Study of Intradermal Quadrivalent Influenza Vaccine in Adults Aged 18 Through 64 Years

• Sponsor: Sanofi Pasteur, a Sanofi Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01712984
• Collaborator: (none)
• Enrollment: 3,360
• Locations: 38
• Arms: 3
• Duration (Months): 12
• Patients Per Site: 88.4
• Patients Per Site Per Month: 7.4

Study Details

Study Description

Brief Summary

The aim of the study is to demonstrate safety and immunogenicity of the quadrivalent influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV) containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage (TIV-ID2) vaccines in producing protection against four strains of influenza virus.

Primary Objective:

• To demonstrate that QIV-ID induces an immune response (as assessed by hemagglutination inhibition (HAI) geometric mean titers (GMTs) and seroconversion rates) that is non-inferior to responses induced by TIV-ID1 and TIV-ID2 for the 4 virus strains at 28 days post-vaccination.

Secondary Objectives:

• To demonstrate that each B strain in QIV-ID induces an immune response (as assessed by HAI GMTs and seroconversion rates) that is superior to the response induced by the TIV-ID that does not contain the corresponding B strain.

• To describe the rate of post-vaccination seroprotection induced by QIV-ID and TIV-ID.

• To describe post-vaccination immunogenicity stratified by age (18-49 years and 50-64 years), race, ethnicity, gender, previous vaccination status, and baseline seropositivity status.

• To describe the safety profile for subjects who receive QIV-ID and TIV-ID.

Observational Objectives:

• To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 2 or Grade 3 solicited systemic reactions combined

• To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 3 solicited injection site reactions combined.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation; Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal; Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal	Phase 3

Detailed Description

All participants will receive a single dose of their assigned vaccine on Day 0. A subset of the participants will be assessed for immunologic response on Day 0 before vaccination and Day 28 after vaccination. All subjects will be monitored for safety for up to 6 months after vaccination.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Immunogenicity and Safety Trial of Quadrivalent Influenza Vaccine Administered by Intradermal Route in Adult Subjects Aged 18 Through 64 Years
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: QIV ID Vaccine Group Participants will receive the intradermal quadrivalent influenza vaccine	Biological: Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation; 0.1mL, Intradermal; Other Names: QIV ID
Active Comparator: TIV ID1 Vaccine Group Participants will receive the trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage	Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal; 0.1mL, Intradermal; Other Names: Fluzone® Intradermal
Active Comparator: TIV ID2 Group Participants will receive the intradermal trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage	Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal; 0.1mL, Intradermal; Other Names: Fluzone® Intradermal

Outcome Measures

Primary Outcome Measures

1. Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route [Day 28 post-vaccination]

   Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.

2. Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route [Day 28 post-vaccination]

   Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer< 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28).

Secondary Outcome Measures

1. Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route [Day 0 (pre-vaccination) and Day 28 post-vaccination]

   Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.

2. Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route [Day 0 (pre-vaccination) and Day 28 post-vaccination]

   Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 [1/dil] at baseline and 28 days after vaccination.

3. Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route [Day 0 up to Day 7 post-vaccination]

   Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Aged 18 through 64 years on the day of inclusion

• Informed consent form (ICF) has been signed and dated

• Able to attend all scheduled visits and to comply with all trial procedures. Exclusion

Criteria:

• Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination)

• Participation at the time of trial enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure

• Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination

• Vaccination against influenza in the past 6 months

• Receipt of immune globulins, blood or blood-derived products in the past 3 months

• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances

• History of thrombocytopenia

• Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion

• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

• Current alcohol abuse or drug addiction

• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

• Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, 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 trial

• Personal or family history of Guillain-Barré Syndrome

• Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, and subjects who have a history of neoplastic disease and who have been disease free for ≥ 5 years.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Hoover	Alabama	United States	35216
2		Huntsville	Alabama	United States	35802
3		Chandler	Arizona	United States	85224
4		Mesa	Arizona	United States	85213
5		Phoenix	Arizona	United States	85020
6		Tucson	Arizona	United States	85704
7		Chula Vista	California	United States	91911
8		Sacramento	California	United States	95816
9		San Diego	California	United States	92103
10		Milford	Connecticut	United States	06460
11		Coral Gables	Florida	United States	33134
12		Melbourne	Florida	United States	32935
13		Pinellas Park	Florida	United States	33781
14		South Miami	Florida	United States	33143
15		Boise	Idaho	United States	83642
16		Iowa City	Iowa	United States	52242
17		Overland Park	Kansas	United States	66212
18		Wichita	Kansas	United States	67207
19		Kansas City	Missouri	United States	64114
20		Springfield	Missouri	United States	65802
21		St. Louis	Missouri	United States	63104
22		Omaha	Nebraska	United States	68134
23		Binghamton	New York	United States	13901
24		Rochester	New York	United States	14609
25		Rochester	New York	United States	14621
26		Allentown	Pennsylvania	United States	18102
27		Bensalem	Pennsylvania	United States	19020
28		Warwick	Rhode Island	United States	02886
29		Mt. Pleasant	South Carolina	United States	29464
30		Dakota Dunes	South Dakota	United States	57049
31		Austin	Texas	United States	78745
32		Fort Worth	Texas	United States	76107
33		Fort Worth	Texas	United States	76135
34		San Angelo	Texas	United States	76904
35		Salt Lake City	Utah	United States	84109
36		Salt Lake City	Utah	United States	84121
37		West Jordan	Utah	United States	84088
38		Marshfield	Wisconsin	United States	54449

Sponsors and Collaborators

• Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Director, Sanofi Pasteur Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• Related Info

Publications

• Gorse GJ, Falsey AR, Ozol-Godfrey A, Landolfi V, Tsang PH. Safety and immunogenicity of a quadrivalent intradermal influenza vaccine in adults. Vaccine. 2015 Feb 25;33(9):1151-9. doi: 10.1016/j.vaccine.2015.01.025. Epub 2015 Jan 19.

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT01712984
• Other Study ID Numbers: QID01; U1111-1124-8066
• First Posted: Oct 24, 2012
• Last Update Posted: May 7, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Sanofi Pasteur, a Sanofi Company: Influenza; Fluzone® Intradermal vaccine; Influenza Virus Vaccine USP Quadrivalent; Influenza Virus Vaccine USP Trivalent Types A and B
• Additional relevant MeSH terms: Influenza, Human; Fluconazole; Vaccines

Study Results

Participant Flow

Recruitment Details	The study participants were enrolled from 22 October 2012 to 28 May 2013 at 38 clinic sites in the United States.
Pre-assignment Detail	A total of 3360 participants who met all of the inclusion and none of the exclusion criteria were randomized, 3355 received one of the trial vaccines and their data are presented in this report.

Arm/Group Title	QIV ID Vaccine Group	TIV ID1 Vaccine Group	TIV ID2 Vaccine Group
Arm/Group Description	Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine	Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)	Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
Period Title: Overall Study
STARTED	1672	837	846
COMPLETED	1656	821	836
NOT COMPLETED	16	16	10

Baseline Characteristics

Arm/Group Title	QIV ID Vaccine Group	TIV ID1 Vaccine Group	TIV ID2 Vaccine Group	Total
Arm/Group Description	Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine	Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)	Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)	Total of all reporting groups
Overall Participants	1672	837	846	3355
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	1672 100%	837 100%	846 100%	3355 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	41.6 (13.2)	41.2 (13.5)	41.9 (13.3)	41.6 (13.3)
Sex: Female, Male (Count of Participants)
Female	1022 61.1%	505 60.3%	528 62.4%	2055 61.3%
Male	650 38.9%	332 39.7%	318 37.6%	1300 38.7%
Region of Enrollment (Number) [Number]
United States	1672 100%	837 100%	846 100%	3355 100%

Outcome Measures

1. Primary Outcome

Title	Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Description	Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.
Time Frame	Day 28 post-vaccination

Outcome Measure Data

Analysis Population Description

Geometric mean titers against the influenza virus antigens were assessed in the Per-protocol Analysis Set.

