Immunogenicity and Safety of PrepandrixTM in Korean Subjects Aged 18 to 60 Years Old

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: Fluarix™; Biological: Prepandrix™

Study type: Interventional

Funder types: Industry

Identifiers

NCT01730378

114695

Details and patient eligibility

About

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.

Full 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™.

Enrollment: 131 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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131 participants in 2 patient groups

Prepandrix Group

Experimental group

Description:

Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).

Treatment:

Biological: Prepandrix™

Fluarix Group

Active Comparator group

Description:

Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.

Treatment:

Biological: Fluarix™