NCT00848887

A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age

A Phase Ib, Randomized, Observer-Blind, Multicenter, Factorial-Design Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Injections of Trivalent Inactivated Influenza Vaccine With or Without a Second Influenza B Strain in Combination With or Without One of Three Different Doses of Adjuvant in Healthy Children, Aged 6 to <36 Months

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and immunogenicity of different combinations of influenza vaccine in healthy young children.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Adjuvanted and un-adjuvanted influenza vaccines	16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator.

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2009-02-20
• Last updated: 2014-01-24

Locations

1 site across 1 country: Belgium