InfluenzaPhase 4NCT01114620
Study of GSK Biologicals' Influenza Vaccine Arepanrix™ in Japanese Adults 65 Years of Age or Older
A Phase 4 study testing Arepanrix™ in people with Influenza, run by GlaxoSmithKline at 1 site in Japan.
Trial summary
The purpose of this study is to comply with the post marketing condition to the exceptional approval of Arepanrix™ in Japan and to assess the immunogenicity and safety of GSK Biologicals' H1N1 influenza vaccine healthy Japanese adults 65 years of age or older. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Arepanrix™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- 17 May 2010to 9 Dec 2010
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Japanese male and female adults 65 years of age or older at time of vaccination.
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- 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.
- Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Show all 10Show fewer
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- 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 and for 2 months after study vaccination.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- History of previous administration of a pandemic H1N1 vaccine.
- 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 vaccination.
- Diagnosed with cancer, or treatment for cancer within three years.
Show all 19Show fewer
- Persons with a history of cancer who are disease-free without treatment for three years or more are eligible.
- Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are accepted and may enrol, but other histologic types of skin cancer are exclusionary.
- Women who are disease-free three years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period. For corticosteroids, this will mean a dose equivalent to 10 mg/day of prednisone or equivalent when administered for > 2 weeks. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.
- Receipt of any immunoglobulins and/or any blood products within three 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. 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 a clinically-apparent bleeding tendency, are eligible.
- An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 months of receipt of seasonal influenza vaccination.
- Administration of any vaccines within 30 days before vaccination or planned administration before blood sampling at Day 21 and within 30 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 consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- 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 12 months preceding the study start.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine Arepanrix™ (GSK2340274A) in Adults 65 Years of Age or Older
The purpose of this study is to comply with the post marketing condition to the exceptional approval of Arepanrix™ in Japan and to assess the immunogenicity and safety of GSK Biologicals' H1N1 influenza vaccine healthy Japanese adults 65 years of age or older.
- Conditions
- Influenza
- Being tested
- Arepanrix™
- Keywords
- elderly, post-marketing, H1N1, Clinical trial, 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.
Arepanrix™Biological
Intramuscular administration, one dose
| Study group | Role | What they receive |
|---|---|---|
| Arepanrix Group | Experimental | Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0. Receives: Biological: Arepanrix™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies
Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Measured: At Day 21
Number of Seroprotected Subjects for HI Antibodies
Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Measured: At Day 21
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Measured: At Day 21
Secondary outcomes (25)
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Measured: At Days 0 and 21
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Measured: At Days 0 and 182
Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Measured: At Days 0 and 21
Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Measured: At Days 0 and 182
Number of Seroconverted Subjects for HI Antibodies
SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Measured: At Day 182
Number of Seroprotected Subjects for HI Antibodies
Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Measured: At Days 0 and 182
GMFR for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Measured: At Day 182
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Seropositivity cut-off values assessed were equal to or above (≥) 1:8 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Measured: At Days 0 and 21
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Seropositivity cut-off values assessed were equal to or above (≥) 1:8 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Measured: At Days 0 and 182
Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:8. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Measured: At Days 0 and 21
Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:8. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Measured: At Days 0 and 182
Number of Subjects With Vaccine Response Rate (VRR) for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
VRR for microneutralization titers was defined as the proportion of vaccinees with at least a 4-fold increase in post-vaccination reciprocal titer relative to Day 0. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Measured: At Day 21
Number of Subjects With VRR for Neutralizing Antibodies Against Flu A/Netherlands/602/2009 Strain of Influenza Disease
VRR for microneutralization titers was defined as the proportion of vaccinees with at least a 4-fold increase in post-vaccination reciprocal titer relative to Day 0. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).
Measured: At Day 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 the 7-day (Days 0-6) post-vaccination period
Number of Days With Solicited Local Symptoms
The number of days with any solicited local symptoms reported during the solicited post-vaccination period.
Measured: During the 7-day (Days 0-6) post-vaccination period
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 Fever [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 fever = fever ≥ 39.0°C to ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Measured: During the 7-day (Days 0-6) post-vaccination period
Number of Days With Solicited General Symptoms
The number of days with any solicited general symptoms reported during the solicited post-vaccination period.
Measured: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Medically Attended AEs (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Measured: During the 21-day (Days 0-20) post-vaccination period
Number of Subjects With MAEs
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Measured: During the 42-day (Days 0-41) post-vaccination period
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
pIMDs are 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 up to Day 182)
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Among hematological and biochemical parameters assessed were alanine aminotransferase (ALAT), albumin, alkaline phosphatase (AP), aspartate aminotransferase (ASAT), basophils, total bilirubin, bilirubin conjugated/direct, cholesterol, chloride, creatine, creatine kinase (CK), eosinophils, gamma-glutamyl transpeptidase (GGT), hematocrit, hemoglobin, potassium, lactate dyhydrogenase (LDH), lymphocytes, monocytes, sodium, neutrophils, platelets, protein, red blood cells, urate/uric acid, blood urea nitrogen (BUN) and white blood cells. Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter.
Measured: At Day 0 and Day 7
Number of Subjects With Abnormal Urine Sampling Parameters
Among assessed urine sampling parameters were glucose, protein, red blood cells and urobilinogen.
Measured: At Day 0 and Day 7
Number of Subjects With 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 the 21-day (Days 0-20) post-vaccination period
Number of Subjects With Unsolicited 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 the 42-day (Days 0-41) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
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 (from Day 0 up to Day 182)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study start17 May 2010
- Primary completion5 Nov 2010
- Study completion9 Dec 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 (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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114620
- Sponsor's protocol ID
- 114270
- Status last verified
- Oct 2019
- First submitted
- 29 Apr 2010
- Last updated
- 5 Nov 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, Tenjinbaru K, Li P, Madan A, Vaughn D. Evaluation of immune response following one dose of an AS03A-adjuvanted H1N1 2009 pandemic influenza vaccine in Japanese adults 65 years of age or older. Hum Vaccin Immunother. 2012 Aug;8(8):1119-25. doi: 10.4161/hv.21081. Epub 2012 Aug 1.
PubMed 22854661
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine Arepanrix™ (GSK2340274A) in Adults 65 Years of Age or Older
- ClinicalTrials.gov ID
- NCT01114620
- Acronym / sponsor ID
- 114270
- Conditions
- Influenza
- Keywords
- elderly, post-marketing, H1N1, Clinical trial, pandemic influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 May 2010 (actual)
- Primary completion
- 5 Nov 2010 (actual)
- Study completion
- 9 Dec 2010 (actual)
- First posted
- 3 May 2010 (estimated)
- Results
- Posted 14 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to comply with the post marketing condition to the exceptional approval of Arepanrix™ in Japan and to assess the immunogenicity and safety of GSK Biologicals' H1N1 influenza vaccine healthy Japanese adults 65 years of age or older.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arepanrix Group | Experimental | Biological: Arepanrix™Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Japanese male and female adults 65 years of age or older at time of vaccination.
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- 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.
Key exclusion criteria (19 listed)
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- History of previous administration of a pandemic H1N1 vaccine.
- 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 vaccination.
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 |
|---|---|---|
| Arepanrix™Intramuscular administration, one dose | Biological | Arepanrix Group |
Primary outcome
Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies
Time frame: At Day 21
Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Number of Seroprotected Subjects for HI Antibodies
Time frame: At Day 21
Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
Time frame: At Day 21
GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
25 secondary outcomes
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Time frame: At Days 0 and 21
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Time frame: At Days 0 and 182
Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain
Time frame: At Days 0 and 21
Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain
Time frame: At Days 0 and 182
Number of Seroconverted Subjects for HI Antibodies
Time frame: At Day 182
Number of Seroprotected Subjects for HI Antibodies
Time frame: At Days 0 and 182
GMFR for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
Time frame: At Day 182
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Time frame: At Days 0 and 21
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Time frame: At Days 0 and 182
Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
Time frame: At Days 0 and 21
Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
Time frame: At Days 0 and 182
Number of Subjects With Vaccine Response Rate (VRR) for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
Time frame: At Day 21
Number of Subjects With VRR for Neutralizing Antibodies Against Flu A/Netherlands/602/2009 Strain of Influenza Disease
Time frame: At Day 182
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period
Number of Days With Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period
Number of Days With Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Medically Attended AEs (MAEs)
Time frame: During the 21-day (Days 0-20) post-vaccination period
Number of Subjects With MAEs
Time frame: During the 42-day (Days 0-41) post-vaccination period
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Time frame: During the entire study period (from Day 0 up to Day 182)
Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
Time frame: At Day 0 and Day 7
Number of Subjects With Abnormal Urine Sampling Parameters
Time frame: At Day 0 and Day 7
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 21-day (Days 0-20) post-vaccination period
Number of Subjects With Unsolicited AEs
Time frame: During the 42-day (Days 0-41) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Day 0 up to Day 182)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22854661Ikematsu H, Tenjinbaru K, Li P, Madan A, Vaughn D. Evaluation of immune response following one dose of an AS03A-adjuvanted H1N1 2009 pandemic influenza vaccine in Japanese adults 65 years of age or older. Hum Vaccin Immunother. 2012 Aug;8(8):1119-25. doi: 10.4161/hv.21081. Epub 2012 Aug 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Arepanrix™ in people with Influenza, run by GlaxoSmithKline at 1 site 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 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 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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 14 Dec 2017). 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 Hemagglutination Inhibition (HI) Antibodies (time frame: At Day 21). The study lists 3 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 NCT01114620, 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 5 Nov 2019.