Clinical trial NCT01196975: A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-09-09
Enrollment: 1707
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
timeFrame: At Day 0 (D0) and at Day 21 (D21) post vaccination.
Secondary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
timeFrame: At Day 0 (D0) and at Day 21 (D21) post vaccination.
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
timeFrame: At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.
measure: Number of Subjects With Medically-attended Adverse Events (MAEs)
timeFrame: From the beginning of the study until study end (from Day 0 to Day 180)
measure: Number of Subjects With Related Medically-attended Adverse Events (MAEs)
timeFrame: From the beginning of the study until study end (from Day 0 to Day 180) .
measure: Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)
timeFrame: From the beginning of the study until study end (from Day 0 to Day 180) .
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs)
timeFrame: From the beginning of the study until study end (from Day 0 to Day 180)
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
timeFrame: At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
timeFrame: At Day 0 (D0) and at Day 21 (D21) after vaccination.
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata
timeFrame: At Day 0 (D0) and at Day 21 (D21) after vaccination.
measure: Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata
timeFrame: At Day 0 (D0) and at Day 21 (D21) after vaccination
measure: Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata
timeFrame: At Day 21 (D21) after vaccination.
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
timeFrame: At Day 21 (D21) after vaccination
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
timeFrame: At Day 0 (D0) and at Day 21 (D21) post vaccination.
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
timeFrame: At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.
measure: Number of Seroconverted Subjects Against 4 Strains of Influenza
timeFrame: At Day 21 (D21) after vaccination.
measure: Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata
timeFrame: At Day 21 (D21) after vaccination.
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
timeFrame: At Day 21 (D21) post vaccination.
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
timeFrame: At Day 21 (D21) post vaccination.
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: Within the 7-day (Days 0-6) follow-up period after vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: Within the 7-day (Days 0-6) follow-up period after vaccination
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: Within the 21-day (Days 0-20) follow-up period after vaccination
measure: Number of Days With Solicited Local Symptoms After Vaccination.
timeFrame: Within the 7-day follow-up period after vaccination (Days 0-6)
measure: Number of Days With Solicited General Symptoms After Vaccination
timeFrame: Within the 7-day follow-up period after vaccination (Days 0-6)
measure: Number of Days With Unsolicited Adverse Events (AEs) After Vaccination
timeFrame: Within the 21-day (Days 0-20) follow-up period post vaccination
Other outcomes:
Locations:
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Elkridge
country: United States
facility: GSK Investigational Site
state: Maryland
city: Endwell
country: United States
facility: GSK Investigational Site
state: New York
city: Jefferson Hills
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Wenatchee
country: United States
facility: GSK Investigational Site
state: Washington
city: Coquitlam
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Surrey
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Quebec City
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Cuernavaca
country: Mexico
facility: GSK Investigational Site
state: Morelos
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Estado de Mexico
country: Mexico
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.