A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults
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
1 other identifier
interventional
1,707
3 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2010
Shorter than P25 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2010
CompletedFirst Posted
Study publicly available on registry
September 9, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2011
CompletedResults Posted
Study results publicly available
December 24, 2012
CompletedSeptember 21, 2018
September 1, 2016
4 months
September 7, 2010
November 21, 2012
August 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Results for Day 21 for the subjects in the GSK2282512A Group are the results specific to this primary outcome measure.
At Day 0 (D0) and at Day 21 (D21) post vaccination.
Secondary Outcomes (24)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
At Day 0 (D0) and at Day 21 (D21) post vaccination.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.
Number of Subjects With Medically-attended Adverse Events (MAEs)
From the beginning of the study until study end (from Day 0 to Day 180)
Number of Subjects With Related Medically-attended Adverse Events (MAEs)
From the beginning of the study until study end (from Day 0 to Day 180) .
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)
From the beginning of the study until study end (from Day 0 to Day 180) .
- +19 more secondary outcomes
Study Arms (5)
GSK2282512A 1 Group
EXPERIMENTALSubjects 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.
GSK2282512A 2 Group
EXPERIMENTALSubjects 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.
GSK2282512A 3 Group
EXPERIMENTALSubjects 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.
Victoria Strain FluLaval Group
ACTIVE COMPARATORSubjects 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.
Yamagata Strain FluLaval Group
ACTIVE COMPARATORSubjects 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.
Interventions
Single intramuscular dose
Single intramuscular dose
Single intramuscular dose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (12)
GSK Investigational Site
Mesa, Arizona, 85213, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Elkridge, Maryland, 21075, United States
GSK Investigational Site
Endwell, New York, 13760, United States
GSK Investigational Site
Jefferson Hills, Pennsylvania, 15025, United States
GSK Investigational Site
Wenatchee, Washington, 98801, United States
GSK Investigational Site
Coquitlam, British Columbia, V3K 3P4, Canada
GSK Investigational Site
Surrey, British Columbia, V3R 8P8, Canada
GSK Investigational Site
Québec, Quebec, G1V 4M6, Canada
GSK Investigational Site
Cuernavaca, Morelos, Mexico
GSK Investigational Site
Durango, 3400, Mexico
GSK Investigational Site
Estado de México, 55075, Mexico
Related Publications (1)
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.
PMID: 24486352DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Analyses of duration for solicited local and general and unsolicited adverse events were not performed. Relationship to vaccination was not computed for medically-attended adverse events. Joint pain data were collected in Canada and Mexico only.
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2010
First Posted
September 9, 2010
Study Start
October 1, 2010
Primary Completion
January 25, 2011
Study Completion
June 24, 2011
Last Updated
September 21, 2018
Results First Posted
December 24, 2012
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.