InfluenzaPhase 2NCT00742885

Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine

A Phase 2 study testing Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted 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

Search all trials

Trial summary

This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' (pre-) pandemic influenza candidate vaccine in healthy Japanese adults. 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 A (H5N1) Virus Monovalent Vaccine, Adjuvanted
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 Sep 2008to 7 Mar 2009
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.
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.
Written informed consent obtained from the subject.
Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

Who cannot join

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.
Diagnosed with cancer, or treatment for cancer within 3 years.
Presence of an axillary temperature >= 37.5 °C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
Receipt of systemic glucocorticoids within 1 month of study enrolment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrolment.

Show all 16Show fewer

Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
Administration of any registered vaccine within 30 days before study enrolment 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.
Use of any investigational or non-registered product within 30 days prior to study enrolment or planned use during the study period.
History of previous H5N1 vaccination, or history of H5N1 influenza infection.
Receipt of any immunoglobulins and/or any blood products within 6 months of study enrolment or planned administration of any of these products during the study period.
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 consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to the time of first vaccination.
Lactating or nursing.
Women of child-bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments; all women will have urine pregnancy tests regardless of their status.
Known receipt of analgesic or antipyretic medication on the day of treatment (Day 0).

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 of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine GSK 1557484A.

This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' (pre-) pandemic influenza candidate vaccine in healthy Japanese adults.

Conditions: Influenza
Being tested: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Keywords: Immunogenicity, Safety, Pandemic Influenza
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 A (H5N1) Virus Monovalent Vaccine, AdjuvantedBiological
Also called PumarixTM
All subjects will receive 2 doses administered as an intramuscular (IM) injection.

Study groups in NCT00742885
Study group	Role	What they receive
Influenza A (H5N1) 20-40 Years Group	Experimental	Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Influenza A (H5N1) 41-64 Years Group	Experimental	Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

What is being measured

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

Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain
Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia/05/2005 antigen (A/Indonesia).
Measured: At Day 0 and Day 42
Number of Subjects Seroconverted for H5N1 HI Antibodies
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The H5N1 vaccine strain included A/Indonesia antigen.
Measured: At Day 42
HI Antibody Seroconversion Factors for H5N1 HI Antibodies
Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.
Measured: At Day 0 and Day 42
Number of Subjects Seroprotected for H5N1 HI Antibodies
A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.
Measured: At Day 42
Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain
Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.
Measured: At Day 0, Day 21 and Day 182

Secondary outcomes (15)

Number of Subjects Seroconverted for H5N1 HI Antibodies
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.
Measured: At Day 21 and Day 182
Seroconversion Factors for H5N1 HI Antibodies
Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.
Measured: At Day 21 and Day 182
Number of Subjects Seroprotected for H5N1 HI Antibodies
A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.
Measured: At Day 0, Day 21 and Day 182
Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies
Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.
Measured: At Day 0, Day 42 and Day 182
Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies
A seroconverted subject was defined as a subject with a minimum 4 fold increase in titer at post-vaccination for neutralising antibody response at Days 42 and 182.
The H5N1 vaccine strain included A/Indonesia antigen.
Measured: At Day 42 and Day 182
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
Biochemical and haematological parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS) and blood urea nitrogen (BUN ). Categories = unknown, below, within, or above the normal ranges.
Measured: At Day 0, Day 7 and Day 42
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
Biochemical and haematological parameters assessed in blood samples include creatinine (CREA), eosinophils (EOS), hemoglobin (HB) and hematocrit (HC).
Categories = unknown, below, within, or above the normal ranges.
Measured: At Day 0, Day 7 and Day 42
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU).
Categories = unknown, below, within, or above the normal ranges.
Measured: At Day 0, Day 7 and Day 42
Number of Subjects With Any Normal or Abnormal Urine Values
Urine parameters assessed were blood, glucose, protein and urobilinogen. Categories = negative, positive
Measured: At Day 0, Day 7 and Day 42
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling/induration. Any=any solicited local symptom reported regardless of their intensity. Grade 3 pain= significant pain at rest that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling/induration=redness and swelling/induration above 100 millimetres (mm).
Measured: During the 7-day post vaccination period (Days 0-6) after any vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increase sweating and fever. Any=any solicited general symptom reported regardless of their intensity grade or their relationship to vaccination. Any fever was ≥ 38.0 degrees celsius (°C). Grade 3 = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever was≥ 39.0°C. Related= general symptom assessed by the investigator as causally related to the study vaccination.
Measured: During the 7-day post vaccination period (Days 0-6) after any vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Unsolicited AE is 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 AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Measured: During the 21-day (Days 0-20) following vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Unsolicited AE is 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 AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Measured: From Day 0 to Day 83 following vaccination
Number of Subjects Reporting Any Medically-significant Conditions (MSCs)
MSCs were defined as AEs with a medically-attended visit (s) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.
Measured: During the 182-day (Days 0-181) post-vaccination period
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: During the entire study period (Day 0 to Day 181)

Timeline

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

1 Sep 20087 Mar 2009

First posted28 Aug 2008 (estimated)
Study start1 Sep 2008
Primary completion7 Mar 2009
Study completion7 Mar 2009

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 (1)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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00742885
Sponsor's protocol ID: 111756
Status last verified: Oct 2016
First submitted: 27 Aug 2008
Last updated: 20 Aug 2018
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

Nagai H, Ikematsu H, Tenjinbaru K, Maeda A, Drame M, Roman FP. A phase II, open-label, multicentre study to evaluate the immunogenicity and safety of an adjuvanted prepandemic (H5N1) influenza vaccine in healthy Japanese adults. BMC Infect Dis. 2010 Nov 25;10:338. doi: 10.1186/1471-2334-10-338.
PubMed 21108818

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?

See locations

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine GSK 1557484A.
ClinicalTrials.gov ID: NCT00742885
Acronym / sponsor ID: 111756
Conditions: Influenza
Keywords: Immunogenicity, Safety, Pandemic Influenza
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Sep 2008
Primary completion: 7 Mar 2009 (actual)
Study completion: 7 Mar 2009 (actual)
First posted: 28 Aug 2008 (estimated)
Results: Posted 24 Feb 2014

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' (pre-) pandemic influenza candidate vaccine in healthy Japanese adults.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Influenza A (H5N1) 20-40 Years Group	Experimental	Biological: Influenza A (H5N1) Virus Monovalent Vaccine, AdjuvantedSubjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Influenza A (H5N1) 41-64 Years Group	Experimental	Biological: Influenza A (H5N1) Virus Monovalent Vaccine, AdjuvantedSubjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.

Who may qualify

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

Key inclusion criteria (6 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.
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.
Written informed consent obtained from the subject.
Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.

Key exclusion criteria (16 listed)

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.
Diagnosed with cancer, or treatment for cancer within 3 years.
Presence of an axillary temperature >= 37.5 °C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.

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 A (H5N1) Virus Monovalent Vaccine, AdjuvantedAlso: PumarixTMAll subjects will receive 2 doses administered as an intramuscular (IM) injection.	Biological	Influenza A (H5N1) 20-40 Years Group, Influenza A (H5N1) 41-64 Years Group

Primary outcome

Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain
Time frame: At Day 0 and Day 42
Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia/05/2005 antigen (A/Indonesia).
Number of Subjects Seroconverted for H5N1 HI Antibodies
Time frame: At Day 42
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The H5N1 vaccine strain included A/Indonesia antigen.
HI Antibody Seroconversion Factors for H5N1 HI Antibodies
Time frame: At Day 0 and Day 42
Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.
Number of Subjects Seroprotected for H5N1 HI Antibodies
Time frame: At Day 42
A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.
Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain
Time frame: At Day 0, Day 21 and Day 182
Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.

15 secondary outcomes

Number of Subjects Seroconverted for H5N1 HI Antibodies
Time frame: At Day 21 and Day 182
Seroconversion Factors for H5N1 HI Antibodies
Time frame: At Day 21 and Day 182
Number of Subjects Seroprotected for H5N1 HI Antibodies
Time frame: At Day 0, Day 21 and Day 182
Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies
Time frame: At Day 0, Day 42 and Day 182
Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies
Time frame: At Day 42 and Day 182
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
Time frame: At Day 0, Day 7 and Day 42
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
Time frame: At Day 0, Day 7 and Day 42
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
Time frame: At Day 0, Day 7 and Day 42
Number of Subjects With Any Normal or Abnormal Urine Values
Time frame: At Day 0, Day 7 and Day 42
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-day post vaccination period (Days 0-6) after any vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day post vaccination period (Days 0-6) after any vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: During the 21-day (Days 0-20) following vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Time frame: From Day 0 to Day 83 following vaccination
Number of Subjects Reporting Any Medically-significant Conditions (MSCs)
Time frame: During the 182-day (Days 0-181) post-vaccination period
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: During the entire study period (Day 0 to Day 181)

Results and safety

Results posted to the registry on 24 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Influenza A (H5N1) 20-40 Years Group	50	49
Influenza A (H5N1) 41-64 Years Group	50	50

Primary outcome: Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain

Time frame: At Day 0 and Day 42. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Influenza A (H5N1) 20-40 Years Group n = 50	Influenza A (H5N1) 41-64 Years Group n = 50
A/Indonesia at Day 0	5.0 (5.0 to 5.0)	5.4 (5.0 to 5.8)
A/Indonesia at Day 42	156.8 (105.8 to 232.3)	142.1 (104.0 to 194.3)

Population analysed: Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.

Primary outcome: Number of Subjects Seroconverted for H5N1 HI Antibodies

Time frame: At Day 42. Count of participants. Unit: Participants

Measure	Influenza A (H5N1) 20-40 Years Group n = 50	Influenza A (H5N1) 41-64 Years Group n = 50
Value	45	46

Primary outcome: HI Antibody Seroconversion Factors for H5N1 HI Antibodies

Time frame: At Day 0 and Day 42. Geometric mean (95% Confidence Interval). Unit: Fold Increase

Measure	Influenza A (H5N1) 20-40 Years Group n = 50	Influenza A (H5N1) 41-64 Years Group n = 50
Value	31.4 (21.2 to 46.5)	26.2 (19.2 to 35.8)

Primary outcome: Number of Subjects Seroprotected for H5N1 HI Antibodies

Time frame: At Day 42. Count of participants. Unit: Participants

Measure	Influenza A (H5N1) 20-40 Years Group n = 50	Influenza A (H5N1) 41-64 Years Group n = 50
Value	45	46

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events = From Days 0-181. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Influenza A (H5N1) 20-40 Years Group	0 of 50 (0%)	50 of 50 (100%)	Not reported
Influenza A (H5N1) 41-64 Years Group	0 of 50 (0%)	50 of 50 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21108818Nagai H, Ikematsu H, Tenjinbaru K, Maeda A, Drame M, Roman FP. A phase II, open-label, multicentre study to evaluate the immunogenicity and safety of an adjuvanted prepandemic (H5N1) influenza vaccine in healthy Japanese adults. BMC Infect Dis. 2010 Nov 25;10:338. doi: 10.1186/1471-2334-10-338.
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.

Related trials for Influenza

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

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 A (H5N1) Virus Monovalent Vaccine, Adjuvanted 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 6 inclusion and 16 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 20 Aug 2018. 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 24 Feb 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?

Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain (time frame: At Day 0 and Day 42). The study lists 5 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 NCT00742885, 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 20 Aug 2018.