Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults

• Sponsor: Sanofi Pasteur, a Sanofi Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00772109
• Collaborator: (none)
• Enrollment: 4,292
• Locations: 49
• Arms: 4
• Duration (Months): 9
• Patients Per Site: 87.6
• Patients Per Site Per Month: 9.8

Study Details

Study Description

Brief Summary

This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route.

Primary Objective:

• To demonstrate lot consistency of the Fluzone ID manufacturing process.

• To provide information concerning the immune response of Fluzone ID.

Secondary Objectives:

Safety

• To describe the safety profile of subjects who receive of Fluzone ID.

Condition or Disease	Intervention/Treatment	Phase
Orthomyxoviridae Infection; Influenza; Myxovirus Infection	Biological: Influenza Virus Vaccine USP Trivalent Types A and B; Biological: Influenza Virus Vaccine USP Trivalent Types A and B; Biological: Influenza Virus Vaccine USP Trivalent Types A and B; Biological: Influenza Virus Vaccine USP Trivalent Types A and B	Phase 3

Detailed Description

Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere formulation will be administered intradermally (ID) using the Becton Dickinson Micro Injection System.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4292 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Lot Consistency, Immunogenicity, and Safety Study of Three Lots of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® Administered Intramuscularly in Adult Subjects Aged 18 to 64 Years
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluzone Intradermal Vaccine Lot 1 Participants will receive a dose of Influenza intradermal vaccine Lot 1	Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.1 mL, Intradermal
Experimental: Fluzone Intradermal Vaccine Lot 2 Participants will receive a dose of Influenza intradermal vaccine Lot 2	Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.1 mL, Intradermal
Experimental: Fluzone Intradermal Vaccine Lot 3 Participants will receive a dose of Influenza intradermal vaccine Lot 3	Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.1 mL, Intradermal
Active Comparator: Fluzone Intramuscular Vaccine Participants will receive a dose of influenza intramuscular vaccine	Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.5 mL, Intramuscular; Other Names: Fluzone®

Outcome Measures

Primary Outcome Measures

1. Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines [Baseline (Day 0) and 28 Days post-vaccination]

   The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay

2. Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine [28 Days post-vaccination]

   The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination.

Secondary Outcome Measures

1. Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM [Before and 28 Days post-vaccination]

   The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroprotection was defined as a HAI antibody titer ≥ 1:40.

2. Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine [Day 0 up to 7 Days post vaccination]

   Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.

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 to 64 years on the day of vaccination.

• Informed consent form signed and dated.

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

• For women of child bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination.

Exclusion Criteria :

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

• For a woman of child-bearing potential: known pregnancy or positive serum/urine pregnancy test.

• Breast-feeding woman.

• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination.

• Planned participation in another clinical trial during the present trial period.

• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy

• Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.

• Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures.

• Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.

• Receipt of any vaccination in the 4 weeks preceding the trial vaccination.

• Planned receipt of any vaccine in the 4 weeks following the trial vaccination.

• Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine.

• Thrombocytopenia or bleeding disorder in the 3 weeks preceding inclusion.

• Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

• 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).

• Personal or family history of Guillain-Barré Syndrome.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Hoover	Alabama	United States	35216
2		Huntsville	Alabama	United States	35802
3		Mobile	Alabama	United States	36608
4		Chandler	Arizona	United States	85224
5		Mesa	Arizona	United States	85213
6		Phoenix	Arizona	United States	85014
7		Tucson	Arizona	United States	85711
8		Fountain Valley	California	United States	92708
9		San Diego	California	United States	92103
10		Milford	Connecticut	United States	06460
11		Melbourne	Florida	United States	32935
12		Pembroke Pines	Florida	United States	33024
13		Pinellas Park	Florida	United States	33781
14		Boise	Idaho	United States	83642
15		Chicago	Illinois	United States	60610
16		Iowa City	Iowa	United States	52242
17		Wichita	Kansas	United States	67207
18		Lexington	Kentucky	United States	40509
19		Madisonville	Kentucky	United States	42431
20		Rockville	Maryland	United States	20850
21		Kansas City	Missouri	United States	64114
22		Springfield	Missouri	United States	65802
23		St. Louis	Missouri	United States	63104
24		Albuquerque	New Mexico	United States	87108
25		Binghamton	New York	United States	13901
26		Endwell	New York	United States	13760
27		Rochester	New York	United States	14609
28		Rochester	New York	United States	14621
29		Cary	North Carolina	United States	27518
30		Raleigh	North Carolina	United States	27609
31		Cincinnati	Ohio	United States	45249
32		Allentown	Pennsylvania	United States	18102
33		Bensalem	Pennsylvania	United States	19020
34		Warwick	Rhode Island	United States	02886
35		Mt. Pleasant	South Carolina	United States	29464
36		Nashville	Tennessee	United States	37203
37		Austin	Texas	United States	78705
38		Fort Worth	Texas	United States	76107
39		Fort Worth	Texas	United States	76135
40		Galveston	Texas	United States	77555
41		San Angelo	Texas	United States	76904
42		Salt Lake City	Utah	United States	84121
43		Salt Lake	Utah	United States	84109
44		West Jordan	Utah	United States	84088
45		Seattle	Washington	United States	98101
46		Marshfield	Wisconsin	United States	54449
47		Castellana Gardens, Carolina		Puerto Rico	00983
48		San Juan		Puerto Rico	00918
49		San Juan		Puerto Rico	00935

Sponsors and Collaborators

• Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Monitor, Sanofi Pasteur Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT00772109
• Other Study ID Numbers: FID31
• First Posted: Oct 15, 2008
• Last Update Posted: Apr 14, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Sanofi Pasteur, a Sanofi Company: Influenza; Orthomyxoviruses; Inactivated Split-virion influenza vaccine; Fluzone®; Adults
• Additional relevant MeSH terms: Infections; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections; Vaccines

Study Results

Participant Flow

Recruitment Details	Participants were enrolled from 13 through 30 October 2008 in 50 clinics in the US.
Pre-assignment Detail	A total of 4276 of the 4292 participants that met the inclusion and exclusion criteria enrolled were vaccinated.

Arm/Group Title	Fluzone Intradermal (ID) Vaccine Lot 1	Fluzone Intradermal (ID) Vaccine Lot 2	Fluzone Intradermal (ID) Vaccine Lot 3	Fluzone Intramuscular (IM) Vaccine
Arm/Group Description	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0	Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
Period Title: Overall Study
STARTED	956	953	955	1428
COMPLETED	935	934	936	1397
NOT COMPLETED	21	19	19	31

Baseline Characteristics

Arm/Group Title	Fluzone Intradermal (ID) Vaccine Lot 1	Fluzone Intradermal (ID) Vaccine Lot 2	Fluzone Intradermal (ID) Vaccine Lot 3	Fluzone Intramuscular (IM) Vaccine	Total
Arm/Group Description	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0	Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0	Total of all reporting groups
Overall Participants	956	953	955	1428	4292
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	956 100%	953 100%	955 100%	1428 100%	4292 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	42.7 (13.41)	42.8 (13.33)	42.2 (13.78)	42.5 (13.55)	42.5 (13.5175)
Sex: Female, Male (Count of Participants)
Female	611 63.9%	619 65%	594 62.2%	899 63%	2723 63.4%
Male	345 36.1%	334 35%	361 37.8%	529 37%	1569 36.6%
Region of Enrollment (Number) [Number]
United States	956 100%	953 100%	955 100%	1428 100%	4292 100%

Outcome Measures

1. Primary Outcome

Title	Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines
Description	The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay
Time Frame	Baseline (Day 0) and 28 Days post-vaccination

Outcome Measure Data

Analysis Population Description

Geometric Mean Titers (GMTs) were analyzed in the per-protocol population

Arm/Group Title	Fluzone Intradermal (ID) Vaccine Lot 1	Fluzone Intradermal (ID) Vaccine Lot 2	Fluzone Intradermal (ID) Vaccine Lot 3	Fluzone Intramuscular (IM) Vaccine
Arm/Group Description	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0	Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
Measure Participants	863	856	860	1286
A/H1N1 (Pre-vaccination, N = 863, 856, 860, 1285)	23.50	25.27	25.29	24.84
A/H1N1 (Post-vaccination, N = 863, 855, 861, 1283)	188.56	185.59	206.10	178.30
A/H3N2 (Pre-vaccination, N = 862, 853, 860, 1286)	18.77	20.56	18.37	19.99
A/H3N2 (Post-vaccination, N = 862, 853, 860, 1284)	260.46	234.03	246.06	230.71
B (Pre-vaccination, N = 862, 855, 860, 1286)	23.77	25.59	24.24	25.05
B (Post-vaccination, N = 861, 856, 860, 1285)	103.72	102.91	100.82	126.91

