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

NCT00559975 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-11-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Novartis Vaccines

    collaborator INDUSTRY

  • Novartis

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Completion
2008-05-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00559975 on ClinicalTrials.gov