A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

• ClinicalTrials.gov Identifier: NCT00743275
• Recruitment Status: Completed
• First Posted: August 28, 2008
• Results First Posted: February 23, 2010
• Last Update Posted: May 16, 2016
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Influenza
• Intervention: Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)
• Enrollment: 120

Participant Flow

Recruitment Details	Participants were enrolled from 26 August to 03 September 2008 at one US clinical center.
Pre-assignment Details	A total of 122 participants who met the inclusion and exclusion criteria were enrolled. Of these, 120 participants were vaccinated.

Arm/Group Title	Age 18-60 Years	Age 61 Years and Older
Arm/Group Description	Participants received one dose of Fluzone® vaccine on Day 0.	Participants received one dose of Fluzone® vaccine on Day 0.
Period Title: Overall Study
Started	59	61
Completed	59	60
Not Completed	0	1
Reason Not Completed
Protocol Violation	0	1

Baseline Characteristics

Arm/Group Title		Age 18-60 Years	Age 61 Years and Older	Total
Arm/Group Description		Participants received one dose of Fluzone® vaccine on Day 0.	Participants received one dose of Fluzone® vaccine on Day 0.	Total of all reporting groups
Overall Number of Baseline Participants		59	61	120
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	59 participants	61 participants	120 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	59 100.0%	8 13.1%	67 55.8%
	>=65 years	0 0.0%	53 86.9%	53 44.2%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	59 participants	61 participants	120 participants
		43.2 (12.14)	74.7 (7.67)	59.2 (18.74)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	59 participants	61 participants	120 participants
	Female	45 76.3%	38 62.3%	83 69.2%
	Male	14 23.7%	23 37.7%	37 30.8%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	59 participants	61 participants	120 participants
		59	61	120

Outcome Measures

1. Primary Outcome

Title	Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Description	Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering
Time Frame	Days 0-3 post-vaccination

Outcome Measure Data

Analysis Population Description

Safety profile was assessed in the intent-to-treat (ITT) population

Arm/Group Title	Age 18-60 Years	Age 61 Years and Older
Arm/Group Description:	Participants received one dose of Fluzone® vaccine on Day 0.	Participants received one dose of Fluzone® vaccine on Day 0.
Overall Number of Participants Analyzed	59	61
Measure Type: Number; Unit of Measure: Participants
Any Solicited Injection Site Reaction	35	18
Any Pain	34	16
Grade 3 Pain (Incapacitating)	0	1
Any Erythema (Redness)	7	2
Grade 3 Erythema (Redness)	0	0
Any Swelling	4	1
Grade 3 Swelling (≥ 5 cm)	0	1
Any Induration	5	1
Grade 3 Induration (≥ 5 cm)	0	0
Any Ecchymosis	2	1
Grade 3 Ecchymosis (≥ 5 cm)	0	0
Any Solicited Systemic Reaction	25	14
Any Fever	1	0
Grade 3 Fever (> 102.2 ºF)	0	0
Any Headache	17	6
Grade 3 Headache	1	0
Any Malaise	9	2
Grade 3 Malaise (Prevents daily activities)	1	0
Any Myalgia	19	10
Grade 3 Myalgia (Prevents daily activities)	1	1
Any Shivering	4	0
Grade 3 Shivering (Prevents daily activities)	0	0

2. Primary Outcome

Title	Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation
Description	[Not Specified]
Time Frame	Day 0 and 21 days post-vaccination

Outcome Measure Data

Analysis Population Description

Analysis of Geometric Mean Titers was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)

Arm/Group Title	Age 18-60 Years	Age 61 Years and Older
Arm/Group Description:	Participants received one dose of Fluzone® vaccine on Day 0.	Participants received one dose of Fluzone® vaccine on Day 0.
Overall Number of Participants Analyzed	50	49
Geometric Mean (95% Confidence Interval); Unit of Measure: Titers
A/Brisbane/59/2007 (H1N1) IVR-148 Pre-dose	26.9; (18.8 to 38.6)	16.9; (13.3 to 21.4)
A/Uruguay (H3N2) X-175-C Pre-dose	34.9; (22.5 to 54.2)	31.5; (21.5 to 46.0)
B/Florida/04/2006 Pre-dose	28.5; (21.0 to 38.6)	21.6; (16.6 to 28.1)
A/Brisbane/59/2007 (H1N1) IVR-148 Post-dose	130.9; (91.1 to 188.1)	46.1; (35.0 to 60.7)
A/Uruguay (H3N2) X-175-C Post-dose	528.7; (351.1 to 796.3)	300.3; (217.9 to 413.7)
B/Florida/04/2006 Post-dose	84.0; (64.9 to 108.6)	56.2; (40.9 to 77.2)

3. Primary Outcome

Title	Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)
Description	Seroprotection was defined as post-vaccination titer value of ≥ 1:40.
Time Frame	21 days post-vaccination

Outcome Measure Data

Analysis Population Description

Analysis of seroprotection was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)

Arm/Group Title	Age 18-60 Years	Age 61 Years and Older
Arm/Group Description:	Participants received one dose of Fluzone® vaccine on Day 0.	Participants received one dose of Fluzone® vaccine on Day 0.
Overall Number of Participants Analyzed	50	49
Measure Type: Number; Unit of Measure: Percentage of Participants
A/Brisbane/59/2007 (H1N1) IVR-148	88	63
A/Uruguay (H3N2) X-175-C	98	98
B/Florida/04/2006	82	67

4. Primary Outcome

Title	Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)
Description	Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is < 10, then 10 is used as the baseline value for the purposes of this calculation
Time Frame	21 days post-vaccination

Outcome Measure Data

Analysis Population Description

Analysis of seroconversion was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)

Arm/Group Title	Age 18-60 Years	Age 61 Years and Older
Arm/Group Description:	Participants received one dose of Fluzone® vaccine on Day 0.	Participants received one dose of Fluzone® vaccine on Day 0.
Overall Number of Participants Analyzed	50	49
Measure Type: Number; Unit of Measure: Percentage of Participants
A/Brisbane/59/2007 (H1N1) IVR-148	42	33
A/Uruguay (H3N2) X 175-C	77	84
B/Florida/04/2006	36	31

Adverse Events

Time Frame	Adverse events data were collected throughout the study from Day 0 to Day 21.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Age 18-60 Years		Age 61 Years and Older
Arm/Group Description	Participants received one dose of Fluzone® vaccine on Day 0.		Participants received one dose of Fluzone® vaccine on Day 0.
All-Cause Mortality
	Age 18-60 Years		Age 61 Years and Older
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Age 18-60 Years		Age 61 Years and Older
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0.00%)		0/61 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Age 18-60 Years		Age 61 Years and Older
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/59 (57.63%)		16/61 (26.23%)
General disorders
Injection site pain † 1	34/59 (57.63%)	34	16/61 (26.23%)	16
Injection site erythema † 1	7/59 (11.86%)	7	2/61 (3.28%)	2
Injection site swelling † 1	4/59 (6.78%)	4	1/61 (1.64%)	1
Injection site induration † 1	5/59 (8.47%)	5	1/61 (1.64%)	1
Malaise † 1	9/59 (15.25%)	9	2/61 (3.28%)	2
Chills † 1	4/59 (6.78%)	4	0/61 (0.00%)	0
Musculoskeletal and connective tissue disorders
Myalgia † 1	19/59 (32.20%)	19	10/61 (16.39%)	10
Nervous system disorders
Headache † 1	17/59 (28.81%)	17	6/61 (9.84%)	6
Respiratory, thoracic and mediastinal disorders
Cough * 1	5/59 (8.47%)	5	0/61 (0.00%)	0
Nasal congestion * 1	4/59 (6.78%)	4	0/61 (0.00%)	0
Pharyngolaryngeal pain * 1	6/59 (10.17%)	6	1/61 (1.64%)	1
Rhinorrhoea * 1	3/59 (5.08%)	3	1/61 (1.64%)	1
† Indicates events were collected by systematic assessment; * Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 10.0

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: NCT00743275
• Other Study ID Numbers: GRC41
• First Submitted: August 27, 2008
• First Posted: August 28, 2008
• Results First Submitted: February 1, 2010
• Results First Posted: February 23, 2010
• Last Update Posted: May 16, 2016