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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Influenza Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Subunit influenza vaccine

Intervention Type BIOLOGICAL

0.5 mL single dose vaccine

2

Group Type ACTIVE_COMPARATOR

Adjuvanted influenza vaccine

Intervention Type BIOLOGICAL

0.5 mL single dose vaccine

3

Group Type EXPERIMENTAL

Adjuvanted influenza vaccine combined with CpG7909

Intervention Type BIOLOGICAL

0.5 ml influenza vaccine combined with 10 mcg of CpG7909

4

Group Type EXPERIMENTAL

Adjuvanted influenza vaccine combine with CpG7909

Intervention Type BIOLOGICAL

0.5 mL single dose vaccine combined with 30 mcg of CpG7909

5

Group Type EXPERIMENTAL

Adjuvanted influenza vaccine combine with CpG7909

Intervention Type BIOLOGICAL

0.5 mL single dose vaccine combined with 100 mcg of CpG7909

Interventions

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Subunit influenza vaccine

0.5 mL single dose vaccine

Intervention Type BIOLOGICAL

Adjuvanted influenza vaccine

0.5 mL single dose vaccine

Intervention Type BIOLOGICAL

Adjuvanted influenza vaccine combined with CpG7909

0.5 ml influenza vaccine combined with 10 mcg of CpG7909

Intervention Type BIOLOGICAL

Adjuvanted influenza vaccine combine with CpG7909

0.5 mL single dose vaccine combined with 30 mcg of CpG7909

Intervention Type BIOLOGICAL

Adjuvanted influenza vaccine combine with CpG7909

0.5 mL single dose vaccine combined with 100 mcg of CpG7909

Intervention Type BIOLOGICAL

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes