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Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US

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ClinicalTrials.gov Identifier: NCT03282240
Recruitment Status : Completed
First Posted : September 13, 2017
Results First Posted : December 17, 2019
Last Update Posted : December 17, 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: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: QIV-HD
Biological: Licensed TIV-HD1
Biological: Investigational TIV-HD2
Enrollment 2670
Recruitment Details Study participants were screened in 35 centers in the Unites States (US) from 08 September 2017 to 15 September 2017.
Pre-assignment Details A total of 2670 participants were randomized in the study.
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccine (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Hide Arm/Group Description Participants randomized to receive a single injection of 0.7 mL high dose quadrivalent influenza vaccine (QIV-HD) by intramuscular (IM) route at Day 0. Participants randomized to receive a single injection of 0.5 mL licensed high dose trivalent influenza vaccine (TIV-HD1) by IM route at Day 0. Participants randomized to receive a single injection of 0.5 mL investigational high dose trivalent influenza vaccine with alternate B strain (TIV-HD2) by IM route at Day 0.
Period Title: Overall Study
Started 1777 443 450
Completed 1767 440 447
Not Completed 10 3 3
Reason Not Completed
Adverse Event             2             2             0
Lost to Follow-up             3             0             0
Protocol Deviation             4             1             2
Withdrawal by Subject             1             0             1
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccine (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) Total
Hide Arm/Group Description Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0. Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0. Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0. Total of all reporting groups
Overall Number of Baseline Participants 1777 443 450 2670
Hide Baseline Analysis Population Description
Analysis was performed on all randomized participants for whom a vaccine group was allocated.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1777 participants 443 participants 450 participants 2670 participants
72.9  (5.63) 72.8  (5.79) 73.2  (5.49) 73.0  (5.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1777 participants 443 participants 450 participants 2670 participants
Female
1027
  57.8%
268
  60.5%
252
  56.0%
1547
  57.9%
Male
750
  42.2%
175
  39.5%
198
  44.0%
1123
  42.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1777 participants 443 participants 450 participants 2670 participants
American Indian or Alaska Native
9
   0.5%
2
   0.5%
3
   0.7%
14
   0.5%
Asian
13
   0.7%
2
   0.5%
3
   0.7%
18
   0.7%
Native Hawaiian or Other Pacific Islander
4
   0.2%
1
   0.2%
1
   0.2%
6
   0.2%
Black or African American
123
   6.9%
41
   9.3%
35
   7.8%
199
   7.5%
White
1618
  91.1%
395
  89.2%
402
  89.3%
2415
  90.4%
More than one race
6
   0.3%
1
   0.2%
2
   0.4%
9
   0.3%
Unknown or Not Reported
4
   0.2%
1
   0.2%
4
   0.9%
9
   0.3%
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Hide Description GMTs of anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set (PPAS): all randomized participants who received at least 1 dose of trial vaccine & had a post-vaccination blood sample HAI result for at least 1 strain, with no relevant protocol deviations. Here, 'number analyzed' = participants with available data for each category.
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled)
Hide Arm/Group Description:
Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
Participants randomized to receive either a single injection of 0.5 mL licensed TIV-HD1 or investigational TIV-HD2 by IM route at Day 0.
Overall Number of Participants Analyzed 1680 423 430 853
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers (1/dilution)
A/H1N1 Number Analyzed 1680 participants 423 participants 430 participants 853 participants
312
(292 to 332)
387
(339 to 442)
362
(317 to 413)
374
(341 to 411)
A/H3N2 Number Analyzed 1679 participants 423 participants 430 participants 853 participants
563
(525 to 603)
588
(513 to 673)
600
(524 to 687)
594
(540 to 653)
B Victoria Number Analyzed 1680 participants 423 participants 0 participants 0 participants
516
(488 to 545)
476
(426 to 532)
B Yamagata Number Analyzed 1680 participants 0 participants 430 participants 0 participants
578
(547 to 612)
580
(519 to 649)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High-Dose Quadrivalent Influenza Vaccine (QIV-HD), High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)
Comments B Victoria: The 2-sided 95% confidence interval (CI) was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is > 0.667 for each of the comparisons.
Method of Estimation Estimation Parameter GMT Ratio (QIV-HD/TIV-HDs)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.958 to 1.224
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High-Dose Quadrivalent Influenza Vaccine (QIV-HD), High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Comments B Yamagata: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is > 0.667 for each of the comparisons.
Method of Estimation Estimation Parameter GMT Ratio (QIV-HD/TIV-HDs)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.881 to 1.129
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection High-Dose Quadrivalent Influenza Vaccine (QIV-HD), High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled)
Comments A/H1N1: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is > 0.667 for each of the comparisons.
Method of Estimation Estimation Parameter GMT Ratio (QIV-HD/TIV-HDs)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.744 to 0.932
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection High-Dose Quadrivalent Influenza Vaccine (QIV-HD), High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled)
Comments A/H3N2: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is > 0.667 for each of the comparisons.
