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

Influenza Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559975
• Other study ID #: V95P1
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2007
• Last updated: November 4, 2009
• Start date: October 2007
• Est. completion date: May 2008

Study information

• Verified date: November 2009
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swiss Medic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy subjects aged 18 to =40 years

Exclusion Criteria:

• Any serious disease, hypersensitivity to egg or vaccine components, neurological symptoms or positive antibody test against dsDNA, RF, ANA or thyroid.

• Abnormal TSH from blood samples collected during the screening visit;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza Infection
• Influenza, Human

Intervention

Biological:
• Subunit influenza vaccine
0.5 mL single dose vaccine
• Adjuvanted influenza vaccine
0.5 mL single dose vaccine
• Adjuvanted influenza vaccine combined with CpG7909
0.5 ml influenza vaccine combined with 10 mcg of CpG7909
• Adjuvanted influenza vaccine combine with CpG7909
0.5 mL single dose vaccine combined with 30 mcg of CpG7909
• Adjuvanted influenza vaccine combine with CpG7909
0.5 mL single dose vaccine combined with 100 mcg of CpG7909

Locations

Country	Name	City	State
Switzerland	Institute for Pharmacokinetic and Analytical Studies	Ligornetto

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Novartis Vaccines

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measures of humoral immunogenicity for each antigen		22 days
Secondary	Measures of vaccine-induced B and T cell immune responses		72 hours
Secondary	Measure of alterated biomarkers and measure of safety		72 hours