Clinical trial NCT04502693: Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults
Official title: A Phase III, Randomized, Controlled, Observer-blind Study to Demonstrate Effectiveness, Immunogenicity and Safety of GSK's Meningococcal Group B and Combined ABCWY Vaccines When Administered to Healthy Adolescents and Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Meningococcal
Keywords: Bexsero
Menveo
MenABCWY
Effectiveness
Invasive meningococcal disease
Meningitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2020-08-06
Enrollment: 3657
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to evaluate the effectiveness of 2 doses or 3 doses of GSK's licenced meningococcal group B Bexsero (rMenB+OMV NZ) vaccine and of 2 doses of GSK's investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy adolescents and young adults. The immunogenicity and safety were evaluated in the study.

Detailed description: As per the feedback from the Center for Biologics Evaluation and Research (CBER), the scope of this post-marketing commitment study was extended to demonstrate the effectiveness, immunogenicity, and safety of GSK's investigational combined meningococcal ABCWY vaccine along with the rMenB+OMV NZ vaccine. Note that the rMenB+OMV and MenACWY vaccines provided to the MenB_0_2_6, MenB_0_6 group, and MenACWY group, respectively, at day 211 were only as part of the standard care of treatment and to maintain blinding. These vaccination schedules were not considered for any endpoint evaluations.

Eligibility criteria: Inclusion Criteria:

* Subjects or/and subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written or witnessed/thumb printed informed consent obtained from the subject/parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
* Written informed assent obtained from the subject (if applicable) prior to performing any study specific procedure.
* A male or female between, and including, 10 and 25 years of age (i.e. 25 years + 364 days) at the time of the first vaccination.
* Healthy subjects as established by medical history physical examination and clinical judgment of the investigator before entering into the study.
* Subjects who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine can participate in the study, if they have received it at least 4 years prior to informed consent and assent as applicable (with the exception of meningococcal C vaccination, if the last dose of MenC was received at ≤24 months of age).
* Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral 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 until 30 days after completion of Visit 6.

    * A female is considered to be of non-childbearing potential prior to menarche and after natural or induced menopause. Natural menopause is recognized to have occurred after 12 consecutive months of amenorrhea for which there is no other obvious pathological or physiological cause. Induced menopause is recognized to have occurred after hysterectomy, after bilateral oophorectomy, or iatrogenic ablation of ovarian function.

Exclusion Criteria:

Medical conditions

* Current or previous, confirmed or suspected disease caused by N. meningitidis.
* Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days of enrolment.
* Progressive, unstable or uncontrolled clinical conditions.
* Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
* Any neuroinflammatory, congenital neurological conditions, encephalopathies, seizures. History of febrile convulsions should not lead to exclusion.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s).

  * Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM 197) and latex medicinal products or medical equipment whose use is foreseen in this study.
* Abnormal function or modification of the immune system resulting from:

  * Autoimmune disorders or immunodeficiency syndromes.
  * Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to study vaccination until the post-vaccination 3 blood sample (Visit 6). This will mean prednisone - ≥20 mg/day (for adult subjects) or ≥0.5 mg/kg/day (for paediatric subjects), or equivalent. Inhaled and topical steroids are allowed.
  * Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.
  * Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

Prior/Concomitant therapy

* Use of any investigational or non-registered product other than the study vaccine(s)/product(s) during the period starting 30 days before the first dose of study vaccine(s)/product(s) (Day -29 to Day 1), or planned use during the study period.
* Previous vaccination against any group B meningococcal vaccine at any time prior to informed consent and assent as applicable.
* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first dose of study vaccine/ product or planned administration during the study period until the post-vaccination 3 blood sample (Visit 6).
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the vaccine/product dose(s) until the post-vaccination 3 blood sample (Visit 6). For corticosteroids, this will mean prednisone ≥20 mg/day (for adult subjects) or ≥0.5 mg/kg/day (for paediatric subjects), or equivalent. Inhaled and topical steroids are allowed.

Prior/Concurrent clinical study experience

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.

Other exclusions

* Child in care.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* History of /current chronic alcohol abuse and/or drug abuse as determined by the investigator.
* Any study personnel or immediate dependants, family, or household member.

