Safety and Immunogenicity of Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2008-2009

NCT ID: NCT00734734

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2008-07-31

Brief Summary

Trial for annual approval of interpandemic influenza vaccines

Conditions

Interpandemic 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

Intervention Type: BIOLOGICAL

1 single intramuscular dose of influenza vaccine, 2008/2009 NH formulation

Interventions

Seasonal Influenza Vaccine

1 single intramuscular dose of influenza vaccine, 2008/2009 NH formulation

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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
• History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate);
• Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
• Receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; suspected or known HIV infection or HIV-related disease
• A bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
• Within the past 12 months, they have received more than one injection of influenza vaccine
• Within the past 6 months, participants had laboratory confirmed influenza disease; received influenza vaccine
• Within the past 4 weeks participants had received another vaccine; any investigational agent
• An acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days

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

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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

Lanciano, , Italy

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

Pianiga, , Italy

Countries

Italy

Other Identifiers

2008-001047-19

Identifier Type: -

Identifier Source: secondary_id

V70P7S

Identifier Type: -

Identifier Source: org_study_id