Clinical trial NCT01730378: Immunogenicity and Safety of PrepandrixTM in Korean Subjects Aged 18 to 60 Years Old
Official title: Immunogenicity and Safety of GlaxoSmithKline Biologicals' (Pre-) Pandemic Influenza Vaccine Prepandrix™ in Korean Subjects Aged 18 to 60 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the immunogenicity and the safety of PrepandrixTM in Korean subjects. A second group of subjects will receive FluarixTM vaccine as control.

Detailed description: Initially, 124 subjects were planned to be enrolled according to a 1:1 randomisation ratio. However, by mistake, the randomisation application was set up consistent with the vaccine supply ratio (2:1) rather than the treatment group randomization ratio (1:1). Subsequently, the protocol was amended to adjust the sample size and randomisation ratio for the study.

The study will enrol 126 subjects randomised 2:1. 84 subjects will receive Prepandrix™ and 42 subjects will receive Fluarix™.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol. Or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
* Korean male or female subject between, and including, 18 and 60 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject/ from the parent(s)/ Legally Acceptable Representative(s).
* Healthy subjects or free of acute aggravation of the health status as established by medical history and clinical examination before entering into the study.
* 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, has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Acute disease and/or fever at the time of enrollment.
* Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
* Diagnosed with cancer, or treatment for cancer, within the past three years.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including history of human immunodeficiency virus (HIV) infection.
* Family history of congenital or hereditary immunodeficiency.
* Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without any clinically-apparent bleeding tendency, are eligible.
* History of any neurological disorders or seizures.
* An acute evolving neurological disorder or history of Guillan-Barré syndrome.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Any administration of long-acting immune-modifying drugs within three months before study start, or a planned administration during the study period.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Clinically or virologically diagnosed influenza infection within six months preceding the study start.
* Administration of any vaccines within 30 days before vaccination, or planned administration during the study start.
* Previous vaccination against influenza with any seasonal or pandemic vaccine within six months preceding the administration of the study vaccine.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* History of allergy or reactions likely to be exacerbated by any component of the vaccines, including history of a severe adverse reaction to a previous dose of influenza vaccine.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Child in care.

Primary outcomes:
measure: Number of Seroconverted Subjects for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
timeFrame: At Day 42
measure: Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
timeFrame: At Day 42
measure: Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
timeFrame: At Day 42
measure: Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
timeFrame: At Day 0 and Day 42
Secondary outcomes:
measure: Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
timeFrame: At Day 21
measure: Number of Subjects Who Were Seroprotected for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
timeFrame: At Day 0 and Day 21
measure: Number of Seroconverted Subjects for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
timeFrame: At Day 21
measure: Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
timeFrame: At Day 21
measure: Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.
timeFrame: At Days 0 and 21
measure: Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.
timeFrame: At Day 21
measure: Mean Geometric Increase (MGI) for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.
timeFrame: At Day 21
measure: Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.
timeFrame: At Day 0 and Day 21
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
timeFrame: During the 7-day (Day 0-6) period after each vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During the 7-day (Days 0-6) post-vaccination period
measure: Number of Subjects Reporting Any Potential Immune Mediated Diseases (pIMDs).
timeFrame: During the entire study period (From Day 0 to Day 182)
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
timeFrame: During the 21 days (Day 0-20) post-vaccination period
measure: Number of Subjects Reporting Unsolicted AEs
timeFrame: During the 84-day (Days 0-83) post vaccination period
measure: Number of Subjects Any Unsolicited AEs
timeFrame: During the 63-day (Days 21-83) post-dose 2 in Prepandrix Group
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
timeFrame: During the entire study period (From Day 0 to 182)
Other outcomes:
Locations:
city: Guro Gu
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Izurieta P, Kim WJ, Wie SH, Lee J, Lee JS, Drame M, Vaughn DW, Schuind A. Immunogenicity and safety of an AS03-adjuvanted H5N1 pandemic influenza vaccine in Korean adults: a phase IV, randomized, open-label, controlled study. Vaccine. 2015 Jun 4;33(24):2800-7. doi: 10.1016/j.vaccine.2015.04.027. Epub 2015 Apr 21.