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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01346592
First received: April 30, 2011
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

This Study Will 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.


Condition Intervention Phase
Influenza Disease
Biological: eTIV_a
Biological: MF59-eTIV
Biological: eTIV_split
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • [1] Serious adverse events and other significant medical occurrences from Day 1 through Day 394; [ Time Frame: 394 days ] [ Designated as safety issue: Yes ]
    [2] Solicited local and systemic reaction 7 days following each vaccination; [3] All unsolicited adverse events from Day 1 to Day 50; [4] Immunogenicity assessments at Day 29, Day 50, and Day 209.


Secondary Outcome Measures:
  • Immunogenicity assessments comparing at-risk vs non-at-risk subjects, naive vs. non-naive subjects, and in specific age cohorts. [ Time Frame: Immunogenicity assesments will be measured at Day 29, 50, and 209. ] [ Designated as safety issue: No ]

Enrollment: 6105
Study Start Date: April 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Adjuvanted Trivalent Subunit Influenza Vaccine Biological: MF59-eTIV
surface antigen, inactivated, adjuvanted with MF-59
Other Name: MF59-eTIV for Fluad
Active Comparator: Non-adjuvanted Trivalent Subunit Influenza Vaccine Biological: eTIV_a
surface antigen, inactivated, adjuvanted with MF-59
Other Name: eTIV_a for Agriflu vaccine
Active Comparator: Non-adjuvanted Trivalent Split Influenza Vaccine Biological: eTIV_split
surface antigen, inactivated, adjuvanted with MF-59
Other Name: eTIV_split for Fluzone

  Eligibility

Ages Eligible for Study:   6 Months to 72 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1.Children 6 months to 72 months of age

Exclusion Criteria:

  1. Children that are hospitalized at the time of enrollment
  2. Any serious reaction or hypersensitivity to any vaccine component, eggs, or chicken protein
  3. Children with known impairment of the immune function
  4. Children with a fever interfering with normal daily activities at the time of enrollment
  5. Children that have 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. Surgery planned during the study period that in the investigator's opinion would interfere with the study visits schedule
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346592

Locations
Argentina
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, Argentina, 1406
409 Centro de Salud 16 Alpatacal y Chile
Guaymallen, Argentina
408 Centro de Salud 31 Serpa y Republica del Libano
Mendoza, Argentina
Australia
206 Vaccine and Immunology Research Trials Unit University Department of Paediatrics 2nd floor Clarence Reiger Bldg Womens and Childrens Hospital
Adelaide, Australia, 5006
201 Royal Children Hospital Department of Respiratory Medicine
Herston, Australia, 4029
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, Australia, 2031
204 National Centre for Immunisation Research and Surveillance Kids Research Institute The Childrens Hospital at Westmead
Westmead, Australia, 2145
Chile
502 Hospital Clinico Pontificia Universidad Catolica de Chile Marcoleta 357
Santiago, Chile
503 Clinica Tabancura Av Tabancura 1185
Santiago, Chile
Philippines
111 DLSHI deCastro De La Salle Health Sciences Institute DBB B Dasmarinas
Cavite, Philippines, 4114
110 De La Salle Health Sciences Institute
Dbbb Dasmarinas Cavite, Philippines, 4114
109 De La Salle Health Sciences Institute
Dbbb Dasmarinas Cavite, Philippines, 4114
103 Philippine General Hospital Taft Avenue
Manila, Philippines, 1000
105 Mary Chiles General Hospital 667 Gastambide St Sampaloc Manila
Manila, Philippines, 1008
107 Philippine General Hospital Taft Avenue
Manila, Philippines, 1000
114 Philippine General Hospital Taft Avenue
Manila, Philippines, 1000
112 PGH Lim Philippine General Hospital Taft Avenue
Manila, Philippines, 1000
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
102 University of the East Ramon Magsaysay Memorial 64 Aurora Boulevard Barangay Dona Imelda
Quezon, Philippines
104 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City
Quezon City, Philippines
101 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
South Africa
303 Emmed Research
Emmed, South Africa, 0084
301 Perinatal HIV Research Unit Friends of Baragwanath Building Old Potch Road Soweto
Johannesburg, South Africa
305 Worthwhile Clinical Trials Lakeview Hospital 1 Mowbray Avenue
Johannesburg, South Africa, 1501
304 Newgate Centre Suite 3
Newgate, South Africa, 2113
302 Soweto Clinical Research
Soweto, South Africa
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01346592     History of Changes
Other Study ID Numbers: V70_29
Study First Received: April 30, 2011
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Instituto de Salud Publica de Chile
Philippines:Food and Drug Administration Philippines
South Africa:Medicine Control Council (MCC)
Australia: Therapeutic Goods Administration (TGA)

Keywords provided by Novartis:
Adjuvanted Trivalent Subunit Influenza Vaccine
vaccine
influenza
adjuvant
MF-59
pediatric

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014