A Study of the Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Subjects Aged 65 Years and Older

Influenza Clinical Trial

Official title:

Safety and Immunogenicity Trial of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular Route in Subjects Aged 65 Years and Older

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553343
• Other study ID #: QHD01
• Secondary ID: U1111-1161-2450
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2015
• Last updated: February 5, 2018
• Start date: September 2015
• Est. completion date: April 4, 2016

Study information

• Verified date: February 2018
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to assess the safety and immunogenicity of two formulations of the high-dose quadrivalent influenza vaccine compared to the licensed high-dose trivalent influenza vaccine control in healthy elderly subjects aged 65 years of age and above.

Primary objectives:

• To describe the safety profile of all subjects in each study group.

• To demonstrate that the high-dose quadrivalent influenza vaccine induces an immune response (as assessed by HAI geometric mean titers (GMTs) that is non-inferior to responses induced by the licensed high-dose trivalent influenza vaccine for the 3 common virus strains at 28 days post-vaccination.

Secondary objectives:

• To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by seroconversion and seroprotection) for subjects who receive the high-dose quadrivalent influenza vaccine and the licensed high-dose trivalent influenza vaccine.

• To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by GMTs, seroconversion, and seroprotection) for subjects who receive the high-dose quadrivalent influenza vaccine and the investigational high-dose trivalent influenza vaccine.

Description:

All eligible participants will be randomized to receive a single injection of either one of the high-dose quadrivalent influenza vaccine formulations or one of the high-dose trivalent influenza vaccines at Day 0. They will provide blood samples for hemagglutination inhibition (HAI) testing. Safety information as solicited, unsolicited reactions, serious adverse events, including adverse events of special interest will be collected in the trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 792
• Est. completion date: April 4, 2016
• Est. primary completion date: April 4, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Aged = 65 years on the day of inclusion

• Informed consent form has been signed and dated

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

Exclusion Criteria:

• Participation at the time of trial enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure

• Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2

• Vaccination against influenza in the past 6 months

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

• 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 (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances

• Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on investigator's judgment

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

• Substance abuse that, in the opinion of the investigator, might interfere with the trial conduct or completion

• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

• Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, or identified as an immediate family member (i.e., parent, spouse) of the Investigator or employee with direct involvement in the proposed trial

• Personal or family history of Guillain-Barré syndrome

• Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy and subjects who have a history of neoplastic disease and have been disease free for = 5 years)

• Known allergy to iodinated radiocontrast media

• Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C [= 100.4°F]). A prospective subject should not be included in the trial until the condition has resolved or the febrile event has subsided.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• High-dose quadrivalent influenza virus vaccine
0.5 mL, Intramuscular (IM), injected into the deltoid area
• High-dose influenza virus vaccine
0.5 mL, Intramuscular (IM), injected into the deltoid area
• High-dose trivalent inactivated influenza vaccine
0.5 mL, Intramuscular (IM), injected into the deltoid area
• High-dose trivalent inactivated influenza vaccine
0.5 mL, Intramuscular (IM), injected into the deltoid area

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	Number of participants reporting solicited injection site and systemic events, unsolicited adverse events and serious adverse events following vaccination with a dose of Fluzone influenza vaccines	Solicited injection site: Pain, Redness, Swelling, Induration, and Ecchymosis. Solicited systemic reaction: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Unsolicited adverse events, including serious adverse events, will also be collected	Day 0 up to 6 months post-vaccination
Primary	Hemagglutination inhibition (HAI) antibody titers to influenza virus antigens following vaccination with Fluzone High Dose quadrivalent influenza vaccine or High Dose trivalent influenza vaccine		Day 28 post-vaccination
Secondary	Seroconversion with respect to vaccine antigens following vaccination with Fluzone High-dose quadrivalent influenza vaccine or High-dose trivalent influenza vaccine	Seroconversion is defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer = 40 (1/dil), or a pre-vaccination titer = 10 (1/dil) and a = 4-fold increase in post-vaccination titer at 28 days after vaccination.	Day 28 post-vaccination
Secondary	Seroprotection with respect to vaccine antigens following vaccination with Fluzone High-dose quadrivalent influenza vaccine or High-dose trivalent influenza vaccine	Seroprotection is defined as a titer = 40 (l/dil) at pre-vaccination and at 28 days after vaccination.	Day 28 post-vaccination

External Links

•   Link
•   Link