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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01346592
Registration number
NCT01346592
Ethics application status
Date submitted
30/04/2011
Date registered
3/05/2011
Date last updated
26/03/2015
Titles & IDs
Public title
Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age
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Scientific title
A Phase III, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety, Tolerability, and Immunogenicity of Fluad and Agriflu Compared to the Non-adjuvanted Trivalent Influenza Vaccine Fluzone in Children 6 to < 72 Months of Age
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Secondary ID [1]
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V70_29
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza Disease
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Trivalent split influenza vaccine (TIV)
Other interventions - MF59-adjuvanted trivalent influenza vaccine (aTIV)
Other interventions - Licensed comparator trivalent split influenza vaccine (comparator TIV)
Active Comparator: aTIV (6 to <72 months) - Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged =36 months received two doses of 0.5 mL each, at Days 1 & 29
Active Comparator: Comparator TIV (6 to <72 months) - Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged =36 months received two doses of 0.5 mL each, at Days 1 & 29
Active Comparator: TIV (6 to <72 months) - Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged =36 months received two doses of 0.5 mL each, at Days 1 & 29
Other interventions: Trivalent split influenza vaccine (TIV)
Other interventions: MF59-adjuvanted trivalent influenza vaccine (aTIV)
Other interventions: Licensed comparator trivalent split influenza vaccine (comparator TIV)
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains
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Assessment method [1]
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The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.
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Timepoint [1]
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Day 1, Day 50
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Primary outcome [2]
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Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or =4-fold Increase in HI Titers Against Homologous Strains
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Assessment method [2]
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The non-inferiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of percentage of subjects achieving seroconversion or =4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.
Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer =40 or at least a 4-fold increase in HI titers from prevaccination HI titer =10.
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Timepoint [2]
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Day 50
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Primary outcome [3]
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Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months)
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Assessment method [3]
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The non-inferiority of HI antibody responses of TIV to that of comparator TIV, in subjects aged 6 to <36 Months, assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.
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Timepoint [3]
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Day 1, Day 50
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Primary outcome [4]
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Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or =4-fold Increase in HI Titer Against Homologous Strains in Subjects 6 to <36 Months of Age
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Assessment method [4]
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The non-inferiority of HI antibody responses of TIV to that of the licensed comparator TIV assessed in terms of percentage of subjects achieving seroconversion or =4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.
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Timepoint [4]
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Day 50
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Secondary outcome [1]
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Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months)
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Assessment method [1]
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The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.
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Timepoint [1]
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Day 1, Day 50
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Secondary outcome [2]
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Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms Percentage of Subjects Achieving Seroconversion or =4-fold Increase in HI Titer Against Homologous Strains (6 to <24 Months)
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Assessment method [2]
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The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion at three weeks after last vaccination against the three homologous vaccine strains.
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Timepoint [2]
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Day 50
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Secondary outcome [3]
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Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS
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Assessment method [3]
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The superiority of HI antibody responses, in subjects 6 to <72 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.
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Timepoint [3]
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Day 1, Day 50
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Secondary outcome [4]
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Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or =4 Fold Increase in HI Titers Against Homologous Strains (6 to <72 Months)-FAS
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Assessment method [4]
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The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion =4 fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.
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Timepoint [4]
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Day 50
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Secondary outcome [5]
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The HI GMTs Against Homologous Strains, by Vaccine Group
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Assessment method [5]
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The HI antibody titers against the three homologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.
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Timepoint [5]
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Day 1, Day 29, Day 50, Day 209
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Secondary outcome [6]
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Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
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Assessment method [6]
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The GMR of post-vaccination versus pre-vaccination HI titers against homologous strains, three weeks (day 29/day 1; day 50/day 1)and six months (day 209/day 1) after vaccination with either aTIV, licensed comparator or TIV.
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Timepoint [6]
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Day 29, Day 50, Day 209
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Secondary outcome [7]
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Percentage of Subjects With HI Titers =40 Against Homologous Strains, by Vaccine Group
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Assessment method [7]
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The percentage of subjects demonstrating HI titers =40,against homologous strains, at three weeks and six months after vaccination with aTIV or licensed comparator or TIV.
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Timepoint [7]
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Day 1, Day 29, Day 50, Day 209
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Secondary outcome [8]
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Percentage of Subjects Achieving Seroconversion or =4 Fold Increase in HI Titers, Against Homologous Strains
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Assessment method [8]
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The percentage of subjects achieving seroconversion =4 fold increase in HI titers from baseline, against homologous strains, at three weeks and six months after vaccination with ATIV or licensed comparator or TIV.
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Timepoint [8]
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Day 29, Day 50, Day 209
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Secondary outcome [9]
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Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, Subjects at Risk/Not at Risk, by Age Subgroup
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Assessment method [9]
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The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.
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Timepoint [9]
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Day 50
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Secondary outcome [10]
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Comparison of Antibody Responses of aTIV Versus Comparator TIV and TIV in Terms of Percentage of Subjects Achieving Seroconversion or =4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Subgroup
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Assessment method [10]
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The non-inferiority of HI antibody responses of aTIV to that of the licensed comparator TIV and to investigational TIV was assessed in terms of percentage of subjects achieving seroconversion or =4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk) , by age sub group.
