Clinical trial NCT00979602: Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and Older
Official title: A Study to Evaluate the Safety, Immunogenicity, and Relative Efficacy of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Adults Aged 18 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: GSK Bio's influenza vaccine GSK2340274A
Influenza Vaccines
GSK Bio's influenza vaccine GSK2340273A
influenza infection
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-09-18
Enrollment: 4048
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: The purpose of this study is to characterize the safety, immunogenicity, and relative efficacy of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.

Detailed description: Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject.
* Male and female adults, \>= 18 years of age at the time of the first vaccination.
* Satisfactory baseline medical assessment by history and physical examination.
* Safety laboratory test results within the parameters specified in the protocol.
* Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits as demonstrated by signature on the informed consent document.
* 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 first 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:

* Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
* Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine.
* With the exception of seasonal influenza vaccination, administration of any vaccine(s) within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0.
* Planned administration of any vaccine other than the study vaccines between Day 0 and the phlebotomy 21 days after vaccination.
* Planned administration of any monovalent pandemic (H1N1)v-like vaccine other than the study vaccines during the whole study (Day 0 - Day 385).
* Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.
* Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
* Presence of a temperature \>= 38.0ºC (\>= 100.4 ºF), oral temperature assessment preferred, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
* Diagnosed with cancer, or treatment for cancer, within 3 years.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Receipt of systemic glucocorticoids within 1month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors, or imiquimod are allowed.
* Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
* Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
* History of an acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
* With the exception of seasonal influenza vaccination, administration of any vaccines within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0.
* Planned administration of any vaccine other than the study vaccine between Day 0 and the phlebotomy 21 days after the second study vaccine dose.
* Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
* Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to vaccination.
* Lactating or nursing women.

Primary outcomes:
measure: Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
timeFrame: At Day 21
measure: Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
timeFrame: At Day 0
measure: Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
timeFrame: At Day 21
measure: Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
timeFrame: At Day 21
measure: Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases
timeFrame: From Day 14 post-vaccination up to study end (at Day 385)
Secondary outcomes:
measure: Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
timeFrame: At Days 0 and 21
measure: Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
timeFrame: At Days 0 and 21
measure: Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
timeFrame: At Day 42
measure: Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
timeFrame: At Day 42
measure: Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
timeFrame: At Day 182
measure: Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
timeFrame: At Day 182
measure: Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
timeFrame: At Day 42
measure: Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
timeFrame: At Day 182
measure: Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
timeFrame: At Day 42
measure: Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
timeFrame: At Day 182
measure: Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
timeFrame: At Day 42
measure: Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain
timeFrame: At Day 182
measure: Number of A/California Influenza Related Cases
timeFrame: From Day 0 up to the end of ILI surveillance (Day 385)
measure: Number of ILI Symptoms in All Reported ILI Cases
timeFrame: From Day 0 up to the end of ILI surveillance (Day 385)
measure: Number of ILI Symptoms in All Reported ILI Cases
timeFrame: From Day 14 post-vaccination through the end of ILI surveillance (Day 385)
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period
measure: Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels
timeFrame: At Days 7 and 21
measure: Number of Subjects With Any Medically-attended Adverse Events (MAEs)
timeFrame: Throughout the entire study period (Day 0 - Day 385)
measure: Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
timeFrame: Throughout the entire study period (Day 0 - Day 385)
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: Within the 42-day (Days 0-41) post-vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: Throughout the entire study period (Day 0 - Day 385)
Other outcomes:
Locations:
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: DeLand
country: United States
facility: GSK Investigational Site
state: Florida
city: Delray Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Columbia
country: United States
facility: GSK Investigational Site
state: Maryland
city: Rockville
country: United States
facility: GSK Investigational Site
state: Maryland
city: Milford
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Somers Point
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Binghamton
country: United States
facility: GSK Investigational Site
state: New York
city: Camillus
country: United States
facility: GSK Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Willoughby Hills
country: United States
facility: GSK Investigational Site
state: Ohio
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Wenatchee
country: United States
facility: GSK Investigational Site
state: Washington
city: Coquitlam
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Bay Roberts
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Saint John's
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Gatineau
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec City
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: St-Romulad
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Yang WH, Dionne M, Kyle M, Aggarwal N, Li P, Madariaga M, Godeaux O, Vaughn DW. Long-term immunogenicity of an AS03-adjuvanted influenza A(H1N1)pdm09 vaccine in young and elderly adults: an observer-blind, randomized trial. Vaccine. 2013 Sep 13;31(40):4389-97. doi: 10.1016/j.vaccine.2013.07.007. Epub 2013 Jul 12.