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

NCT ID: NCT00693706

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-02
• Study Completion Date: 2009-03-26

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

GSK 1388442A Group

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.

Group Type: EXPERIMENTAL

Trivalent influenza vaccine GSK 138842A

Intervention Type: BIOLOGICAL

IM injection on Day 0

Fluarix Group

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.

Group Type: ACTIVE_COMPARATOR

Fluarix

Intervention Type: BIOLOGICAL

IM injection on Day 0

Interventions

Trivalent influenza vaccine GSK 138842A

IM injection on Day 0

Intervention Type: BIOLOGICAL

Fluarix

IM injection on Day 0

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 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

Miami, Florida, United States

GSK Investigational Site

Lenexa, Kansas, United States

Countries

United States

Study Documents

Document Type: Study Protocol

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

View Document

Document Type: Statistical Analysis Plan

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

View Document

Document Type: Individual Participant Data Set

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

View Document

Document Type: Dataset Specification

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

View Document

Document Type: Informed Consent Form

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

View Document

Document Type: Clinical Study Report

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

View Document

Document Type: Annotated Case Report Form

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

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

110127

Identifier Type: -

Identifier Source: org_study_id