Arm/Group Title	QIV ID Vaccine Group	TIV ID1 Vaccine Group	TIV ID2 Vaccine Group
Arm/Group Description	Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine	Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)	Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
Measure Participants	1041	539	533
A/H1N1 (N=1041, 539, 533)	589	728	635
A/H3N2 (N=1041, 538, 533)	368	413	447
B/Texas/6/2011 (B1; N=1041, 539, 533)	105	93.5	54.0
B/Brisbane/60/2008 (B2; N=1041, 538, 533)	136	66.7	130

2. Primary Outcome

Title	Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Description	Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer< 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28).
Time Frame	Day 28 post-vaccination

Outcome Measure Data

Analysis Population Description

Seroconversion to the influenza virus antigens were assessed in the Per Protocol Analysis Set.

Arm/Group Title	QIV ID Vaccine Group	TIV ID1 Vaccine Group	TIV ID2 Vaccine Group
Arm/Group Description	Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine	Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)	Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
Measure Participants	1041	539	533
A/H1N1 (N=1041, 539, 533)	600 35.9%	333 39.8%	314 37.1%
A/H3N2 (N=1040, 538, 533)	608 36.4%	326 38.9%	314 37.1%
B/Texas/6/2011 (B1; N=1041, 539, 533)	580 34.7%	253 30.2%	131 15.5%
B/Brisbane/60/2008 (B2; N=1041, 538, 533)	525 31.4%	119 14.2%	235 27.8%

3. Secondary Outcome

Title	Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Description	Antibodies against the influenza vaccine virus antigens 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

Geometric mean titers against the influenza virus antigens were assessed in the Per Protocol Analysis Set.

Arm/Group Title	QIV ID Vaccine Group	TIV ID1 Vaccine Group	TIV ID2 Vaccine Group
Arm/Group Description	Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine	Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)	Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
Measure Participants	1041	539	533
A/H1N1 Day 0 (N=1041, 539, 533)	66.3	65.2	66.2
A/H1N1 Day 28 (N=1041, 539, 533)	589	728	635
A/H3N2 Day 0 (N=1040, 539, 533)	52.3	56.5	55.7
A/H3N2 Day 28 (N=1041, 538, 533)	368	413	447
B1 Day 0 (N=1041, 539, 533)	21.7	24.7	22.2
B1 Day 28 (N=1041, 539, 533)	105	93.5	54.0
B2 Day 0 (N=1041, 539, 533)	26.8	29.7	25.4
B2 Day 28 (N=1041, 538, 533)	136	66.7	130

4. Secondary Outcome

Title	Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Description	Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 [1/dil] at baseline and 28 days after vaccination.
Time Frame	Day 0 (pre-vaccination) and Day 28 post-vaccination

Outcome Measure Data

Analysis Population Description

Seroprotection against influenza virus antigens was assessed in the Per Protocol Analysis Set.

Arm/Group Title	QIV ID Vaccine Group	TIV ID1 Vaccine Group	TIV ID2 Vaccine Group
Arm/Group Description	Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine	Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)	Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
Measure Participants	1041	539	533
A/H1N1 Day 0 (N=1041, 539, 533)	672 40.2%	334 39.9%	353 41.7%
A/H1N1 Day 28 (N=1041, 539, 533)	1014 60.6%	537 64.2%	524 61.9%
A/H3N2 Day 0 (N=1040, 539, 533)	655 39.2%	340 40.6%	332 39.2%
A/H3N2 Day 28 (N=1041, 538, 533)	1008 60.3%	526 62.8%	519 61.3%
B1 Day 0 (N=1041, 539, 533)	335 20%	210 25.1%	172 20.3%
B1 Day 28 (N=1041, 539, 533)	923 55.2%	464 55.4%	351 41.5%
B2 Day 0 (N=1041, 539, 533)	467 27.9%	262 31.3%	224 26.5%
B2 Day 28 (N=1041, 538, 533)	976 58.4%	403 48.1%	477 56.4%

5. Secondary Outcome

Title	Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Description	Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity.
Time Frame	Day 0 up to Day 7 post-vaccination

Outcome Measure Data

Analysis Population Description

Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.

Arm/Group Title	QIV ID Vaccine Group	TIV ID1 Vaccine Group	TIV ID2 Vaccine Group
Arm/Group Description	Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine	Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)	Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
Measure Participants	1672	837	846
Injection site Pain (N=1656,820,838)	883 52.8%	395 47.2%	420 49.6%
Grade 3 Injection site Pain (N=1656,820,838)	24 1.4%	10 1.2%	12 1.4%
Injection site Erythema (N=1656,820,838)	607 36.3%	279 33.3%	269 31.8%
Grade 3 Injection site Erythema (N=1656,820,838)	7 0.4%	1 0.1%	3 0.4%
Injection site Swelling (N=1655,820,838)	322 19.3%	121 14.5%	123 14.5%
Grade 3 Injection site Swelling (N=1655,820,838)	2 0.1%	0 0%	0 0%
Injection site Induration (N=1656,820,837)	282 16.9%	111 13.3%	94 11.1%
Grade 3 Injection site Induration (N=1656,820,837)	1 0.1%	0 0%	0 0%
Injection site Ecchymosis (N=1656,820,838)	43 2.6%	15 1.8%	15 1.8%
Grade 3 Injection site Ecchymosis (N=1656,820,838)	0 0%	0 0%	0 0%
Fever (N=1649,819,836)	13 0.8%	6 0.7%	4 0.5%
Grade 3 Fever (N=1649,819,836)	3 0.2%	1 0.1%	0 0%
Headache (N=1656,820,838)	548 32.8%	257 30.7%	278 32.9%
Grade 3 Headache (N=1656,820,838)	53 3.2%	20 2.4%	15 1.8%
Malaise (N=1656,820,838)	459 27.5%	216 25.8%	255 30.1%
Grade 3 Malaise (N=1656,820,838)	49 2.9%	15 1.8%	21 2.5%
Myalgia (N=1656,820,838)	564 33.7%	238 28.4%	261 30.9%
Grade 3 Myalgia (N=1656,820,838)	43 2.6%	12 1.4%	21 2.5%
Shivering (N=1656,820,838)	200 12%	85 10.2%	94 11.1%
Grade 3 Shivering (N=1656,820,838)	24 1.4%	5 0.6%	13 1.5%
Injection site Pruritus (N=1656,820,838)	862 51.6%	372 44.4%	374 44.2%
Grade 3 Injection site Pruritus (N=1656,820,838)	47 2.8%	15 1.8%	19 2.2%

