InfluenzaPhase 2NCT01416571
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Monovalent Pandemic H5N1 Vaccine in Adults
A Phase 2 study testing Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted in people with Influenza, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine GSK1557484A, prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when administered up to 5 years following production. Read more about this study
- Who is it for?
- Ages 18 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
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2011to 28 Sep 2012
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- A male or female 18 to 64 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Stable general health as established by medical history and clinical examination before entering into the study.
- Subject access to a consistent means of telephone contact, 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.
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- 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 for 2 months after completion of the vaccination series.
Who cannot join
- Previous vaccination at any time with an H5N1 vaccine.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence of a temperature ≥ 38.0ºC, or acute symptoms greater than "mild" severity on the scheduled date of first dose.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
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- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Receipt of systemic glucocorticoids within 1 month prior to study enrolment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrolment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.
- Receipt of any immunoglobulins and/or any blood products within 3 months before first study vaccination 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 dosing, are eligible. Persons receiving prophylactic antiplatelet medications, and without a clinically-apparent bleeding tendency, are eligible.
- An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
- Administration of an inactivated or a live, attenuated seasonal influenza vaccine within 14 days before the first study vaccine dose, or of any other vaccine(s) not foreseen by the study protocol within 30 days before the first study vaccine dose.
- Planned administration of any vaccine(s) not foreseen by the study protocol through completion of the Day 42 visit.
- Any known or suspected allergy to any constituent of influenza vaccines, or history of severe reaction to a previous influenza vaccination.
- Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to the first study vaccine dose.
- Lactating or nursing women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety Study of GSK Biologicals' Monovalent Pandemic H5N1 Vaccine 1557484A in Adults Aged 18 - 64 Years
This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine GSK1557484A, prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when administered up to 5 years following production.
- Conditions
- Influenza
- Being tested
- Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
- Keywords
- H5N1, Influenza vaccine, influenza infection, GSK1557484A
- 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
Intramuscular (IM), two doses
| Study group | Role | What they receive |
|---|---|---|
| Influenza A (H5N1) Group | Experimental | Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the 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.
Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer less than (<) 1:10 and a post-vaccination reciprocal HI titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.
Measured: At Day 42
Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.
Measured: At Day 42
Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.
Measured: At Day 42
Secondary outcomes (21)
Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.
A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.
Measured: At Day 0 and Day 42
Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.
Titers are presented as geometric mean titers (GMTs).
Measured: At Day 0 and Day 42
Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.
A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.
Measured: At Day 0 and Day 182
Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.
Titers are presented as geometric mean titers (GMTs).
Measured: At Day 0 and Day 182
Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.
Measured: At Day 0 and Day 182
Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal HI titer (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.
Measured: At Day 182
Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.
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 any solicited local symptoms regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities. Grade 3 Redness/Swelling = Redness/Swelling >100 millimeters (mm).
Measured: During the 7-day follow-up period (Days 0-6) after any vaccination
Duration of Solicited Local Symptoms After Vaccination.
Assessed solicited local symptoms were pain, redness and swelling. Duration was defined as the number of days with any grade of local symptoms.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination. Any fever was defined as axillary temperature ≥ 38 degrees Celsius (°C). Grade 3 = general symptom that prevented normal activities. Grade 3 fever = fever ≥ 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination.
Measured: During the 7-day follow-up period (Days 0-6) after any vaccination
Duration of Solicited General Symptoms After Vaccination.
Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, increased sweating and shivering. Duration was defined as the number of days with any grade of general symptoms.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose
Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities Related = event assessed by the investigator as causally related to the study vaccination.
Measured: From Day 0 to Day 84
Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
Measured: From Day 0 to Day 385
Number of Subjects With Potential Immune Mediated Disease (s) (pIMDs).
pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune aetiology.
Measured: From Day 0 to Day 84 and from Day 0 to Day 385
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents BAS, EOS and HCRIT results.
Measured: At Day 0 and Day 42
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents HBIN, LYM and MON results.
Measured: At Day 0 and Day 42
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents NEU, PLA and RBC results.
Measured: At Day 0 and Day 42
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents WBC, ALT and AST results.
Measured: At Day 0 and Day 42
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIL), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents Total BIL, BIL con/dir, CREA and BUN results.
Measured: At Day 0 and Day 42
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an unsolicited AE regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
Measured: From Day 0 to Day 20 and from Day 0 to Day 84.
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Measured: From Day 0 to Day 84 and from Day 0 to Day 385
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study start12 Aug 2011
- Primary completion29 Nov 2011
- Study completion28 Sep 2012
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 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
- NCT01416571
- Sponsor's protocol ID
- 112691
- Status last verified
- Aug 2016
- First submitted
- 12 Aug 2011
- Last updated
- 21 Sep 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
Godeaux O, Izurieta P, Madariaga M, Drame M, Li P, Vaughn DW. Immunogenicity and safety of AS03A-adjuvanted H5N1 influenza vaccine prepared from bulk antigen after stockpiling for 4 years. Vaccine. 2015 Apr 27;33(18):2189-95. doi: 10.1016/j.vaccine.2014.07.062. Epub 2014 Jul 30.
PubMed 25090645
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of GSK Biologicals' Monovalent Pandemic H5N1 Vaccine 1557484A in Adults Aged 18 - 64 Years
- ClinicalTrials.gov ID
- NCT01416571
- Acronym / sponsor ID
- 112691
- Conditions
- Influenza
- Keywords
- H5N1, Influenza vaccine, influenza infection, GSK1557484A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2011
- Primary completion
- 29 Nov 2011 (actual)
- Study completion
- 28 Sep 2012 (actual)
- First posted
- 15 Aug 2011 (estimated)
- Results
- Posted 16 Apr 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 of GSK Biologicals' vaccine GSK1557484A, prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when administered up to 5 years following production.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Influenza A (H5N1) Group | Experimental | Biological: Influenza A (H5N1) Virus Monovalent Vaccine, AdjuvantedHealthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- A male or female 18 to 64 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Stable general health as established by medical history and clinical examination before entering into the study.
- Subject access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
Key exclusion criteria (16 listed)
- Previous vaccination at any time with an H5N1 vaccine.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence of a temperature ≥ 38.0ºC, or acute symptoms greater than "mild" severity on the scheduled date of first dose.
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, AdjuvantedIntramuscular (IM), two doses | Biological | Influenza A (H5N1) Group |
Primary outcome
Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.
Time frame: At Day 42
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer less than (<) 1:10 and a post-vaccination reciprocal HI titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.
Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.
Time frame: At Day 42
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.
Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.
Time frame: At Day 42
A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.
21 secondary outcomes
Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.
Time frame: At Day 0 and Day 42
Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.
Time frame: At Day 0 and Day 42
Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.
Time frame: At Day 0 and Day 182
Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.
Time frame: At Day 0 and Day 182
Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.
Time frame: At Day 0 and Day 182
Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.
Time frame: At Day 182
Mean Geometric Increase (MGI) for the H5N1 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 follow-up period (Days 0-6) after any vaccination
Duration of Solicited Local Symptoms After Vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day follow-up period (Days 0-6) after any vaccination
Duration of Solicited General Symptoms After Vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose
Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Time frame: From Day 0 to Day 84
Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Time frame: From Day 0 to Day 385
Number of Subjects With Potential Immune Mediated Disease (s) (pIMDs).
Time frame: From Day 0 to Day 84 and from Day 0 to Day 385
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Time frame: At Day 0 and Day 42
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Time frame: At Day 0 and Day 42
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Time frame: At Day 0 and Day 42
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Time frame: At Day 0 and Day 42
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Time frame: At Day 0 and Day 42
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: From Day 0 to Day 20 and from Day 0 to Day 84.
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Time frame: From Day 0 to Day 84 and from Day 0 to Day 385
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25090645Godeaux O, Izurieta P, Madariaga M, Drame M, Li P, Vaughn DW. Immunogenicity and safety of AS03A-adjuvanted H5N1 influenza vaccine prepared from bulk antigen after stockpiling for 4 years. Vaccine. 2015 Apr 27;33(18):2189-95. doi: 10.1016/j.vaccine.2014.07.062. Epub 2014 Jul 30.
- 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 2 study testing Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted in people with Influenza, run by GlaxoSmithKline at 1 site in United States.
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 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 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease. (time frame: At Day 42). 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 NCT01416571, 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 21 Sep 2018.