2 2
3.Primary Outcome
Title Number of Participants With Unsolicited Adverse Events After Vaccination
Hide Description An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Time Frame Within 28 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).
Arm/Group Title Cohort 1 and 2: QIV-HD by IM Cohort 1 and 2: QIV-HD by SC Cohort 2: QIV-SD by SC
Hide Arm/Group Description:
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
Overall Number of Participants Analyzed 60 60 55
Measure Type: Count of Participants
Unit of Measure: Participants
4
   6.7%
4
   6.7%
8
  14.5%
4.Primary Outcome
Title Number of Participant With Serious Adverse Events (SAEs) After Vaccination
Hide Description An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Time Frame Up to 6 months after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).
Arm/Group Title Cohort 1 and 2: QIV-HD by IM Cohort 1 and 2: QIV-HD by SC Cohort 2: QIV-SD by SC
Hide Arm/Group Description:
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
Overall Number of Participants Analyzed 60 60 55
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   1.8%
5.Secondary Outcome
Title Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
Hide Description GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using a hemagglutination inhibition (HAI) assay.
Time Frame Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, 'number analyzed' = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.
Arm/Group Title Cohort 2: QIV-HD by IM Cohort 2: QIV-HD by SC Cohort 2: QIV-SD by SC
Hide Arm/Group Description:
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
Overall Number of Participants Analyzed 55 55 54
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers (1/dilution)
A1: Day 0 Number Analyzed 55 participants 55 participants 54 participants
44.5
(29.4 to 67.5)
59.5
(39.7 to 89.2)
41.0
(27.7 to 60.8)
A1-like: Day 0 Number Analyzed 55 participants 55 participants 53 participants
46.2
(35.4 to 60.4)
56.2
(43.0 to 73.5)
42.1
(32.8 to 54.1)
A2: Day 0 Number Analyzed 55 participants 55 participants 54 participants
62.6
(39.9 to 98.1)
101.0
(66.9 to 152.6)
83.7
(53.9 to 129.9)
A2-like: Day 0 Number Analyzed 55 participants 55 participants 54 participants
76.1
(49.6 to 116.7)
107.6
(71.4 to 162.1)
91.0
(57.7 to 143.3)
B1: Day 0 Number Analyzed 55 participants 55 participants 54 participants
116.8
(83.2 to 163.9)
134.1
(92.2 to 195.0)
108.2
(79.5 to 147.1)
B2: Day 0 Number Analyzed 55 participants 55 participants 54 participants
76.1
(49.9 to 115.9)
109.6
(73.4 to 163.8)
97.6
(69.6 to 137.0)
B2-like: Day 0 Number Analyzed 55 participants 55 participants 54 participants
32.7
(22.9 to 46.7)
47.1
(32.8 to 67.6)
41.6
(31.4 to 55.1)
A1: Day 28 Number Analyzed 55 participants 55 participants 54 participants
712.4
(509.7 to 995.7)
550.2
(402.2 to 752.5)
269.1
(181.5 to 399.0)
A1-like: Day 28 Number Analyzed 55 participants 55 participants 54 participants
427.6
(309.1 to 591.5)
356.2
(260.0 to 488.0)
216.3
(157.4 to 297.3)
A2: Day 28 Number Analyzed 55 participants 55 participants 54 participants
1059.5
(759.5 to 1478.0)
839.2
(617.7 to 1140.0)
405.8
(270.5 to 608.6)
A2-like: Day 28 Number Analyzed 55 participants 55 participants 53 participants
940.0
(664.3 to 1330.1)
797.9
(586.8 to 1084.9)
402.3
(263.0 to 615.4)
B1: Day 28 Number Analyzed 55 participants 55 participants 54 participants
877.0
(632.9 to 1215.3)
628.0
(475.4 to 829.6)
336.9
(263.7 to 430.3)
B2: Day 28 Number Analyzed 55 participants 55 participants 54 participants
813.2
(603.0 to 1096.5)
758.7
(589.5 to 976.5)
281.5
(217.0 to 365.0)
B2-like: Day 28 Number Analyzed 55 participants 55 participants 54 participants
269.9
(199.4 to 365.4)
261.6
(201.1 to 340.2)
111.0
(87.6 to 140.7)
6.Secondary Outcome
Title Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
Hide Description GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using an HAI assay. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.
Time Frame Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Data for this outcome measure was not planned to be analyzed for Cohort 1.
