Immunogenicity and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Season Southern Hemisphere) in Adults 18 Years of Age and Above

NCT ID: NCT02369341

Last Updated: 2017-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-29
• Study Completion Date: 2015-06-03

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Southern hemisphere) in adults (18 to 60 years of age) and in the elderly (over 60 years of age).

Conditions

Influenza

Keywords

Southern Hemisphere influenza vaccine; Elderly; Seasonal flu; Fluarix Tetra; Adults; Immunogenicity; Reactogenicity; Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Fluarix Tetra (Southern Hemisphere) Adult Group

Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

Group Type: EXPERIMENTAL

Fluarix Tetra

Intervention Type: BIOLOGICAL

One dose of the Fluarix™ Tetra vaccine was administered to all subjects on Day 0 (Visit 1) intramuscularly into the deltoid of the non-dominant arm.

Fluarix Tetra (Southern Hemisphere) Elderly Group

Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

Group Type: EXPERIMENTAL

Fluarix Tetra

Intervention Type: BIOLOGICAL

One dose of the Fluarix™ Tetra vaccine was administered to all subjects on Day 0 (Visit 1) intramuscularly into the deltoid of the non-dominant arm.

Interventions

Fluarix Tetra

One dose of the Fluarix™ Tetra vaccine was administered to all subjects on Day 0 (Visit 1) intramuscularly into the deltoid of the non-dominant arm.

Intervention Type: BIOLOGICAL

Other Intervention Names

FLU D-QIV (GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra); Influsplit™ Tetra

Eligibility Criteria

Inclusion Criteria

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject prior to performing any study specific procedure.
• A male or female aged 18 years or above at the time of vaccination.
• Healthy subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering into the study.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:

• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination and
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the dose of study vaccine (Day -29 to Day 0), or planned use during the study period.
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
• Administration of long-acting immune-modifying drugs (e.g. rituximab, infliximab, etc.) within 6 months before study start, or planned administration during the study.
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the study vaccination and during the entire study period.
• Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
• Administration of an influenza vaccine within the 6 months preceding the study start or planned use of such vaccines during the study period..
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
• Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Acute disease and/or fever at the time of enrolment.

• Fever is defined as temperature ≥ 38.0°C/100.4°F, measured by any means.
• Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insulin-dependent diabetes mellitus), not stabilised or clinically serious.
• History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
• History of Guillain-Barré syndrome.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, including latex.
• History of severe adverse reaction to a previous influenza vaccination.
• Anaphylaxis following the administration of vaccine(s).
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Belo Horizonte, Minas Gerais, Brazil

GSK Investigational Site

São Paulo, , Brazil

Countries

Brazil

Study Documents

Document Type: Annotated Case Report Form

View Document

Document Type: Study Protocol

View Document

Document Type: Clinical Study Report

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Dataset Specification

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

201959

Identifier Type: -

Identifier Source: org_study_id