Trial Outcomes & Findings for Immunogenicity, Safety and Tolerability of a Trivalent Subunit Inactivated Vaccine in Healthy Subjects 50 Years and Above (NCT NCT01867021)

Last Updated: 2014-10-01

Results Overview

Non-inferiority of Postvaccination Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV (Trivalent Subunit Inactivated Influenza Vaccine) Group Over the Corresponding TIVf Group for All Three Strains, three weeks after vaccination (day 22). The upper limit of the two-sided 95% confidence interval (CI) on the ratio of GMTs (GMT TIVf/GMT TIV) should not exceed the non-inferiority margin of 1.5.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

2902 participants

Primary outcome timeframe

Day 22

Results posted on

2014-10-01

Participant Flow

A total of 24 sites with 3 sites in Thailand, 4 sites in Philippines, 15 sites in South Africa and 2 sites in Czech Republic.

All enrolled subjects were included in the trial.

Participant milestones

Participant milestones
Measure	Agriflu Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV	Fluvirin Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
Overall Study STARTED	1452	1450
Overall Study COMPLETED	1450	1440
Overall Study NOT COMPLETED	2	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Agriflu Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV	Fluvirin Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
Overall Study Adverse Event	0	1
Overall Study Not Eligible	0	1
Overall Study Death	1	0
Overall Study Lost to Follow-up	0	2
Overall Study Withdrawal by Subject	1	6

Baseline Characteristics

Immunogenicity, Safety and Tolerability of a Trivalent Subunit Inactivated Vaccine in Healthy Subjects 50 Years and Above

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Agriflu n=1452 Participants Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV	Fluvirin n=1450 Participants Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf	Total n=2902 Participants Total of all reporting groups
Age, Continuous	64.2 year STANDARD_DEVIATION 8.9 • n=5 Participants	64.2 year STANDARD_DEVIATION 8.9 • n=7 Participants	64.2 year STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	943 Participants n=5 Participants	893 Participants n=7 Participants	1836 Participants n=5 Participants
Sex: Female, Male Male	509 Participants n=5 Participants	557 Participants n=7 Participants	1066 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 22

Population: Analysis was done on the per-protocol set 1 (PPS1) , ie, the subjects who received the vaccine correctly; provided evaluable serum samples at visit 2; and had no major protocol violations as defined prior to analysis.

Outcome measures

Outcome measures
Measure	Agriflu n=1402 Participants Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV	Fluvirin n=1397 Participants Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf	≥65 years_Agriflu Subjects ≥65 years of age who received an investigational vaccine TIV	≥65 years_Fluvirin Subjects ≥65 years of age who received a control vaccine TIVf
Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years A/H1N1(1401, 1397)	315 Titers Interval 281.0 to 352.0	581 Titers Interval 519.0 to 651.0	—	—
Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years A/H3N2(1401, 1397)	697 Titers Interval 635.0 to 764.0	1048 Titers Interval 955.0 to 1149.0	—	—
Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years B	36 Titers Interval 33.0 to 39.0	36 Titers Interval 33.0 to 39.0	—	—

PRIMARY outcome

Timeframe: Day 22

Population: Analysis was done on the PPS2, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at visit 1 and visit 2; and had no major protocol violations as defined prior to analysis

Non-Inferiority was measured as the percentages of subjects who achieved seroconversion in HI titers three weeks (day 22) after vaccination of TIV compared with TIVf, against each of three vaccine strains. Seroconversion is defined as a prevaccination titer \<10 and postvaccination HI ≥40 or as a prevaccination titer ≥10 and at minimum four-fold rise in postvaccination antibody titer. The upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - SeroconversionTIV) should not exceed 10%.

Outcome measures

Outcome measures
Measure	Agriflu n=1399 Participants Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV	Fluvirin n=1391 Participants Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf	≥65 years_Agriflu Subjects ≥65 years of age who received an investigational vaccine TIV	≥65 years_Fluvirin Subjects ≥65 years of age who received a control vaccine TIVf
Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers in the TIV Group Compared With the Corresponding Percentages of Subjects in the TIVf Group for All Three Strains At Day 22, in Healthy Adults Aged ≥50 Years A/H1N1(1397,1391)	75 percentages of subjects Interval 73.0 to 78.0	84 percentages of subjects Interval 82.0 to 86.0	—	—
Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers in the TIV Group Compared With the Corresponding Percentages of Subjects in the TIVf Group for All Three Strains At Day 22, in Healthy Adults Aged ≥50 Years A/H3N2(1398,1390)	72 percentages of subjects Interval 70.0 to 74.0	85 percentages of subjects Interval 83.0 to 87.0	—	—
Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers in the TIV Group Compared With the Corresponding Percentages of Subjects in the TIVf Group for All Three Strains At Day 22, in Healthy Adults Aged ≥50 Years B(1399,1390)	41 percentages of subjects Interval 39.0 to 44.0	40 percentages of subjects Interval 37.0 to 43.0	—	—

