Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Two Different Influenza Vaccines in Healthy Children Aged 6 to <60 Months

Phase 2 Completed 360 enrolled Novartis Novartis Vaccines · collab

RandomizedParallel-groupSingle-blindPrevention

Summary

This a multicenter phase II trial will evaluate safety and immunogenicity of two 0.25 mL or 0.5 mL doses of investigational influenza vaccine and active control influenza vaccine in healthy children aged 6 to \<60 months.

Timeline

Start: 2008-01
Primary completion: 2008-04
Completion: 2008-10

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Influenza Trivalent Inactivated vaccines	Vaccine	0.25 ml	Intramuscular
Comparator	Influenza Trivalent Inactivated vaccines	Vaccine	0.5 ml	Intramuscular
Subject	Influenza Trivalent Inactivated vaccines Novartis	Vaccine	0.25 ml	Intramuscular
Subject	Influenza Trivalent Inactivated vaccines Novartis	Vaccine	0.5 ml	Intramuscular

Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Two Different Influenza Vaccines in Healthy Children Aged 6 to <60 Months

Summary

Timeline

Drugs

Indications