Adverse Events

Time Frame	Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
Arm/Group Title	QIV ID Vaccine Group		TIV ID1 Vaccine Group		TIV ID2 Vaccine Group
Arm/Group Description	Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine		Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)		Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
All Cause Mortality
	QIV ID Vaccine Group		TIV ID1 Vaccine Group		TIV ID2 Vaccine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	QIV ID Vaccine Group		TIV ID1 Vaccine Group		TIV ID2 Vaccine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/1672 (1.2%)		14/837 (1.7%)		11/846 (1.3%)
Cardiac disorders
Acute myocardial infarction	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Aortic valve disease	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Atrial fibrillation	0/1672 (0%)	0	0/837 (0%)	0	1/846 (0.1%)	1
Cardiac tamponade	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Ear and labyrinth disorders
Vertigo	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Gastrointestinal disorders
Colitis	0/1672 (0%)	0	0/837 (0%)	0	1/846 (0.1%)	1
General disorders
Chest pain	0/1672 (0%)	0	0/837 (0%)	0	1/846 (0.1%)	1
Dysplasia	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Hepatobiliary disorders
Bile duct stone	0/1672 (0%)	0	0/837 (0%)	0	1/846 (0.1%)	1
Cholelithiasis	1/1672 (0.1%)	1	1/837 (0.1%)	1	0/846 (0%)	0
Immune system disorders
Sarcoidosis	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Infections and infestations
Clostridium difficile colitis	0/1672 (0%)	0	0/837 (0%)	0	1/846 (0.1%)	1
Osteomyelitis	0/1672 (0%)	0	0/837 (0%)	0	1/846 (0.1%)	1
Pneumonia	2/1672 (0.1%)	2	0/837 (0%)	0	1/846 (0.1%)	1
Pneumonia primary atypical	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Injury, poisoning and procedural complications
Alcohol poisoning	0/1672 (0%)	0	1/837 (0.1%)	1	0/846 (0%)	0
Concussion	0/1672 (0%)	0	1/837 (0.1%)	1	0/846 (0%)	0
Hip fracture	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Joint injury	0/1672 (0%)	0	1/837 (0.1%)	1	0/846 (0%)	0
Laceration	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Lower limb fracture	0/1672 (0%)	0	0/837 (0%)	0	1/846 (0.1%)	1
Neck injury	0/1672 (0%)	0	1/837 (0.1%)	1	0/846 (0%)	0
Seroma	0/1672 (0%)	0	1/837 (0.1%)	1	0/846 (0%)	0
Metabolism and nutrition disorders
Dehydration	0/1672 (0%)	0	0/837 (0%)	0	1/846 (0.1%)	1
Hypovolaemia	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain	0/1672 (0%)	0	0/837 (0%)	0	1/846 (0.1%)	1
Osteoarthritis	1/1672 (0.1%)	1	1/837 (0.1%)	1	1/846 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Lung neoplasm malignant	0/1672 (0%)	0	1/837 (0.1%)	1	0/846 (0%)	0
Nervous system disorders
Cerebrovascular accident	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Headache	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Hemiplegic migraine	0/1672 (0%)	0	1/837 (0.1%)	1	0/846 (0%)	0
Syncope	0/1672 (0%)	0	2/837 (0.2%)	2	0/846 (0%)	0
Pregnancy, puerperium and perinatal conditions
Cervical incompetence	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Psychiatric disorders
Conversion disorder	0/1672 (0%)	0	1/837 (0.1%)	1	0/846 (0%)	0
Renal and urinary disorders
Nephrolithiasis	0/1672 (0%)	0	1/837 (0.1%)	1	0/846 (0%)	0
Renal failure acute	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	0/1672 (0%)	0	0/837 (0%)	0	1/846 (0.1%)	1
Chronic obstructive pulmonary disease	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Pulmonary embolism	0/1672 (0%)	0	1/837 (0.1%)	1	0/846 (0%)	0
Respiratory distress	0/1672 (0%)	0	0/837 (0%)	0	1/846 (0.1%)	1
Respiratory failure	0/1672 (0%)	0	0/837 (0%)	0	1/846 (0.1%)	1
Skin and subcutaneous tissue disorders
Diabetic foot	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Vascular disorders
Hypotension	0/1672 (0%)	0	1/837 (0.1%)	1	1/846 (0.1%)	1
Peripheral vascular disorder	1/1672 (0.1%)	1	0/837 (0%)	0	0/846 (0%)	0
Other (Not Including Serious) Adverse Events
	QIV ID Vaccine Group		TIV ID1 Vaccine Group		TIV ID2 Vaccine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	883/1672 (52.8%)		395/837 (47.2%)		420/846 (49.6%)
General disorders
Injection site Pain	883/1656 (53.3%)	883	395/820 (48.2%)	395	420/838 (50.1%)	420
Injection site Erythema	607/1656 (36.7%)	607	279/820 (34%)	279	269/838 (32.1%)	269
Injection site Swelling	322/1655 (19.5%)	322	121/820 (14.8%)	121	123/838 (14.7%)	123
Injection site Induration	282/1656 (17%)	282	111/820 (13.5%)	111	94/837 (11.2%)	94
Injection site Pruritus	862/1656 (52.1%)	862	372/820 (45.4%)	372	374/838 (44.6%)	374
Malaise	459/1656 (27.7%)	459	216/820 (26.3%)	216	255/838 (30.4%)	255
Shivering	200/1656 (12.1%)	200	85/820 (10.4%)	85	94/838 (11.2%)	94
Musculoskeletal and connective tissue disorders
Myalgia	564/1656 (34.1%)	564	238/820 (29%)	238	261/838 (31.1%)	261
Nervous system disorders
Headache	548/1656 (33.1%)	548	257/820 (31.3%)	257	278/838 (33.2%)	278

Limitations/Caveats

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Principal Investigators are NOT employed by the organization sponsoring the study.

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.