Clinical trial NCT01346592: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza Disease
Keywords: Adjuvanted Trivalent Subunit Influenza Vaccine
vaccine
influenza
adjuvant
MF-59
pediatric
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-05-03
Enrollment: 6104
Sex: ALL
Minimum age (years): 6
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains
timeFrame: Day 1, Day 50
measure: 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
timeFrame: Day 50
measure: Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months)
timeFrame: Day 1, Day 50
measure: 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
timeFrame: Day 50
Secondary outcomes:
measure: Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months)
timeFrame: Day 1, Day 50
measure: 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)
timeFrame: Day 50
measure: Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS
timeFrame: Day 1, Day 50
measure: 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
timeFrame: Day 50
measure: The HI GMTs Against Homologous Strains, by Vaccine Group
timeFrame: Day 1, Day 29, Day 50, Day 209
measure: Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
timeFrame: Day 29, Day 50, Day 209
measure: Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group
timeFrame: Day 1, Day 29, Day 50, Day 209
measure: Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains
timeFrame: Day 29, Day 50, Day 209
measure: 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
timeFrame: Day 50
measure: 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
timeFrame: Day 50
measure: 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
timeFrame: Day 50
measure: 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
timeFrame: Day 50
measure: The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)
timeFrame: Day 1, Day 50, Day 209
measure: Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains
timeFrame: Day 50, Day 209
measure: Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination
timeFrame: Day 1, Day 29
measure: Number of Subjects Reporting Solicited Adverse Events After Vaccination
timeFrame: Day 1 through Day 7 after any vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
timeFrame: Day 1 to Day 394
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: 401 Paideia Jeronimo Salguero 2835 Piso 1
city: Buenos Aires
country: Argentina
facility: 402 Hospital de Ninos Gallo 130
city: Cordoba
country: Argentina
facility: 403 Instituto Medico Rio Cuarto Hipolito Yrigoyen 1020
city: Cordoba
country: Argentina
facility: 405 Hospital Pediatrico Nino Jesus Castro Barros 650
city: Cordoba
country: Argentina
facility: 406 Hospital Nostra Senora de la Misericordia Belgrano 1500
city: Cuidad Automa de Beunos Aires
country: Argentina
facility: 407 Centro Pediatrico Caballito Directorio 1658
city: Guaymallen
country: Argentina
facility: 409 Centro de Salud 16 Alpatacal y Chile
city: Mendoza
country: Argentina
facility: 408 Centro de Salud 31 Serpa y Republica del Libano
city: Adelaide
country: Australia
facility: 206 Vaccine and Immunology Research Trials Unit University Department of Paediatrics 2nd floor Clarence Reiger Bldg Womens and Childrens Hospital
city: Herston
country: Australia
facility: 201 Royal Children Hospital Department of Respiratory Medicine
city: Level 5 207 Bouverie St
country: Australia
facility: 205 Vaccine and Immunisation Research Group Murdoch Childrens Research Institute School Of Population Health
city: Randwick
country: Australia
facility: 202 Sydney Children Hospital Department of Immunology and Infectious Diseases
city: Westmead
country: Australia
facility: 204 National Centre for Immunisation Research and Surveillance Kids Research Institute The Childrens Hospital at Westmead
city: Santiago
country: Chile
facility: 502 Hospital Clinico Pontificia Universidad Catolica de Chile Marcoleta 357
city: Santiago
country: Chile
facility: 503 Clinica Tabancura Av Tabancura 1185
city: Cavite
country: Philippines
facility: 111 DLSHI deCastro De La Salle Health Sciences Institute DBB B Dasmarinas
city: Dbbb Dasmarinas Cavite
country: Philippines
facility: 109 De La Salle Health Sciences Institute
city: Dbbb Dasmarinas Cavite
country: Philippines
facility: 110 De La Salle Health Sciences Institute
city: Manila
country: Philippines
facility: 103 Philippine General Hospital Taft Avenue
city: Manila
country: Philippines
facility: 107 Philippine General Hospital Taft Avenue
city: Manila
country: Philippines
facility: 112 PGH Lim Philippine General Hospital Taft Avenue
city: Manila
country: Philippines
facility: 114 Philippine General Hospital Taft Avenue
city: Manila
country: Philippines
facility: 105 Mary Chiles General Hospital 667 Gastambide St Sampaloc Manila
city: Muntinlupa
country: Philippines
facility: 106 Research Institute for Tropical Medicine Alabang Muntinlupa
city: Muntinlupa
country: Philippines
facility: 108 RITM Research Institute for Tropical Medicine Department of Health Compound FILINVEST Corporate City Alabang
city: Quezon City
country: Philippines
facility: 101 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City
city: Quezon City
country: Philippines
facility: 104 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City
city: Quezon City
country: Philippines
facility: 113 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City
city: Quezon
country: Philippines
facility: 102 University of the East Ramon Magsaysay Memorial 64 Aurora Boulevard Barangay Dona Imelda
city: Benoni
country: South Africa
facility: 305 Worthwhile Clinical Trials Lakeview Hospital 1 Mowbray Avenue
city: Johannesburg
country: South Africa
facility: 304 Newgate Centre Suite 3
city: Pretoria
country: South Africa
facility: 303 Emmed Research
city: Soweto
country: South Africa
facility: 301 Perinatal HIV Research Unit, Baragwanath Hospital
city: Soweto
country: South Africa
facility: 302 Soweto Clinical Research
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
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.