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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: Quadrivalent seasonal influenza vaccine GSK2282512A (Biological); FluLavalTM-VB (Biological); FluLavalTM-YB (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

Official title: Immunogenicity, Reactogenicity and Safety of GSK Biologicals' Quadrivalent Influenza Vaccine FLU Q-QIV (GSK2282512A) When Administered Intramuscularly to Adults 18 Years of Age and Older

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

Secondary outcome:

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

Number of Subjects With Medically-attended Adverse Events (MAEs)

Number of Subjects With Related Medically-attended Adverse Events (MAEs)

Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)

Number of Subjects With Any and Related Serious Adverse Events (SAEs)

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

Number of Seroprotected Subjects Against 4 Strains of Influenza Disease

Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata

Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata

Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

Number of Seroconverted Subjects Against 4 Strains of Influenza

Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Number of Days With Solicited Local Symptoms After Vaccination.

Number of Days With Solicited General Symptoms After Vaccination

Number of Days With Unsolicited Adverse Events (AEs) After Vaccination

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

GSK Investigational Site, Durango 3400, Mexico

GSK Investigational Site, Estado de Mexico 55075, Mexico

GSK Investigational Site, Mesa, Arizona 85213, United States

GSK Investigational Site, Coquitlam, British Columbia V3K 3P4, Canada

GSK Investigational Site, Surrey, British Columbia V3R 8P8, Canada

GSK Investigational Site, Wichita, Kansas 67207, United States

GSK Investigational Site, Elkridge, Maryland 21075, United States

GSK Investigational Site, Cuernavaca, Morelos, Mexico

GSK Investigational Site, Endwell, New York 13760, United States

GSK Investigational Site, Jefferson Hills, Pennsylvania 15025, United States

GSK Investigational Site, Quebec City, Quebec G1V 4M6, Canada

GSK Investigational Site, Wenatchee, Washington 98801, United States

Additional Information

Starting date: October 2010
Last updated: November 21, 2012

Page last updated: August 20, 2015

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