Trial Outcomes & Findings for Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions (NCT NCT00560066)

Last Updated: 2016-02-17

Results Overview

Safety was assessed as the number of all subjects who reported at least one sign of reactogenicity after one vaccination of egg-derived (TIV) or cell culture-derived (cTIV) influenza virus vaccine from Day 1 through Day 7 post-vaccination.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1398 participants

Primary outcome timeframe

From Day 1 up to and including Day 7 post-vaccination

Results posted on

2016-02-17

Participant Flow

Subjects were enrolled at 17 centres in Germany.

All enrolled subjects were included in the trial.

Participant milestones

Participant milestones
Measure	Egg-derived Vaccine (TIV) Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine.	Cell Culture-derived Vaccine (cTIV) Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine.
Overall Study STARTED	396	1002
Overall Study COMPLETED	390	980
Overall Study NOT COMPLETED	6	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Egg-derived Vaccine (TIV) Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine.	Cell Culture-derived Vaccine (cTIV) Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine.
Overall Study Death	2	1
Overall Study Withdrawal by Subject	0	3
Overall Study Lost to Follow-up	4	10
Overall Study Protocol Violation	0	1
Overall Study Administrative reason	0	5
Overall Study Missing primary reason	0	2

Baseline Characteristics

Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Egg-derived Vaccine (TIV) n=396 Participants Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine	Cell Culture-derived Vaccine (cTIV) n=1002 Participants Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine	Total n=1398 Participants Total of all reporting groups
Age, Continuous	47.6 years STANDARD_DEVIATION 17.3 • n=5 Participants	48.7 years STANDARD_DEVIATION 16.3 • n=7 Participants	48.3 years STANDARD_DEVIATION 16.6 • n=5 Participants
Sex: Female, Male Female	206 Participants n=5 Participants	533 Participants n=7 Participants	739 Participants n=5 Participants
Sex: Female, Male Male	190 Participants n=5 Participants	469 Participants n=7 Participants	659 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Day 1 up to and including Day 7 post-vaccination

Population: Analysis was performed on the safety dataset, i.e. all subjects in the exposed set who provided post-baseline safety data.

Outcome measures

Outcome measures
Measure	TIV (Adults) n=396 Participants Subjects ≥18 to ≤60 years years-old received one vaccination of egg-derived influenza virus vaccine	cTIV (Adults) n=1001 Participants Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine	TIV (Elderly) Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine	cTIV (Elderly) Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV Any reaction - Missing	1 Subjects	2 Subjects	—	—
Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV Any reaction - None	204 Subjects	488 Subjects	—	—
Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV Any reaction - Other than severe	186 Subjects	495 Subjects	—	—
Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV Local reaction - Severe	0 Subjects	5 Subjects	—	—
Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV Systemic reaction - Missing	1 Subjects	2 Subjects	—	—
Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV Systemic reaction - None	250 Subjects	616 Subjects	—	—
Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV Any reaction - Severe	5 Subjects	16 Subjects	—	—
Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV Local reaction - Missing	5 Subjects	17 Subjects	—	—
Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV Local reaction - None	274 Subjects	654 Subjects	—	—
Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV Local reaction - Other than severe	117 Subjects	325 Subjects	—	—
Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV Systemic reaction - Other than severe	140 Subjects	369 Subjects	—	—
Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV Systemic reaction - Severe	5 Subjects	14 Subjects	—	—

SECONDARY outcome

Timeframe: From Day 1 through Day 7 post-vaccination

Population: Analysis was done on a subset of safety population (i.e. all subjects in the exposed population who provide postvaccination safety data) which included the healthy adults and elderly.

Analysis was performed on a subset of safety population which included the healthy adults (≥18 to ≤60 years) and elderly (≥61 years).

Outcome measures

Outcome measures
Measure	TIV (Adults) n=70 Participants Subjects ≥18 to ≤60 years years-old received one vaccination of egg-derived influenza virus vaccine	cTIV (Adults) n=235 Participants Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine	TIV (Elderly) n=7 Participants Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine	cTIV (Elderly) n=11 Participants Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV Fever (≥38 °C)	0 Subjects	2 Subjects	0 Subjects	0 Subjects
Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV Pain (N=66,226,7,11)	24 Subjects	107 Subjects	1 Subjects	2 Subjects
Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV Chills (N=66,226,7,11)	1 Subjects	10 Subjects	0 Subjects	0 Subjects
Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV Myalgia (N=66,226,7,11)	10 Subjects	46 Subjects	0 Subjects	0 Subjects
Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV Arthralgia (N=66,226,7,11)	2 Subjects	13 Subjects	0 Subjects	1 Subjects
Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV Malaise (N=66,226,7,11)	7 Subjects	25 Subjects	0 Subjects	0 Subjects
Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV Headache (N=66,226,7,11)	14 Subjects	47 Subjects	0 Subjects	2 Subjects
Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV Sweating (N=66,226,7,11)	1 Subjects	13 Subjects	2 Subjects	0 Subjects
Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV Fatigue (N=66,226,7,11)	11 Subjects	49 Subjects	1 Subjects	1 Subjects

SECONDARY outcome

Timeframe: From Day 1 through Day 7 post-vaccination

Population: Analysis was done on the subset of safety population which included the adults and elderly with underlying medical conditions.

Analysis was performed on a subset of safety population which included the adults (≥18 to ≤60 years) and elderly (≥61 years) with underlying medical conditions.

Outcome measures

Outcome measures
Measure	TIV (Adults) n=220 Participants Subjects ≥18 to ≤60 years years-old received one vaccination of egg-derived influenza virus vaccine	cTIV (Adults) n=490 Participants Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine	TIV (Elderly) n=99 Participants Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine	cTIV (Elderly) n=265 Participants Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV Pain (N=220,484,98,263)	77 Subjects	189 Subjects	15 Subjects	32 Subjects
Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV Chills (N=220,484,98,263)	5 Subjects	15 Subjects	3 Subjects	9 Subjects
Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV Malaise (N=220,484,98,263)	27 Subjects	51 Subjects	5 Subjects	13 Subjects
Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV Sweating (N=220,484,98,263)	12 Subjects	33 Subjects	6 Subjects	10 Subjects
Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV Fatigue (N=220,484,98,263)	37 Subjects	102 Subjects	14 Subjects	33 Subjects
Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV Fever (≥38 °C)	1 Subjects	5 Subjects	2 Subjects	1 Subjects
Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV Myalgia (N=220,484,98,263)	32 Subjects	80 Subjects	15 Subjects	23 Subjects
Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV Arthralgia (N=220,484,98,263)	10 Subjects	35 Subjects	8 Subjects	14 Subjects
Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV Headache (N=220,484,98,263)	40 Subjects	94 Subjects	15 Subjects	40 Subjects

SECONDARY outcome

Timeframe: Before vaccination (Day 1) and three weeks after vaccination (Day 22)

Population: Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions (full analysis set \[FAS\]: all enrolled subjects who received a study vaccine and provided one evaluable serum sample before and after baseline)

Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (Day 1) and three weeks (Day 22) after one vaccination of TIV or cTIV for each of three vaccine strains, evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is \>70% (≥18 to ≤60 years), or \>60% (≥61 years).

Outcome measures

Outcome measures
Measure	TIV (Adults) n=118 Participants Subjects ≥18 to ≤60 years years-old received one vaccination of egg-derived influenza virus vaccine	cTIV (Adults) n=118 Participants Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine	TIV (Elderly) n=25 Participants Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine	cTIV (Elderly) n=25 Participants Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV A/H1N1 (Day 1)	56 Percentages of Subjects Interval 46.0 to 65.0	53 Percentages of Subjects Interval 43.0 to 62.0	40 Percentages of Subjects Interval 21.0 to 61.0	56 Percentages of Subjects Interval 35.0 to 76.0
Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV A/H1N1 (Day 22)	98 Percentages of Subjects Interval 94.0 to 100.0	95 Percentages of Subjects Interval 89.0 to 98.0	96 Percentages of Subjects Interval 80.0 to 100.0	100 Percentages of Subjects Interval 86.0 to 100.0
Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV A/H3N2 (Day 1)	53 Percentages of Subjects Interval 44.0 to 63.0	46 Percentages of Subjects Interval 37.0 to 55.0	80 Percentages of Subjects Interval 59.0 to 93.0	64 Percentages of Subjects Interval 43.0 to 82.0
Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV A/H3N2 (Day 22)	97 Percentages of Subjects Interval 92.0 to 99.0	87 Percentages of Subjects Interval 80.0 to 93.0	100 Percentages of Subjects Interval 86.0 to 100.0	88 Percentages of Subjects Interval 69.0 to 97.0
Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV B (Day 1)	14 Percentages of Subjects Interval 8.0 to 21.0	16 Percentages of Subjects Interval 10.0 to 24.0	40 Percentages of Subjects Interval 21.0 to 61.0	28 Percentages of Subjects Interval 12.0 to 49.0
Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV B (Day 22)	77 Percentages of Subjects Interval 68.0 to 84.0	63 Percentages of Subjects Interval 53.0 to 71.0	68 Percentages of Subjects Interval 46.0 to 85.0	48 Percentages of Subjects Interval 28.0 to 69.0

SECONDARY outcome

Timeframe: Three weeks post-vaccination (Day 22)

Population: Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.

Seroconversion or significant increase in HI titer as per CHMP criteria for each of the three strains is defined as the percentage of subjects with a prevaccination HI titer \<10 to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion/significant increase should be \>40% (≥18 to ≤60 years) or \>30% (≥61 years).

Outcome measures

Outcome measures
Measure	TIV (Adults) n=118 Participants Subjects ≥18 to ≤60 years years-old received one vaccination of egg-derived influenza virus vaccine	cTIV (Adults) n=118 Participants Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine	TIV (Elderly) n=25 Participants Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine	cTIV (Elderly) n=25 Participants Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV A/H1N1	64 Percentages of Subjects Interval 54.0 to 72.0	65 Percentages of Subjects Interval 56.0 to 74.0	72 Percentages of Subjects Interval 51.0 to 88.0	60 Percentages of Subjects Interval 39.0 to 79.0
Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV B	55 Percentages of Subjects Interval 46.0 to 64.0	41 Percentages of Subjects Interval 32.0 to 50.0	24 Percentages of Subjects Interval 9.0 to 45.0	20 Percentages of Subjects Interval 7.0 to 41.0
Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV A/H3N2	62 Percentages of Subjects Interval 52.0 to 71.0	56 Percentages of Subjects Interval 46.0 to 65.0	40 Percentages of Subjects Interval 21.0 to 61.0	40 Percentages of Subjects Interval 21.0 to 61.0

SECONDARY outcome

Timeframe: Before vaccination (Day 1) and three weeks after vaccination (Day 22)

Population: Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.

Immunogenicity was measured as HI geometric mean titers (GMTs) of subjects with underlying conditions, directed against each of three vaccine strains at baseline (Day 1) and three weeks after vaccination (Day 22) in adults (≥18 to ≤60 years) and elderly (≥61 years).

Outcome measures

Outcome measures
Measure	TIV (Adults) n=118 Participants Subjects ≥18 to ≤60 years years-old received one vaccination of egg-derived influenza virus vaccine	cTIV (Adults) n=118 Participants Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine	TIV (Elderly) n=25 Participants Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine	cTIV (Elderly) n=25 Participants Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV A/H1N1 (Day 1)	37 Titers Interval 27.0 to 49.0	34 Titers Interval 25.0 to 46.0	19 Titers Interval 11.0 to 33.0	29 Titers Interval 17.0 to 51.0
Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV A/H1N1 (Day 22)	354 Titers Interval 282.0 to 443.0	308 Titers Interval 246.0 to 386.0	132 Titers Interval 87.0 to 199.0	158 Titers Interval 104.0 to 238.0
Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV A/H3N2 (Day 22)	224 Titers Interval 179.0 to 281.0	156 Titers Interval 125.0 to 196.0	174 Titers Interval 112.0 to 271.0	145 Titers Interval 93.0 to 226.0
Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV B (Day 1)	9.35 Titers Interval 7.96 to 11.0	11 Titers Interval 9.24 to 13.0	20 Titers Interval 13.0 to 31.0	14 Titers Interval 8.86 to 21.0
Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV A/H3N2 (Day 1)	31 Titers Interval 23.0 to 40.0	29 Titers Interval 22.0 to 38.0	56 Titers Interval 32.0 to 97.0	41 Titers Interval 23.0 to 71.0
Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV B (Day 22)	55 Titers Interval 46.0 to 66.0	39 Titers Interval 32.0 to 47.0	43 Titers Interval 26.0 to 72.0	26 Titers Interval 16.0 to 44.0

SECONDARY outcome

Timeframe: Three weeks post-vaccination (Day 22)

Population: Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.

Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI GMTs for each of the three strains, three weeks after one vaccination (Day 22) of TIV or cTIV. CHMP criteria is considered fulfilled for each of the three strains if the geometric mean increase GMR (Day 22/Day 1) in HI antibody titer is \>2.5 (≥18 to ≤60 years) or \>2.0 (≥61 Years).

Outcome measures

Outcome measures
Measure	TIV (Adults) n=118 Participants Subjects ≥18 to ≤60 years years-old received one vaccination of egg-derived influenza virus vaccine	cTIV (Adults) n=118 Participants Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine	TIV (Elderly) n=25 Participants Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine	cTIV (Elderly) n=25 Participants Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV A/H1N1	9.65 Ratio Interval 7.03 to 13.0	9 Ratio Interval 6.55 to 12.0	6.96 Ratio Interval 3.98 to 12.0	5.35 Ratio Interval 3.06 to 9.37
Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV A/H3N2	7.35 Ratio Interval 5.62 to 9.61	5.32 Ratio Interval 4.07 to 6.95	3.12 Ratio Interval 1.76 to 5.51	3.58 Ratio Interval 2.02 to 6.33
Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV B	5.88 Ratio Interval 4.62 to 7.49	3.57 Ratio Interval 2.8 to 4.54	2.17 Ratio Interval 1.3 to 3.64	1.92 Ratio Interval 1.15 to 3.21

Adverse Events

Egg-derived Vaccine (TIV)

Serious events: 10 serious events

Other events: 204 other events

Deaths: 0 deaths

Cell Culture-derived Vaccine (cTIV)

Serious events: 20 serious events

Other events: 568 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Egg-derived Vaccine (TIV) n=396 participants at risk Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine	Cell Culture-derived Vaccine (cTIV) n=1001 participants at risk Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
General disorders Fatigue	15.9% 63/396 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.	18.5% 185/1001 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.
General disorders Injection site pain	29.5% 117/396 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.	33.0% 330/1001 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.
General disorders Malaise	9.8% 39/396 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.	8.9% 89/1001 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.
Infections and infestations Bronchitis	3.5% 14/396 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.	5.9% 59/1001 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.
Infections and infestations Nasopharyngitis	2.5% 10/396 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.	9.0% 90/1001 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 22/396 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.	7.6% 76/1001 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.
Musculoskeletal and connective tissue disorders Myalgia	14.4% 57/396 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.	15.0% 150/1001 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.
Nervous system disorders Headache	18.4% 73/396 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.	19.8% 198/1001 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.3% 21/396 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.	5.6% 56/1001 • Throughout the study period (day 1 to day 181). All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.

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