Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years
Study Details
Study Description
Brief Summary
This phase I/II, randomized, modified double-blind, multi-center study assessed the safety and immunogenicity of a high-dose Quadrivalent influenza vaccine (QIV-HD) in older adults (greater than or equal to [>=] 65 years).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
This phase I/II, randomized, modified double-blind, multi-center study was conducted in 175 healthy Japanese adults aged 65 years and older to describe the safety profile and immune responses (geometric mean titers and seroconversion for the 4 common strains at 28 days post-vaccination) of the QIV-HD administered by intramuscular (IM) and subcutaneous (SC) methods. A local standard-dose Quadrivalent Influenza Vaccine (QIV-SD) administered by SC method served as a control arm.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cohort 1: QIV-HD by IM Participants were randomized to receive a single 0.7-milliliter (mL) injection of QIV-HD by IM route on Day 0. |
Biological: QIV-HD by IM
IM, injected into the upper arm (deltoid area)
Other Names:
|
Experimental: Cohort 1: QIV-HD by SC Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0. |
Biological: QIV-HD by SC
SC, injection into the upper arm (posterior region)
Other Names:
|
Experimental: Cohort 2: QIV-HD by IM Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0. |
Biological: QIV-HD by IM
IM, injected into the upper arm (deltoid area)
Other Names:
|
Experimental: Cohort 2: QIV-HD by SC Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0. |
Biological: QIV-HD by SC
SC, injection into the upper arm (posterior region)
Other Names:
|
Active Comparator: Cohort 2: QIV-SD by SC Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0. |
Biological: QIV-SD by SC
SC, injected into the upper arm (posterior region)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Immediate Unsolicited Adverse Events (AE) After Vaccination [Within 30 minutes after vaccination]
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.
- Number of Participants With Solicited Injection Site and Systemic Reactions [Within 7 days after vaccination]
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.
- Number of Participants With Unsolicited Adverse Events After Vaccination [Within 28 days after vaccination]
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.
- Number of Participant With Serious Adverse Events (SAEs) After Vaccination [Up to 6 months after vaccination]
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.
Secondary Outcome Measures
- Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD [Day 0 (pre-vaccination) and Day 28 (post-vaccination)]
GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using a hemagglutination inhibition (HAI) assay.
- Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD [Day 0 (pre-vaccination) and Day 28 (post-vaccination)]
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.
- Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD [Day 28 (post-vaccination)]
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.
- Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD [Day 0 (pre-vaccination) and Day 28 (post-vaccination)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged >= 65 years on the day of inclusion.
-
Informed consent form has been signed and dated.
-
Able to attend all scheduled visits and to comply 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 present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
-
Receipt of any vaccination with live vaccines within the past 27 days preceding the study vaccination or any vaccination with inactivated vaccines within the past 6 days preceding the study vaccination, or planned receipt of any vaccine prior to Visit 3.
-
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 eggs, chicken proteins, or any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances.
-
Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on Investigator's judgment.
-
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
-
Alcohol 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 study conduct or completion.
-
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, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
-
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 have been disease free for
=5 years).
-
Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >=37.5°Celsius). A prospective participant were not be included in the study until the condition had resolved or the febrile event had subsided.
-
History of convulsions.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Sanofi Pasteur Investigational Site | Tokyo | Japan | ||
2 | Sanofi Pasteur Investigational Site | Ōsaka | Japan |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
- Sanofi K.K.
Investigators
- Study Director: Medical Director, Sanofi Pasteur, a Sanofi Company
Study Documents (Full-Text)
More Information
Additional Information:
Publications
- QHD00008
- U1111-1183-5525
- DFI15130
Study Results
Participant Flow
Recruitment Details | Study participants were enrolled from 15 September 2017 to 26 October 2017 at 2 centers in Japan. |
---|---|
Pre-assignment Detail | 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 |
---|---|---|---|---|---|
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 | 5 | 5 | 55 | 55 | 55 |
Safety Analysis Set (SafAS) | 5 | 5 | 55 | 55 | 55 |
Per-protocol Analysis Set (PPAS) | 5 | 5 | 55 | 55 | 54 |
COMPLETED | 5 | 5 | 55 | 55 | 55 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
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 |
---|---|---|---|---|---|---|
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 Participants | 5 | 5 | 55 | 55 | 55 | 175 |
Age (years) [Mean (Standard Deviation) ] | ||||||
Mean (Standard Deviation) [years] |
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 (Count of Participants) | ||||||
Female |
1
20%
|
1
20%
|
27
49.1%
|
26
47.3%
|
25
45.5%
|
80
45.7%
|
Male |
4
80%
|
4
80%
|
28
50.9%
|
29
52.7%
|
30
54.5%
|
95
54.3%
|
Race (NIH/OMB) (Count of Participants) | ||||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
5
100%
|
5
100%
|
55
100%
|
55
100%
|
55
100%
|
175
100%
|
Native Hawaiian or Other Pacific Islander |
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%
|
White |
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%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
Title | Number of Participants With Immediate Unsolicited Adverse Events (AE) After Vaccination |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|
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. |
Measure Participants | 60 | 60 | 55 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Solicited Injection Site and Systemic Reactions |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|
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. |
Measure Participants | 60 | 60 | 55 |
Injection site pain |
18
360%
|
27
540%
|
15
27.3%
|
Injection site erythema |
11
220%
|
19
380%
|
11
20%
|
Injection site swelling |
9
180%
|
17
340%
|
13
23.6%
|
Injection site induration |
2
40%
|
7
140%
|
2
3.6%
|
Injection site bruising |
0
0%
|
0
0%
|
0
0%
|
Fever |
0
0%
|
1
20%
|
0
0%
|
Headache |
3
60%
|
8
160%
|
1
1.8%
|
Malaise |
1
20%
|
4
80%
|
3
5.5%
|
Myalgia |
9
180%
|
16
320%
|
7
12.7%
|
Shivering |
0
0%
|
2
40%
|
2
3.6%
|
Title | Number of Participants With Unsolicited Adverse Events After Vaccination |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|
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. |
Measure Participants | 60 | 60 | 55 |
Count of Participants [Participants] |
4
80%
|
4
80%
|
8
14.5%
|
Title | Number of Participant With Serious Adverse Events (SAEs) After Vaccination |
---|---|
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 |
Outcome Measure Data
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 |
---|---|---|---|
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. |
Measure Participants | 60 | 60 | 55 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
1
1.8%
|
Title | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD |
---|---|
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) |
Outcome Measure Data
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 |
---|---|---|---|
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. |
Measure Participants | 55 | 55 | 54 |
A1: Day 0 |
44.5
|
59.5
|
41.0
|
A1-like: Day 0 |
46.2
|
56.2
|
42.1
|
A2: Day 0 |
62.6
|
101.0
|
83.7
|
A2-like: Day 0 |
76.1
|
107.6
|
91.0
|
B1: Day 0 |
116.8
|
134.1
|
108.2
|
B2: Day 0 |
76.1
|
109.6
|
97.6
|
B2-like: Day 0 |
32.7
|
47.1
|
41.6
|
A1: Day 28 |
712.4
|
550.2
|
269.1
|
A1-like: Day 28 |
427.6
|
356.2
|
216.3
|
A2: Day 28 |
1059.5
|
839.2
|
405.8
|
A2-like: Day 28 |
940.0
|
