Study of a Pandemic Influenza Vaccine in Elderly Particip... | NCT00376402

Studies
Study of a Pandemic Influenza Vaccine in Elderly Participants

NCT00376402

Sponsor

Seqirus

Status

Completed

Last Update Posted

Jul 19, 2016Estimated

Enrollment

200

Phase

Phase 2

Conditions

Influenza

Interventions

H5N1 Pandemic Influenza Vaccine

Countries

Australia

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

Status Module

Record Verification Date

Nov 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

Oct 2006

Primary Completion Date

Not provided

Completion Date

Jun 2007

First Submitted Date

Sep 11, 2006

First Submission Date that Met QC Criteria

Sep 13, 2006

First Posted Date

Sep 14, 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

Jul 17, 2016

Last Update Posted Date

Jul 19, 2016Estimated

Description Module

Brief Summary

The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is one of the leading candidates to cause the next influenza pandemic. The elderly are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in a healthy elderly population.

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

200

Name	Type	Description	Arm Group Labels	Other Names
H5N1 Pandemic Influenza Vaccine	Biological

Measure	Description	Time Frame
Safety and immunogenicity

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female participants

Exclusion Criteria:

History of clinically significant medical conditions
History of Guillain-Barre syndrome or active neurological disease
Resident of nursing home or long-term care facility

Accepts Healthy Volunteers

Yes

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
Peter Richmond, Dr	Princess Margaret Hospital for Children	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CMAX, a division of IDT Australia		Adelaide	South Australia	5000	Australia
Princess Margaret Hospital for Children

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