Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation

NCT00718146 | Completed Phase 2

• 1 other identifier: GRT83
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

This study is for a new marketing authorization application for the seasonal vaccine strains in compliance with the Note for Guidance (NfG) on harmonization requirements for influenza vaccine from the Committee for Human Medicinal Products (CHMP) Objectives:

• To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine NH 2008-2009 formulation with the requirements of the CHMP NfG CPMP/BWP/214/96.
• To describe the safety of the inactivated, split-virion influenza vaccine, NH 2008-2009 formulation.

Conditions

Influenza; Orthomyxoviridae Infections

Keywords

Influenza; Orthomyxoviridae Infections; Orthomyxoviruses; Split-virion influenza vaccine

Outcome Measures

Primary Outcomes (1)

• Immunogenicity: To provide information concerning the immunogenicity of Influenza vaccine (split virion, inactivated).

  21 days post vaccination

Study Arms (2)

Group 1

EXPERIMENTAL

Age 16 to 60 years

Biological: Split virion, inactivated Influenza vaccine

Group 2

EXPERIMENTAL

Age over 60 years

Biological: Split virion, inactivated Influenza vaccine

Interventions

Split virion, inactivated Influenza vaccine BIOLOGICAL

0.5 mL, Intramuscular (IM)

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of a signed informed consent
• Able to attend all scheduled visits and comply with all trial procedures
• For a woman of child-bearing potential: avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 21 days after vaccination

You may not qualify if:

• For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at visit 01
• Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
• Breast-feeding woman
• Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
• Planned participation in another clinical trial during the present trial period
• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
• Known systemic hypersensitivity to egg proteins, chick proteins, neomycin, formaldehyde and octoxinol 9, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances
• Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
• Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
• Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination
• Planned receipt of any vaccine in the 3 weeks following the trial vaccination
• Previous vaccination against influenza in the previous 6 months
• Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen or Hepatitis C seropositivity
• Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Unknown Facility

Edinburgh, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human; Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Medical Monitor

  Sanofi Pasteur Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2008
• First Posted: July 18, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 17, 2014

Record last verified: 2014-01

Locations

GB (2)