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Trial record 1 of 1 for:    GRC55
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Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines in Adults

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ClinicalTrials.gov Identifier: NCT02258334
Recruitment Status : Completed
First Posted : October 7, 2014
Results First Posted : October 19, 2015
Last Update Posted : October 19, 2015
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
Interventions Biological: Fluzone® Quadrivalent vaccine, 2014-2015 formulation
Biological: Fluzone I®ntradermal vaccine, 2014-2015 formulation
Biological: Fluzone High Dose vaccine, 2014-2015 formulation
Enrollment 208
Recruitment Details Study participants were enrolled from 01 October 2014 to 07 November 2014 at 4 clinical sites in the United States.
Pre-assignment Details A total of 208 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated in this study.
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine. Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
Period Title: Overall Study
Started 50 54 52 52
Completed 49 54 52 52
Not Completed 1 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Total
Hide Arm/Group Description Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine. Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine. Total of all reporting groups
Overall Number of Baseline Participants 50 54 52 52 208
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 54 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
50
 100.0%
54
 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
Age Continuous Number Analyzed 50 participants 54 participants 52 participants 52 participants 208 participants
44.8  (14.9) 48.0  (12.1) 73.9  (5.0) 72.2  (5.4) 59.8  (16.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 54 participants 52 participants 52 participants 208 participants
Female
31
  62.0%
33
  61.1%
32
  61.5%
31
  59.6%
127
  61.1%
Male
19
  38.0%
21
  38.9%
20
  38.5%
21
  40.4%
81
  38.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 54 participants 52 participants 52 participants 208 participants
50 54 52 52 208
1.Primary Outcome
Title Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Hide Description Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:
Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
Overall Number of Participants Analyzed 49 54 52 52
Measure Type: Number
Unit of Measure: Percentage of participants
Injection-site Pain 53.1 51.9 36.5 40.4
Grade 3 Injection-site Pain 0.0 1.9 0 0
Injection-site Erythema 6.1 35.2 3.8 7.7
Grade 3 Injection site Erythema 0.0 0 0 0
Injection-site Swelling 4.1 22.2 5.8 5.8
Grade 3 Injection-site Swelling 0.0 0 0 0
Injection-site Induration 6.1 18.5 0 1.9
Grade 3 Injection-site Induration 0.0 0 0 0
Injection-site Ecchymosis 2.0 5.6 0 1.9
Grade 3 Injection-site Ecchymosis 0.0 0 0 0
Fever 0.0 0 0 0
Grade 3 Fever 0.0 0 0 0
Headache 28.6 18.5 17.3 25.0
Grade 3 Headache 0.0 0 0 1.9
Malaise 16.3 27.8 9.6 15.4
Grade 3 Malaise 0.0 1.9 0 1.9
Myalgia 26.5 25.9 23.1 28.8
Grade 3 Myalgia 0.0 1.9 1.9 1.9
Shivering 4.1 9.3 1.9 1.9
Grade 3 Shivering 0.0 0 0 0
2.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.
Hide Description Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.
Time Frame Day 0 (pre-vaccination) and Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the Per-Protocol Analysis Set.
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:
Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
Overall Number of Participants Analyzed 49 53 52 52
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
A/H1N1; Pre-vaccination (N=49,52,52,52)
153
(90.6 to 260)
148
(94.3 to 231)
148
(96.7 to 226)
171
(124 to 237)
A/H1N1; Post-vaccination (N=49,53,52,52)
707
(490 to 1020)
632
(459 to 870)
288
(200 to 414)
386
(294 to 506)
A/H3N2; Pre-vaccination (N=49,53,52,52)
139
(90.9 to 212)
147
(97.6 to 221)
168
(119 to 237)
275
(193 to 390)
A/H3N2; Post-vaccination (N=49,53,52,52)
613
(439 to 857)
648
(470 to 894)
349
(244 to 499)
680
(490 to 942)
B (Yamagata); Pre-vaccination (N=49,53,52,52)
596
(400 to 888)
471
(324 to 684)
471
(342 to 649)
465
(340 to 635)
B (Yamagata); Post-vaccination (N=49,53,52,52)
1836
(1376 to 2449)
1272
(906 to 1785)
864
(651 to 1146)
994
(777 to 1270)
B (Victoria); Pre-vaccination (N=49,0,52,0)
252
(164 to 385)
NA [1] 
(NA to NA)
273
(195 to 382)
NA [1] 
(NA to NA)
B (Victoria); Post-vaccination (N=49,0,52,0)
1119
(838 to 1495)
NA [1] 
(NA to NA)
568
(430 to 750)
NA [1] 
(NA to NA)
[1]
B (Victoria) antigen was not in the administered vaccine
3.Secondary Outcome
Title Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.
Hide Description Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥40 (l/dilution [dil]) at pre-vaccination and 21 days after vaccination.
Time Frame Day 0 (pre-vaccination) and Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was assessed in the Per-Protocol Analysis Set.
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:
Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
Adults 18 to < 65 years of age randomly assigned to receive an intradermal of Fluzone Intradermal vaccine.
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
Overall Number of Participants Analyzed 49 53 52 52
Measure Type: Number
Unit of Measure: Percentage of participants
A/H1N1; Pre-vaccination (N=49,52,52,52) 77.6 84.6 82.7 90.4
A/H1N1; Post-vaccination (N=49,53,52,52) 98.0 100.0 92.3 100.0
A/H3N2; Pre-vaccination (N=49,53,52,52) 81.6 83.0 90.4 96.2
A/H3N2; Post-vaccination (N=49,53,52,52) 98.0 100.0 94.2 100.0
B (Yamagata); Pre-vaccination (N=49,53,52,52) 98.0 98.1 96.2 100.0
B (Yamagata); Post-vaccination (N=49,53,52,52) 100.0 100.0 100.0 100.0
B (Victoria); Pre-vaccination (n=49,0,52,0) 91.8 NA [1]  94.2 NA [1] 
B (Victoria); Post-vaccination (N=49,0,52,0) 100.0 NA [1]  100.0 NA [1] 
[1]
B (Victoria) antigen was not in the administered vaccine
4.Secondary Outcome
Title Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Hide Description Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil) or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer 21 days after vaccination.
Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion was assessed in the Per-Protocol Analysis Set.
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:
Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
Overall Number of Participants Analyzed 49 53 52 52
Measure Type: Number
Unit of Measure: Percentage of participants
A/H1N1 (N=49,52,52,52) 34.7 42.3 15.4 28.8
A/H3N2 (N=49,53,52,52) 38.8 39.6 23.1 26.9
B (Yamagata) (N=49,53,52,52) 28.6 28.3 15.4 21.2
B (Victoria) (N=49,0,52,0) 51.0 NA [1]  23.1 NA [1] 
[1]
B (Victoria) antigen was not in the administered vaccine
5.Secondary Outcome
Title Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine
Hide Description Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.
Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:
Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
Overall Number of Participants Analyzed 49 53 52 52
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer ratios
A/H1N1 (N=49,52,52,52)
4.32
(2.66 to 7.04)
3.92
(2.54 to 6.06)
1.91
(1.53 to 2.38)
2.25
(1.79 to 2.83)
A/H3N2 (N=49,53,52,52)
4.26
(2.83 to 6.42)
4.24
(2.93 to 6.14)
2.08
(1.65 to 2.62)
2.48
(1.97 to 3.12)
B (Yamagata) (N=49,53,52,52)
3.08
(2.21 to 4.29)
2.70
(1.95 to 3.74)
1.83
(1.48 to 2.28)
2.14
(1.72 to 2.65)
B (Victoria) (N=49,0,52,0)
4.39
(3.05 to 6.30)
NA [1] 
(NA to NA)
2.08
(1.62 to 2.68)
NA [1] 
(NA to NA)
[1]
B (Victoria) antigen was not in the administered vaccine
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine. Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
All-Cause Mortality
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/49 (0.00%)      0/54 (0.00%)      1/52 (1.92%)      0/52 (0.00%)    
Gastrointestinal disorders         
Haematochezia * 1  0/49 (0.00%)  0 0/54 (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
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/49 (53.06%)      28/54 (51.85%)      19/52 (36.54%)      21/52 (40.38%)    
General disorders         
Injection site Pain † 1  26/49 (53.06%)  26 28/54 (51.85%)  28 19/52 (36.54%)  19 21/52 (40.38%)  21
Injection site Erythema † 1  3/49 (6.12%)  3 19/54 (35.19%)  19 2/52 (3.85%)  2 4/52 (7.69%)  4
Injection site Swelling † 1  2/49 (4.08%)  2 12/54 (22.22%)  12 3/52 (5.77%)  3 3/52 (5.77%)  3
Injection site Induration † 1  3/49 (6.12%)  3 10/54 (18.52%)  10 0/52 (0.00%)  0 1/52 (1.92%)  1
Injection site Ecchymosis † 1  1/49 (2.04%)  1 3/54 (5.56%)  3 0/52 (0.00%)  0 1/52 (1.92%)  1
Malaise † 1  8/49 (16.33%)  8 15/54 (27.78%)  15 5/52 (9.62%)  5 8/52 (15.38%)  8
Shivering † 1  2/49 (4.08%)  2 5/54 (9.26%)  5 1/52 (1.92%)  1 1/52 (1.92%)  1
Musculoskeletal and connective tissue disorders         
Myalgia † 1  13/49 (26.53%)  13 14/54 (25.93%)  14 12/52 (23.08%)  12 15/52 (28.85%)  15
Nervous system disorders         
Headache † 1  14/49 (28.57%)  14 10/54 (18.52%)  10 9/52 (17.31%)  9 13/52 (25.00%)  13
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
[Not Specified]
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: NCT02258334    
Other Study ID Numbers: GRC55
U1111-1143-8931 ( Other Identifier: WHO )
First Submitted: October 2, 2014
First Posted: October 7, 2014
Results First Submitted: September 16, 2015
Results First Posted: October 19, 2015
Last Update Posted: October 19, 2015