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

Novartis

Status and phase: Completed; Phase 1

Conditions: Influenza Infection

Treatments: Biological: Adjuvanted influenza vaccine combine with CpG7909; Biological: Adjuvanted influenza vaccine combined with CpG7909; Biological: Adjuvanted influenza vaccine; Biological: Subunit influenza vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00559975

V95P1

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 5 patient groups

1

Active Comparator group

Treatment:

Biological: Subunit influenza vaccine

2

Active Comparator group

Treatment:

Biological: Adjuvanted influenza vaccine

3

Experimental group

Treatment:

Biological: Adjuvanted influenza vaccine combined with CpG7909

4

Experimental group

Treatment:

Biological: Adjuvanted influenza vaccine combine with CpG7909

Biological: Adjuvanted influenza vaccine combine with CpG7909

5

Experimental group

Treatment:

Biological: Adjuvanted influenza vaccine combine with CpG7909

Biological: Adjuvanted influenza vaccine combine with CpG7909