A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age

Influenza Clinical Trial

Official title:

Safety and Immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258595
• Other study ID #: FIM09
• Secondary ID: UTN: U1111-1113-
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2010
• Last updated: September 19, 2011
• Start date: November 2010
• Est. completion date: April 2011

Study information

• Verified date: September 2011
• 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 the study is to generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age

Primary Objective:

• To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV.

• To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as assessed by solicited adverse reactions collected for 7 days post-vaccination, and unsolicited adverse events (including Serious Adverse Events and Adverse Events of Special Interests) collected between Visit 1 and Visit 2

Description:

Participants will be randomized to receive one dose of either High-Dose Trivalent Inactivated Influenza Vaccine or Trivalent Inactivated Influenza Vaccine. They will be followed up for safety for one month post-vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 64 Years

Eligibility

Inclusion Criteria:

• Aged 50 to 64 years (inclusive) on the day of vaccination

• Informed consent form has been signed and dated

• Medically stable

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

• For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination

Exclusion Criteria:

• Known pregnancy, or a positive urine pregnancy test

• Currently breastfeeding a child

• 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

• Planned receipt of any vaccine in the 4 weeks following the trial vaccination (prior to the Visit 2 blood draw)

• Receipt of seasonal or pandemic influenza vaccine in the past 6 months

• Receipt of blood or blood-derived products in the past 3 months

• Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Trivalent Inactivated Influenza Vaccine or a vaccine containing any of the same substances

• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy

• Neoplastic disease or any hematologic malignancy

• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination

• Personal history of Guillain-Barré Syndrome

• Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C

• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

• Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures

• Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator

Study Design

Allocation: Randomized, Endpoint Classification: Safety/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:
• High-Dose Trivalent Inactivated Influenza Vaccine
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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.	Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.	Day 0 and Day 28 post-vaccination	No
Primary	Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine	Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.	Day 0 and Day 28 Post-vaccination	No
Primary	Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine	Seroconversion: For participants with a Day 0 (pre-vaccination) titer < 10 (1/dilution [1/dil]) a titer = 40 (1/dil), and for participants with a Day 0 titer = 10 (1/dil) a = 4 fold increase of titer on Day 28.; Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.	Day 0 and Day 28 post-vaccination	No
Primary	Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine	Seroprotection was defined as a titer = 40 (1/dilution [1/dil]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.	Day 0 and Day 28 post vaccination	No
Secondary	Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine	Solicited Injection Site Reactions: Pain, Erythema, Swelling, Ecchymosis, and Induration. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering	Day 0 through Day 7 post-vaccination	No

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