A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults

NCT ID: NCT01196975

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1707 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-01
• Study Completion Date: 2011-06-24

Brief Summary

This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in adults compared to two other influenza vaccines.

This study will also evaluate the lot-to-lot consistency of three vaccine lots.

Conditions

Influenza

Study Design

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

Study Groups

GSK2282512A 1 Group

Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Quadrivalent seasonal influenza vaccine GSK2282512A

Intervention Type: BIOLOGICAL

Single intramuscular dose

GSK2282512A 2 Group

Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Quadrivalent seasonal influenza vaccine GSK2282512A

Intervention Type: BIOLOGICAL

Single intramuscular dose

GSK2282512A 3 Group

Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Quadrivalent seasonal influenza vaccine GSK2282512A

Intervention Type: BIOLOGICAL

Single intramuscular dose

Victoria Strain FluLaval Group

Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: ACTIVE_COMPARATOR

FluLavalTM-VB

Intervention Type: BIOLOGICAL

Single intramuscular dose

Yamagata Strain FluLaval Group

Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: ACTIVE_COMPARATOR

FluLavalTM-YB

Intervention Type: BIOLOGICAL

Single intramuscular dose

Interventions

Quadrivalent seasonal influenza vaccine GSK2282512A

Single intramuscular dose

Intervention Type: BIOLOGICAL

FluLavalTM-VB

Single intramuscular dose

Intervention Type: BIOLOGICAL

FluLavalTM-YB

Single intramuscular dose

Intervention Type: BIOLOGICAL

Other Intervention Names

GSK2282512A; FluLavalTM containing the Victoria B flu strain; FluLaval®-VB; Victoria Strain FluLaval vaccine; FluLavalTM containing the Yamagata B flu strain; FluLaval®-YB

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes can and will comply with the requirements of the protocol
• A male or female 18 years of age or older, in stable health, as established by medical history and physical examination before entering into the study.
• Written informed consent obtained from the subject.
• Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device.
• 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 an investigational / non-registered product other than the study vaccines within 30 days before study vaccination or planned use during study period.
• Planned administration or administration of a licensed vaccine within 30 days before study vaccination.
• Prior receipt of 2010/2011 influenza vaccine.
• Receipt of any investigational or approved influenza vaccine within six months of the first study visit.
• Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to constituent of vaccine; or a history of severe adverse reaction to a previous influenza vaccine.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• History of Guillain-Barre syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• Presence or evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable / unlikely to provide accurate safety reports.
• Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, based on history and physical examination.
• Presence of significant uncontrolled chronic medical or neuropsychiatric illness, based on history and physical examination
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin
• Chronic administration of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine/product dose.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
• Pregnant or lactating female.
• Fever at the time of enrolment.
• Acute disease at the time of enrolment
• Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

• 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

Mesa, Arizona, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Elkridge, Maryland, United States

GSK Investigational Site

Endwell, New York, United States

GSK Investigational Site

Jefferson Hills, Pennsylvania, United States

GSK Investigational Site

Wenatchee, Washington, United States

GSK Investigational Site

Coquitlam, British Columbia, Canada

GSK Investigational Site

Surrey, British Columbia, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Cuernavaca, Morelos, Mexico

GSK Investigational Site

Durango, , Mexico

GSK Investigational Site

Estado de México, , Mexico

Countries

United States; Canada; Mexico

References

Tinoco JC, Pavia-Ruz N, Cruz-Valdez A, Aranza Doniz C, Chandrasekaran V, Dewe W, Liu A, Innis BL, Jain VK. Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged >/=18 years: a phase III, randomized trial. Vaccine. 2014 Mar 14;32(13):1480-7. doi: 10.1016/j.vaccine.2014.01.022. Epub 2014 Jan 28.

Reference Type: DERIVED

PMID: 24486352 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

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: Individual Participant Data Set

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

View Document

Document Type: Study Protocol

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

Document Type: Clinical Study Report

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

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

112963

Identifier Type: -

Identifier Source: org_study_id