2. Primary Outcome

Title	Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Description	The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination.
Time Frame	28 Days post-vaccination

Outcome Measure Data

Analysis Population Description

Seroprotection was analyzed in the per-protocol population

Arm/Group Title	Fluzone Intradermal (ID) Vaccine Lot 1	Fluzone Intradermal (ID) Vaccine Lot 2	Fluzone Intradermal (ID) Vaccine Lot 3	Fluzone Intramuscular (IM) Vaccine
Arm/Group Description	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0	Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
Measure Participants	863	856	860	1286
A/H1N1 Serogroup	61 6.4%	59 6.2%	63 6.6%	61 4.3%
A/H3N2 Serogroup	76 7.9%	73 7.7%	77 8.1%	75 5.3%
B Serogroup	47 4.9%	45 4.7%	47 4.9%	54 3.8%

3. Secondary Outcome

Title	Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM
Description	The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroprotection was defined as a HAI antibody titer ≥ 1:40.
Time Frame	Before and 28 Days post-vaccination

Outcome Measure Data

Analysis Population Description

4-Fold increase in antibody levels were analyzed in h per-protocol population

Arm/Group Title	Fluzone Intradermal (ID) Vaccine Lot 1	Fluzone Intradermal (ID) Vaccine Lot 2	Fluzone Intradermal (ID) Vaccine Lot 3	Fluzone Intramuscular (IM) Vaccine
Arm/Group Description	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0	Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
Measure Participants	863	857	861	1287
A/H1N1 Serogroup (Pre-vaccination)	39 4.1%	40 4.2%	42 4.4%	39 2.7%
A/H1N1 Serogroup (Post-vaccination)	90 9.4%	90 9.4%	93 9.7%	92 6.4%
A/H3N2 Serogroup (Pre-vaccination)	31 3.2%	32 3.4%	30 3.1%	34 2.4%
A/H3N2 Serogroup (Post-vaccination)	92 9.6%	90 9.4%	91 9.5%	91 6.4%
B Serogroup (Pre-vaccination)	38 4%	42 4.4%	40 4.2%	41 2.9%
B Serogroup (Post-vaccination)	88 9.2%	88 9.2%	86 9%	89 6.2%

4. Secondary Outcome

Title	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Description	Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Time Frame	Day 0 up to 7 Days post vaccination

Outcome Measure Data

Analysis Population Description

Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population

Arm/Group Title	Fluzone Intradermal (ID) Vaccine Lot 1	Fluzone Intradermal (ID) Vaccine Lot 2	Fluzone Intradermal (ID) Vaccine Lot 3	Fluzone Intramuscular (IM) Vaccine
Arm/Group Description	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0	Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
Measure Participants	953	951	951	1421
Any Injection Site Ecchymosis	81 8.5%	82 8.6%	97 10.2%	86 6%
Grade 3 Injection Site Ecchymosis (≥ 5 cm)	8 0.8%	2 0.2%	2 0.2%	6 0.4%
Any Injection Site Erythema	716 74.9%	698 73.2%	726 76%	184 12.9%
Grade 3 Injection Site Erythema (≥ 5 cm)	125 13.1%	118 12.4%	120 12.6%	13 0.9%
Any Injection Site Induration	554 57.9%	533 55.9%	547 57.3%	139 9.7%
Grade 3 Injection Site Induration (≥ 5 cm)	36 3.8%	19 2%	41 4.3%	7 0.5%
Any Injection Site Pain	480 50.2%	449 47.1%	500 52.4%	749 52.5%
Grade 3 Injection Site Pain (Incapacitating)	3 0.3%	6 0.6%	9 0.9%	11 0.8%
Any Injection Site Pruritus	447 46.8%	430 45.1%	438 45.9%	129 9%
Grade 3 Injection Site Pruritus (Incapacitating)	13 1.4%	10 1%	7 0.7%	0 0%
Any Injection Site Swelling	544 56.9%	525 55.1%	519 54.3%	117 8.2%
Grade 3 Injection Site Swelling (≥ 5 cm)	55 5.8%	45 4.7%	52 5.4%	13 0.9%
Any Solicited Fever	29 3%	40 4.2%	40 4.2%	36 2.5%
Grade 3 Solicited Fever (> 102.2°F)	2 0.2%	0 0%	0 0%	3 0.2%
Any Solicited Headache	282 29.5%	279 29.3%	314 32.9%	422 29.6%
Gr 3 Solicited Headache- Prevents daily activities	11 1.2%	16 1.7%	14 1.5%	22 1.5%
Any Solicited Malaise	212 22.2%	202 21.2%	239 25%	309 21.6%
Grd 3 Solicited Malaise- Prevents daily activities	19 2%	26 2.7%	17 1.8%	25 1.8%
Any Solicited Myalgia	252 26.4%	229 24%	260 27.2%	430 30.1%
Grd 3 Solicited Myalgia- Prevents daily activities	13 1.4%	18 1.9%	10 1%	19 1.3%
Any Solicited Shivering	71 7.4%	56 5.9%	77 8.1%	87 6.1%
Gr 3 Solicited Shivering-Prevents daily activities	7 0.7%	8 0.8%	6 0.6%	9 0.6%

