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| ID | Type | Description | Link |
|---|---|---|---|
| IND: 13299 |
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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
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This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US. The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza virus vaccine | Experimental |
| |
| Comparator influenza vaccine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza virus vaccine | Biological | Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age | To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%. | 21 days after vaccination |
| Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age | Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%. | 21 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age | Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age. | 7 days after vaccination |
| Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines and Diagnostics | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 2: C1425AWK | Buenos Aires | Argentina | ||||
| Site 1: X5000BJH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22691101 | Derived | Tregnaghi MW, Stamboulian D, Vanadia PC, Tregnaghi JP, Calvari M, Fragapane E, Casula D, Pellegrini M, Groth N. Immunogenicity, safety, and tolerability of two trivalent subunit inactivated influenza vaccines: a phase III, observer-blind, randomized, controlled multicenter study. Viral Immunol. 2012 Jun;25(3):216-25. doi: 10.1089/vim.2011.0063. |
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All enrolled subjects were included in the trial.
Approximately 6 weeks for enrollment with date of first enrolment on April 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Influenza Virus Vaccine (18 to 64 Years) | One injection of the investigational influenza virus vaccine was administered intramuscularly |
| FG001 | Comparator Influenza Vaccine (18 to 64 Years) | One injection of the comparator influenza vaccine was administered intramuscularly |
| FG002 | Influenza Virus Vaccine (9 to 17 Years) | One injection of the investigational influenza virus vaccine was administered intramuscularly |
| FG003 | Comparator Influenza Vaccine (9 to 17 Years) | One injection of the comparator influenza vaccine was administered intramuscularly |
| FG004 | Influenza Virus Vaccine (3 to 8 Years) | Two injections of the investigational influenza virus vaccine were administered intramuscularly |
| FG005 | Comparator Influenza Vaccine (3 to 8 Years) | Two injections of the comparator influenza vaccine were administered intramuscularly |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Influenza Virus Vaccine | Injections of the investigational influenza virus vaccine were administered intramuscularly |
| BG001 | Comparator Influenza Vaccine | Injections of the comparator influenza vaccine were administered intramuscularly |
| 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 | Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age | To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%. | The analysis was performed on the per-protocol (PP) population. | Posted | Mean | 95% Confidence Interval | Percentages of participants | 21 days after vaccination |
|
Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216).
One subject (18 years of age) in the comparator influenza vaccine group was enrolled in the adolescent age strata but was included in the adult age stratum for the safety analyses.
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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 | Influenza Virus Vaccine (18 to 64 Years) | One injection of the investigational influenza virus vaccine was administered intramuscularly |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced transiently | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Novartis Vaccines and Diagnostics | Novartis Vaccines and Diagnostics | RegContactVacUS.nvdit@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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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Comparator influenza vaccine | Biological | Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age. |
|
To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age. |
| 21 days after vaccination |
| Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age | Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age. | 21 days after vaccination |
| Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age | To evaluate immunogenicity measured by GMTs after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age. | 21 days after vaccination |
| Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age | Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age. | 7 days after vaccination |
| Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age | To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age. | 50 days after last vaccination |
| Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age | Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age. | 50 days after last vaccination |
| Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age | To evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age. | 50 days after last vaccination |
| Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. | Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age. | 7 days after each vaccination |
| Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age | Immunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age. | 21 days after vaccination |
| Córdoba |
| Argentina |
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG001 |
| Influenza Virus Vaccine (A/H3N2) |
One injection of the investigational influenza virus vaccine was administered intramuscularly |
| OG002 | Influenza Virus Vaccine (Strain B) | One injection of the investigational influenza virus vaccine was administered intramuscularly |
| OG003 | Comparator Influenza Vaccine (A/H1N1) | One injection of the comparator influenza vaccine was administered intramuscularly |
| OG004 | Comparator Influenza Vaccine (A/H3N2) | One injection of the comparator influenza vaccine was administered intramuscularly |
| OG005 | Comparator Influenza Vaccine (Strain B) | One injection of the comparator influenza vaccine was administered intramuscularly |
|
|
| Primary | Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age | Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%. | The analysis was performed on the per-protocol (PP) population. | Posted | Mean | 95% Confidence Interval | Percentage of participants | 21 days after vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age | Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age. | The analysis was performed on the safety population. | Posted | Number | participants | 7 days after vaccination |
|
|
|
| Secondary | Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age | To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age. | The analysis was performed on the per-protocol (PP) population. | Posted | Mean | 95% Confidence Interval | Percentage of subjects | 21 days after vaccination |
|
|
|
| Secondary | Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age | Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age. | The analysis was performed on the per-protocol (PP)population. | Posted | Mean | 95% Confidence Interval | Percentage of participants | 21 days after vaccination |
|
|
|
| Secondary | Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age | To evaluate immunogenicity measured by GMTs after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age. | The analysis was performed on the per-protocol (PP)population | Posted | Geometric Mean | 95% Confidence Interval | Titers | 21 days after vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age | Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age. | The analysis was performed on the safety population. | Posted | Number | Participants | 7 days after vaccination |
|
|
|
| Secondary | Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age | To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age. | The analysis was performed on the per-protocol (PP) population | Posted | Mean | 95% Confidence Interval | Percentage of participants | 50 days after last vaccination |
|
|
|
| Secondary | Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age | Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age. | The analysis was performed on the per protocol (PP) population. | Posted | Mean | 95% Confidence Interval | Percentage of participants | 50 days after last vaccination |
|
|
|
| Secondary | Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age | To evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age. | The analysis was performed on the per-protocol (PP)population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 50 days after last vaccination |
|
|
|
| Secondary | Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. | Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age. | The analysis was performed on the safety population. | Posted | Number | Participants | 7 days after each vaccination |
|
|
|
| Secondary | Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age | Immunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age. | The analysis was done on the per protocol population | Posted | Geometric Mean | 95% Confidence Interval | Titers | 21 days after vaccination |
|
|
|
| 6 |
| 460 |
| 235 |
| 460 |
| EG001 | Comparator Influenza Vaccine (18 to 64 Years) | One injection of the comparator influenza vaccine was administered intramuscularly | 2 | 233 | 128 | 233 |
| EG002 | Influenza Virus Vaccine (9 to 17 Years) | One injection of the investigational influenza virus vaccine was administered intramuscularly | 4 | 400 | 167 | 400 |
| EG003 | Comparator Influenza Vaccine (9 to 17 Years) | One injection of the comparator influenza vaccine was administered intramuscularly | 0 | 199 | 80 | 199 |
| EG004 | Influenza Virus Vaccine (3 to 8 Years) | Two injections of the investigational influenza virus vaccine were administered intramuscularly | 3 | 402 | 153 | 402 |
| EG005 | Comparator Influenza Vaccine (3 to 8 Years) | Two injections of the comparator influenza vaccine were administered intramuscularly | 3 | 199 | 91 | 199 |
| Gastritis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| appendicitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| diverticulitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| dysentery | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| ovarian epithelial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| syncope | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| renal colic | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| eye injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| encephalitis | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Injection Site Haemorrhage | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Injection Site Induration | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Injection Site Swelling | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
Not provided
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Induration |
|
| Swelling |
|
| Ecchymosis |
|
| Pain |
|
| Any Systemic Reaction |
|
| Chills |
|
| Malaise |
|
| Myalgia |
|
| Arthralgia |
|
| Headache |
|
| Sweating |
|
| Fatigue |
|
| Fever |
|
| Induration |
|
| Swelling |
|
| Ecchymosis |
|
| Pain |
|
| Any Systemic reaction |
|
| Chills |
|
| Malaise |
|
| Myalgia |
|
| Arthralgia |
|
| Headache |
|
| Sweating |
|
| Fatigue |
|
| Fever |
|
| Erythema |
|
| Induration |
|
| Swelling |
|
| Ecchymosis |
|
| Pain |
|
| Any Systemic Reaction |
|
| Chills |
|
| Malaise |
|
| Myalgia |
|
| Arthralgia |
|
| Headache |
|
| Sweating |
|
| Fatigue |
|
| Fever |
|