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

Primary Purpose

Influenza, Influenza Vaccines

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Pandemic influenza vaccine (GSK1119711A)-formulation 1

Pandemic influenza vaccine (GSK1119711A)-formulation 2

About this trial

This is an interventional prevention trial for Influenza focused on measuring Pandemic Flu, Pandemic influenza vaccine (GSK1119711A)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

GSK1562902A V/I/6 Group

GSK1562902A V/V/6 Group

GSK1562902A 2V/I/6 Group

GSK1562902A 2V/V/6 Group

GSK1562902A V/I/12 Group

GSK1562902A V/V/12 Group

GSK1562902A 2V/I/12 Group

GSK1562902A 2V/V/12 Group

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value

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.

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.

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.

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.

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.

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.

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.

Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

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.

Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

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.

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.

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.

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

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.

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.

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.

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.

Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease

Secondary Outcome Measures

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.

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.

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.

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).

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.

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).

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).

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).

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.

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.

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.

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.

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

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.

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.

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.

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.

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).

Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12

Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6

Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12

Full Information

NCT ID

NCT00430521

First Posted

February 1, 2007

Last Updated

October 4, 2019

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00430521

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

February 5, 2007 (Actual)

Primary Completion Date

October 20, 2008 (Actual)

Study Completion Date

October 20, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Influenza Vaccines

Keywords

Pandemic Flu, Pandemic influenza vaccine (GSK1119711A)

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

512 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK1562902A V/I/6 Group

Arm Type

Experimental

Arm Description

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.

Arm Title

GSK1562902A V/V/6 Group

Arm Type

Experimental

Arm Description

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.

Arm Title

GSK1562902A 2V/I/6 Group

Arm Type

Experimental

Arm Description

Arm Title

GSK1562902A 2V/V/6 Group

Arm Type

Experimental

Arm Description

Arm Title

GSK1562902A V/I/12 Group

Arm Type

Experimental

Arm Description

Arm Title

GSK1562902A V/V/12 Group

Arm Type

Experimental

Arm Description

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.

Arm Title

GSK1562902A 2V/I/12 Group

Arm Type

Experimental

Arm Description

Arm Title

GSK1562902A 2V/V/12 Group

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Pandemic influenza vaccine (GSK1119711A)-formulation 1

Other Intervention Name(s)

VT strain

Intervention Description

2 or 3 doses, intramuscular injection, at different time points.

Intervention Type

Biological

Intervention Name(s)

Pandemic influenza vaccine (GSK1119711A)-formulation 2

Other Intervention Name(s)

IN strain

Intervention Description

2 or 3 doses, intramuscular injection, at different time points.

Primary Outcome Measure Information:

Title

Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value

Description

Time Frame

At Day 0

Title

Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value

Description

Time Frame

At Month 6

Title

Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value

Description

Time Frame

At Month 6 + 7 Days

Title

Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value

Description

Time Frame

At Month 6 + 21 Days

Title

Geometric Mean Titers (GMTs) of H5N1 HI Antibodies

Description

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.

Time Frame

At Day 0

Title

Geometric Mean Titers (GMTs) of H5N1 HI Antibodies

Description

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.

Time Frame

At Month 6

Title

Geometric Mean Titers (GMTs) of H5N1 HI Antibodies

Description

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.

Time Frame

At Month 6 + 7 Days

Title

Geometric Mean Titers (GMTs) of H5N1 HI Antibodies

Description

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.

Time Frame

At Month 6 + 21 Days

Title

Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Description

Time Frame

At Month 6

Title

Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Description

Time Frame

At Month 6 + 7 Days

Title

Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Description

Time Frame

At Month 6 + 21 Days

Title

Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Description

Time Frame

At Month 6

Title

Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Description

Time Frame

At Month 6 + 7 Days

Title

Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Description

Time Frame

At Month 6 + 21 Days

Title

Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Description

Time Frame

At Day 0

Title

Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Description

Time Frame

At Month 6

Title

Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Description

Time Frame

At Month 6 + 7 Days

Title

Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Description

Time Frame

At Month 6 + 21 Days

Title

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Description

Time Frame

During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, up to 6/12 months + 7 days

Title

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Description

Time Frame

During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, up to 12 months + 7 days

