A Phase 2 interventional study of aTIV in Human Influenza, sponsored by Novartis Vaccines. Completed at 1 site in Belgium. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-26.
Sponsored by Novartis Vaccines · Phase 2, Interventional, and Prevention
The present study is designed to confirm the safety and immunogenicity of trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant, formulation 2013/2014 Northern Hemisphere, in adults ≥65 years of age.
For the immunogenicity endpoints the antibody response to each influenza vaccine antigen, will be measured by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post immunization.
The vaccine composition will be based on the World Health Organization (WHO) recommended influenza strains for 2013/2014 Northern Hemisphere.
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 European Union (EU) recommendations for clinical trials related to yearly licensing of influenza vaccines.
2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.
This study's enrollment of 63 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 have 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:
Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
Biological: aTIV
Adjuvanted Trivalent Influenza Virus Vaccine (surface antigen, inactivated, adjuvanted with MF59C.1, egg-derived)
Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV
Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of aTIV. The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>60%.
Time frame: Day 1 (baseline) and Day 22
Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV
Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age achieving seroconversion or significant increase in SRH area against each of the three vaccine strains, three weeks after receiving one dose of aTIV. 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\>30% of subjects achieve seroconversion or significant increase in post-vaccination SRH area.
Time frame: Day 22
Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), Against Each of Three Vaccine Strains After Receiving One Dose of aTIV
The antibody responses following one dose of aTIV were evaluated in terms of geometric mean ratio GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of aTIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \> 2.0.
Time frame: Day 22/Day 1
Percentages of Subjects With Haemagglutinin Inhibition(HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV.
Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of aTIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the of subjects achieving HI titers ≥ 40 is \>60%.
Time frame: Day 1 (baseline) and Day 22
Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV
Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age achieving seroconversion or significant increase in HI antibody titers after receiving one dose of aTIV. 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 \>30% of subjects achieve seroconversion or significant increase in post-vaccination HI titers.
Time frame: Day 22
Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination HI Titers, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV
The antibody responses following one dose of aTIV were evaluated in terms of GMRs of post vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of aTIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \> 2.0.
Time frame: Day 22/Day 1
Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of aTIV
The number of adult subjects ≥65 years of age reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of aTIV are reported.
Time frame: Day 1 to Day 4 post vaccination
Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of aTIV
The number of adult subjects ≥65 years of age subjects reporting any unsolicited adverse event (AEs) between Day 1 to 4 and serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study between Day 1 to Day 22 after receiving one dose of aTIV are reported.
Time frame: Day 1 to Day 22 post-vaccination
| Milestone | aTIV |
|---|---|
| Started | 63 |
| Completed | 63 |
| Not completed | 0 |
Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of aTIV. The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>60%.
| Percentage of subjects | aTIV |
|---|---|
| Day 1 (H1N1 strain) | 46 (33 to 59) |
| Day 22 (H1N1 strain) | 89 (78 to 95) |
| Day 1 (H3N2 strain) | 43 (30 to 56) |
| Day 22 (H3N2 strain) | 90 (80 to 96) |
| Day 1 (B strain) | 28 (17 to 41) |
| Day 22 (B strain) | 79 (66 to 88) |
Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age achieving seroconversion or significant increase in SRH area against each of the three vaccine strains, three weeks after receiving one dose of aTIV. 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\>30% of subjects achieve seroconversion or significant increase in post-vaccination SRH area.
| Percentage of subjects | aTIV |
|---|---|
| H1N1 strain | 57 (44 to 70) |
| H3N2 strain | 61 (47 to 73) |
| B strain | 70 (57 to 81) |
The antibody responses following one dose of aTIV were evaluated in terms of geometric mean ratio GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of aTIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \> 2.0.
| Ratio | aTIV |
|---|---|
| H1N1 strain | 2.63 (2.04 to 3.39) |
| H3N2 strain | 2.34 (1.91 to 2.87) |
| B strain | 2.89 (2.35 to 3.57) |
Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of aTIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the of subjects achieving HI titers ≥ 40 is \>60%.
| Percentage of subjects | aTIV |
|---|---|
| Day 1 (H1N1 strain) | 75 (63 to 86) |
| Day 22 (H1N1 strain) | 97 (89 to 100) |
| Day 1 (H3N2 strain) | 89 (78 to 95) |
| Day 22 (H3N2 strain) | 100 (94 to 100) |
| Day 1 (B strain) | 61 (47 to 73) |
| Day 22 (B strain) | 98 (91 to 100) |
Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age achieving seroconversion or significant increase in HI antibody titers after receiving one dose of aTIV. 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 \>30% of subjects achieve seroconversion or significant increase in post-vaccination HI titers.
| Percentage of subjects | aTIV |
|---|---|
| H1N1 strain | 39 (27 to 53) |
| H3N2 strain | 43 (30 to 56) |
| B strain | 38 (26 to 51) |
The antibody responses following one dose of aTIV were evaluated in terms of GMRs of post vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of aTIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \> 2.0.
| Ratio | aTIV |
|---|---|
| H1N1 strain | 3.57 (2.59 to 4.91) |
| H3N2 strain | 3.32 (2.45 to 4.49) |
| B strain | 2.69 (2.22 to 3.26) |
The number of adult subjects ≥65 years of age reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of aTIV are reported.
| Participants | aTIV |
|---|---|
| Any Local | 26 |
| Injection site induration | 2 |
| Injection site erythema | 3 |
| Injection site ecchymosis | 2 |
| Injection site pain | 21 |
| Any systemic | 15 |
| Chills/shivering | 1 |
| Malaise | 2 |
| Myalgia | 2 |
| Arthralgia | 1 |
| Fatigue | 11 |
| Headache | 5 |
| Fever (≥ 38°C) | 0 |
| Temperature ≥40°C | 0 |
| Prophylactic use of analgesics/antipyretics (N=61) | 0 |
| Therapeutic use of analgesics/antipyretics (N=61) | 2 |
The number of adult subjects ≥65 years of age subjects reporting any unsolicited adverse event (AEs) between Day 1 to 4 and serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study between Day 1 to Day 22 after receiving one dose of aTIV are reported.
| Participants | aTIV |
|---|---|
| Any AE | 12 |
| At least possibly related AEs | 10 |
| Serious AEs | 0 |
| At least possibly related SAEs | 0 |
| Medically attended AEs | 5 |
| AEs leading to withdrawal | 0 |
| Death | 0 |
Collected over All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| aTIV | — | 0/63 (0%) | 32/63 (50.8%) |
| Event | aTIV |
|---|---|
| Injection site painGeneral disorders | 21/63 |
| FatigueGeneral disorders | 11/63 |
| Injection site erythemaGeneral disorders | 5/63 |
| HeadacheNervous system disorders | 5/63 |
| Age, Continuous(year) | aTIV |
|---|---|
| Mean | 71.9 ± 5.0 |
| Sex: Female, Male(Participants) | aTIV |
|---|---|
| Female | 29 |
| Male | 34 |
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