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Timepoint [10]
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Day 50
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Secondary outcome [11]
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Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or =4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Sub Group-FAS
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Assessment method [11]
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The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of of percentage of subjects achieving seroconversion or =4-fold increase in HI Titer at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.
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Timepoint [11]
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Day 50
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Secondary outcome [12]
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Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, at Risk/Not at Risk, by Age Sub Group-FAS
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Assessment method [12]
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The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk), by age sub group.
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Timepoint [12]
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Day 50
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Secondary outcome [13]
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The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)
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Assessment method [13]
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The HI antibody titers against the heterologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.
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Timepoint [13]
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Day 1, Day 50, Day 209
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Secondary outcome [14]
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Percentage of Subjects Achieving Seroconversion or =4 Fold Increase in HI Titers, Against Heterologous Strains
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Assessment method [14]
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The percentage of subjects achieving seroconversion or =4 fold increase in HI titers from baseline, against heterologous strains, at three weeks and six months after last vaccination with aTIV or licensed comparator or TIV.
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Timepoint [14]
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Day 50, Day 209
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Secondary outcome [15]
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Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination
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Assessment method [15]
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To demonstrate the GMTs at three weeks after one dose of aTIV are statistically significantly higher to the corresponding response's of comparator TIV and TIV.
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Timepoint [15]
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Day 1, Day 29
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Secondary outcome [16]
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Number of Subjects Reporting Solicited Adverse Events After Vaccination
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Assessment method [16]
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The number of subjects reporting any solicited local and systemic adverse events (AEs), following vaccination with aTIV or licensed comparator or TIV.
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Timepoint [16]
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Day 1 through Day 7 after any vaccination
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Secondary outcome [17]
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Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
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Assessment method [17]
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The number of subjects reporting any unsolicited adverse events (AEs) between Day 1 to Day 50, serious adverse events (SAEs), AE leading to withdrawal (WD), new onset of chronic disease(NOCD), adverse events of special interest following vaccination with aTIV or licensed comparator or TIV throughout the study (Day 1 to Day 394).
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Timepoint [17]
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Day 1 to Day 394
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Eligibility
Key inclusion criteria
1.Children 6 months to 72 months of age.
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Minimum age
6
Months
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Maximum age
72
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Children
1. Who had been hospitalized at the time of enrollment
2. Who had any serious reaction or hypersensitivity to any vaccine component, eggs, or
chicken protein
3. Who had known impairment of the immune function
4. Who had fever interfering with normal daily activities at the time of enrollment
5. Who had received licensed vaccines within 14 days (for inactivated vaccines) or 28
days (for live vaccines) prior to enrollment in the study
6. Concomitant participation in another clinical study
7. Who had surgery planned during the study period that in the investigator's opinion
would have interfered with the study visits schedule.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2012
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Sample size
Target
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Accrual to date
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Final
6104
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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206 Vaccine and Immunology Research Trials Unit University Department of Paediatrics 2nd floor Clarence Reiger Bldg Womens and Childrens Hospital - Adelaide
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Recruitment hospital [2]
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201 Royal Children Hospital Department of Respiratory Medicine - Herston
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Recruitment hospital [3]
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205 Vaccine and Immunisation Research Group Murdoch Childrens Research Institute School Of Population Health - Level 5 207 Bouverie St
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Recruitment hospital [4]
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202 Sydney Children Hospital Department of Immunology and Infectious Diseases - Randwick
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Recruitment hospital [5]
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204 National Centre for Immunisation Research and Surveillance Kids Research Institute The Childrens Hospital at Westmead - Westmead
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Recruitment postcode(s) [1]
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5006 - Adelaide
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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- Level 5 207 Bouverie St
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Recruitment postcode(s) [4]
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2031 - Randwick
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Recruitment postcode(s) [5]
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2145 - Westmead
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Country [2]
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Argentina
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State/province [2]
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Cordoba
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Country [3]
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Argentina
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State/province [3]
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Cuidad Automa de Beunos Aires
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Country [4]
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Argentina
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State/province [4]
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Guaymallen
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Country [5]
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Argentina
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State/province [5]
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Mendoza
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Country [6]
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Chile
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State/province [6]
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Santiago
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Country [7]
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Philippines
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State/province [7]
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Cavite
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Country [8]
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Philippines
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State/province [8]
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Dbbb Dasmarinas Cavite
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Country [9]
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Philippines
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State/province [9]
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Manila
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Country [10]
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Philippines
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State/province [10]
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Muntinlupa
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Country [11]
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Philippines
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State/province [11]
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Quezon City
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Country [12]
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Philippines
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State/province [12]
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Quezon
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Country [13]
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South Africa
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State/province [13]
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Benoni
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Country [14]
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South Africa
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State/province [14]
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Johannesburg
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Country [15]
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South Africa
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State/province [15]
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Pretoria
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Country [16]
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South Africa
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State/province [16]
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Soweto
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Vaccines
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This Study Aims to Evaluate the Safety, Tolerability, and Immunogenicity of the Adjuvanted
Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza
Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to <
72 Months of Age.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01346592
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Vaccines
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Address
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Novartis Vaccines
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01346592
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