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

Condition(s) targeted: Influenza Disease

Intervention: Trivalent split influenza vaccine (TIV) (Biological); MF59-adjuvanted trivalent influenza vaccine (aTIV) (Biological); Licensed comparator trivalent split influenza vaccine (comparator TIV) (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Vaccines

Official(s) and/or principal investigator(s):
Novartis Vaccines, Study Chair, Affiliation: Novartis Vaccines

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Primary outcome:

Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous 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

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

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

Secondary outcome:

Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months)

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)

Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS

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 HI GMTs Against Homologous Strains, by Vaccine Group

Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains

Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group

Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains

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

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

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

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 HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)

Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains

Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination

Number of Subjects Reporting Solicited Adverse Events After Vaccination

Number of Subjects Reporting Unsolicited Adverse Events After Vaccination

Minimum age: 6 Months. Maximum age: 72 Months. Gender(s): Both.

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.

401 Paideia Jeronimo Salguero 2835 Piso 1, Buenos Aires, Argentina

402 Hospital de Ninos Gallo 130, Buenos Aires, Argentina

403 Instituto Medico Rio Cuarto Hipolito Yrigoyen 1020, Cordoba, Argentina

405 Hospital Pediatrico Nino Jesus Castro Barros 650, Cordoba, Argentina

406 Hospital Nostra Senora de la Misericordia Belgrano 1500, Cordoba, Argentina

407 Centro Pediatrico Caballito Directorio 1658, Cuidad Automa de Beunos Aires 1406, Argentina

409 Centro de Salud 16 Alpatacal y Chile, Guaymallen, Argentina

408 Centro de Salud 31 Serpa y Republica del Libano, Mendoza, Argentina

206 Vaccine and Immunology Research Trials Unit University Department of Paediatrics 2nd floor Clarence Reiger Bldg Womens and Childrens Hospital, Adelaide 5006, Australia

201 Royal Children Hospital Department of Respiratory Medicine, Herston 4029, Australia

205 Vaccine and Immunisation Research Group Murdoch Childrens Research Institute School Of Population Health, Level 5 207 Bouverie St, Australia

202 Sydney Children Hospital Department of Immunology and Infectious Diseases, Randwick 2031, Australia

204 National Centre for Immunisation Research and Surveillance Kids Research Institute The Childrens Hospital at Westmead, Westmead 2145, Australia

502 Hospital Clinico Pontificia Universidad Catolica de Chile Marcoleta 357, Santiago, Chile

503 Clinica Tabancura Av Tabancura 1185, Santiago, Chile

111 DLSHI deCastro De La Salle Health Sciences Institute DBB B Dasmarinas, Cavite 4114, Philippines

109 De La Salle Health Sciences Institute, Dbbb Dasmarinas Cavite 4114, Philippines

110 De La Salle Health Sciences Institute, Dbbb Dasmarinas Cavite 4114, Philippines

103 Philippine General Hospital Taft Avenue, Manila 1000, Philippines

105 Mary Chiles General Hospital 667 Gastambide St Sampaloc Manila, Manila 1008, Philippines

107 Philippine General Hospital Taft Avenue, Manila 1000, Philippines

112 PGH Lim Philippine General Hospital Taft Avenue, Manila 1000, Philippines

114 Philippine General Hospital Taft Avenue, Manila 1000, Philippines

106 Research Institute for Tropical Medicine Alabang Muntinlupa, Muntinlupa, Philippines

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

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

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

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

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

305 Worthwhile Clinical Trials Lakeview Hospital 1 Mowbray Avenue, Benoni 1500, South Africa

304 Newgate Centre Suite 3, Johannesburg 2113, South Africa

303 Emmed Research, Pretoria 0084, South Africa

301 Perinatal HIV Research Unit, Baragwanath Hospital, Soweto, South Africa

302 Soweto Clinical Research, Soweto, South Africa

Starting date: April 2011
Last updated: March 4, 2015