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

NCT01730378 | Completed Phase 4 Results

• 1 other identifier: 114695
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 4

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.

Conditions

Influenza

Keywords

Influenza vaccine

Outcome Measures

Primary Outcomes (4)

• Number of Seroconverted Subjects for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.

  A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.

  At Day 42

• Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.

  MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).

  At Day 42

• Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.

  A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.

  At Day 42

• Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.

  Antibody titers were expressed as Geometric mean titers (GMTs).

  At Day 0 and Day 42

Secondary Outcomes (15)

• Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.

  At Day 21

• Number of Subjects Who Were Seroprotected for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.

  At Day 0 and Day 21

• Number of Seroconverted Subjects for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.

  At Day 21

• Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.

  At Day 21

• Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.

  At Days 0 and 21

Study Arms (2)

Prepandrix Group

EXPERIMENTAL

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).

Biological: Prepandrix™

Fluarix Group

ACTIVE COMPARATOR

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.

Biological: Fluarix™

Interventions

Prepandrix™ BIOLOGICAL

2 doses administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).

Also known as: GlaxoSmithKline [GSK] Biologicals' A/Indonesia/5/2005 (H5N1) (pre-) pandemic influenza adjuvanted vaccine

Prepandrix Group

Fluarix™ BIOLOGICAL

1 dose administered intramuscularly in the deltoid region of non-dominant arm.

Also known as: GSK Biologicals' trivalent inactivated influenza split vaccine (Influsplit SSW® 2012/2013)

Fluarix Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Guro Gu, 152703, South Korea

Location

GSK Investigational Site

Gyeonggi-do, 442-723, South Korea

Location

GSK Investigational Site

Incheon, 400-711, South Korea

Location

GSK Investigational Site

Seoul, 150-950, South Korea

Location

Related Publications (1)

• 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.

  PMID: 25910919 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

halofantrine; Lead; fluarix

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 21, 2012
• Study Start: December 5, 2012
• Primary Completion: December 17, 2013
• Study Completion: December 17, 2013
• Last Updated: September 7, 2018
• Results First Posted: December 24, 2014

Record last verified: 2016-05

Locations

KR (4)