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Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix

Primary Purpose

Influenza

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Trivalent influenza vaccine GSK 138842A

Fluarix

About this trial

This is an interventional prevention trial for Influenza focused on measuring cell culture, Safety, Influenza, Humans, Adults, Immunogenicity, Influenza vaccine, Vaccine

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects who the investigator believes can and will comply with the requirements of the protocol
A male or non-pregnant, non-lactating female between 18 and 49 years of age at the time of vaccination
Access to a telephone for scheduled follow-up telephone contacts
Ability to provide written informed consent
Healthy subjects as established by medical history and physical examination before entering into the study
If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination and continue such precautions for 2 months after receipt of the study vaccine. All women will have a pregnancy test on the day of vaccination.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period
Receipt of systemic glucocorticoids within 30 days of study enrollment
Administration of immunosuppressant, cytotoxic, or other immune-modifying drugs (other than glucocorticoids) or irradiation within 6 months prior to study enrollment or planned administration during the study period
Administration of immunoglobulins and/or blood products within 3 months prior to study enrollment or planned administration during the study period
Previous vaccination against influenza (2007-2008 influenza season)
History of anaphylactic or other allergic reaction to influenza vaccine, any other vaccine, or any vaccine component or excipient
History of Guillain-Barre Syndrome (GBS)
Acute disease, febrile illness, or upper respiratory infection at screening.
History of splenectomy
Any confirmed or suspected, acquired, congenital, or hereditary immunodeficiency or immunosuppressive condition (including human immunodeficiency virus [HIV]) based on medical history and physical examination
Acquired or congenital coagulation disorders or known thrombocytopenia
Current treatment with warfarin or heparin derivatives
Known use of an analgesic or antipyretic medication within 12 hours prior to treatment for the purposes of prophylaxis of adverse events
Any medical condition for which the US Advisory Committee on Immunization Practices recommends vaccination against influenza

Sites / Locations

GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GSK 1388442A Group

Fluarix Group

Arm Description

Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Outcomes

Primary Outcome Measures

Number of Subjects With Solicited Local Symptoms.

Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity.

Number of Subjects With Solicited General Symptoms.

Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination.

Number of Subjects With Medically Attended Adverse Events (MAEs).

Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination.

Number of Subjects With New Onset of Chronic Diseases (NOCDs).

NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.

Number of Subjects With Unsolicited Adverse Events (AEs).

Unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.

Number of Subjects With Serious Adverse Events (SAEs).

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.

Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.

A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease.

GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

Secondary Outcome Measures

Full Information

NCT ID

NCT00693706

First Posted

June 2, 2008

Last Updated

May 9, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00693706

Brief Title

Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix

Official Title

Safety and Immunogenicity Study of GSK Biologicals' Cell Culture-based Influenza Virus Vaccine 1388442A Compared With US Licensed TIV in Healthy Adults

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

June 2, 2008 (undefined)

Primary Completion Date

March 1, 2009 (Actual)

Study Completion Date

March 26, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to compare the safety of & immune response to a single dose of GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed, egg-based trivalent influenza vaccine [Fluarix] in healthy adults.

6. Conditions and Keywords

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

Influenza

Keywords

cell culture, Safety, Influenza, Humans, Adults, Immunogenicity, Influenza vaccine, Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK 1388442A Group

Arm Type

Experimental

Arm Description

Arm Title

Fluarix Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Trivalent influenza vaccine GSK 138842A

Intervention Description

IM injection on Day 0

Intervention Type

Biological

Intervention Name(s)

Fluarix

Intervention Description

IM injection on Day 0

Primary Outcome Measure Information:

Title

Number of Subjects With Solicited Local Symptoms.

Description

Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity.

Time Frame

During the 7-day (Days 0-6) post vaccination period

Title

Number of Subjects With Solicited General Symptoms.

Description

Time Frame

During the 7-day (Days 0-6) post vaccination period

Title

Number of Subjects With Medically Attended Adverse Events (MAEs).

Description

Time Frame

During the entire study period (Days 0-182)

Title

Number of Subjects With New Onset of Chronic Diseases (NOCDs).

Description

NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.

Time Frame

During the entire study period (Days 0-182)

Title

Number of Subjects With Unsolicited Adverse Events (AEs).

Description

Time Frame

During the 90-day (Days 0-89) post-vaccination period

Title

Number of Subjects With Serious Adverse Events (SAEs).

Description

Time Frame

During the entire study period (Days 0-182)

Title

Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease.

Description

Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)

Time Frame

At Day 21

Title

Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.

Description

Time Frame

At Day 21

Title

Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.

Description

Time Frame

At Day 21

Title

Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease.

Description

Time Frame

At Day 0 and Day 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who the investigator believes can and will comply with the requirements of the protocol A male or non-pregnant, non-lactating female between 18 and 49 years of age at the time of vaccination Access to a telephone for scheduled follow-up telephone contacts Ability to provide written informed consent Healthy subjects as established by medical history and physical examination before entering into the study If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination and continue such precautions for 2 months after receipt of the study vaccine. All women will have a pregnancy test on the day of vaccination. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period Receipt of systemic glucocorticoids within 30 days of study enrollment Administration of immunosuppressant, cytotoxic, or other immune-modifying drugs (other than glucocorticoids) or irradiation within 6 months prior to study enrollment or planned administration during the study period Administration of immunoglobulins and/or blood products within 3 months prior to study enrollment or planned administration during the study period Previous vaccination against influenza (2007-2008 influenza season) History of anaphylactic or other allergic reaction to influenza vaccine, any other vaccine, or any vaccine component or excipient History of Guillain-Barre Syndrome (GBS) Acute disease, febrile illness, or upper respiratory infection at screening. History of splenectomy Any confirmed or suspected, acquired, congenital, or hereditary immunodeficiency or immunosuppressive condition (including human immunodeficiency virus [HIV]) based on medical history and physical examination Acquired or congenital coagulation disorders or known thrombocytopenia Current treatment with warfarin or heparin derivatives Known use of an analgesic or antipyretic medication within 12 hours prior to treatment for the purposes of prophylaxis of adverse events Any medical condition for which the US Advisory Committee on Immunization Practices recommends vaccination against influenza

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

33143

Country

United States

Facility Name

GSK Investigational Site

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66219

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

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110127

Available IPD/Information Comments

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

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110127

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

110127

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

110127

Available IPD/Information Comments

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

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110127

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

110127

Available IPD/Information Comments

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

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110127

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 Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix

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