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

PHASE3CompletedINTERVENTIONAL
Enrollment

6,104

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
Influenza Disease
Interventions
BIOLOGICAL

Trivalent split influenza vaccine (TIV)

BIOLOGICAL

MF59-adjuvanted trivalent influenza vaccine (aTIV)

BIOLOGICAL

Licensed comparator trivalent split influenza vaccine (comparator TIV)

Trial Locations (34)

1000

103 Philippine General Hospital Taft Avenue, Manila

107 Philippine General Hospital Taft Avenue, Manila

112 PGH Lim Philippine General Hospital Taft Avenue, Manila

114 Philippine General Hospital Taft Avenue, Manila

1008

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

1406

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

1500

305 Worthwhile Clinical Trials Lakeview Hospital 1 Mowbray Avenue, Benoni

2031

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

2113

304 Newgate Centre Suite 3, Johannesburg

2145

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

4029

201 Royal Children Hospital Department of Respiratory Medicine, Herston

4114

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

109 De La Salle Health Sciences Institute, Dbbb Dasmarinas Cavite

110 De La Salle Health Sciences Institute, Dbbb Dasmarinas Cavite

5006

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

Unknown

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

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

409 Centro de Salud 16 Alpatacal y Chile, Villa Nueva

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

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

503 Clinica Tabancura Av Tabancura 1185, Santiago

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

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

301 Perinatal HIV Research Unit, Baragwanath Hospital, Soweto

302 Soweto Clinical Research, Soweto

0084

303 Emmed Research, Pretoria

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY

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 | Biotech Hunter | Biotech Hunter