797.9
|
402.3
|
B1: Day 28 |
877.0
|
628.0
|
336.9
|
B2: Day 28 |
813.2
|
758.7
|
281.5
|
B2-like: Day 28 |
269.9
|
261.6
|
111.0
|
Title | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD |
---|---|
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) |
Outcome Measure Data
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 |
---|---|---|---|
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. |
Measure Participants | 55 | 55 | 54 |
A1: Day 28/Day 0 |
16.00
|
9.25
|
6.56
|
A1-like: Day 28/Day 0 |
9.25
|
6.34
|
5.13
|
A2: Day 28/Day 0 |
16.93
|
8.31
|
4.85
|
A2-like: Day 28/Day 0 |
12.36
|
7.42
|
4.56
|
B1: Day 28/Day 0 |
7.51
|
4.68
|
3.11
|
B2: Day 28/Day 0 |
10.69
|
6.92
|
2.88
|
B2-like: Day 28/Day 0 |
8.26
|
5.55
|
2.67
|
Title | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD |
---|---|
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) |
Outcome Measure Data
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 |
---|---|---|---|
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. |
Measure Participants | 55 | 55 | 54 |
A1 |
74.5
1490%
|
67.3
1346%
|
55.6
101.1%
|
A1-like |
74.5
1490%
|
69.1
1382%
|
56.6
102.9%
|
A2 |
85.5
1710%
|
63.6
1272%
|
42.6
77.5%
|
A2-like |
74.5
1490%
|
58.2
1164%
|
43.4
78.9%
|
B1 |
58.2
1164%
|
47.3
946%
|
37.0
67.3%
|
B2 |
65.5
1310%
|
63.6
1272%
|
33.3
60.5%
|
B2-like |
67.3
1346%
|
60.0
1200%
|
33.3
60.5%
|
Title | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD |
---|---|
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) |
Outcome Measure Data
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 |
---|---|---|---|
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. |
Measure Participants | 55 | 55 | 54 |
A1: Day 0 |
60.0
1200%
|
65.5
1310%
|
53.7
97.6%
|
A1-like: Day 0 |
58.2
1164%
|
60.0
1200%
|
54.7
99.5%
|
A2: Day 0 |
63.6
1272%
|
83.6
1672%
|
68.5
124.5%
|
A2-like: Day 0 |
65.5
1310%
|
81.8
1636%
|
70.4
128%
|
B1: Day 0 |
76.4
1528%
|
87.3
1746%
|
81.5
148.2%
|
B2: Day 0 |
67.3
1346%
|
78.2
1564%
|
79.6
144.7%
|
B2-like: Day 0 |
49.1
982%
|
52.7
1054%
|
57.4
104.4%
|
A1: Day 28 |
98.2
1964%
|
100
2000%
|
92.6
168.4%
|
A1-like: Day 28 |
98.2
1964%
|
100
2000%
|
98.1
178.4%
|
A2: Day 28 |
100
2000%
|
100
2000%
|
96.3
175.1%
|
A2-like: day 28 |
100
2000%
|
100
2000%
|
96.2
174.9%
|
B1: Day 28 |
98.2
1964%
|
100
2000%
|
98.1
178.4%
|
B2: Day 28 |
98.2
1964%
|
100
2000%
|
98.1
178.4%
|
B2-like: Day 28 |
98.2
1964%
|
100
2000%
|
94.4
171.6%
|
Adverse Events
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 | |||
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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/60 (0%) | 0/60 (0%) | 0/55 (0%) | |||
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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/60 (0%) | 0/60 (0%) | 1/55 (1.8%) | |||
Ear and labyrinth disorders | ||||||
Sudden hearing loss | 0/60 (0%) | 0/60 (0%) | 1/55 (1.8%) | |||
Other (Not Including 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 4/60 (6.7%) | 4/60 (6.7%) | 7/55 (12.7%) | |||
Gastrointestinal disorders | ||||||
Faeces soft | 0/60 (0%) | 0/60 (0%) | 1/55 (1.8%) | |||
Gastrooesophageal reflux disease | 1/60 (1.7%) | 0/60 (0%) | 0/55 (0%) | |||
General disorders | ||||||
Injection site pruritus | 1/60 (1.7%) | 3/60 (5%) | 1/55 (1.8%) | |||
Infections and infestations | ||||||
Cystitis | 1/60 (1.7%) | 0/60 (0%) | 0/55 (0%) | |||
Laryngitis | 1/60 (1.7%) | 0/60 (0%) | 0/55 (0%) | |||
Nasopharyngitis | 0/60 (0%) | 2/60 (3.3%) | 2/55 (3.6%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
Oropharyngeal discomfort | 0/60 (0%) | 0/60 (0%) | 1/55 (1.8%) | |||
Oropharyngeal pain | 0/60 (0%) | 0/60 (0%) | 2/55 (3.6%) | |||
Sneezing | 0/60 (0%) | 0/60 (0%) | 1/55 (1.8%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Name/Title | Medical Director |
---|---|
Organization | Sanofi Pasteur |
Phone | 800-633-1610 ext 1# |
Contact-US@sanofi.com |
- QHD00008
- U1111-1183-5525
- DFI15130