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

November 4, 2009 updated by: Novartis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Ligornetto, Switzerland, 6853
        • Institute for Pharmacokinetic and Analytical Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Biological: Adjuvanted influenza vaccine combine with CpG7909
0.5 mL single dose vaccine combined with 100 mcg of CpG7909
Active Comparator: 1
Biological: Subunit influenza vaccine
0.5 mL single dose vaccine
Experimental: 5
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measures of humoral immunogenicity for each antigen
Time Frame: 22 days
22 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Collaborators

Novartis Vaccines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

November 16, 2007

First Submitted That Met QC Criteria

November 16, 2007

First Posted (Estimate)

November 19, 2007

Study Record Updates

Last Update Posted (Estimate)

November 5, 2009

Last Update Submitted That Met QC Criteria

November 4, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V95P1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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