Study Comparing the Immune Response of Fluarix and Fluzone Influenza Vaccines

Phase 3

Completed

• Conditions: Influenza

• Registration Number: NCT00197288
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to compare two licensed influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and the safety/ any symptoms that may occur for up to six months after vaccination.

Detailed Description

* Experimental design: multi-center, randomized (1:1), observer-blind, active-controlled study in 2 parallel groups with approximately:

* Study vaccine: full dose of Fluarix by IM administration.

* Control vaccine: full dose of Fluzone by IM administration.

* Two scheduled visits per subject at days 0 (visit 1) and 21(visit 2) with blood sample collected at each visit to evaluate the immune response. There will be a final contact with each subject 6 months after vaccination for safety follow up and study conclusion.

* Vaccination schedule: one IM injection at day 0.

* Type of study: Self contained.

Study Timeline

• Study First Submitted: 2005-09-19
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-20
• Study Start: 2005-10
• Primary Completion: 2006-05
• Study Completion: 2006-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1847

Inclusion Criteria

• All adults 18 years and older.
• Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visit and completion of the diary cards) should be enrolled in the study.
• Written informed consent obtained from the subject.
• If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions .

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
• Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
• History of hypersensitivity to a previous dose of influenza vaccine.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, gelatine, formaldehyde, gentamicin sulphate, thimerosal or sodium deoxycholate.
• Acute disease at the time of enrollment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F)).
• History of Guillain Barré syndrome within 6 weeks of prior receipt of inactivated influenza virus vaccine.
• Pregnancy and lactating females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Immunological non-inferiority (GMT & seroconversion rates) of Fluarix vs Fluzone 21 days post-vaccination in adults (18 yrs)

Secondary Outcome Measures

Name	Time	Method
Immuno comparison of Fluarix vs Fluzone post-vacc in immunologically -competent, -compromised, overall, stratified by age
Safety comparison (sol local, general & unsol AEs, SAEs)
Non-inferiority of Fluarix vs Fluzone 21 days post-vacc in elderly (>65 yrs)

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Marshfield, Wisconsin, United States