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Trial record 1 of 1 for:    GRC52
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Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose Influenza Virus Vaccines in Adults

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ClinicalTrials.gov Identifier: NCT01946438
Recruitment Status : Completed
First Posted : September 19, 2013
Results First Posted : September 25, 2014
Last Update Posted : September 25, 2014
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: Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation),
Biological: Fluzone® Intradermal, Influenza Virus Vaccine (2013-2014 formulation),
Biological: Fluzone® High-Dose, Influenza Virus Vaccine (2013-2014 formulation)
Enrollment 208
Recruitment Details The study participants were enrolled from 16 to 24 September 2013 at 4 clinic centers in the United States.
Pre-assignment Details A total of 208 participants who met all of the inclusion and none of the exclusion criteria were enrolled and vaccinated in the study.
Arm/Group Title Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
Hide Arm/Group Description Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation) Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
Period Title: Overall Study
Started 52 52 52 52
Completed 50 52 51 51
Not Completed 2 0 1 1
Reason Not Completed
Adverse Event             0             0             0             1
Serious Adverse event             1             0             0             0
Protocol Violation             0             0             1             0
Withdrawal by Subject             1             0             0             0
Arm/Group Title Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) Elderly Fluzone® High Dose, Influenza Vaccine (Group 4) Total
Hide Arm/Group Description Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation) Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) Total of all reporting groups
Overall Number of Baseline Participants 52 52 52 52 208
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 52 participants 52 participants 208 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
52
 100.0%
52
 100.0%
0
   0.0%
0
   0.0%
104
  50.0%
>=65 years
0
   0.0%
0
   0.0%
52
 100.0%
52
 100.0%
104
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 52 participants 52 participants 52 participants 208 participants
44.2  (15.2) 46.9  (14.7) 71.5  (4.7) 72.6  (5.2) 58.75  (17.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 52 participants 52 participants 208 participants
Female
34
  65.4%
29
  55.8%
32
  61.5%
33
  63.5%
128
  61.5%
Male
18
  34.6%
23
  44.2%
20
  38.5%
19
  36.5%
80
  38.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 52 participants 52 participants 52 participants 52 participants 208 participants
52 52 52 52 208
1.Primary Outcome
Title Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
Hide Description Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm; Fever, ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
Time Frame Day 0 up to Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection-site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.
Arm/Group Title Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
Hide Arm/Group Description:
Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
Overall Number of Participants Analyzed 52 52 52 52
Measure Type: Number
Unit of Measure: Participants
Injection-site pain (N = 52, 52, 52, 52) 27 30 10 21
Grade 3 Injection-site pain (N = 52, 52, 52, 52) 1 0 0 0
Injection-ste erythema (N=52,52,52,51) 0 15 0 2
Grade 3 Injection-site erythema (N =52, 52,52, 51) 0 0 0 0
Injection-site swelling (N = 51, 52, 52, 51) 1 2 0 1
Grade 3 Injection-site swelling (N = 51,52,52,51) 0 0 0 0
Injection-site induration (N = 51, 52, 52, 51) 1 4 0 0
Grade 3 Injection-site induration (N= 51,52,52,51) 0 0 0 0
Injection-site ecchymosis (N = 51, 52, 52, 51) 0 2 0 0
Grade 3 Injection-site ecchymosis (N= 51,52,52,51) 0 0 0 0
Fever (N = 52, 52, 52, 52) 0 0 1 2
Grade 3 Fever (N = 52, 52, 52, 52) 0 0 0 0
Headache (N = 52, 52, 52, 51) 13 8 5 8
Grade 3 Headache (N = 52, 52, 52, 51) 1 1 0 1
Malaise (N = 52, 52, 52, 52) 11 12 2 8
Grade 3 Malaise (N = 52, 52, 52, 52) 1 1 0 1
Myalgia (N = 52, 52, 52, 51) 13 16 6 10
Grade 3 Myalgia (N = 52, 52, 52, 51) 2 1 1 1
Shivering (N = 52, 52, 52, 51) 3 2 2 4
Grade 3 Shivering (N = 52, 52, 52, 51) 1 0 0 3
2.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine
Hide Description Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.
Time Frame Day 0 (pre-vaccination) and Day 21 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers of antibodies against the hemagglutinin (HA) antigens were assessed in the Per-Protocol Analysis Set.
Arm/Group Title Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
Hide Arm/Group Description:
Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Vaccine 2013-2014 formulation
Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
Overall Number of Participants Analyzed 49 52 51 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1 (pre-vaccination)
82.3
(48.0 to 141)
74.3
(46.3 to 119)
54.7
(36.9 to 81.1)
91.0
(60.7 to 136)
A/H1N1 (post-vaccination)
514
(366 to 722)
471
(332 to 669)
163
(119 to 224)
345
(255 to 467)
A/H3N2 (pre-vaccination)
77.2
(45.2 to 132)
128
(81.2 to 203)
185
(128 to 267)
104
(67.7 to 159)
A/H3N2 (post-vaccination)
563
(399 to 796)
531
(396 to 712)
449
(344 to 587)
636
(464 to 871)
B (Yamagata; pre-vaccination)
34.2
(23.3 to 50.4)
38.2
(26.7 to 54.6)
32.4
(24.4 to 43.1)
36.1
(28.2 to 46.3)
B (Yamagata; post-vaccination)
142
(105 to 192)
147
(110 to 196)
67.5
(55.3 to 82.4)
122
(98.5 to 151)
B (Victoria; pre-vaccination)
24.7
(17.6 to 34.7)
NA [1] 
(NA to NA)
34.2
(25.8 to 45.5)
NA [1] 
(NA to NA)
B (Victoria; post-vaccination)
134
(96.6 to 186)
NA [1] 
(NA to NA)
67.5
(52.7 to 86.4)
NA [1] 
(NA to NA)
[1]
B (Victoria) antigen was not in the vaccine administered to this group
3.Secondary Outcome
Title Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine
Hide Description Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer of ≥40 (1/dilution).
Time Frame Day 0 (pre-vaccination) and Day 21 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.
Arm/Group Title Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) Elderly Fluzone® High Dose, Influenza Vaccine (Group 4)
Hide Arm/Group Description:
Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
Overall Number of Participants Analyzed 49 52 51 51
Measure Type: Number
Unit of Measure: Participants
A/H1N1 (pre-vaccination) 34 36 32 39
A/H1N1 (post-vaccination) 47 52 47 51
A/H3N2 (pre-vaccination) 33 41 47 41
A/H3N2 (post-vaccination) 48 52 50 51
B (Yamagata; pre-vaccination) 28 31 26 29
B (Yamagata; post-vaccination) 44 49 45 50
B (Victoria; pre-vaccination) 23 NA [1]  32 NA [1] 
B (Victoria; post-vaccination) 44 NA [1]  42 NA [1] 
[1]
B (Victoria) antigen was not in the vaccine administered to this group
4.Secondary Outcome
Title Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine
Hide Description Influenza virus antibodies were measured using an 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 ≥ 4-fold increase in titer after vaccination.
Time Frame Day 0 (pre-vaccination) and Day 21 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in the Per-Protocol Analysis Set.
Arm/Group Title Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
Hide Arm/Group Description:
Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
Overall Number of Participants Analyzed 49 52 51 51
Measure Type: Number
Unit of Measure: Participants
A/H1N1 23 26 17 25
A/H3N2 27 19 15 33
B (Yamagata) 19 18 5 21
B Victoria 25 NA [1]  9 NA [1] 
[1]
B (Victoria) antigen was not in the vaccine administered to this group
5.Secondary Outcome
Title Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine
Hide Description Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccines.
Time Frame Day 21 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titer ratios against each hemagglutinin antigen were assessed in the Per-Protocol Analysis Set.
Arm/Group Title Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
Hide Arm/Group Description:
Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
Overall Number of Participants Analyzed 49 52 51 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer Ratio
A/H1N1
5.58
(3.29 to 9.44)
5.77
(3.33 to 10.0)
2.89
(2.10 to 3.97)
3.66
(2.78 to 4.83)
A/H3N2
6.42
(4.22 to 9.79)
3.92
(2.62 to 5.87)
2.40
(1.81 to 3.19)
6.10
(4.12 to 9.03)
B (Yamagata)
3.62
(2.56 to 5.12)
3.50
(2.36 to 5.18)
1.95
(1.64 to 2.31)
3.28
(2.58 to 4.18)
B (Victoria)
4.74
(3.23 to 6.95)
NA [1] 
(NA to NA)
1.86
(1.55 to 2.22)
NA [1] 
(NA to NA)
[1]
B (Victoria) antigen was not in the vaccine administered to this group
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 after vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
Hide Arm/Group Description Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation) Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation) Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
All-Cause Mortality
Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/52 (1.92%)      0/52 (0.00%)      1/52 (1.92%)      0/52 (0.00%)    
General disorders         
Device failure * 1  1/52 (1.92%)  1 0/52 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0
Nervous system disorders         
Altered state of consciousness * 1  0/52 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1) Adult Fluzone® Intradermal, Influenza Vaccine (Group 2) Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3) Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/52 (51.92%)      30/52 (57.69%)      10/52 (19.23%)      21/52 (40.38%)    
General disorders         
Injection-site pain  1  27/52 (51.92%)  27 30/52 (57.69%)  30 10/52 (19.23%)  10 21/52 (40.38%)  21
Injection-site erythema  1  0/52 (0.00%)  0 15/52 (28.85%)  15 0/52 (0.00%)  0 2/51 (3.92%)  2
Injection-site induration  1  1/51 (1.96%)  1 4/52 (7.69%)  4 0/52 (0.00%)  0 0/51 (0.00%)  0
Malaise  1  11/52 (21.15%)  11 12/52 (23.08%)  12 2/52 (3.85%)  2 8/52 (15.38%)  8
Shivering  1  3/52 (5.77%)  3 2/52 (3.85%)  2 2/52 (3.85%)  2 4/51 (7.84%)  4
Musculoskeletal and connective tissue disorders         
Myalgia  1  13/52 (25.00%)  13 16/52 (30.77%)  16 6/52 (11.54%)  6 10/51 (19.61%)  10
Nervous system disorders         
Headache  1  13/52 (25.00%)  13 8/52 (15.38%)  8 5/52 (9.62%)  5 8/51 (15.69%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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: NCT01946438     History of Changes
Other Study ID Numbers: GRC52
U1111-1127-7587 ( Other Identifier: WHO )
First Submitted: September 16, 2013
First Posted: September 19, 2013
Results First Submitted: September 17, 2014
Results First Posted: September 25, 2014
Last Update Posted: September 25, 2014