Arm/Group Title Cohort 2: QIV-HD by IM Cohort 2: QIV-HD by SC Cohort 2: QIV-SD by SC
Hide Arm/Group Description:
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
Overall Number of Participants Analyzed 55 55 54
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
A1: Day 28/Day 0
16.00
(10.19 to 25.11)
9.25
(6.11 to 14.00)
6.56
(4.36 to 9.86)
A1-like: Day 28/Day 0
9.25
(6.67 to 12.82)
6.34
(4.79 to 8.38)
5.13
(3.67 to 7.17)
A2: Day 28/Day 0
16.93
(10.99 to 26.10)
8.31
(5.54 to 12.46)
4.85
(3.08 to 7.63)
A2-like: Day 28/Day 0
12.36
(8.03 to 19.01)
7.42
(4.98 to 11.05)
4.56
(2.89 to 7.19)
B1: Day 28/Day 0
7.51
(4.93 to 11.45)
4.68
(3.34 to 6.56)
3.11
(2.29 to 4.24)
B2: Day 28/Day 0
10.69
(7.05 to 16.21)
6.92
(4.79 to 9.99)
2.88
(2.08 to 3.99)
B2-like: Day 28/Day 0
8.26
(5.74 to 11.89)
5.55
(3.97 to 7.76)
2.67
(2.00 to 3.57)
7.Secondary Outcome
Title Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD
Hide Description Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroconversion was defined as either a HAI titer lesser than (<) 10 (1/dilution) at Day 0 and post-vaccination titer greater than or equal to (>=) 40 (1/dilution) at Day 28, or HAI titer >=10 (1/dilution) at Day 0 and a >=4-fold increase in HAI titer (1/dilution) at Day 28.
Time Frame Day 28 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, 'number analyzed' = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.
Arm/Group Title Cohort 2: QIV-HD by IM Cohort 2: QIV-HD by SC Cohort 2: QIV-SD by SC
Hide Arm/Group Description:
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
Overall Number of Participants Analyzed 55 55 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A1 Number Analyzed 55 participants 55 participants 54 participants
74.5
(61.0 to 85.3)
67.3
(53.3 to 79.3)
55.6
(41.4 to 69.1)
A1-like Number Analyzed 55 participants 55 participants 53 participants
74.5
(61.0 to 85.3)
69.1
(55.2 to 80.9)
56.6
(42.3 to 70.2)
A2 Number Analyzed 55 participants 55 participants 54 participants
85.5
(73.3 to 93.5)
63.6
(49.6 to 76.2)
42.6
(29.2 to 56.8)
A2-like Number Analyzed 55 participants 55 participants 53 participants
74.5
(61.0 to 85.3)
58.2
(44.1 to 71.3)
43.4
(29.8 to 57.7)
B1 Number Analyzed 55 participants 55 participants 54 participants
58.2
(44.1 to 71.3)
47.3
(33.7 to 61.2)
37.0
(24.3 to 51.3)
B2 Number Analyzed 55 participants 55 participants 54 participants
65.5
(51.4 to 77.8)
63.6
(49.6 to 76.2)
33.3
(21.1 to 47.5)
B2-like Number Analyzed 55 participants 55 participants 54 participants
67.3
(53.3 to 79.3)
60.0
(45.9 to 73.0)
33.3
(21.1 to 47.5)
8.Secondary Outcome
Title Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD
Hide Description Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroprotection was defined as a HAI titer >=40 (1/dilution) at Day 0 and Day 28.
Time Frame Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, 'number analyzed' = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.
