Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to <72 Months of Age in Mexico.

PHASE3CompletedINTERVENTIONAL
Enrollment

287

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

May 31, 2015

Study Completion Date

May 31, 2015

Conditions
Influenza
Interventions
BIOLOGICAL

Adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29)

A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV, a trivalent (surface antigen, formaldehyde-inactivated) influenza virus vaccine, adjuvanted with MF59C.1, administered at day 1 (for all subjects) and day 29 (for naïve subjects).

BIOLOGICAL

Non-adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29).

A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV , an egg-derived trivalent split influenza vaccine licensed in Mexico, administered at day 1 (for all subjects) and day 29 (for naïve subjects)

Trial Locations (3)

Unknown

03, Centro Médico Universitario, Colonia Chamilpa, Cuernavaca

02, Unidad de Atencion Medica E Investigacion En Salud S.C (Unamis), Mérida

04, Medical Care and Research S.A. de C.V., Mérida

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY