Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults

• ClinicalTrials.gov Identifier: NCT00623181
• Recruitment Status: Completed
• First Posted: February 25, 2008
• Results First Posted: August 11, 2011
• Last Update Posted: April 14, 2016
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Influenza
• Intervention: Biological: Fluzone: Influenza virus vaccine
• Enrollment: 110

Participant Flow

Recruitment Details	Participants were enrolled and treated from 25 January 2008 to 11 March 2008 in 1 medical center in the US.
Pre-assignment Details	A total of 110 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Arm/Group Title	Fluzone Intradermal First, Then Fluzone Intramuscular	Fluzone Intramuscular First, Then Fluzone Intradermal
Arm/Group Description	Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0	Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
Period Title: Overall Study
Started	56	54
Completed	56	54
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Fluzone Intradermal First, Then Fluzone Intramuscular	Fluzone Intramuscular First, Then Fluzone Intradermal	Total
Arm/Group Description		Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0	Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0	Total of all reporting groups
Overall Number of Baseline Participants		56	54	110
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	56 participants	54 participants	110 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	56 100.0%	54 100.0%	110 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	56 participants	54 participants	110 participants
		31.2 (11.44)	31.3 (10.58)	31.27 (10.98)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	56 participants	54 participants	110 participants
	Female	35 62.5%	24 44.4%	59 53.6%
	Male	21 37.5%	30 55.6%	51 46.4%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	56 participants	54 participants	110 participants
		56	54	110

Outcome Measures

1. Primary Outcome

Title	Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
Description	Pain or other discomfort was assessed on a scale of 0 to 10 (None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; Unbearable = 9, 10) according to route of administration: intradermal (ID) as Group 1 and intramuscular (IM) as Group 2. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.
Time Frame	Day 0 and up to 7 days post-vaccination

Outcome Measure Data

Analysis Population Description

Pain or other discomfort was assessed in the Per-Protocol Population. Data were combined for responses following a similar type of vaccination route.

Arm/Group Title	Fluzone Intradermal Vaccine	Fluzone Intramuscular Vaccine
Arm/Group Description:	Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0	Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0
Overall Number of Participants Analyzed	101	101
Measure Type: Number; Unit of Measure: Participants
Any - Day 0	85	75
Severe or Worse - Day 0	4	2
Any - Day 3	44	35
Severe or Worse - Day 3	0	0
Any - Day 7	5	4
Severe or Worse - Day 7	0	0

2. Primary Outcome

Title	Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
Description	Numerical scores were assigned to pain by participants on the preference questionnaire as: None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; or Unbearable = 9, 10. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.
Time Frame	Days 0, 3, and 7 after vaccination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluzone Intradermal Vaccine	Fluzone Intramuscular Vaccine
Arm/Group Description:	Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0.	Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0
Overall Number of Participants Analyzed	101	101
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Day 0	2.97 (2.13)	2.02 (1.90)
Day 3	0.79 (1.23)	0.68 (1.20)
Day 7	0.08 (0.39)	0.05 (0.26)

3. Other Pre-specified Outcome

Title	Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection
Description	Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, Ecchymosis. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.
Time Frame	Days 0 through 7 post-vaccination

Outcome Measure Data

Analysis Population Description

Safety parameters were assessed in all enrolled and vaccinated participants, intend-to-treat population.

Arm/Group Title	Fluzone Intradermal Vaccine	Fluzone Intramuscular Vaccine
Arm/Group Description:	Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0	Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0.
Overall Number of Participants Analyzed	110	110
Measure Type: Number; Unit of Measure: Participants
Any Solicited Injection Site Pain	70	75
Gr 3 Solicited Injection Site -Pain Incapacitating	0	1
Any Solicited Injection Site Pruritus	39	12
Gr 3 Solicited Inj. Siite Pruritus -Incapacitating	1	0
Any Solicited Injection Site Erythema	92	15
Grade 3 Solicited Injection Site Erythema (≥ 5 cm)	11	0
Any Solicited Injection Site Swelling	68	12
Grade 3 Solicited Injection Site Swelling (≥ 5 cm)	1	0
Any Solicited Injection Site Induration	74	19
Gr 3 Solicited Injection Site Induration (≥ 5 cm)	1	0
Any Solicited Injection Site Ecchymosis	14	7
Gr 3 Solicited Injection Site Ecchymosis (≥ 5 cm)	0	0

4. Other Pre-specified Outcome

Title	Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection
Description	Solicited systemic reactions: Fever (temperature); Headache; Malaise; and Myalgia. Data for this outcome were based on the first vaccination type, intradermal or intramuscular.
Time Frame	Days 0 through 7 post-vaccination

Outcome Measure Data

Analysis Population Description

Safety parameters were assessed in all enrolled and vaccinated subjects, intend-to-treat population.

Arm/Group Title	Fluzone Intradermal First, Then Fluzone Intramuscular	Fluzone Intramuscular First, Then Fluzone Intradermal
Arm/Group Description:	Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0	Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
Overall Number of Participants Analyzed	56	54
Measure Type: Number; Unit of Measure: Participants
Any Solicited Fever	6	3
Grade 3 Solicited Fever (> 102.2 °F)	0	0
Any Solicited Headache	25	25
Gr 3 Solicited Headache -Prevents daily activities	3	1
Any Solicited Malaise	18	21
Gr 3 Solicited Malaise (Prevents daily activities)	4	4
Any Solicited Myalgia	31	26
Gr 3 Solicited Myalgia (Prevents daily activities)	3	1

Adverse Events

Time Frame	Adverse event data were collected from the day of vaccination for up to 28 days post-vaccination.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Fluzone Intradermal First, Then Fluzone Intramuscular		Fluzone Intramuscular First, Then Fluzone Intradermal
Arm/Group Description	Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0		Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
All-Cause Mortality
	Fluzone Intradermal First, Then Fluzone Intramuscular		Fluzone Intramuscular First, Then Fluzone Intradermal
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Fluzone Intradermal First, Then Fluzone Intramuscular		Fluzone Intramuscular First, Then Fluzone Intradermal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0.00%)		0/54 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Fluzone Intradermal First, Then Fluzone Intramuscular		Fluzone Intramuscular First, Then Fluzone Intradermal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	92/110 (83.64%)		75/110 (68.18%)
General disorders
Injection Site Pain † 1	70/110 (63.64%)	70	75/110 (68.18%)	75
Injection Site Pruritus † 1	39/110 (35.45%)	39	12/110 (10.91%)	12
Injection Site Erythema † 1	92/110 (83.64%)	92	15/110 (13.64%)	15
Injection Site Swelling † 1	68/110 (61.82%)	68	12/110 (10.91%)	12
Injection Site Induration † 1	74/110 (67.27%)	74	19/110 (17.27%)	19
Injection Site Ecchymosis † 1	14/110 (12.73%)	14	7/110 (6.36%)	7
Fever † 1	6/56 (10.71%)	6	3/54 (5.56%)	3
Malaise † 1	18/56 (32.14%)	18	21/54 (38.89%)	21
Musculoskeletal and connective tissue disorders
Myalgia † 1	31/56 (55.36%)	31	26/54 (48.15%)	26
Nervous system disorders
Headache † 1	25/56 (44.64%)	25	25/54 (46.30%)	25
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 10.1

Limitations and Caveats

[Not Specified]

More Information

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.

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 Inc.
• EMail: RegistryContactUs@sanofipasteur.com

• Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
• ClinicalTrials.gov Identifier: NCT00623181
• Other Study ID Numbers: FID30
• First Submitted: February 6, 2008
• First Posted: February 25, 2008
• Results First Submitted: July 14, 2011
• Results First Posted: August 11, 2011
• Last Update Posted: April 14, 2016