A Phase 3 interventional study of TIVc in Human Influenza, sponsored by Novartis Vaccines. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Novartis Vaccines · Phase 3, Interventional, and Prevention
The present study is designed to confirm the safety and immunogenicity of cell-derived, trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years and the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post immunization. The vaccine composition will be based on the WHO-recommended influenza strains for the 2013/2014 Northern Hemisphere vaccine. The results of this study are intended to support the use of this vaccine in future influenza seasons if the recommended vaccine composition remains the same, in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 126 is below 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.
Exclusion Criteria:
Had a serious chronic or acute disease (in the judgment of the investigator) including, but not limited to
Had a known or suspected (or had a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:
Had the following within the past 6 months:
Subjects in each age cohort received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
Biological: TIVc
Trivalent Influenza Virus Vaccine (surface antigen, inactivated, cell-based)
Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc
Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVc. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years.
Time frame: Day 22 (vaccination is on day 1)
Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc
Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains ,three weeks after receiving one dose of TIVc. Seroconversion is defined as percentage of subjects with a pre-vaccination SRH area ≤4mm2 achieving a post-vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area \>4mm2 achieving at least 50% increase in post-vaccination SRH area. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>40% for adults aged 18 to ≤60 years and \>30% for subjects aged ≥61 years.
Time frame: Day 22 (vaccination is on day 1)
Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVc
The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIVc The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 in for subjects aged ≥61 years.
Time frame: Day 22/day 1
Percentage of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc
Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIVc. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years.
Time frame: Day 22 (vaccination is on day 1)
Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVc
Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIVc. Seroconversion is defined as percentage of subjects with a pre-vaccination HI titer \<10 to a post-vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre-vaccination HI titer \>10 to at least a 4-fold increase in post-vaccination HI antibody titers. The related European (CHMP) criterion for the assessment of immunogenicity is met if \>40 % for adults aged 18 to ≤60 years and \>30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers.
Time frame: Day 22 (vaccination is on day 1)
Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc
The antibody responses following one dose of TIVc were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIVc. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 for subjects aged ≥61 years.
Time frame: Day 22/day 1
Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIVc
The number of adult and elderly subjects reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of TIVc are reported.
Time frame: Day 1 to Day 4 post-vaccination
Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVc
The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period), after receiving one dose of TIVc is reported.
Time frame: Day 1 through Day 22 post-vaccination
| Milestone | TIVc (≥18 to ≤ 60 Years) | TIVc (≥ 61 Years) |
|---|---|---|
| Started | 63 | 63 |
| Completed | 63 | 62 |
| Not completed | 0 | 1 |
Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVc. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years.
| Percentages of Subjects | TIVc (≥18 to ≤ 60 Years) | TIVc (≥ 61 Years) |
|---|---|---|
| Day 1/baseline (H1N1 strain) | 66 (53 to 78) | 41 (29 to 54) |
| Day 22 (H1N1 strain) | 98 (91 to 100) | 84 (72 to 92) |
| Day 1/baseline (H3N2 strain) | 44 (31 to 57) | 39 (27 to 53) |
| Day 22 (H3N2 strain) | 92 (82 to 97) | 77 (65 to 87) |
| Day 1/baseline (B strain) | 68 (55 to 79) | 77 (65 to 87) |
| Day 22 (B strain) | 98 (91 to 100) | 98 (91 to 100) |
Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains ,three weeks after receiving one dose of TIVc. Seroconversion is defined as percentage of subjects with a pre-vaccination SRH area ≤4mm2 achieving a post-vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area \>4mm2 achieving at least 50% increase in post-vaccination SRH area. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>40% for adults aged 18 to ≤60 years and \>30% for subjects aged ≥61 years.
| Percentages of Subjects | TIVc (≥18 to ≤ 60 Years) | TIVc (≥ 61 Years) |
|---|---|---|
| H1N1 | 68 (55 to 79) | 56 (42 to 68) |
| H3N2 | 65 (51 to 76) | 46 (33 to 59) |
| B | 58 (45 to 70) | 39 (27 to 53) |
The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIVc The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 in for subjects aged ≥61 years.
| Ratio | TIVc (≥18 to ≤ 60 Years) | TIVc (≥ 61 Years) |
|---|---|---|
| H1N1 | 2.89 (2.16 to 3.86) | 3.14 (2.29 to 4.31) |
| H3N2 | 2.52 (2.03 to 3.12) | 2.05 (1.67 to 2.53) |
| B | 1.82 (1.54 to 2.16) | 1.5 (1.28 to 1.76) |
Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIVc. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years.
| Percentages of Subjects | TIVc (≥18 to ≤ 60 Years) | TIVc (≥ 61 Years) |
|---|---|---|
| Day 1/baseline (H1N1 strain) | 68 (55 to 79) | 66 (52 to 77) |
| Day 22 (H1N1 strain) | 100 (94 to 100) | 97 (89 to 100) |
| Day 1/baseline (H3N2 strain) | 89 (78 to 95) | 87 (76 to 94) |
| Day 22 (H3N2 strain) | 97 (89 to 100) | 95 (86 to 99) |
| Day 1/baseline (B strain) | 58 (45 to 70) | 46 (33 to 59) |
| Day 22 (B strain) | 94 (84 to 98) | 80 (68 to 89) |
Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIVc. Seroconversion is defined as percentage of subjects with a pre-vaccination HI titer \<10 to a post-vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre-vaccination HI titer \>10 to at least a 4-fold increase in post-vaccination HI antibody titers. The related European (CHMP) criterion for the assessment of immunogenicity is met if \>40 % for adults aged 18 to ≤60 years and \>30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers.
| Percentages of Subjects | TIVc (≥18 to ≤ 60 Years) | TIVc (≥ 61 Years) |
|---|---|---|
| H1N1 | 63 (50 to 75) | 43 (30 to 56) |
| H3N2 | 47 (34 to 60) | 26 (16 to 39) |
| B | 48 (35 to 61) | 28 (17 to 41) |
The antibody responses following one dose of TIVc were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIVc. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 for subjects aged ≥61 years.
| Ratio | TIVc (≥18 to ≤ 60 Years) | TIVc (≥ 61 Years) |
|---|---|---|
| H1N1 | 8.8 (5.66 to 14) | 3.61 (2.61 to 5.01) |
| H3N2 | 3.52 (2.4 to 5.15) | 2.22 (1.63 to 3.01) |
| B | 3.31 (2.45 to 4.47) | 2.4 (1.81 to 3.17) |
The number of adult and elderly subjects reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of TIVc are reported.
| Subjects | TIVc (≥18 to ≤ 60 Years) | TIVc (≥ 61 Years) |
|---|---|---|
| Any local | 32 | 18 |
| Injection site induration | 5 | 1 |
| Injection site erythema | 1 | 1 |
| Injection site ecchymosis | 1 | 0 |
| Injection site pain | 31 | 18 |
| Any systemic | 17 | 8 |
| Chills/shivering | 1 | 1 |
| Malaise | 3 | 2 |
| Myalgia | 1 | 1 |
| Arthralgia | 3 | 3 |
| Headache | 11 | 6 |
| Fatigue | 10 | 2 |
| Fever | 1 | 0 |
| Prophylactic use of analgesics/antipyretics | 2 | 0 |
| Therapeutic use of analgesics/antipyretics | 2 | 1 |
The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period), after receiving one dose of TIVc is reported.
| Subjects | TIVc (≥18 to ≤ 60 Years) | TIVc (≥ 61 Years) |
|---|---|---|
| Any AEs | 6 | 4 |
| At least possibly related AEs | 2 | 0 |
| Serious AEs | 1 | 0 |
| At least possibly related SAEs | 0 | 0 |
| Medically attended AEs | 4 | 3 |
| AEs leading to discontinuation | 0 | 0 |
| Death | 0 | 0 |
Collected over All solicited AEs and unsolicited AEs collected from Day 1 to Day 4; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal collected from Day 1 to Day 22.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TIVc (≥18 to ≤ 60 Years) | — | 1/63 (1.6%) | 36/63 (57.1%) |
| TIVc (≥ 61 Years) | — | 0/63 (0%) | 22/63 (34.9%) |
| Event | TIVc (≥18 to ≤ 60 Years) | TIVc (≥ 61 Years) |
|---|---|---|
| Tooth infectionInfections and infestations | 1/63 | 0/63 |
| Event | TIVc (≥18 to ≤ 60 Years) | TIVc (≥ 61 Years) |
|---|---|---|
| Injection site painGeneral disorders | 32/63 | 18/63 |
| HeadacheNervous system disorders | 11/63 | 6/63 |
| FatigueGeneral disorders | 10/63 | 2/63 |
| Injection site indurationGeneral disorders | 4/63 | 1/63 |
| Age, Continuous(years) | TIVc (≥18 to ≤ 60 Years) | TIVc (≥ 61 Years) | Total |
|---|---|---|---|
| Mean | 39.3 ± 10.7 | 68.3 ± 4.8 | 53.8 ± 16.7 |
| Sex: Female, Male(Participants) | TIVc (≥18 to ≤ 60 Years) | TIVc (≥ 61 Years) | Total |
|---|---|---|---|
| Female | 38 | 33 | 71 |
| Male | 25 | 30 | 55 |
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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