Method of Estimation Estimation Parameter GMT Ratio (QIV-HD/TIV-HDs)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.842 to 1.066
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Hide Description Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Seroconversion was defined as either a HAI titer less than (<) 10 (1/dilution) at Day 0 and post-injection titer greater than or equal to (>=) 40 (1/dilution) at Day 28, or HAI titer >=10 (1/dilution) at Day 0 and a >=4-fold increase in HAI titer (1/dilution) at Day 28. For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS. Here, 'number analyzed' = participants with available data for each category.
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled)
Hide Arm/Group Description:
Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
Participants randomized to receive either a single injection of 0.5 mL licensed TIV-HD1 or investigational TIV-HD2 by IM route at Day 0.
Overall Number of Participants Analyzed 1680 423 430 853
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1 Number Analyzed 1669 participants 420 participants 428 participants 848 participants
50.4
(48.0 to 52.8)
56.2
(51.3 to 61.0)
51.2
(46.3 to 56.0)
53.7
(50.2 to 57.1)
A/H3N2 Number Analyzed 1668 participants 420 participants 428 participants 848 participants
49.8
(47.3 to 52.2)
52.9
(48.0 to 57.7)
48.1
(43.3 to 53.0)
50.5
(47.1 to 53.9)
B Victoria Number Analyzed 1669 participants 421 participants 0 participants 0 participants
36.5
(34.2 to 38.9)
39.0
(34.3 to 43.8)
B Yamagata Number Analyzed 1669 participants 0 participants 428 participants 0 participants
46.6
(44.2 to 49.0)
48.4
(43.5 to 53.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High-Dose Quadrivalent Influenza Vaccine (QIV-HD), High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)
Comments B Victoria: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is > -10%.
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -2.41
Confidence Interval (2-Sided) 95%
-7.66 to 2.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High-Dose Quadrivalent Influenza Vaccine (QIV-HD), High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Comments B Yamagata: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is > -10%.
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -1.75
Confidence Interval (2-Sided) 95%
-7.04 to 3.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection High-Dose Quadrivalent Influenza Vaccine (QIV-HD), High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled)
Comments A/H3N2: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is > -10%.
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-4.83 to 3.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection High-Dose Quadrivalent Influenza Vaccine (QIV-HD), High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled)
Comments A/H1N1: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is > -10%.
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -3.27
Confidence Interval (2-Sided) 95%
-7.37 to 0.86
Estimation Comments [Not Specified]
3.Secondary Outcome
Title GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Hide Description Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). For each B strain, the immunogenicity of QIV-HD was compared to that of TIV-HD group which contains the corresponding B strain. TIV-HD1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on full analysis set (FAS) that consisted who received at least 1 dose of a trial vaccine and had a post-vaccination blood sample HAI result for at least 1 strain. Participants were analyzed according to the vaccine group to which they were randomized.
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Hide Arm/Group Description:
Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
Overall Number of Participants Analyzed 1763 439 446
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers (1/dilution)
B Victoria Number Analyzed 1763 participants 0 participants 446 participants
515
(488 to 543)
253
(227 to 283)
B Yamagata Number Analyzed 1763 participants 439 participants 0 participants
573
(542 to 605)
280
(249 to 316)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High-Dose Quadrivalent Influenza Vaccine (QIV-HD), High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)
Comments The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.
Type of Statistical Test Superiority
Comments Superiority in GMTs was observed if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups was > 1.5 for comparison group.
Method of Estimation Estimation Parameter GMT Ratio (QIV-HD/TIV-HDs)
Estimated Value 2.04
Confidence Interval (2-Sided) 95%
1.804 to 2.315
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High-Dose Quadrivalent Influenza Vaccine (QIV-HD), High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Comments The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.
Type of Statistical Test Superiority
Comments Superiority in GMTs was observed if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups was > 1.5 for comparison group.
Method of Estimation Estimation Parameter GMT Ratio (QIV-HD/TIV-HDs)
Estimated Value 2.03
Confidence Interval (2-Sided) 95%
1.802 to 2.288
Estimation Comments [Not Specified]
4.Secondary Outcome
Title GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Hide Description GMTs of anti-influenza antibodies using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Geometric Mean Titers Ratios (GMTRs) were calculated as the ratio of GMTs post vaccination and pre-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' = participants with available data for each category.
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Hide Arm/Group Description:
Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL investigational high dose trivalent influenza vaccine with alternate B strain (TIV-HD2) by IM route at Day 0.
