InfluenzaPhase 2NCT00771615
Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged 18-64 Years
A Phase 2 study testing GSK A/turkey H5N1 Influenza vaccine in people with Influenza, run by GlaxoSmithKline at 10 sites in 2 countries.
Trial summary
The purpose of this observer-blind study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic when given to adults aged 18-64 years. 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?
- GSK A/turkey H5N1 Influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 469 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 16 Oct 2008to 4 Dec 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female adults 18 to 64 years of age at time of first vaccination, inclusive.
- Written informed consent obtained from the subject.
- Stable health status as defined by absence of a health event satisfying the definition of a SAE, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrollment.
- 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.
- Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
Who cannot join
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically 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 oral temperature >= 37.8ºC, or acute symptoms greater than "mild" severity on the scheduled date of vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficiency condition including history of human immunodeficiency virus (HIV) infection.
- Receipt of systemic glucocorticoids (prednisone >= 10 mg/day for more than 14 consecutive days) within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
- An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
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- Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
- Administration of any vaccines within 30 days before the first study vaccine dose.
- Previous administration of any H5N1 vaccine.
- Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrollment, or during the 12 months following test article administration. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
- Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines; 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 (β-hCG) test result prior to 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 vaccination.
- Known receipt of analgesic or antipyretic medication with the specific intent of prophylaxis of vaccine reactogenicity on the day of vaccination. Subjects on stable chronic regimens of potentially analgesic or anti-pyretic medications for pre-existing diagnoses are not required to discontinue them.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States7 sites
GSK Investigational Site
Anaheim, California, 92801
GSK Investigational Site
Huntsville, Alabama, 35802
GSK Investigational Site
Las Vegas, Nevada, 89130
GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Miami, Florida, 33143
GSK Investigational Site
Missoula, Montana, 59801
GSK Investigational Site
Stockbridge, Georgia, 30281
Canada3 sites
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8
GSK Investigational Site
Sherbrooke, Quebec, J1H 4J6
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2
About this study
Official title: A Trial to Evaluate the Safety & Immunogenicity of Investigational Influenza Vaccine GSK1557484A in Adults 18-64 Yrs of Age
The purpose of this observer-blind study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic when given to adults aged 18-64 years.
Read the detailed description
All enrolled subjects will receive 1 dose of study vaccine. All subjects will attend formal study center visits for safety and immunogenicity assessments on Days 0, 10, 42, 84, and 182 with a telephone safety contact on Day 364.
This Protocol Posting has been updated according to Protocol amendment, 8 Dec 08
- Conditions
- Influenza
- Being tested
- GSK A/turkey H5N1 Influenza vaccine
- Keywords
- human, Avian, safety, vaccines, influenza, pandemic, immunogenicity, H5N1
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK A/turkey H5N1 Influenza vaccineBiological
One dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
| Study group | Role | What they receive |
|---|---|---|
| A/turkey H5N1 influenza Formulation A Group | Experimental | Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: GSK A/turkey H5N1 Influenza vaccine |
| A/turkey H5N1 influenza Formulation B1 Group | Experimental | Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: GSK A/turkey H5N1 Influenza vaccine |
| A/turkey H5N1 influenza Formulation B2 Group | Experimental | Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: GSK A/turkey H5N1 Influenza vaccine |
| A/turkey H5N1 influenza Formulation C1 Group | Experimental | Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: GSK A/turkey H5N1 Influenza vaccine |
| A/turkey H5N1 influenza Formulation C2 Group | Experimental | Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: GSK A/turkey H5N1 Influenza vaccine |
| A/turkey H5N1 influenza Formulation D1 Group | Experimental | Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: GSK A/turkey H5N1 Influenza vaccine |
| A/turkey H5N1 influenza Formulation D2 Group | Experimental | Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: GSK A/turkey H5N1 Influenza vaccine |
| A/turkey H5N1 influenza Formulation E1 Group | Experimental | Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: GSK A/turkey H5N1 Influenza vaccine |
| A/turkey H5N1 influenza Formulation E2 Group | Experimental | Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: GSK A/turkey H5N1 Influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.
Measured: At Day 10
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain
A seroprotected subject against the A/turkey virus strain was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.
Measured: At Day 10
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
HI antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10.
Measured: At Day 10
Secondary outcomes (17)
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.
Measured: At Day 0 to Day 42 and at Day 0 to Day 182
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.
Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10
Measured: At Day 0, Day 10, Day 42 and Day 182
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
Measured: At Day 0 to Day 10, Day 42 and Day 182
HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.
Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10
Measured: At Day 0, Day 10, Day 42 and Day 182
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
A seroprotected subject was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.
Measured: At Day 0, Day 10, Day 42 and Day 182 for A/Indo and at Day 0, Day 42 and Day 182 for A/turkey virus strains.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
Measured: At Day 0 to Day 10, Day 42 and Day 182
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
Measured: At Day 10, Day 42 and Day 182
Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
MN antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28.
Measured: At Day 0, Day 10, Day 42 and Day 182
Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
A seropositive subject was defined as a vaccinated subject who had a MN antibody titer ≥ the cut-off value of 1:28.
Measured: At Day 0, Day 10, Day 42 and Day 182
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.
Measured: At Day 10
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains
VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.
Measured: At Day 42
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.
Measured: At Day 182
Number of Subjects Reporting 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 their intensity grade.
Measured: Within the 7-day (Days 0-6) post vaccination period.
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Solicited general symptoms assessed were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any =occurrence of any solicited general symptoms reported irrespective of intensity grade and relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).
Measured: Within the 7-day (Days 0-6) post vaccination period.
Number of Subjects With Medically-attended Adverse Events (MAEs).
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).
Measured: From Day 0 to Day 378
Number of Subjects Reporting Any 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 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Measured: From Day 0 to Day 42
Number of Subjects Reporting Serious Adverse Events (SAEs).
A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
Measured: From Day 0 to Day 378
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study start16 Oct 2008
- Primary completion26 May 2009
- Study completion4 Dec 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 469 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
- NCT00771615
- Sponsor's protocol ID
- 111729
- Status last verified
- Oct 2016
- First submitted
- 10 Oct 2008
- 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
Risi G, Frenette L, Langley JM, Li P, Riff D, Sheldon E, Vaughn DW, Fries L. Immunological priming induced by a two-dose series of H5N1 influenza antigen, administered alone or in combination with two different formulations of AS03 adjuvant in adults: results of a randomised single heterologous booster dose study at 15 months. Vaccine. 2011 Aug 26;29(37):6408-18. doi: 10.1016/j.vaccine.2011.04.072. Epub 2011 May 7.
PubMed 21554915
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
- A Trial to Evaluate the Safety & Immunogenicity of Investigational Influenza Vaccine GSK1557484A in Adults 18-64 Yrs of Age
- ClinicalTrials.gov ID
- NCT00771615
- Acronym / sponsor ID
- 111729
- Conditions
- Influenza
- Keywords
- human, Avian, safety, vaccines, influenza, pandemic, immunogenicity, H5N1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2008
- Primary completion
- 26 May 2009 (actual)
- Study completion
- 4 Dec 2009 (actual)
- First posted
- 13 Oct 2008 (estimated)
- Results
- Posted 4 Sep 2014
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 observer-blind study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic when given to adults aged 18-64 years.
Detailed description
All enrolled subjects will receive 1 dose of study vaccine. All subjects will attend formal study center visits for safety and immunogenicity assessments on Days 0, 10, 42, 84, and 182 with a telephone safety contact on Day 364.
