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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00559975
First received: November 16, 2007
Last updated: November 4, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Influenza Infection
 Biological: Subunit influenza vaccine
Biological: Adjuvanted influenza vaccine
Biological: Adjuvanted influenza vaccine combined with CpG7909
Biological: Adjuvanted influenza vaccine combine with CpG7909
 Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measures of humoral immunogenicity for each antigen [ Time Frame: 22 days ]

Secondary Outcome Measures:
  • Measures of vaccine-induced B and T cell immune responses [ Time Frame: 72 hours ]
  • Measure of alterated biomarkers and measure of safety [ Time Frame: 72 hours ]

Estimated Enrollment: 60
Study Start Date: October 2007
Study Completion Date: May 2008
Arms Assigned Interventions
Active Comparator: 1 Biological: Subunit influenza vaccine
0.5 mL single dose vaccine
Active Comparator: 2 Biological: Adjuvanted influenza vaccine
0.5 mL single dose vaccine
Experimental: 3 Biological: Adjuvanted influenza vaccine combined with CpG7909
0.5 ml influenza vaccine combined with 10 mcg of CpG7909
Experimental: 4 Biological: Adjuvanted influenza vaccine combine with CpG7909
0.5 mL single dose vaccine combined with 30 mcg of CpG7909
Experimental: 5 Biological: Adjuvanted influenza vaccine combine with CpG7909
0.5 mL single dose vaccine combined with 100 mcg of CpG7909

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559975

Locations
Switzerland
Institute for Pharmacokinetic and Analytical Studies
Ligornetto, Switzerland, 6853
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00559975     History of Changes
Other Study ID Numbers: V95P1
Study First Received: November 16, 2007
Last Updated: November 4, 2009
Health Authority: Switzerland: Swiss Medic

Keywords provided by Novartis:
Adjuvanted Influenza Vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013