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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

Primary Purpose

Influenza Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Trivalent split influenza vaccine (TIV)
MF59-adjuvanted trivalent influenza vaccine (aTIV)
Licensed comparator trivalent split influenza vaccine (comparator TIV)
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza Disease focused on measuring Adjuvanted Trivalent Subunit Influenza Vaccine, vaccine, influenza, adjuvant, MF-59, pediatric

Eligibility Criteria

6 Months - 72 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1.Children 6 months to 72 months of age.

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.

Sites / Locations

  • 401 Paideia Jeronimo Salguero 2835 Piso 1
  • 402 Hospital de Ninos Gallo 130
  • 403 Instituto Medico Rio Cuarto Hipolito Yrigoyen 1020
  • 405 Hospital Pediatrico Nino Jesus Castro Barros 650
  • 406 Hospital Nostra Senora de la Misericordia Belgrano 1500
  • 407 Centro Pediatrico Caballito Directorio 1658
  • 409 Centro de Salud 16 Alpatacal y Chile
  • 408 Centro de Salud 31 Serpa y Republica del Libano
  • 206 Vaccine and Immunology Research Trials Unit University Department of Paediatrics 2nd floor Clarence Reiger Bldg Womens and Childrens Hospital
  • 201 Royal Children Hospital Department of Respiratory Medicine
  • 205 Vaccine and Immunisation Research Group Murdoch Childrens Research Institute School Of Population Health
  • 202 Sydney Children Hospital Department of Immunology and Infectious Diseases
  • 204 National Centre for Immunisation Research and Surveillance Kids Research Institute The Childrens Hospital at Westmead
  • 502 Hospital Clinico Pontificia Universidad Catolica de Chile Marcoleta 357
  • 503 Clinica Tabancura Av Tabancura 1185
  • 111 DLSHI deCastro De La Salle Health Sciences Institute DBB B Dasmarinas
  • 109 De La Salle Health Sciences Institute
  • 110 De La Salle Health Sciences Institute
  • 103 Philippine General Hospital Taft Avenue
  • 107 Philippine General Hospital Taft Avenue
  • 112 PGH Lim Philippine General Hospital Taft Avenue
  • 114 Philippine General Hospital Taft Avenue
  • 105 Mary Chiles General Hospital 667 Gastambide St Sampaloc Manila
  • 106 Research Institute for Tropical Medicine Alabang Muntinlupa
  • 108 RITM Research Institute for Tropical Medicine Department of Health Compound FILINVEST Corporate City Alabang
  • 101 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City
  • 104 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City
  • 113 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City
  • 102 University of the East Ramon Magsaysay Memorial 64 Aurora Boulevard Barangay Dona Imelda
  • 305 Worthwhile Clinical Trials Lakeview Hospital 1 Mowbray Avenue
  • 304 Newgate Centre Suite 3
  • 303 Emmed Research
  • 301 Perinatal HIV Research Unit, Baragwanath Hospital
  • 302 Soweto Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

aTIV (6 to <72 months)

Comparator TIV (6 to <72 months)

TIV (6 to <72 months)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains
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.
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
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.
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months)
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.
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
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.

Secondary Outcome Measures

Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months)
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.
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)
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.
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS
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.
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
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.
The HI GMTs Against Homologous Strains, by Vaccine Group
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.
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
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.
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group
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.
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains
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.
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
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.
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
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.
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
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.
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
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.
The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)
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.
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains
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.
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination
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.
Number of Subjects Reporting Solicited Adverse Events After Vaccination
The number of subjects reporting any solicited local and systemic adverse events (AEs), following vaccination with aTIV or licensed comparator or TIV.
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
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).

Full Information

First Posted
April 30, 2011
Last Updated
March 4, 2015
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT01346592
Brief 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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Disease
Keywords
Adjuvanted Trivalent Subunit Influenza Vaccine, vaccine, influenza, adjuvant, MF-59, pediatric

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
6104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aTIV (6 to <72 months)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Comparator TIV (6 to <72 months)
Arm Type
Active Comparator
Arm Description
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
Arm Title
TIV (6 to <72 months)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Trivalent split influenza vaccine (TIV)
Other Intervention Name(s)
Agriflu
Intervention Type
Biological
Intervention Name(s)
MF59-adjuvanted trivalent influenza vaccine (aTIV)
Other Intervention Name(s)
Fluad
Intervention Type
Biological
Intervention Name(s)
Licensed comparator trivalent split influenza vaccine (comparator TIV)
Other Intervention Name(s)
Fluzone
Primary Outcome Measure Information:
Title
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains
Description
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.
Time Frame
Day 1, Day 50
Title
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
Description
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.
Time Frame
Day 50
Title
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months)
Description
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.
Time Frame
Day 1, Day 50
Title
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
Description
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.
Time Frame
Day 50
Secondary Outcome Measure Information:
Title
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months)
Description
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.
Time Frame
Day 1, Day 50
Title
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)
Description
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.
Time Frame
Day 50
Title
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS
Description
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.
Time Frame
Day 1, Day 50
Title
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
Description
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.
Time Frame
Day 50
Title
The HI GMTs Against Homologous Strains, by Vaccine Group
Description
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.
Time Frame
Day 1, Day 29, Day 50, Day 209
Title
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
Description
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.
Time Frame
Day 29, Day 50, Day 209
Title
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group
Description
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.
Time Frame
Day 1, Day 29, Day 50, Day 209
Title
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains
Description
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.
Time Frame
Day 29, Day 50, Day 209
Title
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
Description
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.
Time Frame
Day 50
Title
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
Description
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.
Time Frame
Day 50
Title
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
Description
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.
Time Frame
Day 50
Title
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
Description
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.
Time Frame
Day 50
Title
The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)
Description
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.
Time Frame
Day 1, Day 50, Day 209
Title
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains
Description
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.
Time Frame
Day 50, Day 209
Title
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination
Description
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.
Time Frame
Day 1, Day 29
Title
Number of Subjects Reporting Solicited Adverse Events After Vaccination
Description
The number of subjects reporting any solicited local and systemic adverse events (AEs), following vaccination with aTIV or licensed comparator or TIV.
Time Frame
Day 1 through Day 7 after any vaccination
Title
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
Description
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).
Time Frame
Day 1 to Day 394

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
72 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1.Children 6 months to 72 months of age. Exclusion Criteria:Children Who had been hospitalized at the time of enrollment Who had any serious reaction or hypersensitivity to any vaccine component, eggs, or chicken protein Who had known impairment of the immune function Who had fever interfering with normal daily activities at the time of enrollment Who had received licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in the study Concomitant participation in another clinical study Who had surgery planned during the study period that in the investigator's opinion would have interfered with the study visits schedule.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
401 Paideia Jeronimo Salguero 2835 Piso 1
City
Buenos Aires
Country
Argentina
Facility Name
402 Hospital de Ninos Gallo 130
City
Buenos Aires
Country
Argentina
Facility Name
403 Instituto Medico Rio Cuarto Hipolito Yrigoyen 1020
City
Cordoba
Country
Argentina
Facility Name
405 Hospital Pediatrico Nino Jesus Castro Barros 650
City
Cordoba
Country
Argentina
Facility Name
406 Hospital Nostra Senora de la Misericordia Belgrano 1500
City
Cordoba
Country
Argentina
Facility Name
407 Centro Pediatrico Caballito Directorio 1658
City
Cuidad Automa de Beunos Aires
ZIP/Postal Code
1406
Country
Argentina
Facility Name
409 Centro de Salud 16 Alpatacal y Chile
City
Guaymallen
Country
Argentina
Facility Name
408 Centro de Salud 31 Serpa y Republica del Libano
City
Mendoza
Country
Argentina
Facility Name
206 Vaccine and Immunology Research Trials Unit University Department of Paediatrics 2nd floor Clarence Reiger Bldg Womens and Childrens Hospital
City
Adelaide
ZIP/Postal Code
5006
Country
Australia
Facility Name
201 Royal Children Hospital Department of Respiratory Medicine
City
Herston
ZIP/Postal Code
4029
Country
Australia
Facility Name
205 Vaccine and Immunisation Research Group Murdoch Childrens Research Institute School Of Population Health
City
Level 5 207 Bouverie St
Country
Australia
Facility Name
202 Sydney Children Hospital Department of Immunology and Infectious Diseases
City
Randwick
ZIP/Postal Code
2031
Country
Australia
Facility Name
204 National Centre for Immunisation Research and Surveillance Kids Research Institute The Childrens Hospital at Westmead
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
502 Hospital Clinico Pontificia Universidad Catolica de Chile Marcoleta 357
City
Santiago
Country
Chile
Facility Name
503 Clinica Tabancura Av Tabancura 1185
City
Santiago
Country
Chile
Facility Name
111 DLSHI deCastro De La Salle Health Sciences Institute DBB B Dasmarinas
City
Cavite
ZIP/Postal Code
4114
Country
Philippines
Facility Name
109 De La Salle Health Sciences Institute
City
Dbbb Dasmarinas Cavite
ZIP/Postal Code
4114
Country
Philippines
Facility Name
110 De La Salle Health Sciences Institute
City
Dbbb Dasmarinas Cavite
ZIP/Postal Code
4114
Country
Philippines
Facility Name
103 Philippine General Hospital Taft Avenue
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
107 Philippine General Hospital Taft Avenue
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
112 PGH Lim Philippine General Hospital Taft Avenue
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
114 Philippine General Hospital Taft Avenue
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
105 Mary Chiles General Hospital 667 Gastambide St Sampaloc Manila
City
Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
106 Research Institute for Tropical Medicine Alabang Muntinlupa
City
Muntinlupa
Country
Philippines
Facility Name
108 RITM Research Institute for Tropical Medicine Department of Health Compound FILINVEST Corporate City Alabang
City
Muntinlupa
Country
Philippines
Facility Name
101 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City
City
Quezon City
Country
Philippines
Facility Name
104 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City
City
Quezon City
Country
Philippines
Facility Name
113 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City
City
Quezon City
Country
Philippines
Facility Name
102 University of the East Ramon Magsaysay Memorial 64 Aurora Boulevard Barangay Dona Imelda
City
Quezon
Country
Philippines
Facility Name
305 Worthwhile Clinical Trials Lakeview Hospital 1 Mowbray Avenue
City
Benoni
ZIP/Postal Code
1500
Country
South Africa
Facility Name
304 Newgate Centre Suite 3
City
Johannesburg
ZIP/Postal Code
2113
Country
South Africa
Facility Name
303 Emmed Research
City
Pretoria
ZIP/Postal Code
0084
Country
South Africa
Facility Name
301 Perinatal HIV Research Unit, Baragwanath Hospital
City
Soweto
Country
South Africa
Facility Name
302 Soweto Clinical Research
City
Soweto
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
25223266
Citation
Nolan T, Bravo L, Ceballos A, Mitha E, Gray G, Quiambao B, Patel SS, Bizjajeva S, Bock H, Nazaire-Bermal N, Forleo-Neto E, Cioppa GD, Narasimhan V. Enhanced and persistent antibody response against homologous and heterologous strains elicited by a MF59-adjuvanted influenza vaccine in infants and young children. Vaccine. 2014 Oct 21;32(46):6146-56. doi: 10.1016/j.vaccine.2014.08.068. Epub 2014 Sep 16.
Results Reference
derived

Learn more about this trial

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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