InfluenzaPhase 2NCT00989612

Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1)

A Phase 2 study testing Influenza investigational vaccine GSK2340274A in people with Influenza, run by GlaxoSmithKline at 2 sites in Japan.

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 trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' influenza investigational vaccine GSK2340274A in healthy Japanese adults aged 20-64 years. Read more about this study

Who is it for?: Ages 20 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Influenza investigational vaccine GSK2340274A
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 2 sitesJapan
Study dates: 1 Oct 2009to 19 Apr 2010
Phase: Phase 2
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 20 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Japanese male and female adults 20 to 64 years of age at time of the first vaccination, inclusive.
Good general health as assessed by medical history and physical examination
Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject.
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.
Females of non-childbearing potential may be enrolled in the study.

Show all 10Show fewer

Female of childbearing potential may be enrolled in the study, if she:
has practiced adequate contraception for 30 days prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Who cannot join

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
History of previous administration of a novel [H1N1]v vaccine.
Previous participation in study NCT00742885.
Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
Presence or 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 an axillary temperature >= 37.5 °C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.

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Diagnosed with cancer, or treatment for cancer within 3 years.
Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period.
Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.
Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
An acute evolving neurological disorder or history of Guillain-Barré syndrome.
Administration of any vaccines within 30 days before vaccination or planned administration within the first vaccination up to blood sampling at Day 42 and within 30 days prior to blood sampling at Day 182, with the exception of seasonal influenza vaccine.
Administration of any seasonal influenza vaccine within 14 days before vaccination on Day 0, or planned administration within the first vaccination up to blood sampling at Day 42 and within 14 days prior to blood sampling at Day 182.
Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine; 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 test result prior to the time of first vaccination.
Lactating or nursing female.
Excessive underweight (Body Mass Index [BMI] < 18.5) or excessive obesity (BMI >= 30).
Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
Clinically or virologically confirmed influenza infection within 6 months preceding the study start.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

GSK Investigational Site
Fukuoka, 813-8588
GSK Investigational Site
Tokyo, 204-8585

Other trials in Japan

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Candidate Vaccine GSK2340274A

This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' influenza investigational vaccine GSK2340274A in healthy Japanese adults aged 20-64 years.

Read the detailed description

This Protocol Posting has been updated following Protocol amendment 1\& 2, October 2009. The sections impacted are study design and outcome measures

Conditions: Influenza
Being tested: Influenza investigational vaccine GSK2340274A
Keywords: influenza infection, GSK Biologicals' influenza vaccine GSK2340272A
Medical subject headings: Influenza, Human

What participants receive

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

Influenza investigational vaccine GSK2340274ABiological
Two intramuscular injections on Day 0 and Day 21, respectively

Study groups in NCT00989612
Study group	Role	What they receive
GSK2340274A GROUP	Experimental	Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. Receives: Biological: Influenza investigational vaccine GSK2340274A

What is being measured

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

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Titers are presented as geometric mean titers (GMTs).
Measured: At Day 0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Titers are presented as geometric mean titers (GMTs).
Measured: At Day 21
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Titers are presented as geometric mean titers (GMTs).
Measured: At Day 42
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
Measured: At Day 0
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
Measured: At Day 21
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
Measured: At Day 42
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
Measured: At Day 21
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
Measured: At Day 42
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Measured: At Day 0
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Measured: At Day 21
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Measured: At Day 42
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.
Measured: At Day 21
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.
Measured: At Day 42

Secondary outcomes (15)

Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
Measured: At Days 0, 21, 42 and 182
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Titers are presented as geometric mean titers (GMTs).
Measured: At Days 0, 21, 42 and 182
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
Measured: At Days 21, 42 and 182
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Measured: At Days 0, 21, 42 and 182
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.
Measured: At Days 21, 42 and 182
Titers for Serum Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Titers are presented as geometric mean titers (GMTs).
Measured: At Days 0, 21, 42 and 182
Number of Seropositive Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:8.
Measured: At Days 0, 21, 42 and 182
Number of Seroconverted Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
A seroconverted subject was defined as a vaccinated subject with a minimum 4-fold increase in post vaccination neutralizing titer.
Measured: At Days 21, 42 and 182
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Measured: During a 7-day (Days 0-6) follow-up after each vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During a 7-day (Days 0-6) follow-up after each vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Measured: During a 21-day (Days 0-20) follow-up period after the first vaccination and during a 63-day (Days 21-84) follow-up after the second vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the entire study period (Days 0-182)
Number of Subjects With Any Adverse Events of Specific Interest (AESIs).
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Measured: During the entire study period (Days 0-182)
Number of Days With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. The number of days with any solicited local symptom was assessed in subjects who have reported at least once the symptom.
Measured: During a 7-day (Days 0-6) follow-up after each vaccination
Number of Days With Any Solicited General Symptoms
Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. The number of days with any solicited general symptom was assessed in subjects who have reported at least once the symptom.
Measured: During a 7-day (Days 0-6) follow-up after each vaccination

Timeline

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

1 Oct 200919 Apr 2010

First posted5 Oct 2009 (estimated)
Study start1 Oct 2009
Primary completion19 Apr 2010
Study completion19 Apr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00989612
Sponsor's protocol ID: 113519
Status last verified: Apr 2017
First submitted: 1 Oct 2009
Last updated: 16 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Ikematsu H, Nagai H, Kawashima M, Kawakami Y, Tenjinbaru K, Li P, Walravens K, Gillard P, Roman F. Characterization and long-term persistence of immune response following two doses of an AS03A-adjuvanted H1N1 influenza vaccine in healthy Japanese adults. Hum Vaccin Immunother. 2012 Feb;8(2):260-6. doi: 10.4161/hv.18469. Epub 2012 Feb 1.
PubMed 22426369
Ikematsu H, Nagai H, Kawashima M, Kawakami Y, Tenjinbaru K, Maeda A, Li P, Gillard P, Roman F. Immunogenicity and safety of a novel AS03(A)-adjuvanted H1N1 2009 pandemic influenza vaccine in adults in Japan. Hum Vaccin. 2010 Nov;6(11):888-93. doi: 10.4161/hv.6.11.12851. Epub 2010 Nov 1.
PubMed 20980795

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Candidate Vaccine GSK2340274A
ClinicalTrials.gov ID: NCT00989612
Acronym / sponsor ID: 113519
Conditions: Influenza
Keywords: influenza infection, GSK Biologicals' influenza vaccine GSK2340272A
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Oct 2009
Primary completion: 19 Apr 2010 (actual)
Study completion: 19 Apr 2010 (actual)
First posted: 5 Oct 2009 (estimated)
Results: Posted 16 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' influenza investigational vaccine GSK2340274A in healthy Japanese adults aged 20-64 years.

Detailed description

This Protocol Posting has been updated following Protocol amendment 1\& 2, October 2009. The sections impacted are study design and outcome measures

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
GSK2340274A GROUP	Experimental	Biological: Influenza investigational vaccine GSK2340274AHealthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.

Who may qualify

Ages: 20 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Japanese male and female adults 20 to 64 years of age at time of the first vaccination, inclusive.
Good general health as assessed by medical history and physical examination
Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject.
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.

Key exclusion criteria (20 listed)

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
History of previous administration of a novel [H1N1]v vaccine.
Previous participation in study NCT00742885.
Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
Presence or 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Influenza investigational vaccine GSK2340274ATwo intramuscular injections on Day 0 and Day 21, respectively	Biological	GSK2340274A GROUP

Primary outcome

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Day 0
Titers are presented as geometric mean titers (GMTs).
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Day 21
Titers are presented as geometric mean titers (GMTs).
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Day 42
Titers are presented as geometric mean titers (GMTs).
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Day 0
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Day 21
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Day 42
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Day 21
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Day 42
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Day 0
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Day 21
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Day 42
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Day 21
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Day 42
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.

15 secondary outcomes

Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Days 0, 21, 42 and 182
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Days 0, 21, 42 and 182
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Days 21, 42 and 182
Number of Seroprotected Subjects Against A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Days 0, 21, 42 and 182
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen
Time frame: At Days 21, 42 and 182
Titers for Serum Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Time frame: At Days 0, 21, 42 and 182
Number of Seropositive Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Time frame: At Days 0, 21, 42 and 182
Number of Seroconverted Subjects for Neutralizing Antibodies Against A/Neth/602/09 (H1N1)V-like Antigen
Time frame: At Days 21, 42 and 182
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During a 7-day (Days 0-6) follow-up after each vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During a 7-day (Days 0-6) follow-up after each vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: During a 21-day (Days 0-20) follow-up period after the first vaccination and during a 63-day (Days 21-84) follow-up after the second vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (Days 0-182)
Number of Subjects With Any Adverse Events of Specific Interest (AESIs).
Time frame: During the entire study period (Days 0-182)
Number of Days With Any Solicited Local Symptoms
Time frame: During a 7-day (Days 0-6) follow-up after each vaccination
Number of Days With Any Solicited General Symptoms
Time frame: During a 7-day (Days 0-6) follow-up after each vaccination

Results and safety

Results posted to the registry on 16 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK2340274A Group	100	100

Primary outcome: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen

Time frame: At Day 0. Geometric mean (97.5% Confidence Interval). Unit: Titers

Measure	GSK2340274A Group n = 100
Value	8.8 (7.3 to 10.5)

Population analysed: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, who received the 2 vaccine doses and for whom assay results for antibodies against vaccine antigen were available.

Primary outcome: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen

Time frame: At Day 21. Geometric mean (97.5% Confidence Interval). Unit: Titers

Measure	GSK2340274A Group n = 100
Value	230.3 (177.7 to 298.4)

Primary outcome: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen

Time frame: At Day 42. Geometric mean (97.5% Confidence Interval). Unit: Titers

Measure	GSK2340274A Group n = 100
Value	485.0 (420.3 to 559.7)

Primary outcome: Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies A/California/7/2009 (H1N1)V-like Antigen

Time frame: At Day 0. Count of participants. Unit: Participants

Measure	GSK2340274A Group n = 100
Value	43

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Day 182).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK2340274A Group	2 of 100 (2%)	100 of 100 (100%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22426369Ikematsu H, Nagai H, Kawashima M, Kawakami Y, Tenjinbaru K, Li P, Walravens K, Gillard P, Roman F. Characterization and long-term persistence of immune response following two doses of an AS03A-adjuvanted H1N1 influenza vaccine in healthy Japanese adults. Hum Vaccin Immunother. 2012 Feb;8(2):260-6. doi: 10.4161/hv.18469. Epub 2012 Feb 1.
Derived from this study: PubMed 20980795Ikematsu H, Nagai H, Kawashima M, Kawakami Y, Tenjinbaru K, Maeda A, Li P, Gillard P, Roman F. Immunogenicity and safety of a novel AS03(A)-adjuvanted H1N1 2009 pandemic influenza vaccine in adults in Japan. Hum Vaccin. 2010 Nov;6(11):888-93. doi: 10.4161/hv.6.11.12851. Epub 2010 Nov 1.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Influenza investigational vaccine GSK2340274A in people with Influenza, run by GlaxoSmithKline at 2 sites in Japan.

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 10 inclusion and 20 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 16 Jan 2019). 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?

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen (time frame: At Day 0). The study lists 13 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 NCT00989612, which also lists 2 linked publications.

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 16 Jan 2019.