Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00831987
First received: January 28, 2009
Last updated: January 16, 2014
Last verified: January 2014

January 28, 2009
January 16, 2014
August 2004
February 2006   (final data collection date for primary outcome measure)
  • Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination [ Time Frame: 0 to 3 days post-vaccination ] [ Designated as safety issue: Yes ]

    Solicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site.

    Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia

  • Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine [ Time Frame: Day 0 and Day 21 Post-Vaccination ] [ Designated as safety issue: No ]
    GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation.
  • Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination [ Time Frame: 21 Days post-vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination [ Time Frame: Day 21 post-vaccination ] [ Designated as safety issue: No ]
  • Safety: To provide information concerning the safety after primary administration of Fluzone [ Time Frame: 4 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]
  • Immunogenicity: To provide information concerning the immunogenicity (or immune response) of Fluzone after primary vaccination. [ Time Frame: 21 days post vaccination ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00831987 on ClinicalTrials.gov Archive Site
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Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine
Annual Study of Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005

To observe and to describe the safety during Days 0 to 21 following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years.

To measure and to describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.

The time of onset and duration of local and systemic solicited reactions will be assessed and reported. Unsolicited adverse events (including serious adverse events) will be collected and categorized throughout the study period.

Antibody levels will be evaluated by hemagglutination inhibition (HI) assay from sera obtained pre-vaccination (Day 0) and 21 days post-vaccination, for antigens from the 2004-2005 influenza virus strains: A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2), and B/Jiangsu/10/2003.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
Biological: Fluzone®: Influenza virus vaccine 2004-2005 formulation
0.5 mL, Intramuscular
Other Name: Fluzone®
  • Experimental: Fluzone® Vaccine Group - Age 18-59 Years
    Participants aged 18 to 59 years at enrollment and received 1 dose of Fluzone® Vaccine
    Intervention: Biological: Fluzone®: Influenza virus vaccine 2004-2005 formulation
  • Experimental: Fluzone® Vaccine Group - Age ≥ 60 Years
    Participants aged at least 60 years or older at enrollment and received 1 dose of Fluzone® Vaccine
    Intervention: Biological: Fluzone®: Influenza virus vaccine 2004-2005 formulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
February 2006
February 2006   (final data collection date for primary outcome measure)

Inclusion Criteria :

  • Participant aged 18 years or older.
  • Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
  • Participant is in reasonably good health as assessed by the investigator.
  • Participant willing and able to meet protocol requirements.
  • Participant willing and able to give informed consent.

Exclusion Criteria :

  • Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
  • An acute illness with or without fever (temperature >100.4°F) in the 72 hours preceding enrollment in the trial.
  • Clinically significant findings in vital signs (including temperature >100.4°F) on review of systems.
  • Self-reported history of severe adverse event to any influenza vaccine.
  • Vaccination against influenza in the 6 months preceding enrollment in the study.
  • Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
  • Participation in any other experimental drug or vaccine trial within the 30 days preceding enrollment into the study.
  • Immunogenicity or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 3 months.
  • Receipt of blood or blood products within the 3 months preceding enrollment in the study.
  • Diabetes mellitus requiring pharmacological control.
  • Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled, or could interfere with the evaluation of the vaccine.
  • Person deprived of freedom by an administrative or court order (having legal or medical guardian).
  • For women of childbearing age, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00831987
GRC20
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP