NCT00649883

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

A Phase II, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Investigational Vaccine and Active Influenza Vaccine in Healthy Children Aged 6 to <60 Months

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Trivalent Inactivated vaccines Novartis	Children 6 to \<36 months of age will receive two 0.25 mL doses, and children 36 to \<60 months of age will receive two 0.5 mL doses of investigational influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.
BIOLOGICAL	Influenza Trivalent Inactivated vaccines	Children 6 to \<36 months of age will receive two 0.25 mL doses, and children 36 to \<60 months of age will receive two 0.5 mL doses of active control influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-04-01
• Completion: 2008-10-01
• First posted: 2008-04-01
• Last updated: 2017-04-07

Locations

5 sites across 1 country: Guatemala