Adverse Events

Time Frame	Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
Arm/Group Title	Fluzone Intradermal (ID) Vaccine Lot 1		Fluzone Intradermal (ID) Vaccine Lot 2		Fluzone Intradermal (ID) Vaccine Lot 3		Fluzone Intramuscular (IM) Vaccine
Arm/Group Description	Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0		Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0		Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0		Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
All Cause Mortality
	Fluzone Intradermal (ID) Vaccine Lot 1		Fluzone Intradermal (ID) Vaccine Lot 2		Fluzone Intradermal (ID) Vaccine Lot 3		Fluzone Intramuscular (IM) Vaccine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Fluzone Intradermal (ID) Vaccine Lot 1		Fluzone Intradermal (ID) Vaccine Lot 2		Fluzone Intradermal (ID) Vaccine Lot 3		Fluzone Intramuscular (IM) Vaccine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/953 (1.8%)		16/951 (1.7%)		14/951 (1.5%)		20/1421 (1.4%)
Blood and lymphatic system disorders
Iron deficiency anaemia	0/953 (0%)	0	1/951 (0.1%)	1	0/951 (0%)	0	1/1421 (0.1%)	1
Cardiac disorders
Atrial fibrillation	0/953 (0%)	0	0/951 (0%)	0	0/951 (0%)	0	2/1421 (0.1%)	2
Bradycardia	0/953 (0%)	0	0/951 (0%)	0	0/951 (0%)	0	1/1421 (0.1%)	1
Cardiac failure acute	0/953 (0%)	0	0/951 (0%)	0	0/951 (0%)	0	1/1421 (0.1%)	1
Cardiac failure congestive	1/953 (0.1%)	1	0/951 (0%)	0	0/951 (0%)	0	1/1421 (0.1%)	1
Myocardial infarction	1/953 (0.1%)	1	0/951 (0%)	0	0/951 (0%)	0	0/1421 (0%)	0
Congenital, familial and genetic disorders
Atrial septal defect	0/953 (0%)	0	0/951 (0%)	0	0/951 (0%)	0	1/1421 (0.1%)	1
Endocrine disorders
Hyperthyroidism	0/953 (0%)	0	0/951 (0%)	0	0/951 (0%)	0	1/1421 (0.1%)	1
Gastrointestinal disorders
Colitis ischaemic	0/953 (0%)	0	0/951 (0%)	0	0/951 (0%)	0	1/1421 (0.1%)	1
Gastritis	1/953 (0.1%)	1	1/951 (0.1%)	1	0/951 (0%)	0	0/1421 (0%)	0
Gastrooesophageal reflux disease	0/953 (0%)	0	1/951 (0.1%)	1	0/951 (0%)	0	0/1421 (0%)	0
Intussusception	0/953 (0%)	0	0/951 (0%)	0	1/951 (0.1%)	1	0/1421 (0%)	0
General disorders
Chest discomfort	0/953 (0%)	0	1/951 (0.1%)	1	0/951 (0%)	0	0/1421 (0%)	0
Chest pain	0/953 (0%)	0	0/951 (0%)	0	1/951 (0.1%)	1	3/1421 (0.2%)	3
Non cardiac chest pain	0/953 (0%)	0	0/951 (0%)	0	0/951 (0%)	0	1/1421 (0.1%)	1
Hepatobiliary disorders
Cholelithiasis	1/953 (0.1%)	1	1/951 (0.1%)	1	1/951 (0.1%)	1	1/1421 (0.1%)	1
Immune system disorders
Anaphylactic reaction	0/953 (0%)	0	1/951 (0.1%)	1	0/951 (0%)	0	0/1421 (0%)	0
