InfluenzaPhase 1NCT01059617
Safety and Immune Response of Candidate H1N1 Influenza Vaccine GSK2340274A Following Seasonal Influenza Vaccination in Adults
A Phase 1 study testing GSK Biologicals' FluLaval®, GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A and GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A in people with Influenza, run by GlaxoSmithKline at 3 sites in United States.
Trial summary
This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 19 to 40 years who have never received influenza vaccination. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GSK Biologicals' FluLaval®, GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A and GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Feb 2010to 21 Oct 2011
- Phase
- Phase 1
- 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 19 to 40 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 (e.g., completion of the diary cards, return for follow-up visits).
- Written informed consent obtained from the subject.
- Male or female adults, 19-40 years of age at the time of the first vaccination.
- Body weight of at least 110 pounds (49.9 kg).
- Safety laboratory tests results within the parameters specified by protocol.
- Satisfactory baseline medical assessment by physical examination (stable health status with no exclusionary conditions). Stable health status is defined as the absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrollment.
Show all 14Show fewer
- Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits as documented by signature on the informed consent document.
- 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 (i.e., a common-use phone serving multiple rooms or apartments).
- 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.
- 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 during the entire treatment period and for 2 months after completion of the vaccination series
Who cannot join
- Previous vaccination with an A/California/7/2009 (H1N1)v-like virus vaccine
- A medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
- Prior receipt at any time of any seasonal influenza vaccine.
- Planned administration of any vaccine not foreseen by the study protocol (including any influenza vaccine other than the study vaccine) between Days 0 and the Day 164 phlebotomy.
- Administration of any licensed vaccine within 30 days before the first study vaccine dose.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Show all 18Show fewer
- Receipt of systemic glucocorticoids (e.g., prednisone ≥ 0.5 mg/kg/day, or ≥ 10 mg/day [whichever is less] for more than 14 consecutive days) within one month prior to study enrolment, or any other cytotoxic or immunosuppressive drug within six 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 9 months of study enrolment or planned administration of any of these products during the study period.
- 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.
- History of anemia.
- Presence of a temperature ≥ 38.0ºC (≥100.4ºF), (oral temperature assessment preferred), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination
- Diagnosed with cancer, or treatment for cancer, within 3 years.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. (No laboratory testing is required.)
- 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 acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
- An acute evolving neurological disorder or history of Guillain-Barré syndrome within six weeks of receipt of any vaccine.
- Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to any vaccine.
- Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-HCG) test result prior to first vaccination.
- Lactating or nursing women.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
GSK Investigational Site
Milford, Massachusetts, 01757
GSK Investigational Site
Salisbury, North Carolina, 28144
GSK Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Study to Evaluate Immune Responses Following A/California/7/2009 (H1N1)V-like Virus Vaccination Given 4 Months Following Seasonal Influenza Vaccination in Adults 19 to 40 Years of Age
This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 19 to 40 years who have never received influenza vaccination.
- Conditions
- Influenza
- Being tested
- GSK Biologicals' FluLaval®, Placebo (saline), GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A, GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A
- Keywords
- Pandemic, GSK Bio's influenza vaccine GSK2340274A, H1N1, 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.
GSK Biologicals' FluLaval®Biological
Intramuscular injection
Placebo (saline)Biological
Intramuscular injection
GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274ABiological
Intramuscular injections
GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273ABiological
Intramuscular injections
| Study group | Role | What they receive |
|---|---|---|
| Flulaval/Arepanrix Group | Experimental | subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143. Receives: Biological: GSK Biologicals' FluLaval®; Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A |
| Flulaval/Unadjuvanted Arepanrix Group | Experimental | subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143. Receives: Biological: GSK Biologicals' FluLaval®; Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A |
| Placebo/Arepanrix Group | Experimental | subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143. Receives: Biological: Placebo (saline); Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A |
| Placebo/Unadjuvanted Arepanrix Group | Experimental | subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143. Receives: Biological: Placebo (saline); Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A |
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 Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Seroconversion rate (SCR) was defined as the number of subjects who have 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.
Measured: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.
Measured: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Geometric mean fold-rise (GMFR), or seronversion 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.
Measured: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 122 to Day 164).
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Measured: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Titers were expressed as geometric mean antibody titers (GMTs).
Measured: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.
Measured: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Measured: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.
Measured: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Geometric mean fold-rise (GMFR), or seronversion 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.
Measured: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 122 to Day 164).
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Measured: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Titers were expressed as geometric mean antibody titers (GMTs).
Measured: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.
Measured: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
Secondary outcomes (32)
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Measured: At Day 122 and Day 304
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Titers were expressed as geometric mean antibody titers (GMTs).
Measured: At Days 122 and 304
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.
Measured: Entire study period up to Day 507
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Measured: At Days 0 and 304
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Titers were expressed as geometric mean antibody titers (GMTs).
Measured: At Day 0 and Day 304
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.
Measured: For the entire study period up to Day 507
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
CD4 T cell-mediated immune responses against the antigens A/California/7/2009, A/Brisbane/59/2007 and A/Uruguay/716/2007 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.
The frequency was presented as number of cytokine-producing CD4+ cells per million CD4+ cells. All doubles= T cell expressing at least 2 cytokines.
Subjects with missing results were not included.
Measured: Before administration of Arepanrix vaccine (Day 0 to Day 122)
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
CD4 T cell-mediated immune responses against the antigens A/California/7/2009, A/Brisbane/59/2007 and A/Uruguay/716/2007 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin2, Tumor Necrosis Factor alpha or Interferongamma. The frequency was presented as number of cytokineproducing CD4+ cells per million CD4+ cells. All doubles= T cell expressing at least 2 cytokines.
Measured: After the administration of Arepanrix vaccine (Day 125 to 304)
Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).
pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.
Measured: During the entire study period (up to Day 507).
Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).
MAEs refer to events that required medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Related = symptom assed by the investigator as causally related to the study vaccination.
Measured: During the entire study period (up to Day 507).
Number of Subjects Reporting Unsolicited AEs.
An unsolicited adverse event is any adverse event (i.e. any 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.
Unsolicited AEs were collected after the administration of the Flulaval vaccine or the placebo dose and the data has been pooled based on the vaccination received at Day 0.
Measured: Up to 21-day (Days 0-20) after vaccination
Number of Subjects Reporting Unsolicited AEs.
Unsolicited AEs were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
An unsolicited adverse event is any adverse event (i.e. any 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.
Measured: Within 84 days following first dose or 63 days following second dose of vaccine.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assed by the investigator as causally related to the study vaccination.
Measured: During the entire study period (up to Day 507).
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assed by the investigator as causally related to the study vaccination. Missing values will be added once they become available.
Measured: Up to Day 234
Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).
MAEs refer to events that required medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Related = symptom assed by the investigator as causally related to the study vaccination.
Measured: Within Days 0-233
Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).
pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.
Measured: Within Days 0-233
Number of Subjects Reporting Solicited Local Symptoms From Flulaval Group and Placebo Group.
Solicited local symptoms assessed were pain, redness and swelling and data collected was pooled by administration of vaccination received at Day 0 (i.e. Flulaval or Saline placebo).
Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).
Measured: During the 7-day (Days 0-6) follow-up period after vaccination.
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (= axillary temperature equal to or above 38.0 degrees Celsius (°C)) and data collected was pooled by administration of vaccination received at Day 0 (i.e. Flulaval or Saline placebo).
Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C.
Measured: During the 7-day (Days 0-6) follow-up period after vaccination.
Number of Subjects Reporting Solicited Local Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group,Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group
Solicited local symptoms assessed were pain, redness and swelling and were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).
Measured: During the 7-day (Days 0-6) follow-up period after vaccination.
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (= axillary temperature equal to or above 38.0 degrees Celsius (°C)) and were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C.
Measured: During the 7-day (Days 0-6) follow-up period after vaccination.
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Laboratory parameters assessed were white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), hemoglobin (Hgb), hematocrit (Hct) and platelets (PLA). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).
Measured: On Days 0, 21, 122 and 164
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatise (AP), creatinine (CREA), blood urea nitrogen (BUN) and bilirubin (BIL) (total (T) and direct (D)).
For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).
Measured: On Days 0, 21, 122 and 164
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Laboratory parameters assessed were white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), hemoglobin (Hgb), hematocrit (Hct) and platelets (PLA). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).
Measured: At Day 304
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (AP), creatinine (CREA), blood urea nitrogen (BUN), and bilirubin (BIL) (total (T) and direct (D)). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).
Measured: At Day 304
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Seropositivity rates of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14 and 21 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Measured: Before vaccination and at Days 7, 14, 21 and 122
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Titers were expressed as geometric mean antibody titers (GMTs). GMTs of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Measured: Before vaccination and at Days 7, 14, 21 and 122
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Measured: At Days 122, 129, 136, 143, 150, 157 and 164.
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Titers were expressed as geometric mean antibody titers (GMTs).
Measured: At Days 122, 129, 136, 143, 150, 157 and 164.
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Seropositivity rates of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Measured: Before vaccination and at Days 7, 14, 21 and 122
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Titers were expressed as geometric mean antibody titers (GMTs). GMTs of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Measured: Before vaccination and at Days 7, 14, 21 and 122
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Measured: At Days 122, 129, 136, 143, 150, 157 and 164.
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Titers were expressed as geometric mean antibody titers (GMTs).
Measured: At Days 122, 129, 136, 143, 150, 157 and 164.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study start9 Feb 2010
- Primary completion14 Jan 2011
- Study completion21 Oct 2011
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.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 133 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
- NCT01059617
- Sponsor's protocol ID
- 113483
- Status last verified
- Jan 2018
- First submitted
- 28 Jan 2010
- Last updated
- 20 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Immune Responses Following A/California/7/2009 (H1N1)V-like Virus Vaccination Given 4 Months Following Seasonal Influenza Vaccination in Adults 19 to 40 Years of Age
- ClinicalTrials.gov ID
- NCT01059617
- Acronym / sponsor ID
- 113483
- Conditions
- Influenza
- Keywords
- Pandemic, GSK Bio's influenza vaccine GSK2340274A, H1N1, Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2010 (actual)
- Primary completion
- 14 Jan 2011 (actual)
- Study completion
- 21 Oct 2011 (actual)
- First posted
- 1 Feb 2010 (estimated)
- Results
- Posted 7 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 19 to 40 years who have never received influenza vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Flulaval/Arepanrix Group | Experimental | Biological: GSK Biologicals' FluLaval®, Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274Asubjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143. |
| Flulaval/Unadjuvanted Arepanrix Group | Experimental | Biological: GSK Biologicals' FluLaval®, Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273Asubjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143. |
| Placebo/Arepanrix Group | Experimental | Biological: Placebo (saline), Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274Asubjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143. |
| Placebo/Unadjuvanted Arepanrix Group | Experimental | Biological: Placebo (saline), Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273Asubjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
- Written informed consent obtained from the subject.
- Male or female adults, 19-40 years of age at the time of the first vaccination.
- Body weight of at least 110 pounds (49.9 kg).
- Safety laboratory tests results within the parameters specified by protocol.
Key exclusion criteria (18 listed)
- Previous vaccination with an A/California/7/2009 (H1N1)v-like virus vaccine
- A medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
- Prior receipt at any time of any seasonal influenza vaccine.
- Planned administration of any vaccine not foreseen by the study protocol (including any influenza vaccine other than the study vaccine) between Days 0 and the Day 164 phlebotomy.
- Administration of any licensed vaccine within 30 days before the first study vaccine 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 |
|---|---|---|
| GSK Biologicals' FluLaval®Intramuscular injection | Biological | Flulaval/Arepanrix Group, Flulaval/Unadjuvanted Arepanrix Group |
| Placebo (saline)Intramuscular injection | Biological | Placebo/Arepanrix Group, Placebo/Unadjuvanted Arepanrix Group |
| GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274AIntramuscular injections | Biological | Flulaval/Arepanrix Group, Placebo/Arepanrix Group |
| GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273AIntramuscular injections | Biological | Flulaval/Unadjuvanted Arepanrix Group, Placebo/Unadjuvanted Arepanrix Group |
Primary outcome
Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Time frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
Seroconversion rate (SCR) was defined as the number of subjects who have 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.
Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Time frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Time frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 122 to Day 164).
Geometric mean fold-rise (GMFR), or seronversion 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.
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Time frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Time frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
Titers were expressed as geometric mean antibody titers (GMTs).
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Time frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.
Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Time frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Time frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Time frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 122 to Day 164).
Geometric mean fold-rise (GMFR), or seronversion 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.
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Time frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Time frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
Titers were expressed as geometric mean antibody titers (GMTs).
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Time frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.
32 secondary outcomes
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Time frame: At Day 122 and Day 304
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Time frame: At Days 122 and 304
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Time frame: Entire study period up to Day 507
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Time frame: At Days 0 and 304
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Time frame: At Day 0 and Day 304
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Time frame: For the entire study period up to Day 507
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
Time frame: Before administration of Arepanrix vaccine (Day 0 to Day 122)
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
Time frame: After the administration of Arepanrix vaccine (Day 125 to 304)
Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).
Time frame: During the entire study period (up to Day 507).
Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).
Time frame: During the entire study period (up to Day 507).
Number of Subjects Reporting Unsolicited AEs.
Time frame: Up to 21-day (Days 0-20) after vaccination
Number of Subjects Reporting Unsolicited AEs.
Time frame: Within 84 days following first dose or 63 days following second dose of vaccine.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
Time frame: During the entire study period (up to Day 507).
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
Time frame: Up to Day 234
Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).
Time frame: Within Days 0-233
Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).
Time frame: Within Days 0-233
Number of Subjects Reporting Solicited Local Symptoms From Flulaval Group and Placebo Group.
Time frame: During the 7-day (Days 0-6) follow-up period after vaccination.
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Time frame: During the 7-day (Days 0-6) follow-up period after vaccination.
Number of Subjects Reporting Solicited Local Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group,Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group
Time frame: During the 7-day (Days 0-6) follow-up period after vaccination.
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Time frame: During the 7-day (Days 0-6) follow-up period after vaccination.
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Time frame: On Days 0, 21, 122 and 164
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
Time frame: On Days 0, 21, 122 and 164
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Time frame: At Day 304
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
Time frame: At Day 304
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Time frame: Before vaccination and at Days 7, 14, 21 and 122
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Time frame: Before vaccination and at Days 7, 14, 21 and 122
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Time frame: At Days 122, 129, 136, 143, 150, 157 and 164.
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
Time frame: At Days 122, 129, 136, 143, 150, 157 and 164.
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Time frame: Before vaccination and at Days 7, 14, 21 and 122
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Time frame: Before vaccination and at Days 7, 14, 21 and 122
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Time frame: At Days 122, 129, 136, 143, 150, 157 and 164.
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
Time frame: At Days 122, 129, 136, 143, 150, 157 and 164.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK Biologicals' FluLaval®, GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A and GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A in people with Influenza, run by GlaxoSmithKline at 3 sites 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 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 7 Jun 2012). 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 Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain. (time frame: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.