NCT00559975

Safety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu Vaccine

A Phase 1, Randomized, Controlled, Observer-Blinded, Dose Escalation Study of the Safety, Tolerability and Immunogenicity of a Single Dose of Adjuvanted Influenza Vaccine Combined With CpG7909 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and tolerability of the an adjuvanted influenza vaccine combined with CpG7909 at three different doses of CpG 7909 as a single intramuscular (IM) administration in healthy adults. Safety will be assessed by observation of symptoms, physical examination findings and laboratory safety testing.

Conditions

• Influenza Infection

Interventions

Type	Name	Description
BIOLOGICAL	Subunit influenza vaccine	0.5 mL single dose vaccine
BIOLOGICAL	Adjuvanted influenza vaccine	0.5 mL single dose vaccine
BIOLOGICAL	Adjuvanted influenza vaccine combined with CpG7909	0.5 ml influenza vaccine combined with 10 mcg of CpG7909
BIOLOGICAL	Adjuvanted influenza vaccine combine with CpG7909	0.5 mL single dose vaccine combined with 30 mcg of CpG7909
BIOLOGICAL	Adjuvanted influenza vaccine combine with CpG7909	0.5 mL single dose vaccine combined with 100 mcg of CpG7909

Timeline

• Start date: 2007-10-01
• Completion: 2008-05-01
• First posted: 2007-11-19
• Last updated: 2009-11-05

Locations

1 site across 1 country: Switzerland