Trial Outcomes & Findings for Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60) (NCT NCT00310804)

Last Updated: 2019-08-15

Results Overview

The haemagglutinin Inhibition (HI) antibody titer response following 1. one dose of cTIV for each of the three lots separately and 2. one dose of cTIV (combined) compared to TIV is reported as Geometric mean titers (GMTs). The HI GMTs were evaluated using egg-derived antigen assay.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1200 participants

Primary outcome timeframe

Day 22 postvaccination

Results posted on

2019-08-15

Participant Flow

1200 subjects were enrolled from 2 sites in Lithuania. Of the 1200 subjects enrolled, 700 (58%) were randomized in site 1 and 500 (42%) in site 2. Baseline characteristics, outcome measures, and adverse event summary are based on retrospective analysis which excluded data from site 2.

All participants enrolled were included in the trial.

Participant milestones

Participant milestones
Measure	cTIV (Combined) Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).	TIV Group Subjects in this group received one dose of Egg derived Trivalent Subunit Influenza Vaccine (TIV).
Overall Study STARTED	1029	171
Overall Study COMPLETED	1024	171
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	cTIV (Combined) Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).	TIV Group Subjects in this group received one dose of Egg derived Trivalent Subunit Influenza Vaccine (TIV).
Overall Study Lost to Follow-up	2	0
Overall Study Withdrawal by Subject	3	0

Baseline Characteristics

Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	cTIV (Combined) n=600 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).	TIV Group n=100 Participants Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).	Total n=700 Participants Total of all reporting groups
Age, Continuous	27.3 years STANDARD_DEVIATION 11.1 • n=93 Participants	26.9 years STANDARD_DEVIATION 11.5 • n=4 Participants	27.2 years STANDARD_DEVIATION 11.1 • n=27 Participants
Sex: Female, Male Female	321 Participants n=93 Participants	58 Participants n=4 Participants	379 Participants n=27 Participants
Sex: Female, Male Male	279 Participants n=93 Participants	42 Participants n=4 Participants	321 Participants n=27 Participants
Region of Enrollment Lithuania	600 participants n=93 Participants	100 participants n=4 Participants	700 participants n=27 Participants

PRIMARY outcome

Timeframe: Day 22 postvaccination

Population: This analysis was done on per protocol (PP) population defined as all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.

Outcome measures

Outcome measures
Measure	cTIV_lot1 n=198 Participants Subjects in this group received one dose of Cell-Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.	cTIV_lot 2 n=193 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2	cTIV_lot3 n=198 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.	cTIV (Combined) n=589 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).	TIV Group n=98 Participants Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects A/H3N2 strain (day 1)	12 Titers Interval 11.0 to 14.0	15 Titers Interval 13.0 to 17.0	16 Titers Interval 14.0 to 19.0	14 Titers Interval 13.0 to 16.0	15 Titers Interval 12.0 to 18.0
Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects A/H3N2 strain (day 22)	175 Titers Interval 147.0 to 207.0	171 Titers Interval 144.0 to 203.0	158 Titers Interval 133.0 to 188.0	168 Titers Interval 152.0 to 185.0	186 Titers Interval 146.0 to 236.0
Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects A/H1N1 strain (day 1)	20 Titers Interval 17.0 to 24.0	20 Titers Interval 17.0 to 25.0	21 Titers Interval 17.0 to 25.0	20 Titers Interval 18.0 to 22.0	22 Titers Interval 18.0 to 29.0
Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects A/H1N1 strain (day 22)	390 Titers Interval 326.0 to 466.0	364 Titers Interval 303.0 to 436.0	366 Titers Interval 306.0 to 437.0	373 Titers Interval 335.0 to 415.0	329 Titers Interval 253.0 to 428.0
Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects B strain (day 1)	13 Titers Interval 11.0 to 15.0	17 Titers Interval 14.0 to 19.0	14 Titers Interval 12.0 to 16.0	14 Titers Interval 13.0 to 16.0	16 Titers Interval 13.0 to 20.0
Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects B strain (day 22)	131 Titers Interval 113.0 to 151.0	157 Titers Interval 136.0 to 182.0	128 Titers Interval 111.0 to 148.0	138 Titers Interval 126.0 to 151.0	124 Titers Interval 99.0 to 154.0

PRIMARY outcome

Timeframe: Day 22 postvaccination

Population: The analysis was performed as PP dataset.

Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) following 1. one dose of cTIV for each of the three vaccine lots separately and 2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. The European licensure (CHMP) criterion is met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is \>2.5.

Outcome measures

Outcome measures
Measure	cTIV_lot1 n=198 Participants Subjects in this group received one dose of Cell-Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.	cTIV_lot 2 n=193 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2	cTIV_lot3 n=198 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.	cTIV (Combined) n=589 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).	TIV Group n=98 Participants Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects A/H1N1 strain (Day22/Day1)	20 Ratio Interval 16.0 to 24.0	18 Ratio Interval 14.0 to 22.0	18 Ratio Interval 14.0 to 22.0	18 Ratio Interval 16.0 to 21.0	15 Ratio Interval 11.0 to 20.0
Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects A/H3N2 strain (Day22/Day1)	14 Ratio Interval 12.0 to 17.0	11 Ratio Interval 9.55 to 14.0	9.92 Ratio Interval 8.28 to 12.0	12 Ratio Interval 11.0 to 13.0	12 Ratio Interval 9.57 to 16.0
Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects B strain (Day22/Day1)	10 Ratio Interval 8.59 to 12.0	9.42 Ratio Interval 7.97 to 11.0	9.37 Ratio Interval 7.94 to 11.0	9.63 Ratio Interval 8.71 to 11.0	7.53 Ratio Interval 5.88 to 9.65

PRIMARY outcome

Timeframe: Day 22 postvaccination

Population: This analysis was done on PP population.

Immunogenicity was assessed in terms of percentage of adult subjects achieving HI titers ≥40, after 1. one dose of cTIV for each of the three vaccine lots separately and 2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is \>70%.

Outcome measures

Outcome measures
Measure	cTIV_lot1 n=198 Participants Subjects in this group received one dose of Cell-Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.	cTIV_lot 2 n=193 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2	cTIV_lot3 n=198 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.	cTIV (Combined) n=589 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).	TIV Group n=98 Participants Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
Percentage of Subjects With HI Titers ≥40 B strain (day 22)	92 Percentages Interval 88.0 to 96.0	94 Percentages Interval 90.0 to 97.0	93 Percentages Interval 89.0 to 96.0	93 Percentages Interval 91.0 to 95.0	93 Percentages Interval 86.0 to 97.0
Percentage of Subjects With HI Titers ≥40 A/H1N1 strain (day 1)	36 Percentages Interval 29.0 to 43.0	38 Percentages Interval 31.0 to 46.0	34 Percentages Interval 27.0 to 41.0	36 Percentages Interval 32.0 to 40.0	38 Percentages Interval 28.0 to 48.0
Percentage of Subjects With HI Titers ≥40 A/H1N1 strain (day 22)	97 Percentages Interval 94.0 to 99.0	97 Percentages Interval 93.0 to 99.0	94 Percentages Interval 90.0 to 97.0	96 Percentages Interval 94.0 to 98.0	97 Percentages Interval 91.0 to 99.0
Percentage of Subjects With HI Titers ≥40 A/H3N2 strain (day 1)	19 Percentages Interval 14.0 to 25.0	31 Percentages Interval 24.0 to 38.0	28 Percentages Interval 22.0 to 35.0	26 Percentages Interval 22.0 to 30.0	28 Percentages Interval 19.0 to 37.0
Percentage of Subjects With HI Titers ≥40 A/H3N2 strain (day 22)	92 Percentages Interval 88.0 to 96.0	93 Percentages Interval 88.0 to 96.0	91 Percentages Interval 86.0 to 95.0	92 Percentages Interval 90.0 to 94.0	97 Percentages Interval 91.0 to 99.0
Percentage of Subjects With HI Titers ≥40 B strain (day 1)	25 Percentages Interval 19.0 to 32.0	31 Percentages Interval 25.0 to 38.0	25 Percentages Interval 19.0 to 31.0	27 Percentages Interval 23.0 to 31.0	31 Percentages Interval 22.0 to 41.0

PRIMARY outcome

Timeframe: Day 22 postvaccination

Population: This analysis was done on PP population.

Immunogenicity was assessed in terms of percentage of adult subjects showing seroconversion or significant increase in HI antibody titers after 1. one dose of cTIV for each of the three vaccine lots separately and 2. one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. European Licensure (CHMP) criterion is met if the percentage of subjects achieving seroconversion or significant increase is \>40%. As per European Licensure (CHMP) criterion seroconversion is defined as percentage of subjects with a prevaccination HI titer \<10 to a postvaccination titer ≥40; whereas, significant increase is defined as HI titer ≥10 prevaccination and ≥4-fold Hi titer increase post-vaccination.

Outcome measures

Outcome measures
Measure	cTIV_lot1 n=198 Participants Subjects in this group received one dose of Cell-Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.	cTIV_lot 2 n=193 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2	cTIV_lot3 n=198 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.	cTIV (Combined) n=589 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).	TIV Group n=98 Participants Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine A/H1N1 strain	80 Percentages Interval 74.0 to 86.0	81 Percentages Interval 75.0 to 86.0	82 Percentages Interval 76.0 to 87.0	81 Percentages Interval 78.0 to 84.0	76 Percentages Interval 66.0 to 84.0
Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine A/H3N2 strain	84 Percentages Interval 78.0 to 89.0	79 Percentages Interval 72.0 to 84.0	78 Percentages Interval 71.0 to 83.0	80 Percentages Interval 77.0 to 83.0	88 Percentages Interval 80.0 to 94.0
Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine B strain	79 Percentages Interval 72.0 to 84.0	81 Percentages Interval 75.0 to 87.0	80 Percentages Interval 74.0 to 85.0	80 Percentages Interval 77.0 to 83.0	70 Percentages Interval 60.0 to 79.0

SECONDARY outcome

Timeframe: Day 1 to Day 7 postvaccination

Population: Analysis was done on safety dataset.

To assess the safety and tolerability in terms of number of subjects reporting solicited adverse events following one injection of 1. one dose of cTIV for each of the three vaccine lots separately and 2. for one dose of cTIV (combined) compared to TIV.

Outcome measures

Outcome measures
Measure	cTIV_lot1 n=200 Participants Subjects in this group received one dose of Cell-Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.	cTIV_lot 2 n=199 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2	cTIV_lot3 n=200 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.	cTIV (Combined) n=599 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).	TIV Group n=100 Participants Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Any Local	57 subjects	40 subjects	37 subjects	134 subjects	16 subjects
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Injection site ecchymosis	6 subjects	7 subjects	3 subjects	16 subjects	5 subjects
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Injection site erythema	32 subjects	18 subjects	16 subjects	66 subjects	8 subjects
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Injection site induration	11 subjects	13 subjects	6 subjects	30 subjects	6 subjects
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Injection site swelling	10 subjects	7 subjects	6 subjects	23 subjects	4 subjects
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Injection site pain	33 subjects	23 subjects	24 subjects	80 subjects	10 subjects
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Any Systemic	62 subjects	53 subjects	55 subjects	170 subjects	29 subjects
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Chills	18 subjects	13 subjects	10 subjects	41 subjects	9 subjects
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Malaise	36 subjects	29 subjects	26 subjects	91 subjects	15 subjects
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Myalgia	14 subjects	13 subjects	11 subjects	38 subjects	8 subjects
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Arthralgia	6 subjects	8 subjects	5 subjects	19 subjects	2 subjects
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Headache	32 subjects	31 subjects	31 subjects	94 subjects	16 subjects
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Sweat	8 subjects	15 subjects	11 subjects	34 subjects	4 subjects
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Fatigue	39 subjects	29 subjects	32 subjects	100 subjects	17 subjects
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Fever (>=38C)	1 subjects	1 subjects	2 subjects	4 subjects	1 subjects
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Other	13 subjects	3 subjects	15 subjects	31 subjects	9 subjects
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Stayed home due to reaction	7 subjects	3 subjects	7 subjects	17 subjects	3 subjects
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. Analgesic Antipyretic medication used	10 subjects	2 subjects	10 subjects	22 subjects	8 subjects

