Drug Use Investigation for Cell-culture Derived Influenza... | NCT01098786

Studies
Drug Use Investigation for Cell-culture Derived Influenza A (H1N1) Emulsion HA Vaccine

NCT01098786

Sponsor

Novartis Vaccines

Status

Completed

Last Update Posted

Mar 14, 2017Actual

Enrollment

556Actual

Phase

Not provided

Conditions

Swine-Origin Influenza A H1N1 Virus

Interventions

Cell-derived A/H1N1 influenza HA vaccine

Countries

Japan

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

Mar 2017

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

Feb 2010

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Mar 31, 2010

First Submission Date that Met QC Criteria

Apr 2, 2010

First Posted Date

Apr 5, 2010Estimated

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

Mar 13, 2017

Last Update Posted Date

Mar 14, 2017Actual

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

556Actual

Label	Type	Description	Intervention Names
Healthy			Biological: Cell-derived A/H1N1 influenza HA vaccine

Name	Type	Description	Arm Group Labels	Other Names
Cell-derived A/H1N1 influenza HA vaccine	Biological	Single group vaccinated	Healthy

Measure	Description	Time Frame
Evaluate clinical symptoms according to the subject background after vaccination		28 days

Measure	Description	Time Frame
The kinds, degrees, durations and onset ratios of adverse events		28 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Healthy Japanese

Exclusion Criteria:

The person has received any other company's new influenza vaccine (swine-derived A/H1N1) before vaccination with this product.
The person has participated in any clinical study of this product or any other company's new influenza vaccine (swine-derived A/H1N1) and received the investigational vaccine.

The person is regarded as a subject in one of the following items 3) to 6) who is not appropriate to receive preventive vaccination as described in the current package insert.
The person shows obvious fever.
The person obviously suffers from serious acute disease.
The person has obviously shown anaphylaxis due to an ingredient of this vaccine.
The person is otherwise in an inappropriate state to receive preventive vaccination.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Community sample

Sampling Method

Non-Probability Sample