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A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age

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ClinicalTrials.gov Identifier: NCT01258595
Recruitment Status : Completed
First Posted : December 13, 2010
Results First Posted : October 27, 2011
Last Update Posted : May 16, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: High-Dose Trivalent Inactivated Influenza Vaccine
Biological: Trivalent Inactivated Influenza Vaccine
Enrollment 300
Recruitment Details Participants were enrolled from 15 November to 10 December 2010 in 4 clinical centers in the US.
Pre-assignment Details A total of 300 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Fluzone® High-Dose Vaccine Group Fluzone® Vaccine Group
Hide Arm/Group Description Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0 Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
Period Title: Overall Study
Started 148 152
Completed 147 151
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             0             1
Arm/Group Title Fluzone® High-Dose Vaccine Group Fluzone® Vaccine Group Total
Hide Arm/Group Description Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0 Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0 Total of all reporting groups
Overall Number of Baseline Participants 148 152 300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants 152 participants 300 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
148
 100.0%
152
 100.0%
300
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 148 participants 152 participants 300 participants
57.6  (4.38) 57.7  (4.14) 57.7  (4.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants 152 participants 300 participants
Female
98
  66.2%
96
  63.2%
194
  64.7%
Male
50
  33.8%
56
  36.8%
106
  35.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 148 participants 152 participants 300 participants
148 152 300
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.
Hide Description Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.
Time Frame Day 0 and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Serum antibody titers to vaccine antigens were assessed in the full analysis set population.
Arm/Group Title Fluzone® High-Dose Vaccine Group Fluzone® Vaccine Group
Hide Arm/Group Description:
Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
Overall Number of Participants Analyzed 147 152
Geometric Mean (95% Confidence Interval)
Unit of Measure: 1/dilution (1/dil)
A/H1N1: California - Pre-vaccination (N=147, 152)
40.5
(30.0 to 54.5)
28.8
(21.8 to 38.1)
A/H3N2: Victoria - Pre-vaccination (N=147, 152)
36.4
(28.0 to 47.4)
41.4
(31.4 to 54.6)
B: Brisbane - Pre-vaccination (N=147, 152)
27.4
(22.4 to 33.6)
28.9
(23.5 to 35.5)
A/H1N1: California - Post-vaccination (N=145, 151)
1067
(868 to 1312)
745
(585 to 948)
A/H3N2: Victoria - Post-vaccination (N = 145, 151)
936
(745 to 1176)
567
(459 to 699)
B: Brisbane - Post-vaccination (N=145, 151)
203
(171 to 241)
127
(104 to 154)
2.Primary Outcome
Title Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Hide Description Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.
Time Frame Day 0 and Day 28 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Serum antibody titers to vaccine antigens were assessed in the full analysis set population.
Arm/Group Title Fluzone® High-Dose Vaccine Group Fluzone® Vaccine Group
Hide Arm/Group Description:
Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
Overall Number of Participants Analyzed 145 151
Geometric Mean (95% Confidence Interval)
Unit of Measure: 1/dilution (1/dil)
A/H1N1: California
21.8
(16.1 to 29.6)
21.2
(15.8 to 28.4)
A/H3N2: Victoria
22.0
(17.2 to 28.1)
12.0
(9.21 to 15.5)
B: Brisbane
6.27
(5.16 to 7.62)
3.91
(3.17 to 4.83)
3.Primary Outcome
Title Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Hide Description

Seroconversion: For participants with a Day 0 (pre-vaccination) titer < 10 (1/dilution [1/dil]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28.

Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.

Time Frame Day 0 and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion to the vaccine antigens was assessed in the full analysis set population.
Arm/Group Title Fluzone® High-Dose Vaccine Group Fluzone® Vaccine Group
Hide Arm/Group Description:
Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
Overall Number of Participants Analyzed 145 151
Measure Type: Number
Unit of Measure: Percentage of Participants
A/H1N1: California 78 78
A/H3N2: Victoria 89 76
B: Brisbane 64 41
4.Primary Outcome
Title Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Hide Description Seroprotection was defined as a titer ≥ 40 (1/dilution [1/dil]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.
Time Frame Day 0 and Day 28 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was assessed in the full analysis set population.
Arm/Group Title Fluzone® High-Dose Vaccine Group Fluzone® Vaccine Group
Hide Arm/Group Description:
Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
Overall Number of Participants Analyzed 147 152
Measure Type: Number
Unit of Measure: Percentage of Participants
A/H1N1: California - Pre-vaccination (N=147, 152) 50 41
A/H3N2: Victoria - Pre-vaccination (N=147, 152) 50 51
B: Brisbane - Pre-vaccination (N=147, 152) 46 47
A/H1N1: California - Post-vaccination (N=145, 151) 100 98
A/H3N2: Victoria - Post-vaccination (N=145, 151) 99 98
B: Brisbane - Post-vaccination (N=145, 151) 97 87
5.Secondary Outcome
Title Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Hide Description Solicited Injection Site Reactions: Pain, Erythema, Swelling, Ecchymosis, and Induration. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering
Time Frame Day 0 through Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated subjects with available reaction data, safety analysis set population.
Arm/Group Title Fluzone® High-Dose Vaccine Group Fluzone® Vaccine Group
Hide Arm/Group Description:
Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
Overall Number of Participants Analyzed 147 152
Measure Type: Number
Unit of Measure: Participants
Any Injection Site Pain 112 85
Grad 3 Injection site Pain-Prevents daily activity 1 0
Any Injection Site Erythema 11 2
Grade 3 Injection Site Erythema (>100 mm) 0 0
Any Injection Site Swelling 9 2
Grade 3 Injection Site Swelling (>100 mm) 0 0
Any Injection Site Ecchymosis 1 1
Grade 3 Injection Site Ecchymosis (>100 mm) 0 0
Any Injection Site Induration 13 3
Grade 3 Injection Site Induration (>100 mm) 0 0
Any Fever 1 0
Grade 3 Fever (≥ 39.0 ºC or ≥ 102.1 ºF) 0 0
Any Headache 46 40
Grade 3 Headache (Prevents daily activity) 5 3
Any Malaise 44 38
Grade 3 Malaise (Prevents daily activity) 10 5
Any Myalgia 70 46
Grade 3 Myalgia (Prevents daily activity) 10 4
Any Shivering 29 21
Grade 3 Shivering (Prevents daily activity) 7 3
Time Frame Adverse events data were collected from the day of vaccination through 28 days post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluzone® High-Dose Vaccine Group Fluzone® Vaccine Group
Hide Arm/Group Description Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0 Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
All-Cause Mortality
Fluzone® High-Dose Vaccine Group Fluzone® Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluzone® High-Dose Vaccine Group Fluzone® Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/148 (0.00%)      0/152 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Fluzone® High-Dose Vaccine Group Fluzone® Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   130/148 (87.84%)      110/152 (72.37%)    
General disorders     
Solicited Injection Site Pain  1  112/148 (75.68%)  112 85/152 (55.92%)  85
Solicited Injection Site Erythema  1  11/147 (7.48%)  11 2/152 (1.32%)  2
Solicited Injection Site Swelling  1  9/147 (6.12%)  9 2/152 (1.32%)  2
Solicited Injection Site Induration  1  13/147 (8.84%)  13 3/152 (1.97%)  3
Solicited Malaise  1  44/147 (29.93%)  44 38/152 (25.00%)  38
Solicited Shivering  1  29/147 (19.73%)  29 21/152 (13.82%)  21
Musculoskeletal and connective tissue disorders     
Solicited Myalgia  1  70/147 (47.62%)  70 46/152 (30.26%)  46
Nervous system disorders     
Solicited Headache  1  46/147 (31.29%)  46 40/152 (26.32%)  40
Respiratory, thoracic and mediastinal disorders     
Cough * 1  11/148 (7.43%)  11 8/152 (5.26%)  8
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
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: NCT01258595     History of Changes
Other Study ID Numbers: FIM09
UTN: U1111-1113-3648 ( Other Identifier: WHO )
First Submitted: December 10, 2010
First Posted: December 13, 2010
Results First Submitted: September 19, 2011
Results First Posted: October 27, 2011
Last Update Posted: May 16, 2016