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Safety and Immunogenicity of Fluzone® Quadrivalent, Flublok® Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2018-2019 Formulations (GRC90)

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ClinicalTrials.gov Identifier: NCT03617523
Recruitment Status : Completed
First Posted : August 6, 2018
Results First Posted : November 25, 2019
Last Update Posted : November 25, 2019
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, 2018-2019 formulation
Biological: Flublok Quadrivalent vaccine, 2018-2019 formulation
Biological: Fluzone High-Dose vaccine, 2018-2019 formulation
Enrollment 240
Recruitment Details Participants were enrolled from 10 September 2018 to 22 October 2018 at 3 centers in the United States.
Pre-assignment Details A total of 240 participants were enrolled in the study.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years Fluzone High-Dose Vaccine Group 5: >=65 Years
Hide Arm/Group Description Participants (aged 6 to less than [<] 36 months) received a 0.25-milliliter (mL) dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. Participants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. Participants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0. Participants (aged greater than or equal to [>=] 65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Period Title: Overall Study
Started 30 30 61 59 60
Completed 30 30 61 59 60
Not Completed 0 0 0 0 0
Arm/Group Title Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years Fluzone High-Dose Vaccine Group 5: >=65 Years Total
Hide Arm/Group Description Participants (aged 6 to <36 months) received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. Participants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. Participants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0. Participants (aged >=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. Total of all reporting groups
Overall Number of Baseline Participants 30 30 61 59 60 240
Hide Baseline Analysis Population Description
Analysis was performed on safety analysis set which included participants who received at least 1 dose of study vaccine.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 61 participants 59 participants 60 participants 240 participants
1.7  (0.44) 5.9  (1.76) 46.7  (13.48) 46.2  (13.44) 73.6  (6.42) 42.6  (26.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 61 participants 59 participants 60 participants 240 participants
Female
13
  43.3%
12
  40.0%
45
  73.8%
42
  71.2%
40
  66.7%
152
  63.3%
Male
17
  56.7%
18
  60.0%
16
  26.2%
17
  28.8%
20
  33.3%
88
  36.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 61 participants 59 participants 60 participants 240 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  30.0%
9
  30.0%
20
  32.8%
12
  20.3%
4
   6.7%
54
  22.5%
White
18
  60.0%
19
  63.3%
41
  67.2%
46
  78.0%
56
  93.3%
180
  75.0%
More than one race
3
  10.0%
2
   6.7%
0
   0.0%
1
   1.7%
0
   0.0%
6
   2.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions
Hide Description A solicited reaction was an adverse event (AE) that was pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection (Inj.) site reactions: tenderness, erythema and swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability.
Time Frame Within 7 days post any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety analysis set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months
Hide Arm/Group Description:
Participants (aged 6 to <36 months) received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
Injection site tenderness
15
  51.7%
Injection site erythema
3
  10.3%
Injection site swelling
4
  13.8%
Fever
2
   6.9%
Vomiting
3
  10.3%
Crying abnormal
4
  13.8%
Drowsiness
9
  31.0%
Appetite lost
10
  34.5%
Irritability
12
  41.4%
2.Primary Outcome
Title Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions
Hide Description A solicited reaction was an AE that was pre-listed in the eCRF and considered to be related to vaccination. Solicited injection site reactions: pain, erythema and swelling. Solicited systemic reactions: fever, headache, malaise, and myalgia.
Time Frame Within 7 days post any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety analysis set.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years Fluzone High-Dose Vaccine Group 5: >=65 Years
Hide Arm/Group Description:
Participants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
Participants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
Participants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
Participants (aged >=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 30 61 59 60
Measure Type: Count of Participants
Unit of Measure: Participants
Injection site pain
9
  30.0%
27
  44.3%
22
  37.3%
24
  40.0%
Injection site erythema
5
  16.7%
1
   1.6%
0
   0.0%
5
   8.3%
Injection site swelling
6
  20.0%
2
   3.3%
0
   0.0%
3
   5.0%
Fever
1
   3.3%
0
   0.0%
0
   0.0%
0
   0.0%
Headache
5
  16.7%
12
  19.7%
13
  22.0%
11
  18.3%
Malaise
6
  20.0%
11
  18.0%
6
  10.2%
9
  15.0%
Myalgia
6
  20.0%
14
  23.0%
11
  18.6%
15
  25.0%
3.Primary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine
Hide Description GMT of anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage.
