Safety and Tolerability of a Cell-Derived Influenza Vacci... | NCT00599443

Studies
Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years

NCT00599443

Sponsor

Solvay Pharmaceuticals

Status

Completed

Last Update Posted

Jun 30, 2008Estimated

Enrollment

120Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Seasonal cell-derived influenza vaccine
Placebo Comparator

Countries

Not provided

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

Jun 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 2007

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Jan 10, 2008

First Submission Date that Met QC Criteria

Jan 10, 2008

First Posted Date

Jan 23, 2008Estimated

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

Jun 27, 2008

Last Update Posted Date

Jun 30, 2008Estimated

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

A controlled, double blinded study to determine the safety and reactogenicity in healthy adults of a single dose of a trivalent cell-derived influenza vaccine administered by intramuscular injection.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Biological: Seasonal cell-derived influenza vaccine
2	Placebo Comparator		Biological: Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Seasonal cell-derived influenza vaccine	Biological	0.5 mL im, single dose	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability of one dose of cell-derived influenza vaccine in healthy adults aged ≧18 years and ≦ 49 years after vaccination.		3 weeks
Long-term safety		6 months

Secondary Outcomes

Measure	Description	Time Frame
HI antibody titers		3 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy female or male subjects aged ≧18 and ≦49 years
Willing and able to give informed consent

Exclusion Criteria:

Influenza vaccination of laboratory confirmed influenza infection within six months of informed consent,
presence of any significant medical condition,
a serious adverse reaction after a previous (influenza) vaccination,
underlying medical conditions for which annual influenza vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP),
chronic diseases requiring long-term immunosuppressive therapy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Director Solvay	Solvay Pharmaceuticals	Study Director

Locations

Not provided