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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014