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Trial record 42 of 597 for:    Fluzone® | Studies With Results

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

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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:
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

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
Hide 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
Arm/Group Title Fluzone Intradermal First, Then Fluzone Intramuscular Fluzone Intramuscular First, Then Fluzone Intradermal Total
Hide 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
Hide 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
1.Primary Outcome
Title Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluzone Intradermal Vaccine Fluzone Intramuscular Vaccine
Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
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
Hide 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   --/--      --/--    
Show Serious Adverse Events Hide 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%)    
Show Other (Not Including Serious) Adverse Events Hide 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
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.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00623181     History of Changes
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