Infections and infestations
Abscess limb	0/953 (0%)	0	0/951 (0%)	0	1/951 (0.1%)	1	0/1421 (0%)	0
Appendicitis	0/953 (0%)	0	1/951 (0.1%)	1	0/951 (0%)	0	1/1421 (0.1%)	1
Chronic sinusitis	1/953 (0.1%)	1	0/951 (0%)	0	0/951 (0%)	0	0/1421 (0%)	0
Diverticulitis	0/953 (0%)	0	1/951 (0.1%)	1	0/951 (0%)	0	1/1421 (0.1%)	1
Escherichia sepsis	0/953 (0%)	0	0/951 (0%)	0	1/951 (0.1%)	1	0/1421 (0%)	0
Gastroenteritis	0/953 (0%)	0	1/951 (0.1%)	1	0/951 (0%)	0	0/1421 (0%)	0
Gastroenteritis viral	0/953 (0%)	0	0/951 (0%)	0	1/951 (0.1%)	1	0/1421 (0%)	0
Pneumonia	1/953 (0.1%)	1	0/951 (0%)	0	1/951 (0.1%)	1	0/1421 (0%)	0
Sepsi	0/953 (0%)	0	0/951 (0%)	0	0/951 (0%)	0	1/1421 (0.1%)	1
Injury, poisoning and procedural complications
Ankle fracture	0/953 (0%)	0	1/951 (0.1%)	1	0/951 (0%)	0	0/1421 (0%)	0
Femur fracture	0/953 (0%)	0	0/951 (0%)	0	1/951 (0.1%)	1	0/1421 (0%)	0
Gun shot wound	1/953 (0.1%)	1	0/951 (0%)	0	0/951 (0%)	0	0/1421 (0%)	0
Injury	0/953 (0%)	0	1/951 (0.1%)	1	0/951 (0%)	0	0/1421 (0%)	0
Lower limb fracture	1/953 (0.1%)	1	0/951 (0%)	0	0/951 (0%)	0	0/1421 (0%)	0
Road traffic accident	0/953 (0%)	0	1/951 (0.1%)	1	1/951 (0.1%)	1	0/1421 (0%)	0
Stent occlusion	0/953 (0%)	0	0/951 (0%)	0	0/951 (0%)	0	1/1421 (0.1%)	1
Therapeutic agent toxicity	0/953 (0%)	0	0/951 (0%)	0	1/951 (0.1%)	1	0/1421 (0%)	0
Wrist fracture	0/953 (0%)	0	0/951 (0%)	0	0/951 (0%)	0	1/1421 (0.1%)	1
Metabolism and nutrition disorders
Hypokalaemia	0/953 (0%)	0	0/951 (0%)	0	0/951 (0%)	0	1/1421 (0.1%)	2
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	1/953 (0.1%)	1	1/951 (0.1%)	1	1/951 (0.1%)	1	0/1421 (0%)	0
Musculoskeletal chest pain	0/953 (0%)	0	0/951 (0%)	0	0/951 (0%)	0	1/1421 (0.1%)	1
Osteoarthritis	1/953 (0.1%)	1	0/951 (0%)	0	0/951 (0%)	0	0/1421 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer	1/953 (0.1%)	1	0/951 (0%)	0	0/951 (0%)	0	0/1421 (0%)	0
Bladder cancer	0/953 (0%)	0	0/951 (0%)	0	1/951 (0.1%)	1	0/1421 (0%)	0
Breast cancer	0/953 (0%)	0	0/951 (0%)	0	0/951 (0%)	0	1/1421 (0.1%)	1
Carcinoid tumour of the gastrointestinal tract	0/953 (0%)	0	1/951 (0.1%)	1	0/951 (0%)	0	0/1421 (0%)	0
Uterine leiomyoma	0/953 (0%)	0	0/951 (0%)	0	0/951 (0%)	0	1/1421 (0.1%)	1
Nervous system disorders
Headache	1/953 (0.1%)	1	0/951 (0%)	0	0/951 (0%)	0	0/1421 (0%)	0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	2/953 (0.2%)	2	0/951 (0%)	0	0/951 (0%)	0	0/1421 (0%)	0
Psychiatric disorders
Bipolar disorder	1/953 (0.1%)	1	0/951 (0%)	0	0/951 (0%)	0	0/1421 (0%)	0
Renal and urinary disorders
Renal infarct	0/953 (0%)	0	1/951 (0.1%)	1	0/951 (0%)	0	0/1421 (0%)	0
Reproductive system and breast disorders
Adenomyosis	0/953 (0%)	0	0/951 (0%)	0	0/951 (0%)	0	1/1421 (0.1%)	1
Cystocele	0/953 (0%)	0	1/951 (0.1%)	1	0/951 (0%)	0	0/1421 (0%)	0
Uterovaginal prolapse	1/953 (0.1%)	1	0/951 (0%)	0	0/951 (0%)	0	0/1421 (0%)	0
Vaginal haemorrhage	0/953 (0%)	0	0/951 (0%)	0	1/951 (0.1%)	1	0/1421 (0%)	0
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic	1/953 (0.1%)	1	0/951 (0%)	0	0/951 (0%)	0	0/1421 (0%)	0
Pulmonary embolism	0/953 (0%)	0	0/951 (0%)	0	1/951 (0.1%)	1	0/1421 (0%)	0
Skin and subcutaneous tissue disorders
Rash	0/953 (0%)	0	0/951 (0%)	0	1/951 (0.1%)	1	0/1421 (0%)	0
Vascular disorders
Arteriovenous fistula	1/953 (0.1%)	1	0/951 (0%)	0	0/951 (0%)	0	0/1421 (0%)	0
Deep vein thrombosis	0/953 (0%)	0	0/951 (0%)	0	1/951 (0.1%)	1	0/1421 (0%)	0
Haematoma	0/953 (0%)	0	1/951 (0.1%)	1	0/951 (0%)	0	0/1421 (0%)	0
Vascular pseudoaneurysm	1/953 (0.1%)	1	0/951 (0%)	0	0/951 (0%)	0	0/1421 (0%)	0
Other (Not Including Serious) Adverse Events
	Fluzone Intradermal (ID) Vaccine Lot 1		Fluzone Intradermal (ID) Vaccine Lot 2		Fluzone Intradermal (ID) Vaccine Lot 3		Fluzone Intramuscular (IM) Vaccine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	716/953 (75.1%)		698/951 (73.4%)		726/951 (76.3%)		749/1421 (52.7%)
General disorders
Injection site ecchymosis	81/935 (8.7%)	81	82/935 (8.8%)	82	97/929 (10.4%)	97	86/1392 (6.2%)	86
Injection site erythema	716/936 (76.5%)	716	698/935 (74.7%)	698	726/930 (78.1%)	726	184/1393 (13.2%)	184
Injection site induration	554/934 (59.3%)	554	533/935 (57%)	533	547/929 (58.9%)	547	139/1392 (10%)	139
Injection site pain	480/936 (51.3%)	480	449/935 (48%)	449	500/931 (53.7%)	500	749/1394 (53.7%)	749
Injection site pruritus	447/936 (47.8%)	447	430/935 (46%)	430	438/931 (47%)	438	129/1394 (9.3%)	129
Injection site swelling	544/934 (58.2%)	544	525/935 (56.1%)	525	519/929 (55.9%)	519	117/1392 (8.4%)	117
Solicited Malaise	212/936 (22.6%)	212	202/935 (21.6%)	202	239/930 (25.7%)	239	309/1394 (22.2%)	309
Musculoskeletal and connective tissue disorders
Solicited Myalgia	252/936 (26.9%)	252	229/935 (24.5%)	229	260/930 (28%)	260	430/1394 (30.8%)	430
Solicited Shivering	71/936 (7.6%)	71	56/935 (6%)	56	77/930 (8.3%)	77	87/1394 (6.2%)	87
Nervous system disorders
Solicited Headache	282/936 (30.1%)	282	279/935 (29.8%)	279	314/930 (33.8%)	314	422/1394 (30.3%)	422

Limitations/Caveats

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

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