Study of Influenza Vaccine (Split Virion, Inactivated) Northern Hemisphere 2009-2010 Formulation

NCT00946179 | Completed Phase 2

• 1 other identifier: GRT86
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

This study is in support of the annual application for the variation of the vaccine strains for a marketing authorization. Objectives:

• To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split virion, inactivated) Northern Hemisphere (NH) 2009-2010 formulation in two adult groups, aged 18 to 60 years and aged 61 years or older.
• To describe the safety of the influenza vaccine (split virion, inactivated) NH 2009-2010 formulation in both adult groups.

Conditions

Influenza

Keywords

Influenza; Influenza virus vaccine; Split virion

Outcome Measures

Primary Outcomes (2)

• To provide information concerning the immunogenicity of intramuscular (IM) Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation.

  21 days post-vaccination

• To provide information concerning the safety of intramuscular (IM) Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation

  0 to 7 days post-vaccination and entire study duration

Study Arms (2)

Group 1

EXPERIMENTAL

Participants aged 18 to 60 years at enrollment

Biological: Influenza virus (split virion, inactivated) vaccine

Group 2

EXPERIMENTAL

Participants aged 61 years or older at enrollment

Biological: Influenza virus (split virion, inactivated) vaccine

Interventions

Influenza virus (split virion, inactivated) vaccine BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Influenza Vaccine Northern Hemisphere 2009-2010 formulation

Group 1; Group 2

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 3 weeks after vaccination

You may not qualify if:

• For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at Visit 1
• Febrile illness (temperature ≥ 38 °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 eggs, chicken proteins, neomycin, formaldehyde and octoxynol-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 (HBs) 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

Allschwil, CH-4123, Switzerland

Location

Unknown Facility

Zurich, CH-8001, Switzerland

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

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: July 22, 2009
• First Posted: July 24, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: January 17, 2014

Record last verified: 2014-01

Locations

CH (2)