NCT00559975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

November 5, 2009

Status Verified

November 1, 2009

First QC Date

November 16, 2007

Last Update Submit

November 4, 2009

Conditions

Influenza Infection

Keywords

Adjuvanted Influenza Vaccine

Outcome Measures

Primary Outcomes (1)

  • Measures of humoral immunogenicity for each antigen

    22 days

Secondary Outcomes (2)

  • Measures of vaccine-induced B and T cell immune responses

    72 hours

  • Measure of alterated biomarkers and measure of safety

    72 hours

Study Arms (5)

1

ACTIVE COMPARATOR
Biological: Subunit influenza vaccine

2

ACTIVE COMPARATOR
Biological: Adjuvanted influenza vaccine

3

EXPERIMENTAL
Biological: Adjuvanted influenza vaccine combined with CpG7909

4

EXPERIMENTAL
Biological: Adjuvanted influenza vaccine combine with CpG7909

5

EXPERIMENTAL
Biological: Adjuvanted influenza vaccine combine with CpG7909

Interventions

Subunit influenza vaccineBIOLOGICAL

0.5 mL single dose vaccine

1
Adjuvanted influenza vaccineBIOLOGICAL

0.5 mL single dose vaccine

2
Adjuvanted influenza vaccine combined with CpG7909BIOLOGICAL

0.5 ml influenza vaccine combined with 10 mcg of CpG7909

3
Adjuvanted influenza vaccine combine with CpG7909BIOLOGICAL

0.5 mL single dose vaccine combined with 30 mcg of CpG7909

4

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects aged 18 to ≤40 years

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Pharmacokinetic and Analytical Studies

Ligornetto, 6853, Switzerland

Location

MeSH Terms

Interventions

ProMune

Study Officials

  • Novartis Vaccines

    Novartis Vaccines

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 19, 2007

Study Start

October 1, 2007

Study Completion

May 1, 2008

Last Updated

November 5, 2009

Record last verified: 2009-11

Locations

CH(1)