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Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to NON Elderly AND Elderly Subjects

Primary Purpose

Influenza

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Surface Antigen, Inactivated, Adjuvanted, Influenza Vaccine, Formulation 2007-2008

About this trial

This is an interventional prevention trial for Influenza focused on measuring Adjuvanted Influenza Vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

> 18 years of age or older

Exclusion Criteria:

any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine known or suspected (or high risk of developing) impairment/alteration of immune function within the past 7 days, any acute disease or infections requiring systemic antibiotic or antiviral therapy fever within the past 3 days.No women in breast feeding.

Sites / Locations

Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto sede legale
Presidio Distrettuale No. 8 Azienda Sanitaria USL 7 di Siena

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Safety and immunogenicity of seasonal inactivated, influenza vaccine, formulation 2007-2008, when administered to non-elderly adult and elderly subjects

Secondary Outcome Measures

Full Information

NCT ID

NCT00518726

First Posted

August 20, 2007

Last Updated

November 30, 2016

Sponsor

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT00518726

Brief Title

Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to NON Elderly AND Elderly Subjects

Official Title

A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Surface Antigen, Inactivated, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged > 18 years

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Adjuvanted Influenza Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

125 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Surface Antigen, Inactivated, Adjuvanted, Influenza Vaccine, Formulation 2007-2008

Intervention Description

seasonal influenza vaccine 15ug

Primary Outcome Measure Information:

Title

Safety and immunogenicity of seasonal inactivated, influenza vaccine, formulation 2007-2008, when administered to non-elderly adult and elderly subjects

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: > 18 years of age or older Exclusion Criteria: any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine known or suspected (or high risk of developing) impairment/alteration of immune function within the past 7 days, any acute disease or infections requiring systemic antibiotic or antiviral therapy fever within the past 3 days.No women in breast feeding.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Vaccines

Organizational Affiliation

Novartis Vaccines

Official's Role

Study Chair

Facility Information:

Facility Name

Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio

City

Via dei Vestini

State/Province

Chieti

Country

Italy

Facility Name

Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto sede legale

City

Via S. Spaventa, 37, Lanciano

State/Province

Chieti

Country

Italy

Facility Name

Presidio Distrettuale No. 8 Azienda Sanitaria USL 7 di Siena

City

Siena

ZIP/Postal Code

53100

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to NON Elderly AND Elderly Subjects

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