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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000545-39 | EudraCT Number |
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The present study is designed to confirm the safety and immunogenicity of trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years.
For the immunogenicity endpoint the antibody response to each influenza vaccine antigen will be evaluated by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post vaccination.
The vaccine composition will be based on the WHO-recommended influenza strains for the 2013/2014 Northern Hemisphere vaccine, and 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIV (18 to ≤ 60 years) | Experimental | Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere |
|
| TIV (≥ 61 years) | Experimental | Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIV | Biological | Trivalent Influenza Virus Vaccine (surface antigen, inactivated, egg-derived) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV | 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 TIV . 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 >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years. | Day 1 (baseline) and Day 22 (postvaccination) |
| Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIV | 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 TIV. 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. | Day 22 (postvaccination) /Day 1 (baseline) |
| Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIV | 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 TIV. 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. | Day 22 (postvaccination) / Day 1 (baseline) |
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Inclusion Criteria:
Exclusion Criteria:
Had behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may have interfered with the subject's ability to participate in the study;
Had a serious chronic or acute disease (in the judgment of the investigator) including, but not limited to:
Had a history of any anaphylactic reaction and/or serious allergic reaction to any component of the study vaccine;
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 known or suspected drug or alcohol abuse within the past 2 years;
Had bleeding diathesis or conditions associated with prolonged bleeding time that, in the investigator's opinion, would interfere with the safety of the subject;
Was not able to comprehend and to follow all required study procedures for the whole period of the study;
Had a history or any illness that, in the opinion of the investigator, would pose additional risk to the subjects because of participation in the study;
Had the following within the past 6 months:
Had received any other vaccine within 4 weeks prior to enrollment in this study or were planning to receive any vaccine during the study;
Had acute or chronic infections requiring antiviral therapy within the last 7 days;
Had experienced fever (ie, body temperature [preferably oral] ≥38.0°C) within the last 3 days of intended study vaccination;
Had been participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intends to participate in another clinical study at any time during the conduct of this study;
Was part of study personnel or has close family members conducting this study;
Had a body mass index (BMI) >35 kg/m2 (BMI is calculated by dividing the subject's weight in kilograms by the subject's height in meters multiplied by the subject's height in meters).
Was pregnant (confirmed by positive urine pregnancy test) or nursing (breastfeeding) or was a female of childbearing potential who refused to use an acceptable method of birth control for the whole duration of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines and Diagnostics | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University & Hospital; CEVAC: Center for Vaccinology, | Ghent | 9000 | Belgium |
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Subjects recruited from a single center in Belgium
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| ID | Title | Description |
|---|---|---|
| FG000 | TIV (18 to ≤ 60 Years) | Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere |
| FG001 | TIV (≥ 61 Years) | Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TIV (18 to ≤ 60 Years) | Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere |
| BG001 | TIV (≥ 61 Years) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV | 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 TIV . 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 >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years. | Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have RT-PCR confirmed influenza during the study | Posted | Number | 95% Confidence Interval | Percentage of subjects | Day 1 (baseline) and Day 22 (postvaccination) |
|
All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TIV (18 to ≤ 60 Years) | Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV | 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 TIV. 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. | Day 1 (baseline) and Day 22 (postvaccination) |
| Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV | 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 TIV. 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. | Day 22 (postvaccination) / Day 1 (baseline) |
| Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV | The antibody responses following one dose of TIV 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 TIV. 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. | Day 22 (postvaccination)/ Day 1 (baseline) |
| Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV | The number of adult and elderly subjects reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of TIV are reported. | Day 1 to Day 4 post vaccination |
| Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIV | 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 (Day 1 to Day 22), after receiving one dose of TIV is reported. | Day 1 through Day 22 post vaccination |
Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
| BG002 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| TIV (18 to ≤ 60 Years) |
Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere |
| OG001 | TIV (≥ 61 Years) | Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere |
|
|
| Primary | Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIV | 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 TIV. 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. | Analysis was done on the per-protocol population | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 22 (postvaccination) /Day 1 (baseline) |
|
|
|
| Primary | Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIV | 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 TIV. 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. | Analysis was done on the per-protocol population | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 22 (postvaccination) / Day 1 (baseline) |
|
|
|
| Primary | Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV | 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 TIV. 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. | Analysis was done on the per-protocol population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 1 (baseline) and Day 22 (postvaccination) |
|
|
|
| Primary | Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV | 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 TIV. 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. | Analysis was done on the per-protocol population | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 22 (postvaccination) / Day 1 (baseline) |
|
|
|
| Primary | Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV | The antibody responses following one dose of TIV 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 TIV. 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. | Analysis was done on the per-protocol population | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 22 (postvaccination)/ Day 1 (baseline) |
|
|
|
| Primary | Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV | The number of adult and elderly subjects reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of TIV are reported. | Posted | Number | Number of subjects | Day 1 to Day 4 post vaccination |
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|
|
| Primary | Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIV | 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 (Day 1 to Day 22), after receiving one dose of TIV is reported. | Analysis was done on the unsolicited safety set population i.e all subjects who have post vaccination unsolicited adverse event data | Posted | Number | Number of subjects | Day 1 through Day 22 post vaccination |
|
|
|
| 0 |
| 63 |
| 41 |
| 63 |
| EG001 | TIV (≥ 61 Years) | Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere | 0 | 63 | 27 | 63 |
| EG002 | Total | Total | 0 | 126 | 68 | 126 |
| Injection site erythema | General disorders | Systematic Assessment |
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| Injection site haemorrhage | General disorders | Systematic Assessment |
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| Injection site induration | General disorders | Systematic Assessment |
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| Injection site pain | General disorders | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| B strain |
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| B strain |
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| Day 1 (H3N2 strain) |
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| Day 22 (H3N2 strain) |
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| Day 1 (B strain) |
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| Day 22 (B strain) |
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| B strain |
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| B strain |
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| Injection site erythema |
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| Injection site ecchymosis |
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| Injection site pain |
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| Any Systemic |
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| Shivering/chills |
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| Myalgia |
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| Arthralgia |
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| Fatigue |
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| Headache |
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| Malaise |
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| Fever (≥ 38°C) |
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| Prophylactic use of analgesics/antipyretics |
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| Therapeutic use of analgesics/antipyretics |
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| Any SAE |
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| At least possibly related SAE |
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| Medically attended AE |
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| AE leading to discontinuation |
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| Death |
|