Arm/Group Title Cohort 2: QIV-HD by IM Cohort 2: QIV-HD by SC Cohort 2: QIV-SD by SC
Hide Arm/Group Description:
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
Overall Number of Participants Analyzed 55 55 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A1: Day 0 Number Analyzed 55 participants 55 participants 54 participants
60.0
(45.9 to 73.0)
65.5
(51.4 to 77.8)
53.7
(39.6 to 67.4)
A1-like: Day 0 Number Analyzed 55 participants 55 participants 53 participants
58.2
(44.1 to 71.3)
60.0
(45.9 to 73.0)
54.7
(40.4 to 68.4)
A2: Day 0 Number Analyzed 55 participants 55 participants 54 participants
63.6
(49.6 to 76.2)
83.6
(71.2 to 92.2)
68.5
(54.4 to 80.5)
A2-like: Day 0 Number Analyzed 55 participants 55 participants 54 participants
65.5
(51.4 to 77.8)
81.8
(69.1 to 90.9)
70.4
(56.4 to 82.0)
B1: Day 0 Number Analyzed 55 participants 55 participants 54 participants
76.4
(63.0 to 86.8)
87.3
(75.5 to 94.7)
81.5
(68.6 to 90.7)
B2: Day 0 Number Analyzed 55 participants 55 participants 54 participants
67.3
(53.3 to 79.3)
78.2
(65.0 to 88.2)
79.6
(66.5 to 89.4)
B2-like: Day 0 Number Analyzed 55 participants 55 participants 54 participants
49.1
(35.4 to 62.9)
52.7
(38.8 to 66.3)
57.4
(43.2 to 70.8)
A1: Day 28 Number Analyzed 55 participants 55 participants 54 participants
98.2
(90.3 to 100.0)
100
(93.5 to 100.0)
92.6
(82.1 to 97.9)
A1-like: Day 28 Number Analyzed 55 participants 55 participants 54 participants
98.2
(90.3 to 100.0)
100
(93.5 to 100.0)
98.1
(90.1 to 100.0)
A2: Day 28 Number Analyzed 55 participants 55 participants 54 participants
100
(93.5 to 100.0)
100
(93.5 to 100.0)
96.3
(87.3 to 99.5)
A2-like: day 28 Number Analyzed 55 participants 55 participants 53 participants
100
(93.5 to 100.0)
100
(93.5 to 100.0)
96.2
(87.0 to 99.5)
B1: Day 28 Number Analyzed 55 participants 55 participants 54 participants
98.2
(90.3 to 100.0)
100
(93.5 to 100.0)
98.1
(90.1 to 100.0)
B2: Day 28 Number Analyzed 55 participants 55 participants 54 participants
98.2
(90.3 to 100.0)
100
(93.5 to 100.0)
98.1
(90.1 to 100.0)
B2-like: Day 28 Number Analyzed 55 participants 55 participants 54 participants
98.2
(90.3 to 100.0)
100
(93.5 to 100.0)
94.4
(84.6 to 98.8)
Time Frame Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Adverse Event Reporting Description Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
 
Arm/Group Title Cohort 1 and 2: QIV-HD by IM Cohort 1 and 2: QIV-HD by SC Cohort 2: QIV-SD by SC
Hide Arm/Group Description Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0. Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0. Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
All-Cause Mortality
Cohort 1 and 2: QIV-HD by IM Cohort 1 and 2: QIV-HD by SC Cohort 2: QIV-SD by SC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%)   0/55 (0.00%) 
Hide Serious Adverse Events
Cohort 1 and 2: QIV-HD by IM Cohort 1 and 2: QIV-HD by SC Cohort 2: QIV-SD by SC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%)   1/55 (1.82%) 
Ear and labyrinth disorders       
Sudden hearing loss † 1  0/60 (0.00%)  0/60 (0.00%)  1/55 (1.82%) 
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 and 2: QIV-HD by IM Cohort 1 and 2: QIV-HD by SC Cohort 2: QIV-SD by SC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/60 (6.67%)   4/60 (6.67%)   7/55 (12.73%) 
Gastrointestinal disorders       
Faeces soft † 1  0/60 (0.00%)  0/60 (0.00%)  1/55 (1.82%) 
Gastrooesophageal reflux disease † 1  1/60 (1.67%)  0/60 (0.00%)  0/55 (0.00%) 
General disorders       
Injection site pruritus † 1  1/60 (1.67%)  3/60 (5.00%)  1/55 (1.82%) 
Infections and infestations       
Cystitis † 1  1/60 (1.67%)  0/60 (0.00%)  0/55 (0.00%) 
Laryngitis † 1  1/60 (1.67%)  0/60 (0.00%)  0/55 (0.00%) 
Nasopharyngitis † 1  0/60 (0.00%)  2/60 (3.33%)  2/55 (3.64%) 
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal discomfort † 1  0/60 (0.00%)  0/60 (0.00%)  1/55 (1.82%) 
Oropharyngeal pain † 1  0/60 (0.00%)  0/60 (0.00%)  2/55 (3.64%) 
Sneezing † 1  0/60 (0.00%)  0/60 (0.00%)  1/55 (1.82%) 
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
[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 subject 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: Medical Director
Organization: Sanofi Pasteur
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
Publications:
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT03233217    
Other Study ID Numbers: QHD00008
U1111-1183-5525 ( Other Identifier: World Health Organization Universal Trial Number )
DFI15130 ( Other Identifier: Sanofi K.K. )
First Submitted: July 25, 2017
First Posted: July 28, 2017
Results First Submitted: November 28, 2019
Results First Posted: December 17, 2019
Last Update Posted: December 17, 2019