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
NCT ID: NCT01346592
Last Updated: 2015-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
6104 participants
INTERVENTIONAL
2011-04-30
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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aTIV (6 to <72 months)
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
MF59-adjuvanted trivalent influenza vaccine (aTIV)
Comparator TIV (6 to <72 months)
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
Licensed comparator trivalent split influenza vaccine (comparator TIV)
TIV (6 to <72 months)
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
Trivalent split influenza vaccine (TIV)
Interventions
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Trivalent split influenza vaccine (TIV)
MF59-adjuvanted trivalent influenza vaccine (aTIV)
Licensed comparator trivalent split influenza vaccine (comparator TIV)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
6 Months
72 Months
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines
Role: STUDY_CHAIR
Novartis Vaccines
Locations
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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
Córdoba, , Argentina
405 Hospital Pediatrico Nino Jesus Castro Barros 650
Córdoba, , Argentina
406 Hospital Nostra Senora de la Misericordia Belgrano 1500
Córdoba, , Argentina
407 Centro Pediatrico Caballito Directorio 1658
Cuidad Automa de Beunos Aires, , Argentina
408 Centro de Salud 31 Serpa y Republica del Libano
Mendoza, , Argentina
409 Centro de Salud 16 Alpatacal y Chile
Villa Nueva, , Argentina
206 Vaccine and Immunology Research Trials Unit University Department of Paediatrics 2nd floor Clarence Reiger Bldg Womens and Childrens Hospital
Adelaide, , Australia
201 Royal Children Hospital Department of Respiratory Medicine
Herston, , Australia
205 Vaccine and Immunisation Research Group Murdoch Childrens Research Institute School Of Population Health
Level 5 207 Bouverie Saint, , Australia
202 Sydney Children Hospital Department of Immunology and Infectious Diseases
Randwick, , Australia
204 National Centre for Immunisation Research and Surveillance Kids Research Institute The Childrens Hospital at Westmead
Westmead, , 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, , Philippines
106 Research Institute for Tropical Medicine Alabang Muntinlupa
City of Muntinlupa, , Philippines
108 RITM Research Institute for Tropical Medicine Department of Health Compound FILINVEST Corporate City Alabang
City of Muntinlupa, , Philippines
109 De La Salle Health Sciences Institute
Dbbb Dasmarinas Cavite, , Philippines
110 De La Salle Health Sciences Institute
Dbbb Dasmarinas Cavite, , Philippines
103 Philippine General Hospital Taft Avenue
Manila, , Philippines
107 Philippine General Hospital Taft Avenue
Manila, , Philippines
112 PGH Lim Philippine General Hospital Taft Avenue
Manila, , Philippines
114 Philippine General Hospital Taft Avenue
Manila, , Philippines
105 Mary Chiles General Hospital 667 Gastambide St Sampaloc Manila
Manila, , Philippines
102 University of the East Ramon Magsaysay Memorial 64 Aurora Boulevard Barangay Dona Imelda
Quezon, , 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
305 Worthwhile Clinical Trials Lakeview Hospital 1 Mowbray Avenue
Benoni, , South Africa
304 Newgate Centre Suite 3
Johannesburg, , South Africa
303 Emmed Research
Pretoria, , South Africa
301 Perinatal HIV Research Unit, Baragwanath Hospital
Soweto, , South Africa
302 Soweto Clinical Research
Soweto, , South Africa
Countries
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References
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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.
Other Identifiers
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V70_29
Identifier Type: -
Identifier Source: org_study_id
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