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

NCT01346592 | Completed Phase 3 Results

• 1 other identifier: V70_29
• Study Type: interventional
• Target: 6,104
• Locations: 5 countries
• Sites: 34

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.

Conditions

Influenza Disease

Keywords

Adjuvanted Trivalent Subunit Influenza Vaccine; vaccine; influenza; adjuvant; MF-59; pediatric

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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)

  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)

  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

  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

  Day 50

• The HI GMTs Against Homologous Strains, by Vaccine Group

  Day 1, Day 29, Day 50, Day 209

Study Arms (3)

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

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

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

Biological: Trivalent split influenza vaccine (TIV)

Interventions

Trivalent split influenza vaccine (TIV) BIOLOGICAL

Also known as: Agriflu

TIV (6 to <72 months)

MF59-adjuvanted trivalent influenza vaccine (aTIV) BIOLOGICAL

Also known as: Fluad

aTIV (6 to <72 months)

Licensed comparator trivalent split influenza vaccine (comparator TIV) BIOLOGICAL

Also known as: Fluzone

Comparator TIV (6 to <72 months)

Eligibility Criteria

• Age: 6 Months - 72 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children 6 months to 72 months of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (34)

401 Paideia Jeronimo Salguero 2835 Piso 1

Buenos Aires, Argentina

Location

402 Hospital de Ninos Gallo 130

Buenos Aires, Argentina

Location

403 Instituto Medico Rio Cuarto Hipolito Yrigoyen 1020

Córdoba, Argentina

Location

405 Hospital Pediatrico Nino Jesus Castro Barros 650

Córdoba, Argentina

Location

406 Hospital Nostra Senora de la Misericordia Belgrano 1500

Córdoba, Argentina

Location

407 Centro Pediatrico Caballito Directorio 1658

Cuidad Automa de Beunos Aires, 1406, Argentina

Location

408 Centro de Salud 31 Serpa y Republica del Libano

Mendoza, Argentina

Location

409 Centro de Salud 16 Alpatacal y Chile

Villa Nueva, Argentina

Location

206 Vaccine and Immunology Research Trials Unit University Department of Paediatrics 2nd floor Clarence Reiger Bldg Womens and Childrens Hospital

Adelaide, 5006, Australia

Location

201 Royal Children Hospital Department of Respiratory Medicine

Herston, 4029, Australia

Location

205 Vaccine and Immunisation Research Group Murdoch Childrens Research Institute School Of Population Health

Level 5 207 Bouverie Saint, Australia

Location

202 Sydney Children Hospital Department of Immunology and Infectious Diseases

Randwick, 2031, Australia

Location

204 National Centre for Immunisation Research and Surveillance Kids Research Institute The Childrens Hospital at Westmead

Westmead, 2145, Australia

Location

502 Hospital Clinico Pontificia Universidad Catolica de Chile Marcoleta 357

Santiago, Chile

Location

503 Clinica Tabancura Av Tabancura 1185

Santiago, Chile

Location

111 DLSHI deCastro De La Salle Health Sciences Institute DBB B Dasmarinas

Cavite, 4114, Philippines

Location

106 Research Institute for Tropical Medicine Alabang Muntinlupa

City of Muntinlupa, Philippines

Location

108 RITM Research Institute for Tropical Medicine Department of Health Compound FILINVEST Corporate City Alabang

City of Muntinlupa, Philippines

Location

109 De La Salle Health Sciences Institute

Dbbb Dasmarinas Cavite, 4114, Philippines

Location

110 De La Salle Health Sciences Institute

Dbbb Dasmarinas Cavite, 4114, Philippines

Location

103 Philippine General Hospital Taft Avenue

Manila, 1000, Philippines

Location

107 Philippine General Hospital Taft Avenue

Manila, 1000, Philippines

Location

112 PGH Lim Philippine General Hospital Taft Avenue

Manila, 1000, Philippines

Location

114 Philippine General Hospital Taft Avenue

Manila, 1000, Philippines

Location

105 Mary Chiles General Hospital 667 Gastambide St Sampaloc Manila

Manila, 1008, Philippines

Location

102 University of the East Ramon Magsaysay Memorial 64 Aurora Boulevard Barangay Dona Imelda

Quezon, Philippines

Location

101 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City

Quezon City, Philippines

Location

104 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City

Quezon City, Philippines

Location

113 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City

Quezon City, Philippines

Location

305 Worthwhile Clinical Trials Lakeview Hospital 1 Mowbray Avenue

Benoni, 1500, South Africa

Location

304 Newgate Centre Suite 3

Johannesburg, 2113, South Africa

Location

303 Emmed Research

Pretoria, 0084, South Africa

Location

301 Perinatal HIV Research Unit, Baragwanath Hospital

Soweto, South Africa

Location

302 Soweto Clinical Research

Soweto, South Africa

Location

Related Publications (1)

• 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.

  PMID: 25223266 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; fluad vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2011
• First Posted: May 3, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: March 26, 2015
• Results First Posted: May 6, 2014

Record last verified: 2015-03

Locations

AU (5); PH (14); AR (8); CL (2); ZA (5)