Title

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Description

Time Frame

During the 30-day (Days 0-29) post-primary vaccination period (Month 6 + 30 days)

Title

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Description

Time Frame

During the 30-day (Days 0-29) post-booster vaccination period (Month 12 + 30 days)

Title

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Description

Time Frame

During the entire study period (Day 0 to Month 18)

Title

Number of Subjects With Serious Adverse Events (SAEs)

Description

Time Frame

During the entire study period (Day 0 to Month 18)

Title

Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease

Description

Time Frame

At Month 6 + 7 Days

Title

Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease

Description

Time Frame

At Month 6 + 21 days

Title

Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease

Description

Time Frame

At Month 6 + 7 Days

Title

Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease

Description

Time Frame

At Month 6 + 21 Days

Secondary Outcome Measure Information:

Title

GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12

Description

GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.

Time Frame

At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and at Month 18

Title

Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12

Description

Time Frame

At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days

Title

Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12

Description

Time Frame

At Month 12 + 7 Days, Month 12 + 21 Days and Month 18

Title

Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12

Description

Time Frame

At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days

Title

Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12

Description

Time Frame

At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days

Title

GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6

Description

GMTs were calculated for H5N1 HI antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.

Time Frame

At Day 0, Day 21, Day 42, Month 6, Month 6+ 7 Days, Month 6+ 21 Days, Month 12 and at Month 18

Title

Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6

Description

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).

Time Frame

At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18

Title

Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6

Description

Time Frame

At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18

Title

Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6

Description

Time Frame

At Day 0, Day 21, Day 42, Month 6, Month 6+ 7 Days, Month 6+ 21 Days, Month 12 and Month 18

Title

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

Description

Time Frame

At Month 12 + 7 Days, Month 12 + 21 Days and Month 18

Title

Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12

Description

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.

Time Frame

At Month 12 + 7 Days and at Month 12 + 21 Days

Title

Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12

Description

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.

Time Frame

At Month 12 + 7 Days, Month 12 + 21 Days and at Month 18

Title

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

Description

Time Frame

At Day 0, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18

Title

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

Description

Time Frame

At Day 0, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and Month 18

Title

GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6

Description

GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.

Time Frame

At Day 0, Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days and Month 12

Title

GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12

Description

GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.

Time Frame

At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days and Month 12 + 21 Days

Title

GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6

Description

GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.

Time Frame

At Day 0, Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18

Title

GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12

Description

GMTs were calculated for H5N1 neutralizing antibodies against the A/Vietnam/1194/2004 or A/Indonesia/05/2005 strains.

Time Frame

At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and Month 18

Title

Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6

Description

Time Frame

At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days and Month 12

Title

Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12

Description

Time Frame

At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days and Month 12 + 21 Days

Title

Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6

Description

Time Frame

At Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18

Title

Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12

Description

Time Frame

At Month 12 + 7 Days and Month 12 + 21 Days

Title

Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12

Description

Time Frame

At Month 12 + 7 Days, Month 12 + 21 Days and Month 18

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Deggendorf

State/Province

Bayern

ZIP/Postal Code

94469

Country

Germany

Facility Name

GSK Investigational Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

81241

Country

Germany

Facility Name

GSK Investigational Site

City

Neu-Ulm

State/Province

Bayern

ZIP/Postal Code

89231

Country

Germany

Facility Name

GSK Investigational Site

City

Regensburg

State/Province

Bayern

ZIP/Postal Code

93053

Country

Germany

Facility Name

GSK Investigational Site

City

Wuerzburg

State/Province

Bayern

ZIP/Postal Code

97070

Country

Germany

Facility Name

GSK Investigational Site

City

Schwerin

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

19055

Country

Germany

Facility Name

GSK Investigational Site

City

Witten

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

58455

Country

Germany

Facility Name

GSK Investigational Site

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10787

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20253

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

22405557

Citation

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.

Results Reference

background

PubMed Identifier

19856521

Citation

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.

Results Reference

background

Links:

URL

https://www.clinicalstudydatarequest.com

Description

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

Available IPD and Supporting Information:

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107495

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107495

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107495

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107495

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107495

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107495

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107495

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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

Influenza, Influenza Vaccines

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial