Influenza DiseasePhase 3NCT01346592
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
A Phase 3 study testing Trivalent split influenza vaccine (TIV), MF59-adjuvanted trivalent influenza vaccine (aTIV) and Licensed comparator trivalent split influenza vaccine (comparator TIV) in people with Influenza Disease, run by Novartis Vaccines at 34 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 72 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza Disease
- What is being tested?
- Trivalent split influenza vaccine (TIV), MF59-adjuvanted trivalent influenza vaccine (aTIV) and Licensed comparator trivalent split influenza vaccine (comparator TIV)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,104 participants
- Where
- 34 sitesin 5 countries
- Study dates
- Apr 2011to Jul 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 72 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1.Children 6 months to 72 months of age.
Who cannot join
- 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.
Trial locations and contacts
34 sites in 5 countries.
34 sites in 5 countries
Philippines14 sites
111 DLSHI deCastro De La Salle Health Sciences Institute DBB B Dasmarinas
Cavite, 4114
106 Research Institute for Tropical Medicine Alabang Muntinlupa
City of Muntinlupa
108 RITM Research Institute for Tropical Medicine Department of Health Compound FILINVEST Corporate City Alabang
City of Muntinlupa
109 De La Salle Health Sciences Institute
Dbbb Dasmarinas Cavite, 4114
110 De La Salle Health Sciences Institute
Dbbb Dasmarinas Cavite, 4114
103 Philippine General Hospital Taft Avenue
Manila, 1000
107 Philippine General Hospital Taft Avenue
Manila, 1000
112 PGH Lim Philippine General Hospital Taft Avenue
Manila, 1000
114 Philippine General Hospital Taft Avenue
Manila, 1000
105 Mary Chiles General Hospital 667 Gastambide St Sampaloc Manila
Manila, 1008
102 University of the East Ramon Magsaysay Memorial 64 Aurora Boulevard Barangay Dona Imelda
Quezon
101 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City
Quezon City
104 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City
Quezon City
113 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City
Quezon City
Argentina8 sites
401 Paideia Jeronimo Salguero 2835 Piso 1
Buenos Aires
402 Hospital de Ninos Gallo 130
Buenos Aires
403 Instituto Medico Rio Cuarto Hipolito Yrigoyen 1020
Córdoba
405 Hospital Pediatrico Nino Jesus Castro Barros 650
Córdoba
406 Hospital Nostra Senora de la Misericordia Belgrano 1500
Córdoba
407 Centro Pediatrico Caballito Directorio 1658
Cuidad Automa de Beunos Aires, 1406
408 Centro de Salud 31 Serpa y Republica del Libano
Mendoza
409 Centro de Salud 16 Alpatacal y Chile
Villa Nueva
Australia5 sites
206 Vaccine and Immunology Research Trials Unit University Department of Paediatrics 2nd floor Clarence Reiger Bldg Womens and Childrens Hospital
Adelaide, 5006
201 Royal Children Hospital Department of Respiratory Medicine
Herston, 4029
205 Vaccine and Immunisation Research Group Murdoch Childrens Research Institute School Of Population Health
Level 5 207 Bouverie Saint
202 Sydney Children Hospital Department of Immunology and Infectious Diseases
Randwick, 2031
204 National Centre for Immunisation Research and Surveillance Kids Research Institute The Childrens Hospital at Westmead
Westmead, 2145
South Africa5 sites
305 Worthwhile Clinical Trials Lakeview Hospital 1 Mowbray Avenue
Benoni, 1500
304 Newgate Centre Suite 3
Johannesburg, 2113
303 Emmed Research
Pretoria, 0084
301 Perinatal HIV Research Unit, Baragwanath Hospital
Soweto
302 Soweto Clinical Research
Soweto
Chile2 sites
502 Hospital Clinico Pontificia Universidad Catolica de Chile Marcoleta 357
Santiago
503 Clinica Tabancura Av Tabancura 1185
Santiago
About this study
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
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.
- Conditions
- Influenza Disease
- Being tested
- Trivalent split influenza vaccine (TIV), MF59-adjuvanted trivalent influenza vaccine (aTIV), Licensed comparator trivalent split influenza vaccine (comparator TIV)
- Keywords
- Adjuvanted Trivalent Subunit Influenza Vaccine, vaccine, influenza, adjuvant, MF-59, pediatric
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent split influenza vaccine (TIV)Biological
Also called Agriflu
MF59-adjuvanted trivalent influenza vaccine (aTIV)Biological
Also called Fluad
Licensed comparator trivalent split influenza vaccine (comparator TIV)Biological
Also called Fluzone
| Study group | Role | What they receive |
|---|---|---|
| aTIV (6 to <72 months) | Active comparator | 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 Receives: Biological: MF59-adjuvanted trivalent influenza vaccine (aTIV) |
| Comparator TIV (6 to <72 months) | Active comparator | 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 Receives: Biological: Licensed comparator trivalent split influenza vaccine (comparator TIV) |
| TIV (6 to <72 months) | Active comparator | 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 Receives: Biological: Trivalent split influenza vaccine (TIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, Day 50
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.
Measured: Day 50
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.
Measured: Day 1, Day 50
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.
Measured: Day 50
Secondary outcomes (17)
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.
Measured: Day 1, Day 50
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.
Measured: Day 50
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.
Measured: Day 1, Day 50
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.
Measured: Day 50
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.
Measured: Day 1, Day 29, Day 50, Day 209
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.
Measured: Day 29, Day 50, Day 209
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.
Measured: Day 1, Day 29, Day 50, Day 209
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.
Measured: Day 29, Day 50, Day 209
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.
Measured: Day 50
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.
Measured: Day 50
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.
Measured: Day 50
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.
Measured: Day 50
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.
Measured: Day 1, Day 50, Day 209
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.
Measured: Day 50, Day 209
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.
Measured: Day 1, Day 29
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.
Measured: Day 1 through Day 7 after any vaccination
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).
Measured: Day 1 to Day 394
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 6,104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines, Study chair, Novartis Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346592
- Sponsor's protocol ID
- V70_29
- Status last verified
- Mar 2015
- First submitted
- 30 Apr 2011
- Last updated
- 26 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 25223266
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01346592
- Acronym / sponsor ID
- V70_29
- Conditions
- Influenza Disease
- Keywords
- Adjuvanted Trivalent Subunit Influenza Vaccine, vaccine, influenza, adjuvant, MF-59, pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,104 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 3 May 2011 (estimated)
- Results
- Posted 6 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aTIV (6 to <72 months) | Active comparator | Biological: MF59-adjuvanted trivalent influenza vaccine (aTIV)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 |
| Comparator TIV (6 to <72 months) | Active comparator | Biological: Licensed comparator trivalent split influenza vaccine (comparator TIV)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 |
| TIV (6 to <72 months) | Active comparator | Biological: Trivalent split influenza vaccine (TIV)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 |
Who may qualify
- Ages
- 6 to 72 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1.Children 6 months to 72 months of age.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trivalent split influenza vaccine (TIV)Also: Agriflu | Biological | TIV (6 to <72 months) |
| MF59-adjuvanted trivalent influenza vaccine (aTIV)Also: Fluad | Biological | aTIV (6 to <72 months) |
| Licensed comparator trivalent split influenza vaccine (comparator TIV)Also: Fluzone | Biological | Comparator TIV (6 to <72 months) |
Primary outcome
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains
Time frame: Day 1, Day 50
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
Time frame: Day 50
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)
Time frame: Day 1, Day 50
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
Time frame: Day 50
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.
17 secondary outcomes
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months)
Time frame: Day 1, Day 50
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)
Time frame: Day 50
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS
Time frame: Day 1, Day 50
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
Time frame: Day 50
The HI GMTs Against Homologous Strains, by Vaccine Group
Time frame: Day 1, Day 29, Day 50, Day 209
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
Time frame: Day 29, Day 50, Day 209
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group
Time frame: Day 1, Day 29, Day 50, Day 209
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains
Time frame: Day 29, Day 50, Day 209
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
Time frame: Day 50
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
Time frame: Day 50
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
Time frame: Day 50
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
Time frame: Day 50
The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)
Time frame: Day 1, Day 50, Day 209
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains
Time frame: Day 50, Day 209
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination
Time frame: Day 1, Day 29
Number of Subjects Reporting Solicited Adverse Events After Vaccination
Time frame: Day 1 through Day 7 after any vaccination
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
Time frame: Day 1 to Day 394
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25223266Nolan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Vaccines study chair
Novartis Vaccines
34 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trivalent split influenza vaccine (TIV), MF59-adjuvanted trivalent influenza vaccine (aTIV) and Licensed comparator trivalent split influenza vaccine (comparator TIV) in people with Influenza Disease, run by Novartis Vaccines at 34 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Philippines, Argentina, Australia, South Africa, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (time frame: Day 1, Day 50). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01346592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.