Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age

PHASE3CompletedINTERVENTIONAL
Enrollment

3,116

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

March 31, 2011

Study Completion Date

September 30, 2011

Conditions
Seasonal Influenza
Interventions
BIOLOGICAL

TIV

Investigational egg-derived trivalent subunit influenza vaccine.

BIOLOGICAL

TIVf

US licensed trivalent inactivated subunit influenza vaccine -Fluvirin (Novartis Vaccines and Diagnostics) is approved for use in subjects ≥4 years.

BIOLOGICAL

Comparator TIV

US licensed trivalent subunit inactivated influenza vaccine- Fluzone (Sanofi Pasteur) is approved for use in children \<4 years.

Trial Locations (13)

1000

Philippine General Hospital, Taft Avenue, Manila

1008

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

1113

University of the East Ramon Magsaysay Medical Center, 64 Aurora Boulevard, Barangay Dona Imelda Quezon City

1781

Research Institute for Tropical Medicine, Department of Health Compound, Filinvest Corporate City, Alabang

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

4115

De La Salle Health Sciences Institute, Dasmarinas Cavite

Unknown

Centro de Atención e Investigación Medica - CAIMED, Carrera 42A # 17-50, Bogotá

Clinical research institute ,S.C(CRI), Blvd Manuel Avila Camacho 1994 Consultorio 1103 Col. San Lucas Tepetlacalco, C.P.54055 Tlalnepantla, Estado de México

Centro de Salud Magally Ruiz, Street Bolivar, Panama - La Chorrera

Clinica Hospital San Fernando, Floor 4 Office 419 via España las Sabanas, Panama City

Consultorios America Floor 2 Office 201-1, Via España Vista Hermosa, Panama City

Consultorios Medicos San Judas Tadeo Principal Street, Floor 5 Office 507, Villa Lucre, Panama City

Philippine Children's Medical Center, Quezon Avenue corner Agham Road, Quezon City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY