Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A)

Reactogenicity and Immunogenicity Study of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1119711A) Administered According to Different Vaccination Schedules

The aim of the study is to assess the safety & immunogenicity of a pandemic influenza vaccine administered at 2 different time points. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Overview

• Status: Completed
• Conditions: Influenza; Influenza Vaccines
• Intervention / Treatment: Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1; Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2

• Study Type: Interventional
• Enrollment (Actual): 512
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10787
    • GSK Investigational Site
  • Hamburg, Germany, 20253
    • GSK Investigational Site
  • Bayern
    • Deggendorf, Bayern, Germany, 94469
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 81241
      • GSK Investigational Site
    • Neu-Ulm, Bayern, Germany, 89231
      • GSK Investigational Site
    • Regensburg, Bayern, Germany, 93053
      • GSK Investigational Site
    • Wuerzburg, Bayern, Germany, 97070
      • GSK Investigational Site
  • Mecklenburg-Vorpommern
    • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Witten, Nordrhein-Westfalen, Germany, 58455
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

• Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
• History of vaccination with investigational influenza pandemic vaccine.
• History of administration of an experimental/licensed vaccine
• Planned administration of a vaccine not foreseen by the study protocol during the following periods: from Day 0 up to Day 51; from 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6 and Month 12; from Month 6 up to Month 6 + 30 days; from Month 12 up to Month 12 + 30 days.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the candidate vaccines
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• History of hypersensitivity to vaccines.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• History of chronic alcohol consumption and/or drug abuse.
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the candidate vaccine or during the study.
• Lactating women.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GSK1562902A V/I/6 Group; Subjects received 1 dose of vaccine formulated from VT strain at Day 0 and 1 dose of the vaccine including IN at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.	Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1; 2 or 3 doses, intramuscular injection, at different time points.; Other Names: VT strain; Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2; 2 or 3 doses, intramuscular injection, at different time points.; Other Names: IN strain
Experimental: GSK1562902A V/V/6 Group; Subjects received 2 doses of vaccine formulated from VT strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.	Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1; 2 or 3 doses, intramuscular injection, at different time points.; Other Names: VT strain
Experimental: GSK1562902A 2V/I/6 Group; Subjects received 2 doses of vaccine formulated from VT strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN strain at Month 6.The vaccine was administered in the deltoid region of the non-dominant arm.	Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1; 2 or 3 doses, intramuscular injection, at different time points.; Other Names: VT strain; Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2; 2 or 3 doses, intramuscular injection, at different time points.; Other Names: IN strain
Experimental: GSK1562902A 2V/V/6 Group; Subjects received 2 doses of vaccine formulated from VT strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.	Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1; 2 or 3 doses, intramuscular injection, at different time points.; Other Names: VT strain
Experimental: GSK1562902A V/I/12 Group; Subjects received 1 dose of vaccine formulated from VT strain at Day 0 and 1 dose of the vaccine including IN strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.	Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1; 2 or 3 doses, intramuscular injection, at different time points.; Other Names: VT strain; Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2; 2 or 3 doses, intramuscular injection, at different time points.; Other Names: IN strain
Experimental: GSK1562902A V/V/12 Group; Subjects received 2 doses of vaccine formulated from VT strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.	Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1; 2 or 3 doses, intramuscular injection, at different time points.; Other Names: VT strain
Experimental: GSK1562902A 2V/I/12 Group; Subjects received 2 doses of vaccine formulated from VT strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN strain at Month 12.The vaccine was administered in the deltoid region of the non-dominant arm.	Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1; 2 or 3 doses, intramuscular injection, at different time points.; Other Names: VT strain; Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2; 2 or 3 doses, intramuscular injection, at different time points.; Other Names: IN strain
Experimental: GSK1562902A 2V/V/12 Group; Subjects received 2 doses of vaccine formulated from VT strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12.The vaccine was administered in the deltoid region of the non-dominant arm.	Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1; 2 or 3 doses, intramuscular injection, at different time points.; Other Names: VT strain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value	The seropositivity cut-off for the assay was an antibody titer equal to or above (≥) 1:10, in the sera of subjects seronegative before vaccination. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004, for adults who received the booster dose at Month 6.	At Day 0
Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value	The seropositivity cut-off for the assay was an antibody titer equal to or above (≥) 1:10, in the sera of subjects seronegative before vaccination. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004, for adults who received the booster dose at Month 6.	At Month 6
Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value	The seropositivity cut-off for the assay was an antibody titer equal to or above (≥) 1:10, in the sera of subjects seronegative before vaccination. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004, for adults who received the booster dose at Month 6.	At Month 6 + 7 Days
Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value	The seropositivity cut-off for the assay was an antibody titer equal to or above (≥) 1:10, in the sera of subjects seronegative before vaccination. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004, for adults who received the booster dose at Month 6.	At Month 6 + 21 Days
Geometric Mean Titers (GMTs) of H5N1 HI Antibodies	GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains, for the groups who received the booster dose at Month 6.	At Day 0
Geometric Mean Titers (GMTs) of H5N1 HI Antibodies	GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains, for the groups who received the booster dose at Month 6.	At Month 6
Geometric Mean Titers (GMTs) of H5N1 HI Antibodies	GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains, for the groups who received the booster dose at Month 6.	At Month 6 + 7 Days
Geometric Mean Titers (GMTs) of H5N1 HI Antibodies	GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains, for the groups who received the booster dose at Month 6.	At Month 6 + 21 Days
Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease	The seroconversion factor (SCF) was defined as the fold change in serum H5N1 HI geometric mean titers (GMTs) post-vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.	At Month 6
Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease	The seroconversion factor (SCF) was defined as the fold change in serum H5N1 HI geometric mean titers (GMTs) post-vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.	At Month 6 + 7 Days
Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease	The seroconversion factor (SCF) was defined as the fold change in serum H5N1 HI geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.	At Month 6 + 21 Days
Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease	A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.	At Month 6
Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease	A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.	At Month 6 + 7 Days
Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease	A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.	At Month 6 + 21 Days
Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease	A seroprotected (SPR) subject was defined as a vaccinated subject with serum H5N1 HI titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.	At Day 0
Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease	A seroprotected (SPR) subject was defined as a vaccinated subject with serum H5N1 HI titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.	At Month 6
Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease	A seroprotected (SPR) subject was defined as a vaccinated subject with serum H5N1 HI titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.	At Month 6 + 7 Days
Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease	A seroprotected (SPR) subject was defined as a vaccinated subject with serum H5N1 HI titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.	At Month 6 + 21 Days
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = spreading beyond 100 millimeters (mm) of injection site.	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, up to 6/12 months + 7 days
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature above (>) 38 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, up to 12 months + 7 days
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.	During the 30-day (Days 0-29) post-primary vaccination period (Month 6 + 30 days)
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.	During the 30-day (Days 0-29) post-booster vaccination period (Month 12 + 30 days)
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.	During the entire study period (Day 0 to Month 18)
Number of Subjects With Serious Adverse Events (SAEs)	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	During the entire study period (Day 0 to Month 18)
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease	Booster seroconversion (SCR) was defined as: For seronegative subjects at pre-booster (Month 6), antibody titer ≥ 1:40 at Month 6 + 7 days; For seropositive subjects at pre-booster (Month 6), antibody titer at Month 6 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 6. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.	At Month 6 + 7 Days
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease	Booster SCR was defined as: For seronegative subjects at pre-booster (Month 6), antibody titer ≥ 1:40 at Month 6 + 7 days; For seropositive subjects at pre-booster (Month 6), antibody titer at Month 6 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 6. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005, for adults who received the booster dose at Month 6.	At Month 6 + 21 days
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease	Booster Factor (Seroconversion Factor booster) was defined as the fold change in H5N1 HI antibodies between the pre- and post-booster vaccination time-points (mean[log10(POST/M6)]). The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005, for groups who received the booster dose at Month 6.	At Month 6 + 7 Days
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease	Booster Factor (Seroconversion Factor booster) was defined as the fold change in H5N1 HI antibodies between the pre- and post-booster vaccination time-points (mean[log10(POST/M6)]). The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005, for groups who received the booster dose at Month 6.	At Month 6 + 21 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12	GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.	At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and at Month 18
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12	A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005.	At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12	Seroconversion defined as: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005.	At Month 12 + 7 Days, Month 12 + 21 Days and Month 18
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12	The seroconversion factor (SCF) was defined as the fold change in serum hemagglutination inhibition (HI) geometric mean titers (GMTs) post-vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005.	At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12	A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).	At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days
GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6	GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.	At Day 0, Day 21, Day 42, Month 6, Month 6+ 7 Days, Month 6+ 21 Days, Month 12 and at Month 18
Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6	A seroconverted (SCR) subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).	At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18
Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6	The seroconversion factor (SCF) was defined as the fold change in serum hemagglutination inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).	At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18
Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6	A seroprotected (SPR) subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).	At Day 0, Day 21, Day 42, Month 6, Month 6+ 7 Days, Month 6+ 21 Days, Month 12 and Month 18
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, A/Vietnam/1194/2004 and A/Indonesia/5/2005, for Groups Who Received Booster Dose at Month 12	Booster seroconversion (SCR) was defined as: For seronegative subjects at pre-booster (Month 12), antibody titer ≥ 1:40 at Month 12 + 7 days; For seropositive subjects at pre-booster (Month 12), antibody titer at Month 12 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 12.	At Month 12 + 7 Days, Month 12 + 21 Days and Month 18
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12	Booster Factor (Seroconversion Factor booster) was defined as the fold change in H5N1 HI antibodies between the pre- and post-booster vaccination time-points (mean[log10(POST/M12)]). The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005, for groups who received the booster dose at Month 12.	At Month 12 + 7 Days and at Month 12 + 21 Days
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12	Booster Factor (Seroconversion Factor booster) was defined as the fold change in H5N1 HI antibodies between the pre- and post-booster vaccination time-points (mean[log10(POST/M12)]). The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/05/2005, for groups who received the booster dose at Month 12.	At Month 12 + 7 Days, Month 12 + 21 Days and at Month 18
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6	Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 All Doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The 2 flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.	At Day 0, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18
Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12	Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 All Doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The 2 flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.	At Day 0, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and Month 18
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6	GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.	At Day 0, Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days and Month 12
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12	GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.	At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days and Month 12 + 21 Days
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6	GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.	At Day 0, Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18
GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12	GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.	At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and Month 18
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6	Seroconversion (SCR) was defined as the percentage of vaccinees with a minimum 4-fold increase in neutralizing antibody titer at the post-vaccination time-point compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).	At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days and Month 12
Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12	Seroconversion (SCR) was defined as the percentage of vaccinees with a minimum 4-fold increase in neutralizing antibody titer at the post-vaccination time-point compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).	At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days and Month 12 + 21 Days
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6	Booster SCR was defined as: For seronegative subjects at pre-booster (Month 6), antibody titer ≥ 1:40 at Month 6 + 7 days; For seropositive subjects at pre-booster (Month 6), antibody titer at Month 6 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 6. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005.	At Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12	Booster seroconversion (SCR) was defined as: For seronegative subjects at pre-booster (Month 12), antibody titer ≥ 1:40 at Month 12 + 7 days; For seropositive subjects at pre-booster (Month 12), antibody titer at Month 12 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 12. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005.	At Month 12 + 7 Days and Month 12 + 21 Days
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12	Booster seroconversion (SCR) was defined as: For seronegative subjects at pre-booster (Month 12), antibody titer ≥ 1:40 at Month 12 + 7 days; For seropositive subjects at pre-booster (Month 12), antibody titer at Month 12 + 7 days ≥ 4 fold the pre-vaccination antibody titer at Month 12. The 2 flu strains assessed were A/Vietnam/1194/2004 and A/Indonesia/5/2005.	At Month 12 + 7 Days, Month 12 + 21 Days and Month 18

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Gillard P, Caplanusi A, Knuf M, Roman F, Walravens K, Moris P, Drame M, Schwarz TF. An assessment of prime-boost vaccination schedules with AS03A -adjuvanted prepandemic H5N1 vaccines: a randomized study in European adults. Influenza Other Respir Viruses. 2013 Jan;7(1):55-65. doi: 10.1111/j.1750-2659.2012.00349.x. Epub 2012 Mar 9.
• Schwarz TF, Horacek T, Knuf M, Damman HG, Roman F, Drame M, Gillard P, Jilg W. Single dose vaccination with AS03-adjuvanted H5N1 vaccines in a randomized trial induces strong and broad immune responsiveness to booster vaccination in adults. Vaccine. 2009 Oct 23;27(45):6284-90. doi: 10.1016/j.vaccine.2009.01.040.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2007
• Primary Completion (Actual): October 20, 2008
• Study Completion (Actual): October 20, 2008

Study Registration Dates

• First Submitted: February 1, 2007
• First Submitted That Met QC Criteria: February 1, 2007
• First Posted (Estimate): February 2, 2007

Study Record Updates

• Last Update Posted (Actual): October 28, 2019
• Last Update Submitted That Met QC Criteria: October 4, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Pandemic Flu; Pandemic influenza vaccine (GSK1119711A)
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 107495; 2006-005477-22 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Informed Consent Form
   Information identifier: 107495
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Clinical Study Report
   Information identifier: 107495
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Study Protocol
   Information identifier: 107495
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: 107495
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Annotated Case Report Form
   Information identifier: 107495
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Individual Participant Data Set
   Information identifier: 107495
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Statistical Analysis Plan
   Information identifier: 107495
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register