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

Influenza Clinical Trial

Official title:

Annual Study of Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831987
• Other study ID #: GRC20
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2009
• Last updated: April 12, 2016
• Start date: August 2004
• Est. completion date: February 2006

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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

Intervention

Biological:
• Fluzone®: Influenza virus vaccine 2004-2005 formulation
0.5 mL, Intramuscular
• Fluzone®: Influenza virus vaccine 2004-2005 formulation
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination	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	0 to 3 days post-vaccination	Yes
Primary	Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine	GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation.	Day 0 and Day 21 Post-Vaccination	No
Primary	Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination		21 Days post-vaccination	Yes
Primary	Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination		Day 21 post-vaccination	No

External Links

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