Overall Number of Participants Analyzed 1680 423 430
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: ratio
A/H1N1: Day28/Day 0 Number Analyzed 1669 participants 420 participants 428 participants
4.38
(4.11 to 4.66)
5.57
(4.85 to 6.39)
4.76
(4.16 to 5.44)
A/H3N2: Day28/Day 0 Number Analyzed 1668 participants 420 participants 428 participants
4.65
(4.35 to 4.98)
4.82
(4.24 to 5.48)
4.94
(4.32 to 5.65)
B Victoria: Day28/Day 0 Number Analyzed 1669 participants 421 participants 428 participants
3.17
(2.99 to 3.35)
3.35
(2.99 to 3.76)
1.65
(1.52 to 1.78)
B Yamagata: Day28/Day 0 Number Analyzed 1669 participants 421 participants 428 participants
3.82
(3.62 to 4.03)
1.86
(1.73 to 2.02)
3.82
(3.43 to 4.24)
5.Secondary Outcome
Title Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Hide Description Seroconversion was defined as either a HAI titer <10 (1/dilution) at Day 0 and post-injection titer >=40 (1/dilution) at Day 28, or HAI titer >=10 (1/dilution) at Day 0 and a >=4-fold increase in HAI titer (1/dilution) at Day 28.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS. Here, 'number analyzed' = participants with available data for each category.
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Hide Arm/Group Description:
Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
Overall Number of Participants Analyzed 1763 439 446
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
B Victoria Number Analyzed 1751 participants 0 participants 444 participants
36.3
(34.1 to 38.6)
15.5
(12.3 to 19.3)
B Yamagata Number Analyzed 1751 participants 437 participants 0 participants
46.7
(44.3 to 49.0)
17.4
(14.0 to 21.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High-Dose Quadrivalent Influenza Vaccine (QIV-HD), High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)
Comments B Yamagata: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.
Type of Statistical Test Superiority
Comments Superiority in seroconversion was observed if the lower limit of the 2-sided 95% CI of the difference of seroconversion rates between groups is > 10% for each applicable comparison.
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 29.27
Confidence Interval (2-Sided) 95%
24.78 to 33.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High-Dose Quadrivalent Influenza Vaccine (QIV-HD), High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Comments B Victoria: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.
Type of Statistical Test Superiority
Comments Superiority in seroconversion was observed if the lower limit of the 2-sided 95% CI of the difference of seroconversion rates between groups is > 10% for each applicable comparison.
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 20.78
Confidence Interval (2-Sided) 95%
16.5 to 24.61
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Hide Description Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). Seroprotection was defined as a HAI titer >=40 (1/dilution) at Day 0 and Day 28.
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' = participants with available data for each category.
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Hide Arm/Group Description:
Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
Overall Number of Participants Analyzed 1680 423 430
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1: Day 0 Number Analyzed 1669 participants 420 participants 430 participants
69.4
(67.2 to 71.6)
67.9
(63.2 to 72.3)
70.1
(65.5 to 74.4)
A/H3N2: Day 0 Number Analyzed 1668 participants 420 participants 430 participants
77.4
(75.3 to 79.4)
78.1
(73.8 to 82.0)
77.8
(73.6 to 81.7)
B Victoria: Day 0 Number Analyzed 1669 participants 421 participants 430 participants
88.9
(87.2 to 90.3)
87.9
(84.4 to 90.8)
88.8
(85.4 to 91.6)
B Yamagata : Day 0 Number Analyzed 1669 participants 421 participants 430 participants
89.6
(88.0 to 91.0)
88.1
(84.6 to 91.1)
90.9
(87.8 to 93.4)
A/H1N1: Day 28 Number Analyzed 1680 participants 423 participants 430 participants
95.1
(94.0 to 96.1)
96.7
(94.5 to 98.2)
95.6
(93.2 to 97.3)
A/H3N2: Day 28 Number Analyzed 1679 participants 423 participants 430 participants
96.9
(96.0 to 97.7)
96.9
(94.8 to 98.4)
96.7
(94.6 to 98.2)
B Victoria: Day 28 Number Analyzed 1680 participants 423 participants 430 participants
99.0
(98.5 to 99.5)
99.1
(97.6 to 99.7)
96.5
(94.3 to 98.0)
B Yamagata : Day 28 Number Analyzed 1680 participants 423 participants 430 participants
99.3
(98.8 to 99.7)
96.7
(94.5 to 98.2)
99.1
(97.6 to 99.7)
7.Secondary Outcome
Title Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Hide Description GMTs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2).
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
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Hide Analysis Population Description
Expanded immunogenicity subset:participants who received at least 1 dose of trial vaccine& had post-vaccination blood sample HAI result for at least 1 strain& were randomized into expanded immunogenicity subset with at least 1 post-vaccination SN assay result for at least 1 strain.'Number analyzed'=participants with available data for each category
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Hide Arm/Group Description:
Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
Overall Number of Participants Analyzed 102 102 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers (1/dilution)
A/H1N1: Day 0 Number Analyzed 102 participants 100 participants 99 participants
412
(306 to 555)
427
(328 to 556)
416
(311 to 555)
A/H3N2: Day 0 Number Analyzed 102 participants 100 participants 99 participants
497
(417 to 592)
536
(436 to 660)
593
(493 to 715)
B Victoria: Day 0 Number Analyzed 102 participants 100 participants 99 participants
458
(359 to 583)
452
(367 to 556)
430
(344 to 537)
B Yamagata: Day 0 Number Analyzed 102 participants 100 participants 99 participants
156
(124 to 196)
155
(126 to 190)
192
(152 to 242)
A/H1N1: Day 28 Number Analyzed 102 participants 102 participants 99 participants
2229
(1789 to 2776)
2050
(1564 to 2687)
1686
(1331 to 2135)
A/H3N2: Day 28 Number Analyzed 102 participants 102 participants 99 participants
1404
(1133 to 1741)
1327
(1056 to 1667)
1301
(1070 to 1583)
B Victoria: Day 28 Number Analyzed 102 participants 102 participants 99 participants
1288
(1055 to 1573)
1114
(916 to 1354)
590
(476 to 730)
B Yamagata: Day 28 Number Analyzed 102 participants 102 participants 99 participants
546
(438 to 682)
259
(207 to 325)
494
(390 to 626)
8.Secondary Outcome
Title GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Hide Description GMTRs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on expanded immunogenicity subset. Here, 'number analyzed' = participants with available data for each category.
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Hide Arm/Group Description:
Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
Overall Number of Participants Analyzed 102 102 99
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: ratio
A/H1N1: Day28/Day 0 Number Analyzed 102 participants 100 participants 99 participants
5.40
(3.90 to 7.48)
5.05
(3.86 to 6.60)
4.06
(3.17 to 5.18)
A/H3N2: Day28/Day 0 Number Analyzed 102 participants 100 participants 99 participants
2.83
(2.31 to 3.46)
2.50
(2.04 to 3.06)
2.19
(1.80 to 2.67)
B Victoria: Day28/Day 0 Number Analyzed 102 participants 100 participants 99 participants
2.81
(2.21 to 3.58)
2.47
(2.04 to 2.99)
1.37
(1.16 to 1.62)
B Yamagata: Day28/Day 0 Number Analyzed 102 participants 100 participants 99 participants
3.51
(2.80 to 4.39)
1.66
(1.41 to 1.95)
2.58
(2.18 to 3.05)
9.Secondary Outcome
Title Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28
Hide Description Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Neutralizing antibody was defined as titers >=20 (1/dilution), >=40 (1/dilution), >=80 (1/dilution) at Day 0 and Day 28.
Time Frame Day 0, Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on expanded immunogenicity subset.
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Hide Arm/Group Description:
Participants randomized to receive a single injection of the high dose QIV-HD by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
Overall Number of Participants Analyzed 102 102 99
Measure Type: Count of Participants
Unit of Measure: Participants
A/H1N1: >=20 (1/dil): Day 0
97
  95.1%
99
  97.1%
98
  99.0%
A/H1N1: >=40 (1/dil): Day 0
95
  93.1%
96
  94.1%
91
  91.9%
A/H1N1: >=80 (1/dil): Day 0
89
  87.3%
89
  87.3%
84
  84.8%
A/H3N2: >=20 (1/dil): Day 0
102
 100.0%
100
  98.0%
99
 100.0%
A/H3N2: >=40 (1/dil): Day 0
102
 100.0%
100
  98.0%
99
 100.0%
A/H3N2: >=80 (1/dil): Day 0
99
  97.1%
100
  98.0%
98
  99.0%
B Victoria: >=20 (1/dil): Day 0
101
  99.0%
100
  98.0%
99
 100.0%
B Victoria: >=40 (1/dil): Day 0
97
  95.1%
99
  97.1%
99
 100.0%
B Victoria: >=80 (1/dil): Day 0
91
  89.2%
96
  94.1%
93
  93.9%
B Yamagata: >=20 (1/dil): Day 0
98
  96.1%
98
  96.1%
99
 100.0%
B Yamagata: >=40 (1/dil): Day 0
91
  89.2%
93
  91.2%
87
  87.9%
B Yamagata: >=80 (1/dil): Day 0
75
  73.5%
75
  73.5%
74
  74.7%
A/H1N1: >=20 (1/dil): Day 28
102
 100.0%
102
 100.0%
99
 100.0%
A/H1N1: >=40 (1/dil): Day 28
102
 100.0%
102
 100.0%
99
 100.0%
A/H1N1: >=80 (1/dil): Day 28
102
 100.0%
100
  98.0%
99
 100.0%
A/H3N2: >=20 (1/dil): Day 28
102
 100.0%
102
 100.0%
99
 100.0%
A/H3N2: >=40 (1/dil): Day 28
102
 100.0%
102
 100.0%
99
 100.0%
A/H3N2: >=80 (1/dil): Day 28
102
 100.0%
101
  99.0%
99
 100.0%
B Victoria: >=20 (1/dil): Day 28
102
 100.0%
102
 100.0%
99
 100.0%
B Victoria: >=40 (1/dil): Day 28
102
 100.0%
102
 100.0%
99
 100.0%
B Victoria: >=80 (1/dil): Day 28
102
 100.0%
102
 100.0%
97
  98.0%
B Yamagata: >=20 (1/dil): Day 28
102
 100.0%
101
  99.0%
99
 100.0%
B Yamagata: >=40 (1/dil): Day 28
102
 100.0%
99
  97.1%
97
  98.0%
B Yamagata: >=80 (1/dil): Day 28
99
  97.1%
83
  81.4%
91
  91.9%
10.Secondary Outcome
Title Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28
Hide Description Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). 2-fold and 4-fold rise was defined as the computed value = post-vaccination computed value / baseline computed value.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on expanded immunogenicity subset. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Hide Arm/Group Description:
Participants randomized to receive a single injection of the high dose QIV-HD by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL investigational high dose trivalent influenza vaccine with alternate B strain (TIV-HD2) by IM route at Day 0.
Overall Number of Participants Analyzed 102 100 99
Measure Type: Count of Participants
Unit of Measure: Participants
Participants With 2-Fold Rise: A/H1N1
74
  72.5%
71
  71.0%
64
  64.6%
Participants With 4-Fold Rise: A/H1N1
43
  42.2%
50
  50.0%
41
  41.4%
Participants With 2-Fold Rise: A/H3N2
52
  51.0%
48
  48.0%
42
  42.4%
Participants With 4-Fold Rise: A/H3N2
27
  26.5%
24
  24.0%
23
  23.2%
Participants With 2-Fold Rise: B Victoria
52
  51.0%
51
  51.0%
24
  24.2%
Participants With 4-Fold Rise: B Victoria
28
  27.5%
23
  23.0%
8
   8.1%
Participants With 2-Fold Rise: B Yamagata
65
  63.7%
31
  31.0%
55
  55.6%
Participants With 4-Fold Rise: B Yamagata
36
  35.3%
11
  11.0%
29
  29.3%
11.Secondary Outcome
Title Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28
Hide Description Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Detectable neutralization antibody titer >= 1:10 (1/dilution) at Day 0 and Day 28.
Time Frame Day 0, Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on expanded immunogenicity subset. Here, 'number analyzed' = participants with available data for each category.
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Hide Arm/Group Description:
Participants randomized to receive a single injection of the high dose QIV-HD by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
Overall Number of Participants Analyzed 102 102 99
Measure Type: Count of Participants
Unit of Measure: Participants
A/H1N1: Titer >= 1:10: Day 0 Number Analyzed 102 participants 100 participants 99 participants
100
  98.0%
100
 100.0%
99
 100.0%
A/H1N1: Titer >= 1:10: Day 28 Number Analyzed 102 participants 102 participants 99 participants
102
 100.0%
102
 100.0%
99
 100.0%
A/H3N2: Titer >= 1:10: Day 0 Number Analyzed 102 participants 100 participants 99 participants
102
 100.0%
100
 100.0%
99
 100.0%
A/H3N2: Titer >= 1:10: Day 28 Number Analyzed 102 participants 102 participants 99 participants
102
 100.0%
102
 100.0%
99
 100.0%
B Victoria: Titer >= 1:10: Day 0 Number Analyzed 102 participants 100 participants 99 participants
102
 100.0%
100
 100.0%
99
 100.0%
B Victoria: Titer >= 1:10: Day 28 Number Analyzed 102 participants 102 participants 99 participants
102
 100.0%
102
 100.0%
99
 100.0%
B Yamagata: Titer >= 1:10: Day 0 Number Analyzed 102 participants 100 participants 99 participants
100
  98.0%
100
 100.0%
99
 100.0%
B Yamagata: Titer >= 1:10: Day 28 Number Analyzed 102 participants 102 participants 99 participants
102
 100.0%
102
 100.0%
99
 100.0%
12.Secondary Outcome
Title Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Hide Description Solicited injection site: Pain, Erythema, Swelling, Induration, and Bruising. Grade 3 reactions: Pain - interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention; Erythema, Swelling, Induration, and Bruising: >100 millimeters (mm). Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 reactions: Fever: >=39°C; Headache, Malaise, Myalgia, and Shivering: interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Time Frame Within 7 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety analysis set that included all participants who had received study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Here, 'number analyzed' = participants with available data for each specified category.
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Hide Arm/Group Description:
Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
Overall Number of Participants Analyzed 1777 443 450
Measure Type: Count of Participants
Unit of Measure: Participants
Fever: Any Grade Number Analyzed 1761 participants 437 participants 448 participants
7
   0.4%
3
   0.7%
5
   1.1%
Fever: Grade 3 Number Analyzed 1761 participants 437 participants 448 participants
3
   0.2%
1
   0.2%
1
   0.2%
Headache: Any Grade Number Analyzed 1768 participants 440 participants 449 participants
254
  14.4%
63
  14.3%
58
  12.9%
Headache: Grade 3 Number Analyzed 1768 participants 440 participants 449 participants
11
   0.6%
2
   0.5%
2
   0.4%
Malaise: Any Grade Number Analyzed 1768 participants 440 participants 449 participants
233
  13.2%
52
  11.8%
67
  14.9%
Malaise: Grade 3 Number Analyzed 1768 participants 440 participants 449 participants
13
   0.7%
3
   0.7%
1
   0.2%
Myalgia: Any Grade Number Analyzed 1768 participants 440 participants 449 participants
402
  22.7%
80
  18.2%
88
  19.6%
Myalgia: Grade 3 Number Analyzed 1768 participants 440 participants 449 participants
16
   0.9%
3
   0.7%
3
   0.7%
Shivering: Any Grade Number Analyzed 1768 participants 440 participants 449 participants
95
   5.4%
20
   4.5%
22
   4.9%
Shivering: Grade 3 Number Analyzed 1768 participants 443 participants 449 participants
5
   0.3%
3
   0.7%
0
   0.0%
Injection Site Bruising: Any Number Analyzed 1765 participants 439 participants 448 participants
23
   1.3%
6
   1.4%
4
   0.9%
Injection Site Bruising: Grade 3 Number Analyzed 1765 participants 439 participants 448 participants
0
   0.0%
0
   0.0%
0
   0.0%
Injection Site Erythema: Any Number Analyzed 1768 participants 440 participants 449 participants
110
   6.2%
30
   6.8%
21
   4.7%
Injection Site Erythema: Grade 3 Number Analyzed 1768 participants 440 participants 449 participants
11
   0.6%
1
   0.2%
1
   0.2%
Injection Site Induration: Any Number Analyzed 1766 participants 439 participants 448 participants
66
   3.7%
17
   3.9%
14
   3.1%
Injection Site Induration: Grade 3 Number Analyzed 1766 participants 439 participants 448 participants
3
   0.2%
0
   0.0%
1
   0.2%
Injection Site Pain: Any Number Analyzed 1768 participants 440 participants 449 participants
731
  41.3%
172
  39.1%
152
  33.9%
Injection Site Pain: Grade 3 Number Analyzed 1768 participants 440 participants 449 participants
12
   0.7%
1
   0.2%
1
   0.2%
Injection Site Swelling: Any Number Analyzed 1766 participants 439 participants 448 participants
86
   4.9%
23
   5.2%
19
   4.2%
Injection Site Swelling: Grade 3 Number Analyzed 1766 participants 439 participants 448 participants
5
   0.3%
0
   0.0%
1
   0.2%
13.Secondary Outcome
Title Number of Participants With Immediate Adverse Event (AEs)
Hide Description Participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurring during that time was recorded as immediate unsolicited systemic AEs (AEs that were related to the investigational product) in the case report book (CRB). Unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/ or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
Time Frame Within 30 minutes after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety analysis set.
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Hide Arm/Group Description:
Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
Overall Number of Participants Analyzed 1777 443 450
Measure Type: Count of Participants
Unit of Measure: Participants
5
   0.3%
0
   0.0%
2
   0.4%
14.Secondary Outcome
Title Number of Participant With Unsolicited Adverse Event (AE)
Hide Description An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
Time Frame Within 28 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety analysis set.
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Hide Arm/Group Description:
Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
Overall Number of Participants Analyzed 1777 443 450
Measure Type: Count of Participants
Unit of Measure: Participants
292
  16.4%
79
  17.8%
68
  15.1%
15.Secondary Outcome
Title Number of Participant With Serious Adverse Event
Hide Description An serious adverse event was any untoward medical occurrence that at any dose results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity,is a congenital anomaly/birth defect, or was an important medical event.
Time Frame Up to 6 months after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety analysis set.
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Hide Arm/Group Description:
Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
Overall Number of Participants Analyzed 1777 443 450
Measure Type: Count of Participants
Unit of Measure: Participants
80
   4.5%
29
   6.5%
19
   4.2%
Time Frame Adverse events were collected from Day 0 (post-vaccination) up to 28 days after last vaccination. Solicited Reaction (SR) data were collected up to Day 7 after each vaccination. Serious adverse event data were collected throughout the study (up to 180 days after last vaccination).
Adverse Event Reporting Description Analysis was performed on safety analysis set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
 
Arm/Group Title High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Hide Arm/Group Description Participants randomized to receive a single injection of the high dose QIV-HD by IM route at Day 0. Participants randomized to receive a single injection of the licensed high dose TIV-HD1 by IM route at Day 0. Participants randomized to receive a single injection of the investigational TIV-HD2 by IM route at Day 0.
