A Phase 3 interventional study of Cell culture derived influenza vaccine and egg-derived influenza subunit vaccine in Influenza, sponsored by Novartis Vaccines. Completed at 5 sites in Poland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-14.
Sponsored by Novartis Vaccines · Phase 3, Interventional, and Prevention
The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 2,235 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Novartis Vaccines is the lead sponsor of 161 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
in good health as determined by:
Exclusion Criteria:
Any serious disease such as, for example:
Known or suspected impairment/alteration of immune function resulting from:
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.
Biological: Cell culture derived influenza vaccine
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.
Biological: egg-derived influenza subunit vaccine
Subjects (≥61 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.
Biological: Cell culture derived influenza vaccine
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.
Biological: egg-derived influenza subunit vaccine
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.
Biological: egg-derived influenza subunit vaccine
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.
Biological: Cell culture derived influenza vaccine
Subjects (≥61 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.
Biological: egg-derived influenza subunit vaccine
Subjects (≥61 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.
Biological: Cell culture derived influenza vaccine
as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine
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 .
Time frame: Day 1 to Day 7 postvaccination
Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine
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.
Time frame: Up to 6 months postvaccination
Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects
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.
Time frame: Day 22 postvaccination
Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects
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.
Time frame: Day 22 postvaccination
Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine.
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.
Time frame: Day 22 postvaccination
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.
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.
Time frame: Day 22 postvaccination
Subjects were enrolled from 5 study centers in Poland.
| Milestone | Adults (cTIV\cTIV) + (TIV\cTIV) | Adults (cTIV\TIV) + (TIV\TIV) | Elderly (cTIV\cTIV) + (TIV\cTIV) | Elderly (cTIV\TIV) + (TIV\TIV) |
|---|---|---|---|---|
| Started | 533 | 534 | 572 | 596 |
| Completed | 527 | 527 | 567 | 590 |
| Not completed | 6 | 7 | 5 | 6 |
| Withdrew: Lost to follow-up | 3 | 4 | 3 | 0 |
| Withdrew: Withdrawal by subject | 2 | 3 | 0 | 3 |
| Withdrew: Adverse event | 0 | 0 | 1 | 1 |
| Withdrew: Death | 1 | 0 | 1 | 2 |
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.
| Participants | cTIV\cTIV (Adults) | cTIV\TIV (Adults) | cTIV\cTIV (Elderly) | cTIV\TIV (Elderly) | TIV\TIV (Adults) | TIV\cTIV (Adults) | TIV\TIV (Elderly) | TIV\cTIV (Elderly) |
|---|---|---|---|---|---|---|---|---|
| Any AE | 50 | 38 | 70 | 58 | 35 | 44 | 67 | 76 |
| At least possibly related AE | 2 | 4 | 2 | 5 | 2 | 4 | 2 | 5 |
| Any SAE | 5 | 4 | 13 | 13 | 0 | 4 | 17 | 10 |
| At least possibly related SAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any death | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 2 |
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.
| Titers | cTIV\cTIV (Adults) | cTIV\TIV (Adults) | cTIV\cTIV (Elderly) | cTIV\TIV (Elderly) | TIV\TIV (Adults) | TIV\cTIV (Adults) | TIV\TIV (Elderly) | TIV\cTIV (Elderly) |
|---|---|---|---|---|---|---|---|---|
| A/H1N1 strain (Day 1) | 40 (28 to 58) | 34 (24 to 48) | 26 (19 to 35) | 20 (15 to 27) | 35 (25 to 51) | 36 (25 to 51) | 24 (18 to 32) | 26 (19 to 35) |
| A/H1N1 strain (Day 22) | 87 (65 to 116) | 83 (62 to 111) | 57 (43 to 76) | 61 (46 to 80) | 72 (53 to 96) | 104 (78 to 140) | 61 (46 to 81) | 80 (61 to 106) |
| A/H3N2 strain (Day 1) | 16 (12 to 21) | 18 (13 to 23) | 20 (15 to 26) | 26 (19 to 34) | 19 (15 to 25) | 21 (16 to 28) | 19 (14 to 25) | 20 (15 to 27) |
| A/H3N2 strain (Day 22) | 173 (129 to 233) | 109 (81 to 146) | 229 (163 to 321) | 197 (141 to 277) | 78 (58 to 105) | 170 (127 to 229) | 125 (89 to 175) | 251 (178 to 352) |
| B strain (Day 1) | 30 (22 to 40) | 26 (19 to 35) | 36 (27 to 48) | 48 (36 to 64) | 37 (27 to 50) | 35 (26 to 48) | 26 (19 to 34) | 37 (27 to 49) |
| B strain (Day 22) | 77 (60 to 99) | 71 (55 to 91) | 84 (64 to 111) | 128 (97 to 168) | 67 (52 to 86) | 104 (81 to 133) | 68 (51 to 89) | 116 (88 to 154) |
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.