This Protocol Posting has been updated according to Protocol amendment, 8 Dec 08
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| A/turkey H5N1 influenza Formulation A Group | Experimental | Biological: GSK A/turkey H5N1 Influenza vaccineSubjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| A/turkey H5N1 influenza Formulation B1 Group | Experimental | Biological: GSK A/turkey H5N1 Influenza vaccineSubjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| A/turkey H5N1 influenza Formulation B2 Group | Experimental | Biological: GSK A/turkey H5N1 Influenza vaccineSubjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| A/turkey H5N1 influenza Formulation C1 Group | Experimental | Biological: GSK A/turkey H5N1 Influenza vaccineSubjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| A/turkey H5N1 influenza Formulation C2 Group | Experimental | Biological: GSK A/turkey H5N1 Influenza vaccineSubjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| A/turkey H5N1 influenza Formulation D1 Group | Experimental | Biological: GSK A/turkey H5N1 Influenza vaccineSubjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| A/turkey H5N1 influenza Formulation D2 Group | Experimental | Biological: GSK A/turkey H5N1 Influenza vaccineSubjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| A/turkey H5N1 influenza Formulation E1 Group | Experimental | Biological: GSK A/turkey H5N1 Influenza vaccineSubjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| A/turkey H5N1 influenza Formulation E2 Group | Experimental | Biological: GSK A/turkey H5N1 Influenza vaccineSubjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female adults 18 to 64 years of age at time of first vaccination, inclusive.
- Written informed consent obtained from the subject.
- Stable health status as defined by absence of a health event satisfying the definition of a SAE, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrollment.
- 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.
- 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 evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically 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 oral temperature >= 37.8ºC, or acute symptoms greater than "mild" severity on the scheduled date of vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficiency condition including history of human immunodeficiency virus (HIV) infection.
- Receipt of systemic glucocorticoids (prednisone >= 10 mg/day for more than 14 consecutive days) within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
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 |
|---|---|---|
| GSK A/turkey H5N1 Influenza vaccineOne dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested. | Biological | A/turkey H5N1 influenza Formulation A Group, A/turkey H5N1 influenza Formulation B1 Group, A/turkey H5N1 influenza Formulation B2 Group, A/turkey H5N1 influenza Formulation C1 Group, A/turkey H5N1 influenza Formulation C2 Group, A/turkey H5N1 influenza Formulation D1 Group, A/turkey H5N1 influenza Formulation D2 Group, A/turkey H5N1 influenza Formulation E1 Group, A/turkey H5N1 influenza Formulation E2 Group |
Primary outcome
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Time frame: At Day 10
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain
Time frame: At Day 10
A seroprotected subject against the A/turkey virus strain was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Time frame: At Day 10
HI antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10.
17 secondary outcomes
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
Time frame: At Day 0 to Day 42 and at Day 0 to Day 182
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.
Time frame: At Day 0, Day 10, Day 42 and Day 182
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
Time frame: At Day 0 to Day 10, Day 42 and Day 182
HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.
Time frame: At Day 0, Day 10, Day 42 and Day 182
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
Time frame: At Day 0, Day 10, Day 42 and Day 182 for A/Indo and at Day 0, Day 42 and Day 182 for A/turkey virus strains.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
Time frame: At Day 0 to Day 10, Day 42 and Day 182
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
Time frame: At Day 10, Day 42 and Day 182
Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
Time frame: At Day 0, Day 10, Day 42 and Day 182
Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
Time frame: At Day 0, Day 10, Day 42 and Day 182
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
Time frame: At Day 10
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains
Time frame: At Day 42
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
Time frame: At Day 182
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Time frame: Within the 7-day (Days 0-6) post vaccination period.
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Time frame: Within the 7-day (Days 0-6) post vaccination period.
Number of Subjects With Medically-attended Adverse Events (MAEs).
Time frame: From Day 0 to Day 378
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Time frame: From Day 0 to Day 42
Number of Subjects Reporting Serious Adverse Events (SAEs).
Time frame: From Day 0 to Day 378
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 21554915Risi G, Frenette L, Langley JM, Li P, Riff D, Sheldon E, Vaughn DW, Fries L. Immunological priming induced by a two-dose series of H5N1 influenza antigen, administered alone or in combination with two different formulations of AS03 adjuvant in adults: results of a randomised single heterologous booster dose study at 15 months. Vaccine. 2011 Aug 26;29(37):6408-18. doi: 10.1016/j.vaccine.2011.04.072. Epub 2011 May 7.
- 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
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK A/turkey H5N1 Influenza vaccine in people with Influenza, run by GlaxoSmithKline at 10 sites in 2 countries.
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 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 10 sites in United States, Canada. 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 4 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. (time frame: At Day 10). 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 NCT00771615, 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.