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Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03308825
Recruitment Status : Completed
First Posted : October 13, 2017
Results First Posted : December 17, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Influenza
Flu
Interventions Biological: Fluzone Quadrivalent vaccine
Biological: Fluzone High-Dose vaccine
Enrollment 240
Recruitment Details Study participants were enrolled in 3 centers in the United States from 11 September 2017 to 25 October 2017.
Pre-assignment Details A total of 240 participants were enrolled and vaccinated in the study.
Arm/Group Title Group 1: 6 to < 36 Months Group 2: 3 to < 9 Years Group 3: 18 to < 65 Years Group 4: >= 65 Years
Hide Arm/Group Description Children aged 6 to < 36 months received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28. Children aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28. Adults aged 18 to < 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Adults aged >= 65 years received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Period Title: Overall Study
Started 59 [1] 61 [1] 60 60
Completed 57 57 59 60
Not Completed 2 4 1 0
Reason Not Completed
Lost to Follow-up             2             2             1             0
Protocol Violation             0             2             0             0
[1]
1 child in Group 1 received a 0.5mL dose instead of a 0.25 mL dose and is included in Group 2.
Arm/Group Title Group 1: 6 to < 36 Months Group 2: 3 to < 9 Years Group 3: 18 to < 65 Years Group 4: >= 65 Years Total
Hide Arm/Group Description Children aged 6 to < 36 months received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28. Children aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28. Adults aged 18 to < 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Adults 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 59 61 60 60 240
Hide Baseline Analysis Population Description
Safety Analysis set included all participants who received at least 1 dose of study vaccine, according to the vaccine they actually received.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 61 participants 60 participants 60 participants 240 participants
<=18 years
59
 100.0%
61
 100.0%
1
   1.7%
0
   0.0%
121
  50.4%
Between 18 and 65 years
0
   0.0%
0
   0.0%
59
  98.3%
0
   0.0%
59
  24.6%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
60
 100.0%
60
  25.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 61 participants 60 participants 60 participants 240 participants
Female
25
  42.4%
31
  50.8%
46
  76.7%
39
  65.0%
141
  58.8%
Male
34
  57.6%
30
  49.2%
14
  23.3%
21
  35.0%
99
  41.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 61 participants 60 participants 60 participants 240 participants
Hispanic or Latino
3
   5.1%
6
   9.8%
0
   0.0%
1
   1.7%
10
   4.2%
Not Hispanic or Latino
56
  94.9%
55
  90.2%
60
 100.0%
59
  98.3%
230
  95.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 61 participants 60 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%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
1
   0.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
29
  49.2%
30
  49.2%
16
  26.7%
5
   8.3%
80
  33.3%
White
29
  49.2%
25
  41.0%
43
  71.7%
53
  88.3%
150
  62.5%
More than one race
1
   1.7%
6
   9.8%
1
   1.7%
1
   1.7%
9
   3.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months)
Hide Description Solicited injection site reactions: Pain, Erythema and Swelling (Grade 3: Pain: cries when injected limb moved/ limb movement reduced, erythema and swelling >= 50 mm). Solicited systemic reactions: Fever, vomiting, abnormal crying, drowsiness, appetite lost, Irritability (Grade 3: Fever: >= 39.5 degrees Celsius [103.1 degree Fahrenheit {°F}], vomiting >= six episodes per 24 hours, abnormal crying : > 3 hours, drowsiness: sleeping most of the time or difficult to wake up, appetite lost: refuses >= 3 feeds/meals or refuses most feeds/meals, Irritability: Inconsolable).
Time Frame Within 7 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed using the Safety Analysis Set. Here, “Number analyzed” corresponds to participants with available data for each listed solicited reaction.
Arm/Group Title Group 1: 6 to < 36 Months
Hide Arm/Group Description:
Children aged 6 to < 36 months received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
Overall Number of Participants Analyzed 59
Measure Type: Count of Participants
Unit of Measure: Participants
Tenderness Number Analyzed 56 participants
16
  28.6%
Tenderness : Grade 3 Number Analyzed 56 participants
1
   1.8%
Erythema Number Analyzed 56 participants
4
   7.1%
Erythema : Grade 3 Number Analyzed 56 participants
0
   0.0%
Swelling Number Analyzed 56 participants
2
   3.6%
Swelling : Grade 3 Number Analyzed 56 participants
0
   0.0%
Fever Number Analyzed 55 participants
6
  10.9%
Fever : Grade 3 Number Analyzed 55 participants
0
   0.0%
Vomiting Number Analyzed 56 participants
2
   3.6%
Vomiting : Grade 3 Number Analyzed 56 participants
0
   0.0%
Crying Abnormal Number Analyzed 56 participants
10
  17.9%
Crying Abnormal : Grade 3 Number Analyzed 56 participants
0
   0.0%
Drowsiness Number Analyzed 56 participants
11
  19.6%
Drowsiness : Grade 3 Number Analyzed 56 participants
0
   0.0%
Appetite Lost Number Analyzed 56 participants
7
  12.5%
Appetite Lost : Grade 3 Number Analyzed 56 participants
0
   0.0%
Irritability Number Analyzed 56 participants
13
  23.2%
Irritability : Grade 3 Number Analyzed 56 participants
0
   0.0%
2.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years)
Hide Description Solicited injection site reactions: Pain (Group 2: Grade 3: Incapacitating; Group 3 and 4: Grade 3: significant; prevents daily activity), erythema & swelling (Group 2: Grade 3: >= 50 mm, Group 3 and 4: Grade 3: > 100 mm). Solicited systemic reactions: Fever (Grade 3: >= 39.0 degrees Celsius [102.2°F]), headache, malaise & myalgia (Grade 3: significant interference with daily activities).
Time Frame Within 7 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed using Safety Analysis Set. Here, “Number analyzed” corresponds to participants with available data for each listed solicited reaction.
Arm/Group Title Group 2: 3 to < 9 Years Group 3: 18 to < 65 Years Group 4: >= 65 Years
Hide Arm/Group Description:
Children aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
Adults aged 18 to < 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
Adults aged >= 65 years received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 61 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
Pain Number Analyzed 56 participants 58 participants 60 participants
25
  44.6%
27
  46.6%
20
  33.3%
Pain: Grade 3 Number Analyzed 56 participants 58 participants 60 participants
1
   1.8%
1
   1.7%
0
   0.0%
Erythema Number Analyzed 57 participants 58 participants 60 participants
9
  15.8%
0
   0.0%
3
   5.0%
Erythema : Grade 3 Number Analyzed 57 participants 58 participants 60 participants
3
   5.3%
0
   0.0%
0
   0.0%
Swelling Number Analyzed 57 participants 58 participants 60 participants
11
  19.3%
1
   1.7%
2
   3.3%
Swelling : Grade 3 Number Analyzed 57 participants 58 participants 60 participants
2
   3.5%
0
   0.0%
0
   0.0%
Fever Number Analyzed 56 participants 58 participants 60 participants
1
   1.8%
0
   0.0%
1
   1.7%
Fever : Grade 3 Number Analyzed 56 participants 58 participants 60 participants
1
   1.8%
0
   0.0%
1
   1.7%
Headache Number Analyzed 56 participants 58 participants 60 participants
2
   3.6%
10
  17.2%
6
  10.0%
Headache : Grade 3 Number Analyzed 56 participants 58 participants 60 participants
0
   0.0%
1
   1.7%
0
   0.0%
Malaise Number Analyzed 56 participants 58 participants 60 participants
3
   5.4%
5
   8.6%
9
  15.0%
Malaise: Grade 3 Number Analyzed 56 participants 58 participants 60 participants
1
   1.8%
1
   1.7%
0
   0.0%
Myalgia Number Analyzed 56 participants 58 participants 60 participants
11
  19.6%
13
  22.4%
17
  28.3%
Myalgia : Grade 3 Number Analyzed 56 participants 58 participants 60 participants
0
   0.0%
1
   1.7%
1
   1.7%
3.Primary Outcome
Title Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
Hide Description Anti-influenza antibodies were measured using the hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage.
Time Frame Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Analysis Set (PPAS) included all participants who received at least 1dose of study vaccine, had a valid post-final vaccination serology result for at least 1 strain and did not have any major protocol deviations. Here, “Number analyzed” corresponds to participants with available data for each listed strain.
Arm/Group Title Group 1: 6 to < 36 Months Group 2: 3 to < 9 Years
Hide Arm/Group Description:
Children aged 6 to < 36 months received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
Children aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
Overall Number of Participants Analyzed 52 55
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
Pre-Vaccination: A/H1N1 Number Analyzed 51 participants 55 participants
19.9
(11.9 to 33.1)
306
(198 to 473)
Pre-Vaccination: A/H3N2 Number Analyzed 51 participants 52 participants
49.7
(27.7 to 89.2)
415
(253 to 681)
Pre-Vaccination: B Victoria Number Analyzed 50 participants 55 participants
32.0
(19.7 to 52.0)
180
(112 to 290)
Pre-Vaccination: B Yamagata Number Analyzed 50 participants 55 participants
43.5
(27.6 to 68.5)
334
(219 to 510)
Post-Final Vaccination: A/H1N1 Number Analyzed 52 participants 55 participants
450
(301 to 671)
1606
(1198 to 2153)
Post-Final Vaccination: A/H3N2 Number Analyzed 52 participants 54 participants
568
(336 to 958)
2370
(1712 to 3282)
Post-Final Vaccination: B Victoria Number Analyzed 52 participants 55 participants
481
(313 to 738)
1668
(1142 to 2436)
Post-Final Vaccination: B Yamagata Number Analyzed 52 participants 55 participants
698
(465 to 1047)
2187
(1610 to 2971)
4.Primary Outcome
Title GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
Hide Description Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4).
Time Frame Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS. Here, “Number analyzed” corresponds to participants with available data for each listed strain and “0” in the number analyzed field signifies that none of the participants were analyzed, since the 2017-2018 formulation of Fluzone High-Dose vaccine did not contain the B Yagamata lineage strain.
Arm/Group Title Group 3: 18 to < 65 Years Group 4: >= 65 Years
Hide Arm/Group Description:
Adults aged 18 to < 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
Adults aged >= 65 years received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 56 59
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
Pre-Vaccination: A/H1N1 Number Analyzed 55 participants 59 participants
165
(110 to 248)
74.6
(52.3 to 106)
Pre-Vaccination: A/H3N2 Number Analyzed 53 participants 59 participants
231
(150 to 356)
194
(130 to 291)
Pre-Vaccination: B Victoria Number Analyzed 56 participants 59 participants
276
(185 to 412)
215
(151 to 305)
Pre-Vaccination: B Yamagata Number Analyzed 55 participants 0 participants
425
(308 to 587)
Post-Final Vaccination: A/H1N1 Number Analyzed 56 participants 59 participants
756
(539 to 1062)
393
(275 to 561)
Post-Final Vaccination: A/H3N2 Number Analyzed 55 participants 59 participants
1128
(791 to 1610)
864
(612 to 1218)
Post-Final Vaccination: B Victoria Number Analyzed 56 participants 59 participants
1117
(853 to 1463)
644
(465 to 892)
Post-Final Vaccination: B Yamagata Number Analyzed 56 participants 0 participants
1312
(1010 to 1704)
5.Primary Outcome
Title GMT Ratios (GMTRs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
Hide Description GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage, measured using the HAI assay.
Time Frame Day 0 (pre-vaccination) and Day 28 (post-final vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS. Here, “Number analyzed” corresponds to participants with available data for each listed strain.
Arm/Group Title Group 1: 6 to < 36 Months Group 2: 3 to < 9 Years
Hide Arm/Group Description:
Children aged 6 to < 36 months received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
Children aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
Overall Number of Participants Analyzed 52 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Titer Ratio
A/H1N1 Number Analyzed 51 participants 55 participants
17.6
(12.1 to 25.6)
5.05
(3.56 to 7.16)
A/H3N2 Number Analyzed 51 participants 52 participants
10.8
(7.54 to 15.4)
5.54
(3.67 to 8.37)
B Victoria Number Analyzed 50 participants 55 participants
13.1
(8.86 to 19.3)
9.02
(6.06 to 13.4)
B Yamagata Number Analyzed 50 participants 55 participants
14.0
(9.44 to 20.8)
6.46
(4.70 to 8.88)
6.Primary Outcome
Title GMTRs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
Hide Description GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4), measured using the HAI assay.
Time Frame Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS. Here, “Number analyzed” corresponds to participants with available data for each listed strain and “0” in the number analyzed field signifies that none of the participants were analyzed, since the 2017-2018 formulation of Fluzone High-Dose vaccine did not contain the B Yagamata lineage strain.
Arm/Group Title Group 3: 18 to < 65 Years Group 4: Adults >= 65 Years
Hide Arm/Group Description:
Adults aged 18 to < 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
Adults >= 65 years of age received an intramuscular 0.5-mL dose of Fluzone High-Dose vaccine on Day 0.
Overall Number of Participants Analyzed 56 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Titer Ratio
A/H1N1 Number Analyzed 55 participants 59 participants
4.31
(2.91 to 6.40)
5.15
(3.50 to 7.57)
A/H3N2 Number Analyzed 53 participants 59 participants
4.44
(2.88 to 6.85)
4.45
(3.09 to 6.40)
B Victoria Number Analyzed 56 participants 59 participants
4.05
(2.55 to 6.43)
2.96
(2.26 to 3.88)
B Yamagata Number Analyzed 55 participants 0 participants
3.09
(2.16 to 4.42)
7.Primary Outcome
Title Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
Hide Description Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroprotection was defined as antibody titer >=40 (1/ dilution) at pre-vaccination or at post-final vaccination.
Time Frame Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS. Here, “Number analyzed” corresponds to participants with available data for each listed strain.
Arm/Group Title Group 1: 6 to < 36 Months Group 2: 3 to < 9 Years
Hide Arm/Group Description:
Children aged 6 to < 36 months received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
Children aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
Overall Number of Participants Analyzed 52 55
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-Vaccination: A/H1N1 Number Analyzed 51 participants 55 participants
15
  29.4%
48
  87.3%
Pre-Vaccination: A/H3N2 Number Analyzed 51 participants 52 participants
24
  47.1%
46
  88.5%
Pre-Vaccination: B Victoria Number Analyzed 50 participants 55 participants
21
  42.0%
44
  80.0%
Pre-Vaccination: B Yamagata Number Analyzed 50 participants 55 participants
31
  62.0%
50
  90.9%
Post-Final Vaccination: A/H1N1 Number Analyzed 52 participants 55 participants
51
  98.1%
54
  98.2%
Post-Final Vaccination: A/H3N2 Number Analyzed 52 participants 54 participants
50
  96.2%
54
 100.0%
Post-Final Vaccination: B Victoria Number Analyzed 52 participants 55 participants
50
  96.2%
54
  98.2%
Post-Final Vaccination: B Yamagata Number Analyzed 52 participants 55 participants
50
  96.2%
55
 100.0%
8.Primary Outcome
Title Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
Hide Description Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroprotection was defined as antibody titer >= 40 (1/ dilution) at pre-vaccination or at post-final vaccination.
Time Frame Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS. Here, “Number analyzed” corresponds to participants with available data for each listed strain and “0” in the number analyzed field signifies that none of the participants were analyzed, since the 2017-2018 formulation of Fluzone High-Dose vaccine did not contain the B Yagamata lineage strain.
Arm/Group Title Group 3: 18 to < 65 Years Group 4: >= 65 Years
Hide Arm/Group Description:
Adults aged 18 to < 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
Adults aged >= 65 years received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 56 59
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-Vaccination: A/H1N1 Number Analyzed 55 participants 59 participants
45
  81.8%
40
  67.8%
Pre-Vaccination: A/H3N2 Number Analyzed 53 participants 59 participants
48
  90.6%
49
  83.1%
Pre-Vaccination: B Victoria Number Analyzed 56 participants 59 participants
48
  85.7%
55
  93.2%
Pre-Vaccination: B Yamagata Number Analyzed 55 participants 0 participants
54
  98.2%
Post-Final Vaccination: A/H1N1 Number Analyzed 56 participants 59 participants
55
  98.2%
57
  96.6%
Post-Final Vaccination: A/H3N2 Number Analyzed 55 participants 59 participants
55
 100.0%
59
 100.0%
Post-Final Vaccination: B Victoria Number Analyzed 56 participants 59 participants
56
 100.0%
58
  98.3%
Post-Final Vaccination: B Yamagata Number Analyzed 56 participants 0 participants
56
 100.0%
9.Primary Outcome
Title Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
Hide Description Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-final vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-final vaccination titer.
Time Frame Day 0 (pre-vaccination) and Day 28 (post-final vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS. Here, “Number analyzed” corresponds to participants with available data for each listed strain.
Arm/Group Title Group 1: 6 to < 36 Months Group 2: 3 to < 9 Years
Hide Arm/Group Description:
Children aged 6 to < 36 months received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
Children aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
Overall Number of Participants Analyzed 52 55
Measure Type: Count of Participants
Unit of Measure: Participants
A/H1N1 Number Analyzed 51 participants 55 participants
45
  88.2%
28
  50.9%
A/H3N2 Number Analyzed 51 participants 52 participants
42
  82.4%
30
  57.7%
B Victoria Number Analyzed 50 participants 55 participants
44
  88.0%
39
  70.9%
B Yamagata Number Analyzed 50 participants 55 participants
46
  92.0%
36
  65.5%
10.Primary Outcome
Title Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)
Hide Description Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-final vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-final vaccination titer.
Time Frame Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS. Here, “Number analyzed” corresponds to participants with available data for each listed strain and “0” in the number analyzed field signifies that none of the participants were analyzed, since the 2017-2018 formulation of Fluzone High-Dose vaccine did not contain the B Yagamata lineage strain.
Arm/Group Title Group 3: 18 to < 65 Years Group 4: >= 65 Years
Hide Arm/Group Description:
Adults aged 18 to < 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.
Adults aged >= 65 years received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 56 59
Measure Type: Count of Participants
Unit of Measure: Participants
A/H1N1 Number Analyzed 55 participants 59 participants
26
  47.3%
33
  55.9%
A/H3N2 Number Analyzed 53 participants 59 participants
22
  41.5%
33
  55.9%
B Victoria Number Analyzed 56 participants 59 participants
19
  33.9%
18
  30.5%
B Yamagata Number Analyzed 55 participants 0 participants
22
  40.0%
Time Frame Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 56 for Groups 1 and 2; up to Day 21 for Groups 3 and 4.
Adverse Event Reporting Description A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
 
Arm/Group Title Group 1: 6 to < 36 Months Group 2: 3 to < 9 Years Group 3: 18 to < 65 Years Group 4: >= 65 Years
Hide Arm/Group Description Children aged 6 to < 36 months received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28. Children aged 3 to < 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28. Adults aged 18 to < 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Adults aged >= 65 years received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.
All-Cause Mortality
Group 1: 6 to < 36 Months Group 2: 3 to < 9 Years Group 3: 18 to < 65 Years Group 4: >= 65 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)      0/61 (0.00%)      0/60 (0.00%)      0/60 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: 6 to < 36 Months Group 2: 3 to < 9 Years Group 3: 18 to < 65 Years Group 4: >= 65 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/59 (0.00%)      0/61 (0.00%)      2/60 (3.33%)      0/60 (0.00%)    
Pregnancy, puerperium and perinatal conditions         
Abortion Spontaneous  1  0/59 (0.00%)  0 0/61 (0.00%)  0 1/60 (1.67%)  1 0/60 (0.00%)  0
Psychiatric disorders         
Anxiety  1  0/59 (0.00%)  0 0/61 (0.00%)  0 1/60 (1.67%)  1 0/60 (0.00%)  0
Depression  1  0/59 (0.00%)  0 0/61 (0.00%)  0 1/60 (1.67%)  1 0/60 (0.00%)  0
1
Term from vocabulary, MedDra 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: 6 to < 36 Months Group 2: 3 to < 9 Years Group 3: 18 to < 65 Years Group 4: >= 65 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/59 (50.85%)      30/61 (49.18%)      29/60 (48.33%)      30/60 (50.00%)    
Gastrointestinal disorders         
Vomiting  1  3/59 (5.08%)  3 1/61 (1.64%)  1 0/60 (0.00%)  0 0/60 (0.00%)  0
General disorders         
Crying  1  10/59 (16.95%)  11 1/61 (1.64%)  1 0/60 (0.00%)  0 0/60 (0.00%)  0
Injection Site Erythema  1  4/59 (6.78%)  4 9/61 (14.75%)  9 0/60 (0.00%)  0 3/60 (5.00%)  3
Injection Site Pain  1  16/59 (27.12%)  18 26/61 (42.62%)  26 27/60 (45.00%)  27 20/60 (33.33%)  20
Injection Site Swelling  1  2/59 (3.39%)  2 11/61 (18.03%)  11 1/60 (1.67%)  1 2/60 (3.33%)  2
Malaise  1  0/59 (0.00%)  0 3/61 (4.92%)  3 5/60 (8.33%)  5 9/60 (15.00%)  9
Pyrexia  1  8/59 (13.56%)  9 2/61 (3.28%)  2 0/60 (0.00%)  0 1/60 (1.67%)  1
Metabolism and nutrition disorders         
Decreased Appetite  1  7/59 (11.86%)  7 1/61 (1.64%)  1 0/60 (0.00%)  0 0/60 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Myalgia  1  0/59 (0.00%)  0 11/61 (18.03%)  11 13/60 (21.67%)  13 17/60 (28.33%)  17
Nervous system disorders         
Headache  1  1/59 (1.69%)  1 2/61 (3.28%)  2 10/60 (16.67%)  10 7/60 (11.67%)  7
Somnolence  1  11/59 (18.64%)  13 1/61 (1.64%)  1 0/60 (0.00%)  0 0/60 (0.00%)  0
Psychiatric disorders         
Irritability  1  13/59 (22.03%)  13 1/61 (1.64%)  1 0/60 (0.00%)  0 0/60 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  4/59 (6.78%)  5 0/61 (0.00%)  0 0/60 (0.00%)  0 2/60 (3.33%)  2
1
Term from vocabulary, MedDra 19.0
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.
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
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Phone: 800-633-1610 ext 1#
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT03308825     History of Changes
Other Study ID Numbers: GRC73
U1111-1183-5816 ( Other Identifier: WHO Universal Trial Number (UTN) )
First Submitted: September 28, 2017
First Posted: October 13, 2017
Results First Submitted: November 22, 2018
Results First Posted: December 17, 2018
Last Update Posted: December 17, 2018