Primary outcomes:
measure: Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic US N. Meningitidis Serogroup B Strains at 1 Month After the 3-dose (0,2,6-M), 2-dose(0,6-M) Vaccination Schedule of rMenB+OMV and 1 Dose of MenACWY
timeFrame: At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group, and Day 31 for ACWY group)
measure: Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic US N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose (0,2-M) Vaccination Schedule of rMenB+OMV and 1 Dose of MenACWY
timeFrame: At 1 month after vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2-dose schedule] and Day 31 for ACWY group)
measure: Percentage of Participants Whose Sera Kill Greater Than or Equal to (>=) 70% of the Strains Tested Using Enc-hSBA at 1 Month After the 3-dose (0,2,6-M) Schedule of rMenB+OMV and 2-dose(0,6-M) Schedule of rMenB+OMV
timeFrame: At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group)
measure: Percentage of Participants Whose Sera Kill >=70% of the Strains Tested Using Enc-hSBA at 1 Month After the 2-dose (0,2-M) Schedule of rMenB+OMV
timeFrame: At 1 month after vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2-dose schedule])
measure: Geometric Mean Titers (GMTs) Against Serogroups A, C, W and Y for Each Lot (ABCWY-1 Group, ABCWY-2 Group and ABCWY-3 Group) at 1 Month After the Last Vaccination of MenABCWY
timeFrame: At 1 month after the last vaccination of MenABCWY (Day 211)
measure: Percentage of Participants With 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y at 1 Month After Last MenABCWY Vaccination (Pooled Lots) and MenACWY Vaccination (for the ACWY Group), Relative to Baseline
timeFrame: At 1 month after vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 31 for the ACWY Group) compared to Day 1 (baseline)
measure: Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After Last MenABCWY Vaccination (Pooled Lots) and MenACWY Vaccination (for the ACWY Group)
timeFrame: At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 31 for the ACWY group)
measure: Percentage of Blood Samples With Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose (Pooled Lots) and 2-dose(0,2-M) Schedule of rMenB+OMV
timeFrame: At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 91 for the MenB_0_2_6 Group [2-dose schedule])
measure: Percentage of Participants Whose Sera Kill >=70% of the Strains Tested Using Enc-hSBA at 1 Month After the Last Vaccination in the ABCWY Group (Pooled Lots)
timeFrame: At 1 month after the last vaccination of MenABCWY (Day 211)
measure: Number of Participants With Any Solicited Local Adverse Events (AEs) After the First Study Intervention Administration
timeFrame: During 7 days after the first study intervention administration occurring at Day 1
measure: Number of Participants With Any Solicited Local Adverse Events (AEs) After the Second Study Intervention Administration
timeFrame: During 7 days after the second study intervention administration occurring at Day 61
measure: Number of Participants With Any Solicited Local Adverse Events (AEs) After the Third Study Intervention Administration
timeFrame: During 7 days after the third study intervention administration occurring at Day 181
measure: Number of Participants With Any Solicited Systemic AEs After the First Study Intervention Administration
timeFrame: During 7 days after the first study intervention administration occurring at Day 1
measure: Number of Participants With Any Solicited Systemic AEs After the Second Study Intervention Administration
timeFrame: During 7 days after the second study intervention administration occurring at Day 61
measure: Number of Participants With Any Solicited Systemic AEs After the Third Study Intervention Administration
timeFrame: During 7 days after the third study intervention administration occurring at Day 181
measure: Number of Participants With Any Unsolicited AEs After the First Study Intervention Administration
timeFrame: During the 30 days after the first study intervention administration occurring at Day 1
measure: Number of Participants With Any Unsolicited AEs After the Second Study Intervention Administration
timeFrame: During the 30 days after the second study intervention administration occurring at Day 61
measure: Number of Participants With Any Unsolicited AEs After the Third Study Intervention Administration
timeFrame: During the 30 days after the third study intervention administration occurring at Day 181
measure: Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs
timeFrame: Throughout the study period (Day 1 to Day 361)
Secondary outcomes:
measure: Percentage of Participants With 4-fold Rise in hSBA Titers Against N.Meningitidis Group B Strains at 1 Month After Last MenABCWY Dose(ABCWY Group-pooled Lots) and 1 Month After 2-dose(0,2-M) Schedule of rMenB+OMV NZ Relative to Baseline
timeFrame: At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 91 for the MenB_0_2_6 Group [2-dose schedule]) compared to Day 1 (Baseline)
measure: Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY
timeFrame: At 1 month after the vaccination schedule (i.e., Day 211 for the MenB_0_2_6 group [3 dose schedule], MenB_0_6 group, ABCWY_Pooled group and Day 31 for the MenACWY group)
measure: Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY
timeFrame: At 1 month after the vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2 dose schedule] and Day 31 for the MenACWY group)
measure: Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination Schedule for the MenB_0_2_6 Group [3 Dose], MenB_0_6 Group and Last MenABCWY Dose (Pooled Lots)
timeFrame: At 1 month after the vaccination schedule (Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group)
measure: Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)
timeFrame: At 1 month after the vaccination schedule (Day 91 for MenB_0_2_6 group [2 dose schedule])
measure: Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)
timeFrame: At Day 1 (pre-vaccination) and1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group and ABCWY_Pooled group)
measure: Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)
timeFrame: At Day 1 (pre-vaccination) and1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group [2 dose schedule])
measure: Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)
timeFrame: At 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group and ABCWY_Pooled group) compared to Day 1 (baseline)
measure: Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2 Months)
timeFrame: At 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 [2-dose schedule]) compared to Day 1 (baseline)
measure: hSBA Geometric Mean Titres (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)
timeFrame: At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group)
measure: hSBA GMTs Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)
timeFrame: At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group[2-dose schedule])
measure: hSBA Geometric Mean Ratios (GMRs) for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)
