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

Novartis60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Influenza Infection

Interventions

Subunit influenza vaccineBIOLOGICAL

0.5 mL single dose vaccine

Adjuvanted influenza vaccineBIOLOGICAL

0.5 mL single dose vaccine

Adjuvanted influenza vaccine combined with CpG7909BIOLOGICAL

0.5 ml influenza vaccine combined with 10 mcg of CpG7909

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Locations (1)

Institute for Pharmacokinetic and Analytical Studies

Ligornetto, Switzerland

Outcomes

Primary Outcomes

Measures of humoral immunogenicity for each antigen

Time frame: 22 days

Secondary Outcomes

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

Data from ClinicalTrials.gov

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