Trial Outcomes & Findings for Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly (NCT NCT00306527)

Last Updated: 2019-08-14

Results Overview

To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine .

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2235 participants

Primary outcome timeframe

Day 1 to Day 7 postvaccination

Results posted on

2019-08-14

Participant Flow

Subjects were enrolled from 5 study centers in Poland.

All subjects enrolled were included in the trial.

Participant milestones

Participant milestones
Measure	Adults (cTIV\cTIV) + (TIV\cTIV) Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.	Adults (cTIV\TIV) + (TIV\TIV) Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.	Elderly (cTIV\cTIV) + (TIV\cTIV) Subjects(≥61years of age ) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.	Elderly (cTIV\TIV) + (TIV\TIV) Subjects (≥61years) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
Overall Study STARTED	533	534	572	596
Overall Study COMPLETED	527	527	567	590
Overall Study NOT COMPLETED	6	7	5	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Adults (cTIV\cTIV) + (TIV\cTIV) Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.	Adults (cTIV\TIV) + (TIV\TIV) Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.	Elderly (cTIV\cTIV) + (TIV\cTIV) Subjects(≥61years of age ) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.	Elderly (cTIV\TIV) + (TIV\TIV) Subjects (≥61years) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
Overall Study Lost to Follow-up	3	4	3	0
Overall Study Withdrawal by Subject	2	3	0	3
Overall Study Adverse Event	0	0	1	1
Overall Study Death	1	0	1	2

Baseline Characteristics

Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adults (cTIV\cTIV) + (TIV\cTIV) n=533 Participants Subjects(18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine, received one dose of cTIV in this study, one year later.	Elderly (cTIV\cTIV) + (TIV\cTIV) n=572 Participants Subjects(≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine, received one dose of cTIV in this study, one year later.	Adults (cTIV\TIV) + (TIV\TIV) n=534 Participants Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.	Elderly (cTIV\TIV) + (TIV\TIV) n=596 Participants Subjects (≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.	Total n=2235 Participants Total of all reporting groups
Age, Continuous	39.8 years STANDARD_DEVIATION 12.7 • n=5 Participants	69.2 years STANDARD_DEVIATION 5.7 • n=7 Participants	39.0 years STANDARD_DEVIATION 12.5 • n=5 Participants	69.9 years STANDARD_DEVIATION 5.7 • n=4 Participants	55.2 years STANDARD_DEVIATION 17.9 • n=21 Participants
Sex: Female, Male Female	308 Participants n=5 Participants	308 Participants n=7 Participants	309 Participants n=5 Participants	353 Participants n=4 Participants	1278 Participants n=21 Participants
Sex: Female, Male Male	225 Participants n=5 Participants	264 Participants n=7 Participants	225 Participants n=5 Participants	243 Participants n=4 Participants	957 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 7 postvaccination

Population: This analysis was done on safety dataset

To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine .

Outcome measures

Outcome measures
Measure	cTIV\cTIV (Adults) n=272 Participants Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.	cTIV\TIV (Adults) n=274 Participants Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	cTIV\cTIV (Elderly) n=290 Participants Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.	cTIV\TIV (Elderly) n=297 Participants Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\TIV (Adults) n=260 Participants Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\cTIV (Adults) n=261 Participants Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.	TIV\TIV (Elderly) n=300 Participants Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\cTIV (Elderly) n=281 Participants Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Local	78 Participants	73 Participants	47 Participants	51 Participants	76 Participants	84 Participants	47 Participants	55 Participants
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Injection site ecchymosis	13 Participants	11 Participants	12 Participants	15 Participants	13 Participants	13 Participants	18 Participants	11 Participants
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Injection site erythema	32 Participants	26 Participants	22 Participants	19 Participants	40 Participants	27 Participants	16 Participants	24 Participants
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Injection site induration	17 Participants	11 Participants	10 Participants	7 Participants	20 Participants	18 Participants	10 Participants	14 Participants
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Injection site swelling	8 Participants	4 Participants	7 Participants	5 Participants	12 Participants	9 Participants	4 Participants	8 Participants
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Injection site pain	52 Participants	45 Participants	22 Participants	21 Participants	46 Participants	63 Participants	19 Participants	26 Participants
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Systemic	41 Participants	46 Participants	37 Participants	40 Participants	42 Participants	46 Participants	37 Participants	47 Participants
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Chills	7 Participants	4 Participants	8 Participants	7 Participants	4 Participants	8 Participants	5 Participants	10 Participants
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Malaise	20 Participants	18 Participants	19 Participants	19 Participants	20 Participants	27 Participants	20 Participants	29 Participants
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Myalgia	19 Participants	20 Participants	13 Participants	9 Participants	22 Participants	19 Participants	10 Participants	21 Participants
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Arthralgia	10 Participants	7 Participants	14 Participants	14 Participants	9 Participants	11 Participants	11 Participants	15 Participants
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Headache	24 Participants	21 Participants	16 Participants	22 Participants	21 Participants	27 Participants	15 Participants	20 Participants
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Sweat	10 Participants	8 Participants	10 Participants	11 Participants	11 Participants	13 Participants	7 Participants	16 Participants
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Fatigue	18 Participants	19 Participants	22 Participants	24 Participants	23 Participants	23 Participants	16 Participants	26 Participants
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Fever (≥38°C)	2 Participants	2 Participants	2 Participants	0 Participants	3 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Other	15 Participants	11 Participants	7 Participants	10 Participants	13 Participants	12 Participants	10 Participants	12 Participants
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Stayed at home due to reaction	3 Participants	2 Participants	3 Participants	2 Participants	6 Participants	3 Participants	4 Participants	5 Participants
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine Analgesic antipyretic medication used	14 Participants	11 Participants	7 Participants	9 Participants	11 Participants	10 Participants	8 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to 6 months postvaccination

Population: This analysis was done on the safety dataset.

To collect additional safety data for 6 months after vaccination with one dose of cell culture derived or egg-derived influenza vaccine 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.

Outcome measures

Outcome measures
Measure	cTIV\cTIV (Adults) n=272 Participants Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.	cTIV\TIV (Adults) n=274 Participants Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	cTIV\cTIV (Elderly) n=290 Participants Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.	cTIV\TIV (Elderly) n=297 Participants Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\TIV (Adults) n=260 Participants Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\cTIV (Adults) n=261 Participants Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.	TIV\TIV (Elderly) n=300 Participants Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\cTIV (Elderly) n=281 Participants Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine Any AE	50 Participants	38 Participants	70 Participants	58 Participants	35 Participants	44 Participants	67 Participants	76 Participants
Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine At least possibly related AE	2 Participants	4 Participants	2 Participants	5 Participants	2 Participants	4 Participants	2 Participants	5 Participants
Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine Any SAE	5 Participants	4 Participants	13 Participants	13 Participants	0 Participants	4 Participants	17 Participants	10 Participants
Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine At least possibly related SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine Any death	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 22 postvaccination

Population: The analysis was done on the immunogenicity subset.

The haemagglutinin inhibition (HI) antibody titer response following one 0.5 mL dose of either cell derived (cTIV) or egg-derived vaccine (TIV) in adult and elderly subjects is reported as GMTs. The HI GMTs were evaluated using egg-derived antigen assay.

Outcome measures

Outcome measures
Measure	cTIV\cTIV (Adults) n=60 Participants Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.	cTIV\TIV (Adults) n=60 Participants Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	cTIV\cTIV (Elderly) n=61 Participants Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.	cTIV\TIV (Elderly) n=61 Participants Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\TIV (Adults) n=59 Participants Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\cTIV (Adults) n=60 Participants Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.	TIV\TIV (Elderly) n=61 Participants Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\cTIV (Elderly) n=61 Participants Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects A/H1N1 strain (Day 1)	40 Titers Interval 28.0 to 58.0	34 Titers Interval 24.0 to 48.0	26 Titers Interval 19.0 to 35.0	20 Titers Interval 15.0 to 27.0	35 Titers Interval 25.0 to 51.0	36 Titers Interval 25.0 to 51.0	24 Titers Interval 18.0 to 32.0	26 Titers Interval 19.0 to 35.0
Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects A/H1N1 strain (Day 22)	87 Titers Interval 65.0 to 116.0	83 Titers Interval 62.0 to 111.0	57 Titers Interval 43.0 to 76.0	61 Titers Interval 46.0 to 80.0	72 Titers Interval 53.0 to 96.0	104 Titers Interval 78.0 to 140.0	61 Titers Interval 46.0 to 81.0	80 Titers Interval 61.0 to 106.0
Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects A/H3N2 strain (Day 1)	16 Titers Interval 12.0 to 21.0	18 Titers Interval 13.0 to 23.0	20 Titers Interval 15.0 to 26.0	26 Titers Interval 19.0 to 34.0	19 Titers Interval 15.0 to 25.0	21 Titers Interval 16.0 to 28.0	19 Titers Interval 14.0 to 25.0	20 Titers Interval 15.0 to 27.0
Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects A/H3N2 strain (Day 22)	173 Titers Interval 129.0 to 233.0	109 Titers Interval 81.0 to 146.0	229 Titers Interval 163.0 to 321.0	197 Titers Interval 141.0 to 277.0	78 Titers Interval 58.0 to 105.0	170 Titers Interval 127.0 to 229.0	125 Titers Interval 89.0 to 175.0	251 Titers Interval 178.0 to 352.0
Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects B strain (Day 1)	30 Titers Interval 22.0 to 40.0	26 Titers Interval 19.0 to 35.0	36 Titers Interval 27.0 to 48.0	48 Titers Interval 36.0 to 64.0	37 Titers Interval 27.0 to 50.0	35 Titers Interval 26.0 to 48.0	26 Titers Interval 19.0 to 34.0	37 Titers Interval 27.0 to 49.0
Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects B strain (Day 22)	77 Titers Interval 60.0 to 99.0	71 Titers Interval 55.0 to 91.0	84 Titers Interval 64.0 to 111.0	128 Titers Interval 97.0 to 168.0	67 Titers Interval 52.0 to 86.0	104 Titers Interval 81.0 to 133.0	68 Titers Interval 51.0 to 89.0	116 Titers Interval 88.0 to 154.0

SECONDARY outcome

Timeframe: Day 22 postvaccination

Population: The analysis was done on the immunogenicity subset.

Immunogenicity was assessed in terms of GMR in adult and elderly subjects following one 0.5ml dose of either the cTIV vaccine or the TIV vaccine, according to the CHMP criteria. The European licensure (CHMP) criteria was met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is \>2.5 for adults and \>2.0 for elderly subjects.

Outcome measures

Outcome measures
Measure	cTIV\cTIV (Adults) n=60 Participants Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.	cTIV\TIV (Adults) n=60 Participants Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	cTIV\cTIV (Elderly) n=61 Participants Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.	cTIV\TIV (Elderly) n=61 Participants Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\TIV (Adults) n=59 Participants Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\cTIV (Adults) n=60 Participants Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.	TIV\TIV (Elderly) n=61 Participants Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\cTIV (Elderly) n=61 Participants Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects A/H1N1 strain	2.14 Ratio Interval 1.67 to 2.74	2.46 Ratio Interval 1.92 to 3.15	2.2 Ratio Interval 1.71 to 2.84	2.98 Ratio Interval 2.31 to 3.84	2.02 Ratio Interval 1.58 to 2.6	2.91 Ratio Interval 2.27 to 3.73	2.54 Ratio Interval 1.97 to 3.28	3.11 Ratio Interval 2.41 to 4.02
Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects A/H3N2 strain	11 Ratio Interval 8.13 to 14.0	6.17 Ratio Interval 4.64 to 8.2	12 Ratio Interval 8.49 to 16.0	7.64 Ratio Interval 5.58 to 10.0	4.09 Ratio Interval 3.07 to 5.45	8.05 Ratio Interval 6.06 to 11.0	6.59 Ratio Interval 4.81 to 9.04	12 Ratio Interval 8.94 to 17.0
Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects B strain	2.61 Ratio Interval 2.07 to 3.29	2.7 Ratio Interval 2.14 to 3.41	2.37 Ratio Interval 1.86 to 3.03	2.67 Ratio Interval 2.09 to 3.42	1.81 Ratio Interval 1.43 to 2.29	2.93 Ratio Interval 2.32 to 3.7	2.64 Ratio Interval 2.07 to 3.38	3.19 Ratio Interval 2.5 to 4.07

SECONDARY outcome

Timeframe: Day 22 postvaccination

Population: This analysis was done on immunogenicity subset.

Immunogenicity was assessed in terms of percentages of adult and elderly subjects achieving HI titers≥40,after one dose of either the cTIV vaccine or the TIV vaccine. European (CHMP) criteria is met if the percentage of subjects achieving HI titers ≥ 40 is \> 70% for adults and \>60% for elderly.

Outcome measures

Outcome measures
Measure	cTIV\cTIV (Adults) n=60 Participants Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.	cTIV\TIV (Adults) n=60 Participants Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	cTIV\cTIV (Elderly) n=61 Participants Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.	cTIV\TIV (Elderly) n=61 Participants Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\TIV (Adults) n=59 Participants Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\cTIV (Adults) n=60 Participants Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.	TIV\TIV (Elderly) n=61 Participants Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\cTIV (Elderly) n=61 Participants Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. A/H1N1 strain (Day 1)	57 Percentages of subjects Interval 43.0 to 69.0	48 Percentages of subjects Interval 35.0 to 62.0	49 Percentages of subjects Interval 36.0 to 62.0	36 Percentages of subjects Interval 24.0 to 49.0	54 Percentages of subjects Interval 41.0 to 67.0	57 Percentages of subjects Interval 43.0 to 69.0	36 Percentages of subjects Interval 24.0 to 49.0	48 Percentages of subjects Interval 35.0 to 61.0
Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. A/H1N1 strain (Day 22)	85 Percentages of subjects Interval 73.0 to 93.0	80 Percentages of subjects Interval 68.0 to 89.0	77 Percentages of subjects Interval 65.0 to 87.0	74 Percentages of subjects Interval 61.0 to 84.0	80 Percentages of subjects Interval 67.0 to 89.0	90 Percentages of subjects Interval 79.0 to 96.0	69 Percentages of subjects Interval 56.0 to 80.0	82 Percentages of subjects Interval 70.0 to 91.0
Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. A/H3N2 strain (Day 1)	25 Percentages of subjects Interval 15.0 to 38.0	27 Percentages of subjects Interval 16.0 to 40.0	30 Percentages of subjects Interval 19.0 to 43.0	39 Percentages of subjects Interval 27.0 to 53.0	32 Percentages of subjects Interval 21.0 to 46.0	33 Percentages of subjects Interval 22.0 to 47.0	26 Percentages of subjects Interval 16.0 to 39.0	34 Percentages of subjects Interval 23.0 to 48.0
Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. A/H3N2 strain (Day 22)	92 Percentages of subjects Interval 82.0 to 97.0	95 Percentages of subjects Interval 86.0 to 99.0	97 Percentages of subjects Interval 89.0 to 100.0	95 Percentages of subjects Interval 86.0 to 99.0	86 Percentages of subjects Interval 75.0 to 94.0	92 Percentages of subjects Interval 82.0 to 97.0	87 Percentages of subjects Interval 76.0 to 94.0	92 Percentages of subjects Interval 82.0 to 97.0
Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. B strain (Day 1)	50 Percentages of subjects Interval 37.0 to 63.0	50 Percentages of subjects Interval 37.0 to 63.0	59 Percentages of subjects Interval 46.0 to 71.0	61 Percentages of subjects Interval 47.0 to 73.0	54 Percentages of subjects Interval 41.0 to 67.0	58 Percentages of subjects Interval 45.0 to 71.0	43 Percentages of subjects Interval 30.0 to 56.0	62 Percentages of subjects Interval 49.0 to 74.0
Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. B strain (Day 22)	80 Percentages of subjects Interval 68.0 to 89.0	90 Percentages of subjects Interval 79.0 to 96.0	84 Percentages of subjects Interval 72.0 to 92.0	92 Percentages of subjects Interval 82.0 to 97.0	85 Percentages of subjects Interval 73.0 to 93.0	87 Percentages of subjects Interval 75.0 to 94.0	84 Percentages of subjects Interval 72.0 to 92.0	90 Percentages of subjects Interval 80.0 to 96.0

SECONDARY outcome

Timeframe: Day 22 postvaccination

Population: This analysis was done on the immunogenicity subset.

Immunogenicity was assessed in terms of percentages of adult and elderly subjects showing seroconversion or significant increase in HI antibody titers after one dose of cell culture-derived or the egg-derived influenza vaccine. Seroconversion or significant increase as per European Licensure (CHMP) criteria is defined as percentage of subjects with a prevaccination HI titer \<10 to a postvaccination titer ≥ 40 for adults and ≥ 30 for elderly. Significant increase is defined as percentage of subjects with a prevaccination HI titer ≥ 10 and a ≥ 4-fold increase in postvaccination HI antibody titer.

Outcome measures

Outcome measures
Measure	cTIV\cTIV (Adults) n=60 Participants Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.	cTIV\TIV (Adults) n=60 Participants Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	cTIV\cTIV (Elderly) n=61 Participants Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.	cTIV\TIV (Elderly) n=61 Participants Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\TIV (Adults) n=59 Participants Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\cTIV (Adults) n=60 Participants Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.	TIV\TIV (Elderly) n=61 Participants Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.	TIV\cTIV (Elderly) n=61 Participants Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. A/H1N1 strain	22 Percentages of subjects Interval 12.0 to 34.0	32 Percentages of subjects Interval 20.0 to 45.0	30 Percentages of subjects Interval 19.0 to 43.0	34 Percentages of subjects Interval 23.0 to 48.0	24 Percentages of subjects Interval 14.0 to 37.0	30 Percentages of subjects Interval 19.0 to 43.0	30 Percentages of subjects Interval 19.0 to 43.0	43 Percentages of subjects Interval 30.0 to 56.0
Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. A/H3N2 strain	82 Percentages of subjects Interval 70.0 to 90.0	85 Percentages of subjects Interval 73.0 to 93.0	84 Percentages of subjects Interval 72.0 to 92.0	80 Percentages of subjects Interval 68.0 to 89.0	61 Percentages of subjects Interval 47.0 to 73.0	80 Percentages of subjects Interval 68.0 to 89.0	77 Percentages of subjects Interval 65.0 to 87.0	82 Percentages of subjects Interval 70.0 to 91.0
Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. B strain	28 Percentages of subjects Interval 17.0 to 41.0	33 Percentages of subjects Interval 22.0 to 47.0	28 Percentages of subjects Interval 17.0 to 41.0	34 Percentages of subjects Interval 23.0 to 48.0	27 Percentages of subjects Interval 16.0 to 40.0	40 Percentages of subjects Interval 28.0 to 53.0	31 Percentages of subjects Interval 20.0 to 44.0	41 Percentages of subjects Interval 29.0 to 54.0

Adverse Events

Adults (cTIV\cTIV) + (TIV\cTIV)

Serious events: 9 serious events

Other events: 188 other events

Deaths: 0 deaths

Adults (cTIV/TIV) + (TIV\TIV)

Serious events: 4 serious events

Other events: 172 other events

Deaths: 0 deaths

Elderly (cTIV\cTIV) + (TIV\cTIV)

Serious events: 23 serious events

Other events: 140 other events

Deaths: 0 deaths

Elderly (cTIV\TIV) + (TIV\TIV)

Serious events: 30 serious events

Other events: 148 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Adults (cTIV\cTIV) + (TIV\cTIV) n=533 participants at risk Subjects(18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.	Adults (cTIV/TIV) + (TIV\TIV) n=534 participants at risk Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.	Elderly (cTIV\cTIV) + (TIV\cTIV) n=571 participants at risk Subjects(≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.	Elderly (cTIV\TIV) + (TIV\TIV) n=597 participants at risk Subjects (≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
General disorders Fatigue	7.7% 41/533 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	8.1% 43/534 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	8.6% 49/571 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	6.9% 41/597 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).
General disorders Injection site erythema	11.1% 59/533 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	12.4% 66/534 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	8.1% 46/571 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	5.9% 35/597 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).
General disorders Injection site induration	6.6% 35/533 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	5.8% 31/534 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	4.2% 24/571 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	2.8% 17/597 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).
General disorders Injection site haemorrhage	4.9% 26/533 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	4.5% 24/534 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	4.0% 23/571 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	5.5% 33/597 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).
General disorders Injection site pain	21.6% 115/533 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	17.0% 91/534 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	8.4% 48/571 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	6.7% 40/597 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).
General disorders Malaise	9.0% 48/533 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	8.1% 43/534 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	8.6% 49/571 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	6.5% 39/597 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).
Musculoskeletal and connective tissue disorders Myalgia	7.5% 40/533 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	7.9% 42/534 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	6.3% 36/571 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	3.4% 20/597 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).
Nervous system disorders Headache	10.3% 55/533 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	7.9% 42/534 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	6.7% 38/571 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	6.2% 37/597 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).
Musculoskeletal and connective tissue disorders Arthralgia	4.1% 22/533 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	3.0% 16/534 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	5.4% 31/571 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).	4.5% 27/597 • Through out the study period Post-injection solicited adverse events were collected from Day 1-7. Other AEs and SAEs were collected through out the study period (Day 1 to 6 months).

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