Time Frame 28 days post-final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on per-protocol analysis set which included participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result for at least 1 strain without any protocol deviations.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
Hide Arm/Group Description:
Participants (aged 6 to <36 months) received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
Participants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
Overall Number of Participants Analyzed 26 29
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers (1/dilution)
A/H1N1
229
(108 to 487)
1008
(605 to 1680)
A/H3N2
239
(94.0 to 606)
1109
(671 to 1833)
B Victoria
160
(79.3 to 323)
688
(390 to 1211)
B Yamagata
295
(167 to 524)
1343
(811 to 2223)
4.Primary Outcome
Title Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine
Hide Description GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5.
Time Frame Day 21 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on per-protocol analysis set.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years Fluzone High-Dose Vaccine Group 5: >=65 Years
Hide Arm/Group Description:
Participants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
Participants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
Participants (aged >=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 61 58 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers (1/dilutions)
A/H1N1
525
(386 to 712)
708
(498 to 1007)
266
(195 to 363)
A/H3N2
379
(276 to 523)
644
(456 to 909)
359
(255 to 507)
B Victoria
588
(447 to 773)
525
(388 to 711)
453
(337 to 608)
B Yamagata
759
(571 to 1009)
1102
(829 to 1465)
NA [1] 
(NA to NA)
[1]
Data not reported since the immune response to the B Yamagata lineage strain was not assessed in Group 5 participants.
5.Primary Outcome
Title Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine
Hide Description GMT of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. GMTRs were calculated as the ratio of GMTs post-final vaccination and pre-vaccination.
Time Frame Day 0 (pre-vaccination), 28 days post-final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on per-protocol analysis set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
Hide Arm/Group Description:
Participants (aged 6 to <36 months) received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
Participants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
Overall Number of Participants Analyzed 25 28
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
A/H1N1(post-final vaccination/pre-vaccination)
9.06
(5.38 to 15.3)
4.47
(2.39 to 8.35)
A/H3N2(post-final vaccination/pre-vaccination)
3.94
(1.92 to 8.12)
6.40
(3.95 to 10.4)
B Victoria(post-final vaccination/pre-vaccination)
8.11
(4.84 to 13.6)
13.3
(8.61 to 20.5)
B Yamagata(post-final vaccination/pre-vaccination)
11.8
(7.24 to 19.2)
8.41
(4.98 to 14.2)
6.Primary Outcome
Title Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine
Hide Description GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.
Time Frame Day 0 (pre-vaccination), Day 21 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on per-protocol analysis set.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years Fluzone High-Dose Vaccine Group 5: >=65 Years
Hide Arm/Group Description:
Participants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
Participants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
Participants (aged >=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 61 58 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
A/H1N1 (post-vaccination/pre-vaccination)
2.93
(2.02 to 4.23)
6.34
(4.17 to 9.63)
3.07
(2.34 to 4.02)
A/H3N2 (post-vaccination/pre-vaccination)
3.55
(2.60 to 4.85)
8.19
(5.56 to 12.1)
3.69
(2.68 to 5.08)
B Victoria (post-vaccination/pre-vaccination)
3.39
(2.43 to 4.73)
4.40
(3.13 to 6.19)
3.65
(2.79 to 4.76)
B Yamagata (post-vaccination/pre-vaccination)
2.84
(2.10 to 3.85)
5.20
(3.76 to 7.21)
NA [1] 
(NA to NA)
[1]
Data not reported since the immune response to the B Yamagata lineage strain was not assessed in Group 5 participants.
7.Primary Outcome
Title Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2
Hide Description Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Seroprotection was defined as antibody titer >=40 (1/ dilution) at pre-vaccination and at post-final vaccination.
Time Frame 28 days post-final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on per-protocol analysis set.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
Hide Arm/Group Description:
Participants (aged 6 to <36 months) received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
Participants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
Overall Number of Participants Analyzed 26 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1
84.6
(65.1 to 95.6)
96.6
(82.2 to 99.9)
A/H3N2
80.8
(60.6 to 93.4)
96.6
(82.2 to 99.9)
B Victoria
80.8
(60.6 to 93.4)
100
(88.1 to 100)
B Yamagata
92.3
(74.9 to 99.1)
96.6
(82.2 to 99.9)
8.Primary Outcome
Title Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5
Hide Description Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. Seroprotection was defined as antibody titer >=40 (1/dilution) at pre-vaccination and at post-final vaccination.
Time Frame Day 21 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on per-protocol analysis set.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years Fluzone High-Dose Vaccine Group 5: >=65 Years
Hide Arm/Group Description:
Participants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
Participants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.
Participants (aged >=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 61 58 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1
100
(94.1 to 100)
100
(93.8 to 100)
93.3
(83.8 to 98.2)
A/H3N2
98.4
(91.2 to 100)
100
(93.8 to 100)
98.3
(91.1 to 100)
B Victoria
100
(94.1 to 100)
98.3
(90.8 to 100)
98.3
(91.1 to 100)
B Yamagata
100
(94.1 to 100)
100
(93.8 to 100)
NA [1] 
(NA to NA)
[1]
Data not reported since the immune response to the B Yamagata lineage strain was not assessed in Group 5 participants.
9.Primary Outcome
Title Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2
Hide Description Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Seroconversion was defined as either a pre-vaccination titer <10 (1/dilution) and a post-final vaccination titer >= 40 (1/dilution) or a pre-vaccination titer >= 10 (1/dilution) and >=4-fold increase in post-final vaccination titer.
Time Frame 28 days post-final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on per-protocol analysis set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years
Hide Arm/Group Description:
Participants (aged 6 to <36 months) received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
Participants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
Overall Number of Participants Analyzed 25 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1
80.0
(59.3 to 93.2)
42.9
(24.5 to 62.8)
A/H3N2
56.0
(34.9 to 75.6)
64.3
(44.1 to 81.4)
B Victoria
80.0
(59.3 to 93.2)
92.9
(76.5 to 99.1)
B Yamagata
88.0
(68.8 to 97.5)
78.6
(59.0 to 91.7)
10.Primary Outcome
Title Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5
Hide Description Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Group 3 and 4, and using an HAI assay for 3 strains: A/H1N1, A/H3N2, and B Victoria lineage in Group 5. Seroconversion was defined as either a pre-vaccination titer <10 (1/dilution) and a post-vaccination titer >= 40 (1/dilution) or a pre-vaccination titer >= 10 (1/dilution) and >=4-fold increase in post-vaccination titer.
Time Frame Day 21 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on per-protocol analysis set.
Arm/Group Title Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years Fluzone High-Dose Vaccine Group 5: >=65 Years
Hide Arm/Group Description:
Participants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
Participants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0.

Participants (aged >=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.

.

Overall Number of Participants Analyzed 61 58 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1
32.8
(21.3 to 46.0)
51.7
(38.2 to 65.0)
46.7
(33.7 to 60.0)
A/H3N2
44.3
(31.5 to 57.6)
70.7
(57.3 to 81.9)
50.0
(36.8 to 63.2)
B Victoria
32.8
(21.3 to 46.0)
46.6
(33.3 to 60.1)
46.7
(33.7 to 60.0)
B Yamagata
27.9
(17.1 to 40.8)
55.2
(41.5 to 68.3)
NA [1] 
(NA to NA)
[1]
Data not reported since the immune response to the B Yamagata lineage strain was not assessed in Group 5 participants.
Time Frame Adverse events were collected from Day 0 (post-vaccination) up to study end ( i.e., up to Day 21 for adult participants or Day 28 for child participants who received 1 dose; up to Day 56 for participants who received 2 doses).