SECONDARY outcome

Timeframe: Day 1 - Day 181 postvaccination

Population: This analysis was done on safety dataset.

Additional safety data from day 1 through day 181 after one dose of cTIV (combined) or TIV in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study is reported.

Outcome measures

Outcome measures
Measure	cTIV_lot1 n=599 Participants Subjects in this group received one dose of Cell-Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.	cTIV_lot 2 n=571 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2	cTIV_lot3 n=100 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.	cTIV (Combined) n=97 Participants Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).	TIV Group Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine Any AEs	74 subjects	62 subjects	13 subjects	6 subjects	—
Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine At least possibly related AEs	45 subjects	1 subjects	10 subjects	0 subjects	—
Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine Serious AEs	2 subjects	14 subjects	0 subjects	2 subjects	—
Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine At least possibly related SAEs	0 subjects	0 subjects	0 subjects	0 subjects	—
Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine Death	0 subjects	1 subjects	0 subjects	0 subjects	—
Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine AE leading to withdrawal	0 subjects	1 subjects	0 subjects	0 subjects	—

Adverse Events

cTIV (Combined)

Serious events: 16 serious events

Other events: 237 other events

Deaths: 0 deaths

TIV Group

Serious events: 2 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	cTIV (Combined) n=599 participants at risk Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).	TIV Group n=100 participants at risk Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
General disorders Chills	6.8% 41/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	9.0% 9/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
General disorders Fatigue	16.7% 100/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	17.0% 17/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
General disorders Injection Site Erythema	11.0% 66/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	8.0% 8/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
General disorders Injection Site Induration	5.0% 30/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	6.0% 6/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
General disorders Injection Site Pain	13.4% 80/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	10.0% 10/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
General disorders Malaise	15.4% 92/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	15.0% 15/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Musculoskeletal and connective tissue disorders Myalgia	6.3% 38/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	8.0% 8/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Nervous system disorders Headache	15.9% 95/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	16.0% 16/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Infections and infestations Rhinitis	3.2% 19/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	6.0% 6/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.7% 34/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	4.0% 4/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	cTIV (Combined) n=599 participants at risk Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).	TIV Group n=100 participants at risk Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
Ear and labyrinth disorders Vestibular disorder	0.17% 1/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	0.00% 0/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Gastrointestinal disorders Diarrhoea	0.17% 1/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	0.00% 0/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Hepatobiliary disorders Cholelithiasis	0.17% 1/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	0.00% 0/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Infections and infestations Influenza	0.67% 4/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	1.0% 1/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Infections and infestations Rhinitis	0.17% 1/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	0.00% 0/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Injury, poisoning and procedural complications Injury Asphyxiation	0.17% 1/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	0.00% 0/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Injury, poisoning and procedural complications Lower Limb Fracture	0.17% 1/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	0.00% 0/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.17% 1/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	0.00% 0/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.17% 1/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	0.00% 0/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Nervous system disorders Vertebrobasilar Insufficiency	0.17% 1/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	0.00% 0/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Psychiatric disorders Schizoaffective disorder	0.17% 1/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	0.00% 0/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Psychiatric disorders Schizoid Personality Disorder	0.00% 0/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	1.0% 1/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Reproductive system and breast disorders Uterine Polyp	0.17% 1/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	0.00% 0/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Vascular disorders Essential Hypertension	0.17% 1/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	0.00% 0/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Vascular disorders Varicose Vein	0.17% 1/599 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.	0.00% 0/100 • Through out the study period Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months). Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV. In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.