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Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults

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ClinicalTrials.gov Identifier: NCT01430819
Recruitment Status : Completed
First Posted : September 8, 2011
Results First Posted : May 16, 2013
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
Biological: Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation
Enrollment 300
Recruitment Details Study participants were enrolled from 07 September through 24 October 2011 in 6 clinic sites in the US.
Pre-assignment Details A total of 300 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Arm/Group Title Fluzone® Vaccine Group Fluzone® High-Dose Vaccine Group
Hide Arm/Group Description Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation Participants received the Influenza Virus Vaccine, Fluzone® High-Dose 2011-2012 Formulation.
Period Title: Overall Study
Started 150 150
Completed 150 150
Not Completed 0 0
Arm/Group Title Fluzone® Vaccine Group Fluzone® High-Dose Vaccine Group Total
Hide Arm/Group Description Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation. Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation. Total of all reporting groups
Overall Number of Baseline Participants 150 150 300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 150 participants 300 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
150
 100.0%
150
 100.0%
300
 100.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 150 participants 150 participants 300 participants
72.6  (5.8) 71.6  (4.8) 72.1  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 150 participants 300 participants
Female
91
  60.7%
92
  61.3%
183
  61.0%
Male
59
  39.3%
58
  38.7%
117
  39.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 150 participants 150 participants 300 participants
150 150 300
1.Primary Outcome
Title Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Hide Description

Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.

Grade 3 solicited reactions were defined as: Fever ≥ 39.0°C; Pain, Headache, Malaise and Myalgia, significant, prevents daily activities; Erythema and Swelling > 100 mm.

Time Frame Day 0 to up to Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, Intent-to-treat population (Safety Analysis Set).
Arm/Group Title Fluzone® Vaccine Group Fluzone® High-Dose Vaccine Group
Hide Arm/Group Description:
Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
Overall Number of Participants Analyzed 150 150
Measure Type: Number
Unit of Measure: Participants
Any injection site Pain 36 79
Grade 3 injection site Pain 1 0
Any injection site Erythema 7 13
Grade 3 injection site Erythema 0 2
Any injection site Swelling 4 10
Grade 3 injection site Swelling 0 0
Any Fever 2 1
Grade 3 Fever 0 0
Any Headache 26 25
Grade 3 Headache 2 0
Any Malaise 21 24
Grade 3 Malaise 5 0
Any Myalgia 25 44
Grade 3 Myalgia 3 1
2.Other Pre-specified Outcome
Title Geometric Mean Titers of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.
Hide Description Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.
Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
GMTs of antibodies against Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population
Arm/Group Title Fluzone® Vaccine Group Fluzone® High-Dose Vaccine Group
Hide Arm/Group Description:
Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
Overall Number of Participants Analyzed 147 145
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1 (Pre-vaccination; N = 147, 145)
63.9
(50.1 to 81.5)
57.5
(44.6 to 74.1)
A/H1N1 (Post-vaccination; N = 147, 144)
228
(187 to 279)
442
(362 to 540)
A/H3N2 (Pre-vaccination; N = 147, 145)
104
(80.2 to 134)
102
(78.1 to 133)
A/H3N2 (Post-vaccination; N = 147, 145)
384
(317 to 465)
880
(721 to 1072)
B (Pre-vaccination; N = 147, 145)
32.4
(27.2 to 38.5)
31.1
(25.8 to 37.5)
B (Post-vaccination; N = 147, 145)
73.0
(63.4 to 84.0)
106
(90.2 to 125)
3.Other Pre-specified Outcome
Title Number of Participants With Seroconversion Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine
Hide Description

Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.

Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40; or a pre-vaccination titer ≥ 1:10 and a four-fold increase in post-vaccination titer.

Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion to Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population
Arm/Group Title Fluzone® Vaccine Group Fluzone® High-Dose Vaccine Group
Hide Arm/Group Description:
Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
Overall Number of Participants Analyzed 147 145
Measure Type: Number
Unit of Measure: Participants
A/H1N1 (N = 147, 144) 53 88
A/H3N2 (N = 147, 145) 60 100
B (N = 147, 145) 32 60
4.Other Pre-specified Outcome
Title Geometric Mean of Titer Ratios (GMTR) of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.
Hide Description

Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.

Geometric mean of titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer ratios.

Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean of titer ratios of antibodies against Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population
Arm/Group Title Fluzone® Vaccine Group Fluzone® High-Dose Vaccine Group
Hide Arm/Group Description:
Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
Overall Number of Participants Analyzed 147 145
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1 (N = 147, 144)
3.28
(2.69 to 4.01)
7.14
(5.61 to 9.11)
A/H3N2 (N = 147, 145)
3.5
(2.88 to 4.24)
8.23
(6.45 to 10.5)
B (N = 147, 145)
2.13
(1.90 to 2.38)
3.14
(2.69 to 3.67)
Time Frame Adverse events were recorded following vaccination (Day 0) for up to 28 days post-vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluzone® Vaccine Group Fluzone® High-Dose Vaccine Group
Hide Arm/Group Description Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation. Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
All-Cause Mortality
Fluzone® Vaccine Group Fluzone® High-Dose Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluzone® Vaccine Group Fluzone® High-Dose Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/150 (0.67%)      0/150 (0.00%)    
Injury, poisoning and procedural complications     
Joint injury * 1  1/150 (0.67%)  1 0/150 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Fluzone® Vaccine Group Fluzone® High-Dose Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/150 (24.00%)      79/150 (52.67%)    
General disorders     
Injection site Pain  1  36/150 (24.00%)  36 79/150 (52.67%)  79
Injection site Erythema  1  7/150 (4.67%)  7 13/150 (8.67%)  13
Injection site Swelling  1  4/150 (2.67%)  4 10/150 (6.67%)  10
Malaise  1  21/150 (14.00%)  21 24/150 (16.00%)  24
Musculoskeletal and connective tissue disorders     
Myalgia  1  25/150 (16.67%)  25 44/150 (29.33%)  44
Nervous system disorders     
Headache  1  26/150 (17.33%)  26 25/150 (16.67%)  25
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01430819     History of Changes
Other Study ID Numbers: GRC48
U 1111-1120-1287 ( Other Identifier: WHO )
First Submitted: September 7, 2011
First Posted: September 8, 2011
Results First Submitted: March 18, 2013
Results First Posted: May 16, 2013
Last Update Posted: May 27, 2013