Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older

Influenza Clinical Trial

Official title:

Multi-Year Efficacy Study of Fluzone High-Dose Trivalent Vaccine Compared With Fluzone® Vaccine In Adults ≥ 65 Years of Age

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00976027
• Other study ID #: FIM07
• Secondary ID: UTN: U1111-1111-
• Status: Terminated
• Phase: Phase 3
• First received: September 11, 2009
• Last updated: July 24, 2012
• Start date: September 2009
• Est. completion date: April 2012

Study information

• Verified date: July 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine the efficacy of Fluzone High Dose vaccine and that of Fluzone® vaccine in the elderly.

Primary objective:

To measure the efficacy of the vaccine, defined as the prevention of laboratory-confirmed influenza caused by viral types/subtypes that are antigenically similar to those contained in the respective annual vaccine formulations.

Secondary objectives:

• To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, with respect to laboratory-confirmed influenza illness caused by any type or subtype of influenza virus.

• To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, in preventing culture-confirmed influenza illness caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations.

Description:

The occurrence of influenza-like illness (ILI) will be determined in elderly participants vaccinated with either Fluzone High Dose or Fluzone® vaccine.

The presence of influenza virus in the respiratory tract of vaccinated individuals with ILI will be confirmed by two methods.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9172
• Est. completion date: April 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria :

• Aged = 65 years on the day of vaccination

• Informed consent form signed and dated.

• Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria :

• Participation in another interventional clinical trial investigating a vaccine, drug, medical device, herbal supplement, or a medical procedure in the 4 weeks preceding the trial vaccination or planned participation in another clinical trial investigating a vaccine, drug, medical device, herbal supplement, or a medical procedure during each year of participation in the study trial.

• Vaccination against influenza in the 6 months preceding the trial vaccination.

• Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone vaccine or to a vaccine containing any of the same substances.

• Personal history of Guillain-Barré syndrome.

• Dementia or any other cognitive condition at a stage that could interfere with following the trial procedures.

• Thrombocytopenia, bleeding disorder, or anticoagulation therapy contraindicating intramuscular (IM) vaccination.

• Known or suspected human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C seropositivity.

• Alcohol abuse or drug addiction that could interfere with the subject's ability to comply with trial procedures.

• Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

• Bedridden subjects.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Trivalent inactivated influenza vaccine High Dose
0.5 mL, Intramuscular
• Trivalent inactivated influenza vaccine
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI)	Events associated with Protocol defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre-existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).	Day 0 (pre-vaccination) up to the end of the influenza season	No
Other	Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI)	Events associated with CDC defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).	Day 14 (post-vaccination) up to 12 Months post-vaccination	No
Other	Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone	Adverse events of special interest: new onset of Guillain Barre Syndrome (GBS), Bell's Palsy, encephalitis or myelitis, optic neuritis, Stevens Johnson Syndrome, and toxic epidermal necrolysis	Day 0 before vaccination to Day 180 after vaccination	No
Primary	Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations.	The presence (and specific identification) of influenza virus in the respiratory tract of vaccinated individuals with influenza like illness (ILI) was confirmed by tissue culture (for infectious virus) and molecular techniques (polymerase chain reaction based assays), with results reported for cases cause by any viral type or subtype.	Day 0 (pre-vaccination) up to Year 1 post-vaccination	No

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