Adverse Event Reporting Description Solicited reaction (SR) is an AE prelisted in eCRF and considered related to vaccination. A SR is, therefore, an adverse drug reaction observed and reported under conditions prelisted (solicited) in eCRF. An Unsolicited AE is an observed AE that does not fulfill conditions prelisted in eCRF in terms of symptom and/or time to onset post-vaccination. Non-serious adverse events (non-SAE) included SR (within 7 days after vaccination) and unsolicited non-SAE (within 28 days after final vaccination)
 
Arm/Group Title Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years Fluzone High-Dose Vaccine Group 5: >=65 Years
Hide Arm/Group Description Participants (aged 6 to <36 months) received a 0.25 mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. Participants (aged 3 to <9 years) received a 0.5 mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. Participants (aged 18 to <65 years) received a 0.5 mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants (aged 18 to <65 years) received a 0.5 mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0. Participants (aged >=65 years) received a 0.5 mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
All-Cause Mortality
Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years Fluzone High-Dose Vaccine Group 5: >=65 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/30 (0.00%)      0/61 (0.00%)      0/59 (0.00%)      0/60 (0.00%)    
Hide Serious Adverse Events
Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years Fluzone High-Dose Vaccine Group 5: >=65 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)      0/61 (0.00%)      0/59 (0.00%)      0/60 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years Fluzone High-Dose Vaccine Group 5: >=65 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/30 (70.00%)      13/30 (43.33%)      33/61 (54.10%)      29/59 (49.15%)      34/60 (56.67%)    
Gastrointestinal disorders           
Vomiting  1  4/30 (13.33%)  4 0/30 (0.00%)  0 0/61 (0.00%)  0 0/59 (0.00%)  0 0/60 (0.00%)  0
General disorders           
Crying  1  4/30 (13.33%)  5 0/30 (0.00%)  0 0/61 (0.00%)  0 0/59 (0.00%)  0 0/60 (0.00%)  0
Injection Site Erythema  1  3/30 (10.00%)  3 5/30 (16.67%)  5 1/61 (1.64%)  1 0/59 (0.00%)  0 5/60 (8.33%)  5
Injection Site Pain  1  15/30 (50.00%)  16 9/30 (30.00%)  9 27/61 (44.26%)  27 22/59 (37.29%)  22 24/60 (40.00%)  24
Injection Site Swelling  1  4/30 (13.33%)  5 6/30 (20.00%)  6 2/61 (3.28%)  2 0/59 (0.00%)  0 3/60 (5.00%)  3
Malaise  1  0/30 (0.00%)  0 6/30 (20.00%)  6 11/61 (18.03%)  11 6/59 (10.17%)  6 9/60 (15.00%)  9
Pyrexia  1  3/30 (10.00%)  3 2/30 (6.67%)  2 0/61 (0.00%)  0 0/59 (0.00%)  0 2/60 (3.33%)  2
Infections and infestations           
Gastroenteritis Viral  1  0/30 (0.00%)  0 3/30 (10.00%)  3 0/61 (0.00%)  0 0/59 (0.00%)  0 0/60 (0.00%)  0
Metabolism and nutrition disorders           
Decreased Appetite  1  10/30 (33.33%)  12 0/30 (0.00%)  0 0/61 (0.00%)  0 0/59 (0.00%)  0 0/60 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Myalgia  1  0/30 (0.00%)  0 6/30 (20.00%)  6 15/61 (24.59%)  15 11/59 (18.64%)  11 15/60 (25.00%)  15
Nervous system disorders           
Headache  1  0/30 (0.00%)  0 5/30 (16.67%)  5 12/61 (19.67%)  12 14/59 (23.73%)  15 11/60 (18.33%)  11
Somnolence  1  9/30 (30.00%)  10 0/30 (0.00%)  0 0/61 (0.00%)  0 0/59 (0.00%)  0 0/60 (0.00%)  0
Psychiatric disorders           
Irritability  1  12/30 (40.00%)  14 0/30 (0.00%)  0 0/61 (0.00%)  0 0/59 (0.00%)  0 0/60 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Cough  1  5/30 (16.67%)  5 0/30 (0.00%)  0 0/61 (0.00%)  0 0/59 (0.00%)  0 0/60 (0.00%)  0
Skin and subcutaneous tissue disorders           
Rash  1  0/30 (0.00%)  0 2/30 (6.67%)  2 0/61 (0.00%)  0 0/59 (0.00%)  0 0/60 (0.00%)  0
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
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.
The 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.
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT03617523    
Other Study ID Numbers: GRC90
U1111-1211-4864 ( Other Identifier: UTN )
First Submitted: July 25, 2018
First Posted: August 6, 2018
Results First Submitted: November 5, 2019
Results First Posted: November 25, 2019
Last Update Posted: November 25, 2019