timeFrame: At 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group) compared to Day 1 (baseline)
measure: hSBA GMRs for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)
timeFrame: At 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group [2-dose schedule]) compared to Day 1 (baseline)
measure: Percentage of Participants With hSBA Titers >= LLOQ for Each of the N. Meningitidis Serogroups A,C,W,Y at Day 1 and at 1 Month After the First and the Last MenABCWY Vaccination for ABCWY_Pooled Group and 1 Month After the MenACWY Vaccine for ACWY Group
timeFrame: At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])
measure: Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First MenABCWY Dose for ABCWY_Pooled Group Compared to the MenACWY Vaccine for ACWY Group Relative to Baseline (Day 1)
timeFrame: At 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled group] and for ACWY Group) relative to baseline (Day 1)
measure: hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY_Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group
timeFrame: At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])
measure: GMRs for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY _Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group
timeFrame: 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose]) compared to baseline (Day 1)
measure: Total Immunoglobulin G (IgG) Antibodies Concentrations Against N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for ABCWY _Pooled Group and 1 Month After the MenACWY Vaccination for ACWY Group
timeFrame: At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])
Other outcomes:
Locations:
city: Chandler
country: United States
facility: GSK Investigational Site
state: Arizona
city: Glendale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Bell Gardens
country: United States
facility: GSK Investigational Site
state: California
city: Canoga Park
country: United States
facility: GSK Investigational Site
state: California
city: Garden Grove
country: United States
facility: GSK Investigational Site
state: California
city: Inglewood
country: United States
facility: GSK Investigational Site
state: California
city: Los Gatos
country: United States
facility: GSK Investigational Site
state: California
city: Cutler Bay
country: United States
facility: GSK Investigational Site
state: Florida
city: Lake City
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Oviedo
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Adairsville
country: United States
facility: GSK Investigational Site
state: Georgia
city: Buford
country: United States
facility: GSK Investigational Site
state: Georgia
city: Columbus
country: United States
facility: GSK Investigational Site
state: Georgia
city: Hinesville
country: United States
facility: GSK Investigational Site
state: Georgia
city: Nampa
country: United States
facility: GSK Investigational Site
state: Idaho
city: Oak Brook
country: United States
facility: GSK Investigational Site
state: Illinois
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Metairie
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Beverly
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Fall River
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Grosse Pointe Woods
country: United States
facility: GSK Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Petal
country: United States
facility: GSK Investigational Site
state: Mississippi
city: Missoula
country: United States
facility: GSK Investigational Site
state: Montana
city: Missoula
country: United States
facility: GSK Investigational Site
state: Montana
city: Bronx
country: United States
facility: GSK Investigational Site
state: New York
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Grants Pass
country: United States
facility: GSK Investigational Site
state: Oregon
city: Greenville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: North Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: West Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Laredo
country: United States
facility: GSK Investigational Site
state: Texas
city: Plano
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Kaysville
country: United States
facility: GSK Investigational Site
state: Utah
city: Layton
country: United States
facility: GSK Investigational Site
state: Utah
city: Murray
country: United States
facility: GSK Investigational Site
state: Utah
city: Orem
country: United States
facility: GSK Investigational Site
state: Utah
city: Roy
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: South Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Syracuse
country: United States
facility: GSK Investigational Site
state: Utah
city: Falls Church
country: United States
facility: GSK Investigational Site
state: Virginia
city: Newport News
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Suffolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Cheney
country: United States
facility: GSK Investigational Site
state: Washington
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: Marshfield
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Sydney
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Gold Coast
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Taringa
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Tarragindi
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Geelong
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Québec City
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Québec
country: Canada
facility: GSK Investigational Site
city: Ceske Budejovice
country: Czechia
facility: GSK Investigational Site
city: Hradec Kralove
country: Czechia
facility: GSK Investigational Site
city: Jindrichuv Hradec
country: Czechia
facility: GSK Investigational Site
city: Kladno
country: Czechia
facility: GSK Investigational Site
city: Melnik
country: Czechia
facility: GSK Investigational Site
city: Pardubice
country: Czechia
facility: GSK Investigational Site
city: Pardubice
country: Czechia
facility: GSK Investigational Site
city: Praha 6
country: Czechia
facility: GSK Investigational Site
city: Pribram
country: Czechia
facility: GSK Investigational Site
city: Trutnov
country: Czechia
facility: GSK Investigational Site
city: Tynec nad Sazavou
country: Czechia
facility: GSK Investigational Site
city: České Budejovice
country: Czechia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Espoo
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Jarvenpaa
country: Finland
facility: GSK Investigational Site
city: Kokkola
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Pori
country: Finland
facility: GSK Investigational Site
city: Seinajoki
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Adana
country: Turkey
facility: GSK Investigational Site
city: Ankara
country: Turkey
facility: GSK Investigational Site
city: Eskisehir
country: Turkey
facility: GSK Investigational Site
city: Izmir
country: Turkey
facility: GSK Investigational Site
city: Kayseri
country: Turkey
facility: GSK Investigational Site
Study officials:
References: