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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718146
• Other study ID #: GRT83
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2008
• Last updated: January 16, 2014
• Start date: June 2008
• Est. completion date: September 2008

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria :

• Aged 18 to 60 years or 61 years and older on the day of inclusion

• 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

Exclusion Criteria :

• 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

• Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Orthomyxoviridae Infections

Intervention

Biological:
• Split virion, inactivated Influenza vaccine
0.5 mL, Intramuscular (IM)
• Split virion, inactivated Influenza vaccine
0.5 mL, Intramuscular (IM)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity: To provide information concerning the immunogenicity of Influenza vaccine (split virion, inactivated).		21 days post vaccination	No

External Links

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