SECONDARY outcome

Timeframe: Day 22

Population: Analysis was done on the PPS1 for HI Titer ≥1:40 at day 22 and PPS2 for Seroconversion

Percentage of subjects achieving HI seroconversion against each of three vaccine strains was measured three weeks after vaccination of TIV and TIVf vaccine (day 22). Percentage of subjects who achieved HI titer ≥1:40 against each of three vaccine strains was measured three weeks after one vaccination of TIV and TIVf vaccine. According to Center for Biologics Evaluation and Research recommendations (CBER 2007), the criterion for seroconversion is considered met if the lower limit of the two-sided 95% CI for the percentage of subjects with HI seroconversion is ≥40% (\<65 years) or ≥30% (≥65 years). As per the CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects who achieved HI titer ≥ 1:40 should be ≥70% (\<65 years) or ≥60% (≥65 years).

Outcome measures

Outcome measures
Measure	Agriflu n=691 Participants Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV	Fluvirin n=691 Participants Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf	≥65 years_Agriflu n=711 Participants Subjects ≥65 years of age who received an investigational vaccine TIV	≥65 years_Fluvirin n=706 Participants Subjects ≥65 years of age who received a control vaccine TIVf
Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine A/H1N1 - Seroconversion(687, 686, 710, 705)	78 Percentages of subjects Interval 74.0 to 81.0	87 Percentages of subjects Interval 84.0 to 89.0	73 Percentages of subjects Interval 70.0 to 77.0	81 Percentages of subjects Interval 78.0 to 84.0
Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine A/H3N2 - Seroconversion(688, 686, 710, 704)	78 Percentages of subjects Interval 75.0 to 81.0	88 Percentages of subjects Interval 85.0 to 90.0	66 Percentages of subjects Interval 63.0 to 70.0	82 Percentages of subjects Interval 79.0 to 85.0
Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine B - Seroconversion(688, 686, 711, 704)	44 Percentages of subjects Interval 40.0 to 48.0	45 Percentages of subjects Interval 41.0 to 49.0	39 Percentages of subjects Interval 35.0 to 42.0	35 Percentages of subjects Interval 32.0 to 39.0
Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine A/H1N1 - HI ≥1:40 (Day 22)[691, 691, 710, 706]	94 Percentages of subjects Interval 92.0 to 96.0	96 Percentages of subjects Interval 94.0 to 97.0	91 Percentages of subjects Interval 89.0 to 93.0	92 Percentages of subjects Interval 90.0 to 94.0
Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine A/H3N2 - HI ≥1:40 (Day 22)[691, 691, 710, 706]	99 Percentages of subjects Interval 99.0 to 100.0	99 Percentages of subjects Interval 98.0 to 100.0	99 Percentages of subjects Interval 98.0 to 99.0	98 Percentages of subjects Interval 97.0 to 99.0
Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine B - HI ≥1:40 (Day 22)[691, 691, 711, 706]	58 Percentages of subjects Interval 55.0 to 62.0	59 Percentages of subjects Interval 55.0 to 63.0	59 Percentages of subjects Interval 55.0 to 62.0	56 Percentages of subjects Interval 52.0 to 60.0

SECONDARY outcome

Timeframe: Day 22

Population: Analysis was done on the PPS1

Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs against each of three vaccine strains, three weeks after vaccination of TIV and TIVf vaccine (day 22).

Outcome measures

Outcome measures
Measure	Agriflu n=688 Participants Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV	Fluvirin n=686 Participants Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf	≥65 years_Agriflu n=711 Participants Subjects ≥65 years of age who received an investigational vaccine TIV	≥65 years_Fluvirin n=705 Participants Subjects ≥65 years of age who received a control vaccine TIVf
Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine A/H1N1(687, 686, 710, 705)	18 Ratios Interval 15.0 to 22.0	35 Ratios Interval 29.0 to 42.0	15 Ratios Interval 12.0 to 19.0	27 Ratios Interval 21.0 to 33.0
Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine A/H3N2(688, 686, 710, 704)	13 Ratios Interval 11.0 to 15.0	18 Ratios Interval 15.0 to 20.0	9.65 Ratios Interval 7.94 to 12.0	16 Ratios Interval 13.0 to 20.0
Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine B(688, 686, 711, 704)	3.85 Ratios Interval 3.43 to 4.31	3.91 Ratios Interval 3.49 to 4.39	3.1 Ratios Interval 2.71 to 3.54	3 Ratios Interval 2.62 to 3.44

SECONDARY outcome

Timeframe: Day 1 to 7 postvaccination

Population: Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.

Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIV and control.

Outcome measures

Outcome measures
Measure	Agriflu n=1428 Participants Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV	Fluvirin n=1433 Participants Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf	≥65 years_Agriflu Subjects ≥65 years of age who received an investigational vaccine TIV	≥65 years_Fluvirin Subjects ≥65 years of age who received a control vaccine TIVf
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Pain(1412, 1424)	264 Subjects	254 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Ecchymosis Type I(1419, 1425)	26 Subjects	33 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Ecchymosis Type II(1419, 1425)	7 Subjects	11 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Erythema Type I(1410, 1427)	91 Subjects	93 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Erythema Type II(1410, 1427)	16 Subjects	10 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Induration Type I(1423, 1429)	78 Subjects	65 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Induration Type II(1423, 1429)	25 Subjects	19 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Swelling Type I(1419, 1427)	50 Subjects	44 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Swelling Type II(1419, 1427)	21 Subjects	15 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Chills(1403,1407)	64 Subjects	68 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Malaise(1402,1405)	88 Subjects	95 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Nausea(1401,1405)	48 Subjects	44 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Myalgia(1400,1403)	128 Subjects	140 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Arthralgia(1396,1403)	83 Subjects	87 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Headache(1397,1403)	153 Subjects	161 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Sweating(1403,1405)	99 Subjects	102 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Fatigue(1404,1407)	143 Subjects	145 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Loss of Appetite(1404,1403)	43 Subjects	59 Subjects	—	—
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf Fever(>=38°C)[1422,1428]	20 Subjects	21 Subjects	—	—

Adverse Events

Agriflu

Serious events: 3 serious events

Other events: 471 other events

Deaths: 0 deaths

Fluvirin

Serious events: 5 serious events

Other events: 467 other events

Deaths: 0 deaths

Total

Serious events: 8 serious events

Other events: 938 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Agriflu n=1452 participants at risk Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV	Fluvirin n=1445 participants at risk Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf	Total n=2897 participants at risk Total number of Subjects
Cardiac disorders MYOCARDIAL INFARCTION	0.07% 1/1452 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.07% 1/1445 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.07% 2/2897 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.
Gastrointestinal disorders DYSPEPSIA	0.07% 1/1452 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.00% 0/1445 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.03% 1/2897 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.
Gastrointestinal disorders PEPTIC ULCER	0.07% 1/1452 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.00% 0/1445 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.03% 1/2897 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.
Hepatobiliary disorders CHOLELITHIASIS	0.07% 1/1452 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.00% 0/1445 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.03% 1/2897 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.
Hepatobiliary disorders JAUNDICE CHOLESTATIC	0.00% 0/1452 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.07% 1/1445 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.03% 1/2897 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.
Infections and infestations URINARY TRACT INFECTION	0.07% 1/1452 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.00% 0/1445 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.03% 1/2897 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/1452 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.07% 1/1445 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.03% 1/2897 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.
Nervous system disorders BASAL GANGLIA HAEMORRHAGE	0.00% 0/1452 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.07% 1/1445 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.03% 1/2897 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.00% 0/1452 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.07% 1/1445 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.03% 1/2897 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.
Vascular disorders HYPERTENSION	0.00% 0/1452 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.07% 1/1445 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	0.03% 1/2897 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.

Other adverse events

Other adverse events
Measure	Agriflu n=1452 participants at risk Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV	Fluvirin n=1445 participants at risk Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf	Total n=2897 participants at risk Total number of Subjects
General disorders Fatigue	9.9% 144/1452 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	10.1% 146/1445 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	10.0% 290/2897 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.
General disorders Injection Site Pain	19.4% 281/1452 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	19.1% 276/1445 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	19.2% 557/2897 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.
General disorders Malaise	6.1% 89/1452 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	6.6% 95/1445 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	6.4% 184/2897 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 85/1452 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	6.1% 88/1445 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	6.0% 173/2897 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.
Musculoskeletal and connective tissue disorders Myalgia	9.2% 133/1452 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	9.8% 141/1445 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	9.5% 274/2897 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.
Musculoskeletal and connective tissue disorders Headach	11.0% 159/1452 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	11.3% 164/1445 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	11.1% 323/2897 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.
Skin and subcutaneous tissue disorders Hyperhidrosis	6.8% 99/1452 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	7.1% 103/1445 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.	7.0% 202/2897 • Up to 22 days Adverse events and Serious Adverse Events were collected from day 1 through day 22. The number of subjects analyzed in this section is from the safety set. Safety Set (Overall) includes all subjects in the exposed set who had either postvaccination AE or solicited AE data.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial
Publication restrictions are in place

Restriction type: OTHER