A Study to Evaluate the Safety of Two Influenza Vaccines in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications

PHASE3CompletedINTERVENTIONAL
Enrollment

430

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2014

Conditions
Influenza
Interventions
BIOLOGICAL

TIVc

Madin Darby Canine Kidney (MDCK) cell culture derived subunit influenza vaccine TIVc contained the purified viral envelope glycoproteins, hemagglutinin (HA) and neuraminidase (NA) derived from 3 strains (including HA for each strain \[A/H1N1-like, A/H3N2-like, and B-like\]) intramuscular (IM) injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere

BIOLOGICAL

TIV

A conventional egg derived subunit influenza vaccine (TIV) contained the purified viral envelope-glycoproteins, HA and NA derived from 3 strains (including HA for each strain \[A/ H1N1-like, A/H3N2-like, and B-like\]) IM injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere.

Trial Locations (16)

165

Novartis Investigational Site 023, Roma

8916

Novartis Investigational Site 031, Badalona

12004

Novartis Investigational Site 016, Castellon

12530

Novartis Investigational Site 017, Burriana

16132

Novartis Investigational Site 020, Genova

20157

Novartis Investigational Site 021, Milan

28050

Novartis Investigational Site 030, Madrid

29011

Novartis Investigational Site 011, Málaga

29603

Novartis Investigational Site 010, Marbella

46017

Novartis Investigational Site 019, Valencia

46020

Novartis Investigational Site 014, Valencia

46024

Novartis Investigational Site 012, Valencia

46183

Novartis Investigational Site 015, L'Eliana

46200

Novartis Investigational Site 013, Paiporta

46930

Novartis Investigational Site 018, Quart de Poblet

50139

Novartis Investigational Site 022, Florence

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY