Non-Inferiority Study Comparing the Subunit Vaccines Infl... | NCT00325260

Studies
Non-Inferiority Study Comparing the Subunit Vaccines Influvac and Agrippal in China

NCT00325260

Sponsor

Solvay Pharmaceuticals

Status

Completed

Last Update Posted

Nov 1, 2006Estimated

Enrollment

900

Phase

Phase 3

Conditions

Healthy

Interventions

Influvac; subunit influenza vaccine

Countries

China

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

Oct 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

Mar 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 11, 2006

First Submission Date that Met QC Criteria

May 11, 2006

First Posted Date

May 12, 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

Oct 31, 2006

Last Update Posted Date

Nov 1, 2006Estimated

Description Module

Brief Summary

In the study Influvac will be compared to Agrippal, another subunit influenza vaccine that is already on the market in China. The main objective of the study is to show that both vaccines are comparable with regard to efficacy. In addition, safety and efficacy data with Influvac will be assessed in the Chinese 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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

900

Name	Type	Description	Arm Group Labels	Other Names
Influvac; subunit influenza vaccine	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HI titers 4 weeks after vaccination (efficacy) and safety and tolerability

Secondary Outcomes

Measure	Description	Time Frame
HI derived parameters: seroprotection, seroconversion and mean fold increase 4 weeks after vaccination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

signed and dated informed consent
being healthy
mental health enough to understand the study, the informed consent form and the questionnaire

Exclusion Criteria:

known to be allergic to constituents of the vaccine
having an autoimmune disorder, taking immunomodulating drugs or having immune disfunction secondary to HIV
having had a documented serious adverse reaction to previous influenza vaccination
having had documented influenza infection or vaccination in the six months prior to the start of the study
having received any other vaccines, immunoglobulins or investigational drugs in the month prior to the start of the study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Global Clinical Director Solvay	Solvay Pharmaceuticals	Study Director

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