Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1, Seasonal Influenza Vaccine, Formulation 2009-2010

NCT ID: NCT00956761

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2009-06-30

Brief Summary

This is a trial for annual registration of the updated seasonal influenza vaccine formulation.

Conditions

Seasonal Influenza

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Seasonal Influenza Vaccine (MF59C.1)

Intervention Type: BIOLOGICAL

1 dose of a surface antigen, inactivated, adjuvanted with MF59C.1, seasonal influenza vaccine, formulation 2009-2010

Interventions

Seasonal Influenza Vaccine (MF59C.1)

1 dose of a surface antigen, inactivated, adjuvanted with MF59C.1, seasonal influenza vaccine, formulation 2009-2010

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects of 65 years of age or older
• Mentally competent
• Willing and able to give written informed consent prior to study entry
• Able to comply with all the study requirements
• In general good health

Exclusion Criteria

• Any serious chronic or acute disease disease
• History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
• A proven hypersensitivity to any component of the study vaccine
• Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
• Bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
• Within the past 12 months, participants had received more than one injection of influenza vaccine
• Within the past 6 months, participants had laboratory confirmed influenza disease or received influenza vaccine

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

Site 2: Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37

Lanciano, , Italy

Site 3: Pianiga Distretto n. 2 - Area Sud - Azienda ULSS 13 Mirano-Via Nazionale 48

Pianiga, , Italy

Countries

Italy

Other Identifiers

2009-010586-23

Identifier Type: -

Identifier Source: secondary_id

V70_09S

Identifier Type: -

Identifier Source: org_study_id