Study to Evaluate Safety, Tolerability and Immunogenicity... | NCT00735020

Studies
Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines

NCT00735020

Sponsor

Novartis Vaccines

Status

Completed

Last Update Posted

Jan 24, 2014Estimated

Enrollment

72Actual

Phase

Phase 1

Conditions

Influenza

Interventions

Adjuvanted Influenza Vaccine
Influenza Vaccine

Countries

Switzerland

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

Jan 2014

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 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Aug 13, 2008

First Submission Date that Met QC Criteria

Aug 13, 2008

First Posted Date

Aug 14, 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

Jan 23, 2014

Last Update Posted Date

Jan 24, 2014Estimated

Description Module

Brief Summary

This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.

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

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Biological: Adjuvanted Influenza Vaccine
2	Active Comparator		Biological: Influenza Vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adjuvanted Influenza Vaccine	Biological	1 dose of Adjuvanted Influenza Vaccine	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers.		36 Days

Secondary Outcomes

Measure	Description	Time Frame
To evaluate immunogenicity of a single IM injection of adjuvanted Influenza vaccine		36 Days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy 18 to 39 year old males and females who are in good health and have provided informed consent prior to enrollment

Exclusion Criteria:

serious medical conditions
allergies to vaccine components, including but not limited to egg/chicken products
reduced immune function
recent use of immunosuppressive therapy
recent use of influenza vaccine

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Vaccines	Novartis Vaccines	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
I.P.A.S.		Ligornetto		36 6853	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21906647	Result	Della Cioppa G, Vesikari T, Sokal E, Lindert K, Nicolay U. Trivalent and quadrivalent MF59((R))-adjuvanted influenza vaccine in young children: a dose- and schedule-finding study. Vaccine. 2011 Nov 3;29(47):8696-704. doi: 10.1016/j.vaccine.2011.08.111. Epub 2011 Sep 9.

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures