Back to results

Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Influenza vaccine (A/H3N2, A/H1N1, and B strains)

Fluarix

About this trial

This is an interventional prevention trial for Influenza focused on measuring Thimerosal reduced content, Immunogenicity, safety, reactogenicity, Young and elderly adults, Influenza vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or female adults (≥18 yrs)
Stable health status
Provide informed consent
Access to direct phone service (NOT a pay phone or a common-use phone service)
Eligible females must have a negative pregnancy test

Exclusion Criteria:

Febrile illness (>38.0°C oral temperature)
High blood pressure (≥140/90 mmHg)
Significant acute or chronic
Uncontrolled medical or psychiatric illness within 1 month prior to vaccination
Immunosuppressive condition (confirmed or suspected)
Renal impairment
Hepatic dysfunction
Complicated insulin-dependent diabetes mellitus
Unstable cardiopulmonary disease
Blood dyscrasias
Cytotoxic, immunosuppressive drug, or glucocorticoids use within 1 month of vaccination (nasal glucocorticoids allowed)
History of demyelinating disease
Active neurological disorder
Significant alcohol or drug abuse
Significant coagulation disorder (prophylactic antiplatelet medications allowed)
Influenza vaccine administrated within 6 months prior to study vaccination
Administration of any other vaccine from 30 days prior to the end of the study
Use of non-registered drug within 30 days prior to study vaccination
Receipt of immunoglobulins and/or any blood products within 3 months of study vaccination
History or suspected allergy to previous influenza vaccine, or to any constituent of FluLaval™ TR and Fluarix®, or reaction to eggs consumption
Pregnant or nursing female subjects
Female subjects not protected by an acceptable contraception method (except if surgically sterile or post-menopausal)

Sites / Locations

GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site

Outcomes

Primary Outcome Measures

21 days after vaccination: seroconversion rate, seroprotection rate,

geometric mean titer fold increase

Secondary Outcome Measures

Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination;

SAEs over the whole study period

Full Information

NCT ID

NCT00380211

First Posted

September 21, 2006

Last Updated

October 6, 2016

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00380211

Brief Title

Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults

Official Title

A Randomized, Double-Blind Trial Evaluating the Safety and Immunogenicity of an Influenza Vaccine With Reduced Preservative (FluLaval™ TR) and a Standard Influenza Vaccine (Fluarix®) in Subjects Between 18-60 and Over 60 Years of Age.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be compared to a standard immune response criteria, for both young and elderly populations.

Detailed Description

This randomized trial will assess the immune protection offered at Day 21 by FluLaval™ TR, Fluarix® being the comparator. In both groups, immune response will be assessed through a blood test before and 21 days following vaccination. The safety and tolerability of the study vaccine will be contrasted to the comparator vaccine over a period of 42 days following vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Thimerosal reduced content, Immunogenicity, safety, reactogenicity, Young and elderly adults, Influenza vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

660 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Influenza vaccine (A/H3N2, A/H1N1, and B strains)

Intervention Type

Biological

Intervention Name(s)

Fluarix

Primary Outcome Measure Information:

Title

21 days after vaccination: seroconversion rate, seroprotection rate,

Title

geometric mean titer fold increase

Secondary Outcome Measure Information:

Title

Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination;

Title

SAEs over the whole study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female adults (≥18 yrs) Stable health status Provide informed consent Access to direct phone service (NOT a pay phone or a common-use phone service) Eligible females must have a negative pregnancy test Exclusion Criteria: Febrile illness (>38.0°C oral temperature) High blood pressure (≥140/90 mmHg) Significant acute or chronic Uncontrolled medical or psychiatric illness within 1 month prior to vaccination Immunosuppressive condition (confirmed or suspected) Renal impairment Hepatic dysfunction Complicated insulin-dependent diabetes mellitus Unstable cardiopulmonary disease Blood dyscrasias Cytotoxic, immunosuppressive drug, or glucocorticoids use within 1 month of vaccination (nasal glucocorticoids allowed) History of demyelinating disease Active neurological disorder Significant alcohol or drug abuse Significant coagulation disorder (prophylactic antiplatelet medications allowed) Influenza vaccine administrated within 6 months prior to study vaccination Administration of any other vaccine from 30 days prior to the end of the study Use of non-registered drug within 30 days prior to study vaccination Receipt of immunoglobulins and/or any blood products within 3 months of study vaccination History or suspected allergy to previous influenza vaccine, or to any constituent of FluLaval™ TR and Fluarix®, or reaction to eggs consumption Pregnant or nursing female subjects Female subjects not protected by an acceptable contraception method (except if surgically sterile or post-menopausal)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

GSK Investigational Site

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66219

Country

United States

Facility Name

GSK Investigational Site

City

Binghamton

State/Province

New York

ZIP/Postal Code

13901

Country

United States

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

GSK Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76135

Country

United States

Facility Name

GSK Investigational Site

City

Burke

State/Province

Virginia

ZIP/Postal Code

22015

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Links:

URL

https://www.clinicalstudydatarequest.com

Description

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

Available IPD and Supporting Information:

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

IDB-200-001

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

IDB-200-001

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

IDB-200-001

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

IDB-200-001

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

IDB-200-001

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults

We'll reach out to this number within 24 hrs