All-Cause Mortality
High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/1777 (0.17%)      2/443 (0.45%)      0/450 (0.00%)    
Hide Serious Adverse Events
High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   80/1777 (4.50%)      29/443 (6.55%)      19/450 (4.22%)    
Blood and lymphatic system disorders       
Haemorrhagic Anaemia  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Cardiac disorders       
Acute Myocardial Infarction  1  3/1777 (0.17%)  3 0/443 (0.00%)  0 0/450 (0.00%)  0
Angina Pectoris  1  2/1777 (0.11%)  2 0/443 (0.00%)  0 1/450 (0.22%)  1
Atrial Fibrillation  1  2/1777 (0.11%)  2 0/443 (0.00%)  0 1/450 (0.22%)  1
Atrioventricular Block Complete  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Cardiac Failure Congestive  1  2/1777 (0.11%)  2 1/443 (0.23%)  1 1/450 (0.22%)  2
Coronary Artery Disease  1  2/1777 (0.11%)  2 3/443 (0.68%)  3 0/450 (0.00%)  0
Myocardial Infarction  1  2/1777 (0.11%)  2 1/443 (0.23%)  1 1/450 (0.22%)  1
Pericarditis  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Sinus Bradycardia  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Stress Cardiomyopathy  1  0/1777 (0.00%)  0 1/443 (0.23%)  1 0/450 (0.00%)  0
Ventricular Tachycardia  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Gastrointestinal disorders       
Colitis  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Constipation  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Diverticulum Intestinal Haemorrhagic  1  0/1777 (0.00%)  0 1/443 (0.23%)  1 0/450 (0.00%)  0
Gastritis  1  0/1777 (0.00%)  0 0/443 (0.00%)  0 1/450 (0.22%)  1
Gastrointestinal Haemorrhage  1  0/1777 (0.00%)  0 1/443 (0.23%)  2 0/450 (0.00%)  0
Gastrointestinal Ulcer Haemorrhage  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Inguinal Hernia  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Pancreatitis  1  3/1777 (0.17%)  3 0/443 (0.00%)  0 0/450 (0.00%)  0
Small Intestinal Obstruction  1  2/1777 (0.11%)  2 1/443 (0.23%)  1 0/450 (0.00%)  0
General disorders       
Non-Cardiac Chest Pain  1  1/1777 (0.06%)  1 1/443 (0.23%)  1 0/450 (0.00%)  0
Pyrexia  1  0/1777 (0.00%)  0 0/443 (0.00%)  0 1/450 (0.22%)  1
Sudden Death  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Vascular Stent Thrombosis  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Hepatobiliary disorders       
Cholangitis  1  0/1777 (0.00%)  0 0/443 (0.00%)  0 1/450 (0.22%)  1
Cholecystitis  1  1/1777 (0.06%)  1 1/443 (0.23%)  1 0/450 (0.00%)  0
Cholecystitis Acute  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Cholelithiasis  1  0/1777 (0.00%)  0 0/443 (0.00%)  0 1/450 (0.22%)  1
Infections and infestations       
Bacteraemia  1  2/1777 (0.11%)  2 0/443 (0.00%)  0 0/450 (0.00%)  0
Bronchitis  1  0/1777 (0.00%)  0 1/443 (0.23%)  1 0/450 (0.00%)  0
Diverticulitis  1  2/1777 (0.11%)  2 0/443 (0.00%)  0 0/450 (0.00%)  0
Endocarditis  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Influenza  1  0/1777 (0.00%)  0 1/443 (0.23%)  1 0/450 (0.00%)  0
Parainfluenzae Viral Laryngotracheobronchitis  1  0/1777 (0.00%)  0 0/443 (0.00%)  0 1/450 (0.22%)  1
Pneumonia  1  6/1777 (0.34%)  7 2/443 (0.45%)  3 0/450 (0.00%)  0
Respiratory Tract Infection  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Septic Shock  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Staphylococcal Infection  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Streptococcal Infection  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Urinary Tract Infection  1  2/1777 (0.11%)  2 0/443 (0.00%)  0 0/450 (0.00%)  0
Viral Infection  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Injury, poisoning and procedural complications       
Anaesthetic Complication  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Ankle Fracture  1  0/1777 (0.00%)  0 0/443 (0.00%)  0 1/450 (0.22%)  1
Bone Contusion  1  0/1777 (0.00%)  0 1/443 (0.23%)  1 0/450 (0.00%)  0
Femur Fracture  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Incisional Hernia  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Postpericardiotomy Syndrome  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Rib Fracture  1  0/1777 (0.00%)  0 1/443 (0.23%)  1 1/450 (0.22%)  1
Road Traffic Accident  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Spinal Compression Fracture  1  0/1777 (0.00%)  0 0/443 (0.00%)  0 1/450 (0.22%)  1
Tendon Rupture  1  0/1777 (0.00%)  0 1/443 (0.23%)  1 0/450 (0.00%)  0
Investigations       
Troponin Increased  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Metabolism and nutrition disorders       
Type 2 Diabetes Mellitus  1  0/1777 (0.00%)  0 0/443 (0.00%)  0 1/450 (0.22%)  1
Musculoskeletal and connective tissue disorders       
Back Pain  1  2/1777 (0.11%)  2 0/443 (0.00%)  0 0/450 (0.00%)  0
Groin Pain  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Intervertebral Disc Protrusion  1  0/1777 (0.00%)  0 0/443 (0.00%)  0 1/450 (0.22%)  1
Lumbar Spinal Stenosis  1  0/1777 (0.00%)  0 0/443 (0.00%)  0 1/450 (0.22%)  1
Osteoarthritis  1  6/1777 (0.34%)  6 4/443 (0.90%)  4 0/450 (0.00%)  0
Pain In Extremity  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Rotator Cuff Syndrome  1  0/1777 (0.00%)  0 1/443 (0.23%)  1 0/450 (0.00%)  0
Spinal Osteoarthritis  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder Cancer  1  1/1777 (0.06%)  1 1/443 (0.23%)  1 0/450 (0.00%)  0
Brain Neoplasm  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Breast Cancer  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 1/450 (0.22%)  1
Cholangiocarcinoma  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Invasive Ductal Breast Carcinoma  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Malignant Melanoma  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Neoplasm Malignant  1  0/1777 (0.00%)  0 1/443 (0.23%)  1 0/450 (0.00%)  0
Pancreatic Carcinoma  1  0/1777 (0.00%)  0 1/443 (0.23%)  2 0/450 (0.00%)  0
Prostate Cancer  1  2/1777 (0.11%)  2 1/443 (0.23%)  1 0/450 (0.00%)  0
Uterine Leiomyoma  1  0/1777 (0.00%)  0 1/443 (0.23%)  1 0/450 (0.00%)  0
Nervous system disorders       
Carotid Artery Occlusion  1  0/1777 (0.00%)  0 0/443 (0.00%)  0 1/450 (0.22%)  1
Carotid Artery Stenosis  1  2/1777 (0.11%)  2 0/443 (0.00%)  0 0/450 (0.00%)  0
Cerebrospinal Fluid Leakage  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Cerebrovascular Accident  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Facial Paralysis  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 2/450 (0.44%)  2
Ischaemic Cerebral Infarction  1  0/1777 (0.00%)  0 1/443 (0.23%)  1 0/450 (0.00%)  0
Seizure  1  0/1777 (0.00%)  0 0/443 (0.00%)  0 1/450 (0.22%)  1
Small Fibre Neuropathy  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Syncope  1  3/1777 (0.17%)  3 0/443 (0.00%)  0 2/450 (0.44%)  2
Transient Ischaemic Attack  1  3/1777 (0.17%)  3 0/443 (0.00%)  0 0/450 (0.00%)  0
Psychiatric disorders       
Mental Status Changes  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Renal and urinary disorders       
Nephrolithiasis  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Nephropathy  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Urinary Retention  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Reproductive system and breast disorders       
Benign Prostatic Hyperplasia  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chronic Obstructive Pulmonary Disease  1  1/1777 (0.06%)  1 1/443 (0.23%)  1 0/450 (0.00%)  0
Dyspnoea  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Pulmonary Embolism  1  4/1777 (0.23%)  4 0/443 (0.00%)  0 0/450 (0.00%)  0
Respiratory Failure  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
Skin and subcutaneous tissue disorders       
Skin Ulcer  1  0/1777 (0.00%)  0 0/443 (0.00%)  0 1/450 (0.22%)  1
Vascular disorders       
Aortic Stenosis  1  2/1777 (0.11%)  2 1/443 (0.23%)  1 0/450 (0.00%)  0
Deep Vein Thrombosis  1  0/1777 (0.00%)  0 0/443 (0.00%)  0 1/450 (0.22%)  1
Peripheral Vascular Disorder  1  1/1777 (0.06%)  1 0/443 (0.00%)  0 0/450 (0.00%)  0
1
Term from vocabulary, MedDRA-20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
High-Dose Quadrivalent Influenza Vaccine (QIV-HD) High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   935/1777 (52.62%)      234/443 (52.82%)      206/450 (45.78%)    
General disorders       
Chills  1  96/1777 (5.40%)  97 20/443 (4.51%)  20 22/450 (4.89%)  22
Injection Site Erythema  1  110/1777 (6.19%)  112 30/443 (6.77%)  31 21/450 (4.67%)  21
Injection Site Pain  1  731/1777 (41.14%)  731 172/443 (38.83%)  172 152/450 (33.78%)  152
Injection Site Swelling  1  86/1777 (4.84%)  87 23/443 (5.19%)  23 19/450 (4.22%)  19
Malaise  1  233/1777 (13.11%)  234 52/443 (11.74%)  53 67/450 (14.89%)  67
Musculoskeletal and connective tissue disorders       
Myalgia  1  404/1777 (22.73%)  404 81/443 (18.28%)  81 88/450 (19.56%)  88
Nervous system disorders       
Headache  1  258/1777 (14.52%)  262 65/443 (14.67%)  65 59/450 (13.11%)  61
1
Term from vocabulary, MedDRA-20.1
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 partcipant 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: Trial Transparency Team
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: NCT03282240    
Other Study ID Numbers: QHD00013
U1111-1183-5556 ( Other Identifier: World Health Organization Universal Trial Number )
First Submitted: September 12, 2017
First Posted: September 13, 2017
Results First Submitted: November 28, 2019
Results First Posted: December 17, 2019
Last Update Posted: December 17, 2019