Safety, Tolerability, Immunogenicity And CPG Dosage Findi... | NCT00559975

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

NCT00559975

Sponsor

Novartis

Status

Completed

Last Update Posted

Nov 5, 2009Estimated

Enrollment

60Estimated

Phase

Phase 1

Conditions

Influenza Infection

Interventions

Subunit influenza vaccine
Adjuvanted influenza vaccine
Adjuvanted influenza vaccine combined with CpG7909
Adjuvanted influenza vaccine combine with CpG7909
Adjuvanted influenza vaccine combine with CpG7909

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Not provided

Completion Date

May 2008Actual

First Submitted Date

Nov 16, 2007

First Submission Date that Met QC Criteria

Nov 16, 2007

First Posted Date

Nov 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2009

Last Update Posted Date

Nov 5, 2009Estimated

Name	Class
Novartis Vaccines	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Subunit influenza vaccine	Biological	0.5 mL single dose vaccine	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measures of humoral immunogenicity for each antigen		22 days

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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;

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Vaccines	Novartis Vaccines	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute for Pharmacokinetic and Analytical Studies		Ligornetto		6853	Switzerland

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms