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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00559975

Enrollment

Registered

2007-11-19

Start date

2007-10-31

Completion date

2008-05-31

Last updated

2009-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza Infection

Keywords

Adjuvanted Influenza Vaccine

Brief summary

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.

Interventions

BIOLOGICALSubunit influenza vaccine

0.5 mL single dose vaccine

BIOLOGICALAdjuvanted influenza vaccine

0.5 mL single dose vaccine

BIOLOGICALAdjuvanted influenza vaccine combined with CpG7909

0.5 ml influenza vaccine combined with 10 mcg of CpG7909

BIOLOGICALAdjuvanted influenza vaccine combine with CpG7909

0.5 mL single dose vaccine combined with 30 mcg of CpG7909

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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;

Design outcomes

Primary

Measure	Time frame
Measures of humoral immunogenicity for each antigen	22 days

Secondary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026