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InfluenzaPhase 4NCT01730378

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

A Phase 4 study testing Prepandrix™ and Fluarix™ in people with Influenza, run by GlaxoSmithKline at 4 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Prepandrix™ and Fluarix™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
4 sitesSouth Korea
Study dates
5 Dec 2012to 17 Dec 2013
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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 locations and contacts

4 sites in 1 country.

South Korea4 sites

  • GSK Investigational Site

    Guro Gu, 152703

  • GSK Investigational Site

    Gyeonggi-do, 442-723

  • GSK Investigational Site

    Incheon, 400-711

  • GSK Investigational Site

    Seoul, 150-950

Other trials in South Korea

About this study

Official title: Immunogenicity and Safety of GlaxoSmithKline Biologicals' (Pre-) Pandemic Influenza Vaccine Prepandrix™ in Korean Subjects Aged 18 to 60 Years Old

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.

Read the 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™.

Conditions
Influenza
Being tested
Prepandrix™, Fluarix™
Keywords
Influenza vaccine
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prepandrix™Biological

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

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

  • Fluarix™Biological

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

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

Study groups in NCT01730378
Study groupRoleWhat they receive
Prepandrix GroupExperimentalSubjects 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).
Receives: Biological: Prepandrix™
Fluarix GroupActive comparatorSubjects 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.
Receives: Biological: Fluarix™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At Day 42

  2. 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).

    Measured: At Day 42

  3. 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.

    Measured: At Day 42

  4. 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).

    Measured: At Day 0 and Day 42

Secondary outcomes (15)

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

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

    Measured: At Day 21

  2. Number of Subjects Who Were Seroprotected for 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.

    Measured: At Day 0 and Day 21

  3. Number of Seroconverted Subjects for 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.

    Measured: At Day 21

  4. 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).

    Measured: At Day 21

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

    Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).

    Measured: At Days 0 and 21

  6. Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix 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. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2)and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).

    Measured: At Day 21

  7. Mean Geometric Increase (MGI) for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.

    MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).

    Measured: At Day 21

  8. Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix 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. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).

    Measured: At Day 0 and Day 21

  9. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.

    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.

    Measured: During the 7-day (Day 0-6) period after each vaccination

  10. Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.

    Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increased sweating and fever [axillary temperature above 38.0 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider. Grade 3 fever = axillary temperature above 39.0°C

    Measured: During the 7-day (Days 0-6) post-vaccination period

  11. Number of Subjects Reporting Any Potential Immune Mediated Diseases (pIMDs).

    Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

    Measured: During the entire study period (From Day 0 to Day 182)

  12. Number of Subjects Reporting Unsolicited Adverse Events (AEs)

    Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

    Measured: During the 21 days (Day 0-20) post-vaccination period

  13. Number of Subjects Reporting Unsolicted AEs

    Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

    Measured: During the 84-day (Days 0-83) post vaccination period

  14. Number of Subjects Any Unsolicited AEs

    Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

    Measured: During the 63-day (Days 21-83) post-dose 2 in Prepandrix Group

  15. Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)

    A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

    Measured: During the entire study period (From Day 0 to 182)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2012 (estimated)
  2. Study start5 Dec 2012
  3. Primary completion17 Dec 2013
  4. Study completion17 Dec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01730378
Sponsor's protocol ID
114695
Status last verified
May 2016
First submitted
15 Nov 2012
Last updated
7 Sep 2018

Publications

  • 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.

    PubMed 25910919

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prepandrix™ and Fluarix™ in people with Influenza, run by GlaxoSmithKline at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Seroconverted Subjects for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. (time frame: At Day 42). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01730378, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.

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