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Study of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines in Adults

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ClinicalTrials.gov Identifier: NCT02563093
Recruitment Status : Completed
First Posted : September 29, 2015
Results First Posted : December 12, 2016
Last Update Posted : December 12, 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
Interventions Biological: Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative
Biological: Fluzone Intradermal Quadrivalent vaccine, 2015-2016 formulation
Biological: Fluzone High-Dose vaccine, 2015-2016 formulation
Enrollment 208
Recruitment Details Study participants were enrolled from 28 September 2015 to 03 November 2015 at 4 clinic centers in the United States.
Pre-assignment Details A total of 208 participants who met all of the inclusion criteria and no exclusion criteria were enrolled and vaccinated.
Arm/Group Title Fluzone Quadrivalent Vaccine (18 to < 65 Years) Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) Fluzone Quadrivalent Vaccine (≥ 65 Years) Fluzone High-Dose Vaccine (≥ 65 Years)
Hide Arm/Group Description Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
Period Title: Overall Study
Started 52 52 53 51
Completed 52 52 53 51
Not Completed 0 0 0 0
Arm/Group Title Fluzone Quadrivalent Vaccine (18 to < 65 Years) Fluzone Quadrivalent Intradermal Vaccine Fluzone Quadrivalent Vaccine (≥ 65 Years) Fluzone High-Dose Vaccine Total
Hide Arm/Group Description Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine Total of all reporting groups
Overall Number of Baseline Participants 52 52 53 51 208
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 53 participants 51 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%
53
 100.0%
51
 100.0%
104
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 52 participants 53 participants 51 participants 208 participants
46.4  (13.5) 43.4  (14.7) 72.8  (5.2) 74.2  (6.2) 59.2  (17.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 53 participants 51 participants 208 participants
Female
37
  71.2%
39
  75.0%
28
  52.8%
26
  51.0%
130
  62.5%
Male
15
  28.8%
13
  25.0%
25
  47.2%
25
  49.0%
78
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 52 participants 52 participants 53 participants 51 participants 208 participants
52 52 53 51 208
1.Primary Outcome
Title Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Hide Description

Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 solicited injection-site reactions: Pain, Significant; prevents daily activity. Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 solicited systemic reactions: Fever, ≥ 39.0°C or ≥ 102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity.

A participant (18 to < 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was excluded from the Per-protocol analysis Set and was included in the Fluzone Quadrivalent vaccine Group in the Safety Analysis Set and the assigned group in the Full Analysis Set.
Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The vaccine safety outcomes were assessed in the Safety Analysis Set. A participant (18 to < 65 Years) who was assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to < 65 Years) group in the Safety Analysis Set.
Arm/Group Title Fluzone Quadrivalent Vaccine (18 to < 65 Years) Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) Fluzone Quadrivalent Vaccine (≥ 65 Years) Fluzone High-Dose Vaccine (≥ 65 Years)
Hide Arm/Group Description:
Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
Overall Number of Participants Analyzed 53 51 53 51
Measure Type: Number
Unit of Measure: Participants
Injection-site Pain (N=53, 51, 53, 51) 29 29 15 22
Grade 3 Injection-site Pain (N=53, 51, 53, 51) 0 0 1 0
Injection-site Erythema (N=53, 51, 53, 51) 1 17 0 7
Grade 3 Injection-site Erythema (N=53, 51, 53, 51) 0 0 0 0
Injection-site Swelling (N=53, 51, 53, 51) 1 10 0 3
Grade 3 Injection-site Swelling (N=53, 51, 53, 51) 0 0 0 0
Injection-site Induration (N=53, 51, 53, 51) 1 6 0 1
Grade 3 Injection-site Induration (N=53,51,53,51) 0 0 0 0
Injection-site Ecchymosis (N=53, 51, 53, 51) 1 1 0 2
Grade 3 Injection-site Ecchymosis (N=53,51,53,51) 0 0 0 0
Fever (N=52, 51, 53, 51) 0 0 0 0
Grade 3 Fever (N=52, 51, 53, 51) 0 0 0 0
Headache (N=53, 51, 53, 51) 13 12 9 6
Grade 3 Headache (N=53, 51, 53, 51) 0 2 1 0
Malaise (N=53, 51, 53, 51) 7 11 10 6
Grade 3 Malaise (N=53, 51, 53, 51) 0 2 0 0
Myalgia (N=53, 51, 53, 51) 15 11 9 13
Grade 3 Myalgia (N=53, 51, 53, 51) 1 1 0 0
Shivering (N=53, 51, 53, 51) 6 0 1 0
Grade 3 Shivering (N=53, 51, 53, 51) 0 0 0 0
2.Secondary Outcome
Title Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Hide Description Anti-influenza antibodies were measured using an hemagglutination inhibition assay.
Time Frame Day 0 (pre-vaccination) and 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.
Arm/Group Title Fluzone Quadrivalent Vaccine (18 to < 65 Years) Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) Fluzone Quadrivalent Vaccine (≥ 65 Years) Fluzone High-Dose Vaccine (≥ 65 Years)
Hide Arm/Group Description:
Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
Adults 18 to < 65 years of age who received an Intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
Overall Number of Participants Analyzed 51 50 53 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
A/H1N1; Pre-vaccination (N=51,50,53,51)
274
(173 to 433)
196
(134 to 286)
160
(109 to 234)
62.2
(44.4 to 87.3)
A/H1N1; Post-vaccination (N=51,50,53,51)
764
(564 to 1034)
631
(435 to 915)
283
(196 to 407)
324
(242 to 435)
A/H3N2; Pre-vaccination (N=51,50,53,51)
49.4
(32.0 to 76.2)
61.9
(44.4 to 86.3)
48.0
(34.4 to 67.0)
50.1
(36.4 to 68.7)
A/H3N2; Post-vaccination (N=51,50,53,51)
1051
(687 to 1609)
1033
(717 to 1488)
379
(248 to 580)
769
(517 to 1143)
B Yamagata; Pre-vaccination (N=51,50,53,51)
186
(118 to 293)
307
(208 to 454)
208
(147 to 293)
134
(101 to 179)
B Yamagata; Post-vaccination (N=51,50,53,51)
881
(581 to 1336)
1099
(822 to 1469)
438
(311 to 617)
471
(352 to 632)
B Victoria; Pre-vaccination (N=51,50,53,0)
234
(161 to 340)
290
(213 to 397)
178
(122 to 258)
NA [1] 
(NA to NA)
B Victoria; Post-vaccination (N=51,50,53,0)
1237
(901 to 1700)
844
(621 to 1149)
355
(260 to 485)
NA [1] 
(NA to NA)
[1]
B Victoria Influenza antigen not in administered vaccine for this group
3.Secondary Outcome
Title Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Hide Description Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroprotection was defined as the number of participants with a titer ≥ 40 (1/dilution) at pre-vaccination and 21 days post-vaccination.
Time Frame Day 0 (Pre-vaccination) and 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.
Arm/Group Title Fluzone Quadrivalent Vaccine (18 to < 65 Years) Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) Fluzone Quadrivalent Vaccine (≥ 65 Years) Fluzone High-Dose Vaccine (≥ 65 Years)
Hide Arm/Group Description:
Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
Overall Number of Participants Analyzed 51 50 53 51
Measure Type: Number
Unit of Measure: Participants
A/H1N1; Pre-vaccination (N=51,50,53,51) 45 47 47 38
A/H1N1; Post-vaccination (N=51,50,53,51) 51 50 50 50
A/H3N2; Pre-vaccination (N=51,50,53,51) 32 35 36 28
A/H3N2; Post vaccination (N=51,50,53,51) 50 50 50 51
B Yamagata; Pre-vaccination (N=51,50,53,51) 41 48 51 48
B Yamagata; Post-vaccination (N=51,50,53,51) 51 50 53 51
B Victoria; Pre-vaccination (N=51,50,53,0) 47 49 49 NA [1] 
B Victoria; Post-vaccination (N=51,50,53,0) 51 49 53 NA [1] 
[1]
B Victoria Influenza antigen not in administered vaccine for this group
4.Secondary Outcome
Title Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Hide Description Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroconversion was defined as either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer post-vaccination.
Time Frame 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.
Arm/Group Title Fluzone Quadrivalent Vaccine (18 to < 65 Years) Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) Fluzone Quadrivalent Vaccine (≥ 65 Years) Fluzone High-Dose Vaccine (≥ 65 Years)
Hide Arm/Group Description:
Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
Overall Number of Participants Analyzed 51 50 53 51
Measure Type: Number
Unit of Measure: Participants
A/H1N1 (N=51,50,53,51) 15 17 9 27
A/H3N2 (N=51,50,53,51) 44 42 35 44
B Yamagata (N=51,50,53,51) 29 24 13 23
B Victoria (N=51,50,53,0) 27 15 9 NA [1] 
[1]
B Victoria Influenza antigen not in administered vaccine for this group
5.Secondary Outcome
Title Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
Hide Description Anti-influenza antibodies were measured using an hemagglutination inhibition assay.
Time Frame 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.
Arm/Group Title Fluzone Quadrivalent Vaccine (18 to < 65 Years) Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) Fluzone Quadrivalent Vaccine (≥ 65 Years) Fluzone High-Dose Vaccine (≥ 65 Years)
Hide Arm/Group Description:
Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
Overall Number of Participants Analyzed 51 50 53 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer ratio
A/H1N1 (N=51,50,53,51)
2.72
(1.92 to 3.84)
3.18
(2.25 to 4.49)
1.77
(1.38 to 2.26)
5.07
(3.50 to 7.35)
A/H3N2 (N=51,50,53,51)
19.4
(12.5 to 29.9)
16.4
(10.4 to 26.1)
7.49
(4.97 to 11.3)
15.2
(10.2 to 22.5)
B Yamagata (N=51,50,53,51)
4.74
(3.22 to 6.98)
3.58
(2.52 to 5.09)
2.11
(1.60 to 2.78)
3.52
(2.59 to 4.76)
B Victoria (N=51,50,53,0)
5.29
(3.54 to 7.89)
2.87
(2.15 to 3.83)
1.97
(1.52 to 2.57)
NA [1] 
(NA to NA)
[1]
B Victoria Influenza antigen not in administered vaccine for this group
Time Frame Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
Adverse Event Reporting Description A participant (18 to < 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to < 65 Years) Group in the Safety Analysis Set.
 
Arm/Group Title Fluzone Quadrivalent Vaccine (18 to < 65 Years) Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) Fluzone Quadrivalent Vaccine (≥ 65 Years) Fluzone High-Dose Vaccine (≥ 65 Years)
Hide Arm/Group Description Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
All-Cause Mortality
Fluzone Quadrivalent Vaccine (18 to < 65 Years) Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) Fluzone Quadrivalent Vaccine (≥ 65 Years) Fluzone High-Dose Vaccine (≥ 65 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Fluzone Quadrivalent Vaccine (18 to < 65 Years) Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) Fluzone Quadrivalent Vaccine (≥ 65 Years) Fluzone High-Dose Vaccine (≥ 65 Years)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/53 (0.00%)      0/51 (0.00%)      0/53 (0.00%)      1/51 (1.96%)    
Cardiac disorders         
Atrial fibrillation * 1  0/53 (0.00%)  0 0/51 (0.00%)  0 0/53 (0.00%)  0 1/51 (1.96%)  1
Cardiac failure acute * 1  0/53 (0.00%)  0 0/51 (0.00%)  0 0/53 (0.00%)  0 1/51 (1.96%)  1
Nervous system disorders         
Transient ischaemic attack * 1  0/53 (0.00%)  0 0/51 (0.00%)  0 0/53 (0.00%)  0 1/51 (1.96%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Fluzone Quadrivalent Vaccine (18 to < 65 Years) Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) Fluzone Quadrivalent Vaccine (≥ 65 Years) Fluzone High-Dose Vaccine (≥ 65 Years)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/53 (54.72%)      29/51 (56.86%)      15/53 (28.30%)      22/51 (43.14%)    
General disorders         
Injection site Pruritus † 1  0/53 (0.00%)  0 4/51 (7.84%)  4 0/53 (0.00%)  0 0/51 (0.00%)  0
Injection site Pain † 1  29/53 (54.72%)  29 29/51 (56.86%)  29 15/53 (28.30%)  15 22/51 (43.14%)  22
Injection site Erythema † 1  1/53 (1.89%)  1 17/51 (33.33%)  17 0/53 (0.00%)  0 7/51 (13.73%)  7
Injection site Swelling † 1  1/53 (1.89%)  1 10/51 (19.61%)  10 0/53 (0.00%)  0 3/51 (5.88%)  3
Injection site Induration † 1  1/53 (1.89%)  1 6/51 (11.76%)  6 0/53 (0.00%)  0 1/51 (1.96%)  1
Malaise † 1  7/53 (13.21%)  7 11/51 (21.57%)  11 10/53 (18.87%)  10 6/51 (11.76%)  6
Shivering † 1  6/53 (11.32%)  6 0/51 (0.00%)  0 1/53 (1.89%)  1 0/51 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Myalgia † 1  15/53 (28.30%)  15 11/51 (21.57%)  11 9/53 (16.98%)  9 13/51 (25.49%)  13
Nervous system disorders         
Headache † 1  13/53 (24.53%)  13 12/51 (23.53%)  12 9/53 (16.98%)  9 6/51 (11.76%)  6
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
[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: NCT02563093    
Other Study ID Numbers: GRC57
U1111-1161-2491 ( Other Identifier: WHO )
First Submitted: September 28, 2015
First Posted: September 29, 2015
Results First Submitted: August 26, 2016
Results First Posted: December 12, 2016
Last Update Posted: December 12, 2016