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

Phase 3 Completed 6104 enrolled Novartis Vaccines

RandomizedParallel-groupSingle-blindPrevention

Summary

This Study Aims to 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.

Timeline

Start: 2011-04
Primary completion: 2012-07
Completion: 2012-07

Publications

Nolan T, Bravo L, Ceballos A, Mitha E, Gray G, Quiambao B, Patel SS, Bizjajeva S, Bock H, Nazaire-Bermal N, Forleo-Neto E, Cioppa GD, Narasimhan V. Enhanced and persistent antibody response against homologous and heterologous strains elicited by a MF59-adjuvanted influenza vaccine in infants and young children. Vaccine. 2014 Oct 21;32(46):6146-56. doi: 10.1016/j.vaccine.2014.08.068. Epub 2014 Sep 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Licensed comparator trivalent split influenza vaccine	Vaccine	0.25 ml	—
Comparator	Licensed comparator trivalent split influenza vaccine	Vaccine	0.5 ml	—
Comparator	MF59-adjuvanted trivalent influenza vaccine	Vaccine	0.25 ml	—
Comparator	MF59-adjuvanted trivalent influenza vaccine	Vaccine	0.5 ml	—
Comparator	trivalent split influenza vaccine	Vaccine	0.25 ml	—
Comparator	trivalent split influenza vaccine	Vaccine	0.5 ml	—

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

Summary

Timeline

Publications

Drugs

Indications