| Ratio | cTIV\cTIV (Adults) | cTIV\TIV (Adults) | cTIV\cTIV (Elderly) | cTIV\TIV (Elderly) | TIV\TIV (Adults) | TIV\cTIV (Adults) | TIV\TIV (Elderly) | TIV\cTIV (Elderly) |
|---|---|---|---|---|---|---|---|---|
| A/H1N1 strain | 2.14 (1.67 to 2.74) | 2.46 (1.92 to 3.15) | 2.2 (1.71 to 2.84) | 2.98 (2.31 to 3.84) | 2.02 (1.58 to 2.6) | 2.91 (2.27 to 3.73) | 2.54 (1.97 to 3.28) | 3.11 (2.41 to 4.02) |
| A/H3N2 strain | 11 (8.13 to 14) | 6.17 (4.64 to 8.2) | 12 (8.49 to 16) | 7.64 (5.58 to 10) | 4.09 (3.07 to 5.45) | 8.05 (6.06 to 11) | 6.59 (4.81 to 9.04) | 12 (8.94 to 17) |
| B strain | 2.61 (2.07 to 3.29) | 2.7 (2.14 to 3.41) | 2.37 (1.86 to 3.03) | 2.67 (2.09 to 3.42) | 1.81 (1.43 to 2.29) | 2.93 (2.32 to 3.7) | 2.64 (2.07 to 3.38) | 3.19 (2.5 to 4.07) |
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.
| Percentages of subjects | cTIV\cTIV (Adults) | cTIV\TIV (Adults) | cTIV\cTIV (Elderly) | cTIV\TIV (Elderly) | TIV\TIV (Adults) | TIV\cTIV (Adults) | TIV\TIV (Elderly) | TIV\cTIV (Elderly) |
|---|---|---|---|---|---|---|---|---|
| A/H1N1 strain (Day 1) | 57 (43 to 69) | 48 (35 to 62) | 49 (36 to 62) | 36 (24 to 49) | 54 (41 to 67) | 57 (43 to 69) | 36 (24 to 49) | 48 (35 to 61) |
| A/H1N1 strain (Day 22) | 85 (73 to 93) | 80 (68 to 89) | 77 (65 to 87) | 74 (61 to 84) | 80 (67 to 89) | 90 (79 to 96) | 69 (56 to 80) | 82 (70 to 91) |
| A/H3N2 strain (Day 1) | 25 (15 to 38) | 27 (16 to 40) | 30 (19 to 43) | 39 (27 to 53) | 32 (21 to 46) | 33 (22 to 47) | 26 (16 to 39) | 34 (23 to 48) |
| A/H3N2 strain (Day 22) | 92 (82 to 97) | 95 (86 to 99) | 97 (89 to 100) | 95 (86 to 99) | 86 (75 to 94) | 92 (82 to 97) | 87 (76 to 94) | 92 (82 to 97) |
| B strain (Day 1) | 50 (37 to 63) | 50 (37 to 63) | 59 (46 to 71) | 61 (47 to 73) | 54 (41 to 67) | 58 (45 to 71) | 43 (30 to 56) | 62 (49 to 74) |
| B strain (Day 22) | 80 (68 to 89) | 90 (79 to 96) | 84 (72 to 92) | 92 (82 to 97) | 85 (73 to 93) | 87 (75 to 94) | 84 (72 to 92) | 90 (80 to 96) |
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.
