NCT02255279

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

A Phase 3, Observed-Blind, Randomized, Multi-center Study to Evaluate Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to <72 Months of Age in Mexico.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 6 Months – 71 Months
• Healthy volunteers: Accepted

Summary

The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a more immunogenic and effective response compared with conventional influenza vaccines in elderly and adults. The aim of this study is to evaluate safety and immunogenicity of Novartis aTIV in children 6 to \<72 months of age, Mexican population, in comparison to Fluzone, a non-adjuvanted trivalent influenza vaccine (TIV).

Conditions

• Influenza

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-10-02
• Last updated: 2017-01-27
• Results posted: 2016-02-03

Locations

3 sites across 1 country: Mexico