Safety and Immunogenicity of Trivalent Split Influenza Va... | NCT00498303

Studies
Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2007/2008

NCT00498303

Sponsor

Novartis

Status

Completed

Last Update Posted

Apr 22, 2008Estimated

Enrollment

120

Phase

Phase 3

Conditions

Seasonal Influenza
Vaccine

Interventions

trivalent split influenza vaccine

Countries

Germany

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
2007-001403-38

Status Module

Record Verification Date

Apr 2008

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 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 9, 2007

First Submission Date that Met QC Criteria

Jul 9, 2007

First Posted Date

Jul 10, 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

Apr 21, 2008

Last Update Posted Date

Apr 22, 2008Estimated

Name	Class
Novartis Vaccines	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Annual trial for registration of trivalent split influenza vaccine with the strain composition of the season 2007/2008 in healthy adult and 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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
trivalent split influenza vaccine	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
evaluate the antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21
evaluate safety of trivalent split influenza vaccine

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
available for all the visits scheduled in the study and able to comply with all study requirements
in good health as determined by: medical history, physical examination, clinical judgment of the investigator

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis Vaccines	Novartis Vaccines	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Werksarztzentrum Herborn		Herborn		35745	Germany

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