| Percentages of subjects | cTIV\cTIV (Adults) | cTIV\TIV (Adults) | cTIV\cTIV (Elderly) | cTIV\TIV (Elderly) | TIV\TIV (Adults) | TIV\cTIV (Adults) | TIV\TIV (Elderly) | TIV\cTIV (Elderly) |
|---|---|---|---|---|---|---|---|---|
| A/H1N1 strain | 22 (12 to 34) | 32 (20 to 45) | 30 (19 to 43) | 34 (23 to 48) | 24 (14 to 37) | 30 (19 to 43) | 30 (19 to 43) | 43 (30 to 56) |
| A/H3N2 strain | 82 (70 to 90) | 85 (73 to 93) | 84 (72 to 92) | 80 (68 to 89) | 61 (47 to 73) | 80 (68 to 89) | 77 (65 to 87) | 82 (70 to 91) |
| B strain | 28 (17 to 41) | 33 (22 to 47) | 28 (17 to 41) | 34 (23 to 48) | 27 (16 to 40) | 40 (28 to 53) | 31 (20 to 44) | 41 (29 to 54) |
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 .
| Participants | cTIV\cTIV (Adults) | cTIV\TIV (Adults) | cTIV\cTIV (Elderly) | cTIV\TIV (Elderly) | TIV\TIV (Adults) | TIV\cTIV (Adults) | TIV\TIV (Elderly) | TIV\cTIV (Elderly) |
|---|---|---|---|---|---|---|---|---|
| Local | 78 | 73 | 47 | 51 | 76 | 84 | 47 | 55 |
| Injection site ecchymosis | 13 | 11 | 12 | 15 | 13 | 13 | 18 | 11 |
| Injection site erythema | 32 | 26 | 22 | 19 | 40 | 27 | 16 | 24 |
| Injection site induration | 17 | 11 | 10 | 7 | 20 | 18 | 10 | 14 |
| Injection site swelling | 8 | 4 | 7 | 5 | 12 | 9 | 4 | 8 |
| Injection site pain | 52 | 45 | 22 | 21 | 46 | 63 | 19 | 26 |
| Systemic | 41 | 46 | 37 | 40 | 42 | 46 | 37 | 47 |
| Chills | 7 | 4 | 8 | 7 | 4 | 8 | 5 | 10 |
| Malaise | 20 | 18 | 19 | 19 | 20 | 27 | 20 | 29 |
| Myalgia | 19 | 20 | 13 | 9 | 22 | 19 | 10 | 21 |
| Arthralgia | 10 | 7 | 14 | 14 | 9 | 11 | 11 | 15 |
| Headache | 24 | 21 | 16 | 22 | 21 | 27 | 15 | 20 |
| Sweat | 10 | 8 | 10 | 11 | 11 | 13 | 7 | 16 |
| Fatigue | 18 | 19 | 22 | 24 | 23 | 23 | 16 | 26 |
| Fever (≥38°C) | 2 | 2 | 2 | 0 | 3 | 0 | 2 | 0 |
| Other | 15 | 11 | 7 | 10 | 13 | 12 | 10 | 12 |
| Stayed at home due to reaction | 3 | 2 | 3 | 2 | 6 | 3 | 4 | 5 |
| Analgesic antipyretic medication used | 14 | 11 | 7 | 9 | 11 | 10 | 8 | 10 |
Collected over Through out the study period. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adults (cTIV\cTIV) + (TIV\cTIV) | — | 9/533 (1.7%) | 188/533 (35.3%) |
| Adults (cTIV/TIV) + (TIV\TIV) | — | 4/534 (0.7%) | 172/534 (32.2%) |
| Elderly (cTIV\cTIV) + (TIV\cTIV) | — | 23/571 (4%) | 140/571 (24.5%) |
| Elderly (cTIV\TIV) + (TIV\TIV) | — | 30/597 (5%) | 148/597 (24.8%) |
| Event | Adults (cTIV\cTIV) + (TIV\cTIV) | Adults (cTIV/TIV) + (TIV\TIV) | Elderly (cTIV\cTIV) + (TIV\cTIV) | Elderly (cTIV\TIV) + (TIV\TIV) |
|---|---|---|---|---|
| CholelithiasisHepatobiliary disorders | 0/533 | 1/534 | 0/571 | 3/597 |
| Acute myocardial infractionCardiac disorders | 0/533 | 0/534 | 2/571 | 1/597 |
| Adams stokes syndromeCardiac disorders | 0/533 | 0/534 | 2/571 | 0/597 |
| Atrial fibrillationCardiac disorders | 0/533 | 0/534 | 1/571 | 2/597 |
| Myocardial ischaemiaCardiac disorders | 1/533 | 0/534 | 1/571 | 1/597 |
| Abdominal herniaGastrointestinal disorders | 1/533 | 0/534 | 0/571 | 0/597 |
| Pancreatitis chronicGastrointestinal disorders | 1/533 | 0/534 | 0/571 | 0/597 |
| Spilgelian herniaGastrointestinal disorders | 1/533 | 0/534 | 0/571 | 0/597 |
| Chest painGeneral disorders | 1/533 | 0/534 | 1/571 | 0/597 |
| Joint contractureMusculoskeletal and connective tissue disorders | 1/533 | 0/534 | 0/571 | 0/597 |
| Event | Adults (cTIV\cTIV) + (TIV\cTIV) | Adults (cTIV/TIV) + (TIV\TIV) | Elderly (cTIV\cTIV) + (TIV\cTIV) | Elderly (cTIV\TIV) + (TIV\TIV) |
|---|---|---|---|---|
| Injection site painGeneral disorders | 115/533 | 91/534 | 48/571 | 40/597 |
| Injection site erythemaGeneral disorders | 59/533 | 66/534 | 46/571 | 35/597 |
| HeadacheNervous system disorders | 55/533 | 42/534 | 38/571 | 37/597 |
| MalaiseGeneral disorders | 48/533 | 43/534 | 49/571 | 39/597 |
| FatigueGeneral disorders | 41/533 | 43/534 | 49/571 | 41/597 |
| MyalgiaMusculoskeletal and connective tissue disorders | 40/533 | 42/534 | 36/571 | 20/597 |
| Injection site indurationGeneral disorders | 35/533 | 31/534 | 24/571 | 17/597 |
| Injection site haemorrhageGeneral disorders | 26/533 | 24/534 | 23/571 | 33/597 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 22/533 | 16/534 | 31/571 | 27/597 |
| Age, Continuous(years) | Adults (cTIV\cTIV) + (TIV\cTIV) | Elderly (cTIV\cTIV) + (TIV\cTIV) | Adults (cTIV\TIV) + (TIV\TIV) | Elderly (cTIV\TIV) + (TIV\TIV) | Total |
|---|---|---|---|---|---|
| Mean | 39.8 ± 12.7 | 69.2 ± 5.7 | 39.0 ± 12.5 | 69.9 ± 5.7 | 55.2 ± 17.9 |
| Sex: Female, Male(Participants) | Adults (cTIV\cTIV) + (TIV\cTIV) | Elderly (cTIV\cTIV) + (TIV\cTIV) | Adults (cTIV\TIV) + (TIV\TIV) | Elderly (cTIV\TIV) + (TIV\TIV) | Total |
|---|---|---|---|---|---|
| Female | 308 | 308 | 309 | 353 | 1278 |
| Male | 225 | 264 | 225 | 243 | 957 |
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