Safety and Immunogenicity of an Adjuvanted Influenza Vacc... | NCT00316628

Studies
Safety and Immunogenicity of an Adjuvanted Influenza Vaccine in Subjects Aged 65 Years and Over.

NCT00316628

Sponsor

Novartis

Status

Completed

Last Update Posted

Sep 14, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Influenza

Interventions

influenza vaccine

Countries

Italy

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Eudract number: 2005-000621-38

Status Module

Record Verification Date

Sep 2006

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

Jun 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 19, 2006

First Submission Date that Met QC Criteria

Apr 19, 2006

First Posted Date

Apr 21, 2006Estimated

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

Sep 13, 2006

Last Update Posted Date

Sep 14, 2006Estimated

Name	Class
Novartis Vaccines	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of an adjuvanted influenza vaccine in elderly subjects.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
influenza vaccine	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.

Secondary Outcomes

Measure	Description	Time Frame
Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

65 years of age or older and in good health

Exclusion Criteria:

Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure.
any acute disease or infections requiring systemic antibiotic or antiviral therapy
hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine
history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
known or suspected (or high risk of developing) impairment/alteration of immune function within the past 7 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Vaccines - Drug Information Services	Novartis	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
G. D'Annunzio University		Chieti		66100	Italy
Office of Hygiene and Public Health, ASL Lanciano

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007252	Influenza Vaccines

Ancestor Terms

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided