Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 3 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and are followed up until the study end. |
Biological: RSVPreF3 OA investigational vaccine
RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
| Experimental: Group B Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and are followed up until the study end. |
Biological: RSVPreF3 OA investigational vaccine
RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
| Experimental: Group C Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until the study end. |
Biological: RSVPreF3 OA investigational vaccine
RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
|
Outcome Measures
Primary Outcome Measures
- Humoral immune response in terms of RSV-A neutralizing antibody Geometric Mean Titers (GMTs) [At Day 1 (pre-vaccination)]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
- Humoral immune response in terms of RSV-A neutralizing antibody GMTs [At Day 31]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
- Humoral immune response in terms of RSV-A neutralizing antibody GMTs [At Month 6]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
- Humoral immune response in terms of RSV-A neutralizing antibody GMTs [At Month 12]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
- Humoral immune response in terms of RSV-B neutralizing antibody titers [At Day 1 (pre-vaccination)]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
- Humoral immune response in terms of RSV-B neutralizing antibody titers [At Day 31]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
- Humoral immune response in terms of RSV-B neutralizing antibody titers [At Month 6]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
- Humoral immune response in terms of RSV-B neutralizing antibody titers [At Month 12]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
Secondary Outcome Measures
- Humoral immune response in terms of RSVPreF3 Immunoglobulin G (IgG) antibody geometric mean concentrations (GMCs) [At Day 1 (pre-vaccination)]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by enzyme-linked immunosorbent assay (ELISA). The corresponding antibody GMC is expressed in Elisa Laboratory Units/milliliter (ELU/mL).
- Humoral immune response in terms of RSVPreF3 IgG antibody GMCs [At Day 31]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
- Humoral immune response in terms of RSVPreF3 IgG antibody GMCs [At Month 6]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
- Humoral immune response in terms of RSVPreF3 IgG antibody GMCs [At Month 12]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
- Humoral immune response in terms of RSV-A neutralizing antibody GMTs [At Month 18]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
- Humoral immune response in terms of RSV-A neutralizing antibody GMTs [At Month 24]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
- Humoral immune response in terms of RSV-A neutralizing antibody GMTs [At Month 30]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
- Humoral immune response in terms of RSV-A neutralizing antibody GMTs [At Month 36]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
- Humoral immune response in terms of RSV-A neutralizing antibody GMTs [At Month 13]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
- Humoral immune response in terms of RSV-A neutralizing antibody GMTs [At Month 25]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
- Humoral immune response in terms of RSV-B neutralizing antibody titers [At Month 18]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
- Humoral immune response in terms of RSV-B neutralizing antibody titers [At Month 24]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
- Humoral immune response in terms of RSV-B neutralizing antibody titers [At Month 30]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
- Humoral immune response in terms of RSV-B neutralizing antibody titers [At Month 36]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
- Humoral immune response in terms of RSV-B neutralizing antibody titers [At Month 13]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
- Humoral immune response in terms of RSV-B neutralizing antibody titers [At Month 25]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
- Humoral immune response in terms of RSVPreF3 IgG antibody GMCs [At Month 18]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
- Humoral immune response in terms of RSVPreF3 IgG antibody GMCs [At Month 24]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
- Humoral immune response in terms of RSVPreF3 IgG antibody GMCs [At Month 30]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
- Humoral immune response in terms of RSVPreF3 IgG antibody GMCs [At Month 36]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
- Humoral immune response in terms of RSVPreF3 IgG antibody GMCs [At Month 13]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
- Humoral immune response in terms of RSVPreF3 IgG antibody GMCs [At Month 25]
Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC is expressed in ELU/mL.
- CMI response in terms of frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ and/or CD8+ T cells expressing at least 2 activation markers [At Day 1(pre-vaccination)]
Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
- CMI response in terms of frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers [At Day 31]
Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
- CMI response in terms of frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers [At Month 6]
Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
- CMI response in terms of frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers [At Month 12]
Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
- CMI response in terms of frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers [At Month 18]
Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
- CMI response in terms of frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers [At Month 24]
Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
- CMI response in terms of frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers [At Month 30]
Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
- CMI response in terms of frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers [At Month 36]
Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
- CMI response in terms of frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers [At Month 13]
Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
- CMI response in terms of frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers [At Month 25]
Among markers expressed are interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
- Number of participants with at least one solicited administration-site event and solicited systemic event [During the 4 days (including the day of vaccination) following vaccination at Day 1]
The solicited administration-site events are pain, erythema and swelling at the injection site. The solicited systemic events include fever (defined as temperature equal to or above 38.0 degree Celsius (°C)), headache, fatigue, myalgia and arthralgia.
- Number of participants with at least one solicited administration-site event and solicited systemic event [During the 4 days (including the day of vaccination) following vaccination at Month 12]
The solicited administration-site events are pain, erythema and swelling at the injection site. The solicited systemic events include fever (defined as temperature equal to or above 38.0 degree Celsius (°C)), headache, fatigue, myalgia and arthralgia.
- Number of participants with at least one solicited administration-site event and solicited systemic event [During the 4 days (including the day of vaccination) following vaccination at Month 24.]
The solicited administration-site events are pain, erythema and swelling at the injection site. The solicited systemic events include fever (defined as temperature equal to or above 38.0 degree Celsius (°C)), headache, fatigue, myalgia and arthralgia.
- Number of participants with any unsolicited adverse events (AEs) [During the 30 days (including the day of vaccination) following vaccination at Day 1]
An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
- Number of participants with any unsolicited AEs [During the 30 days (including the day of vaccination) following vaccination at Month 12]
An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
- Number of participants with any unsolicited AEs [During the 30 days (including the day of vaccination) following vaccination at Month 24]
An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
- Number of participants with serious adverse events (SAE) [From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6)]
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study participant.
- Number of participants with SAEs [From revaccination (Month 12) up to 6 months post-revaccination (Month 18)]
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study participant.
- Number of participants with SAEs [From revaccination (Month 24) up to 6 months post-revaccination (Month 30)]
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study participant.
- Number of participants reporting any potential immune-mediated disease (pIMD) [From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6)]
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
- Number of participants reporting any pIMD [From revaccination (Month 12) up to 6 months post-revaccination (Month 18)]
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
- Number of participants reporting any pIMD [From revaccination (Month 24) up to 6 months post-revaccination (Month 30)]
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
- Number of participants with a fatal SAE, related SAE and related pIMDs [From first vaccination (Day 1) up to study end (Month 36)]
A fatal SAE is any untoward medical occurrence that results in death. A related SAE is an SAE considered to be causally related to the study intervention. A related pIMD is a pIMD considered to be causally related to the study intervention
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female participants ≥60 YOA at first vaccination, who live in the community (CD participants) or in a Long-term care facility (LTCF participants).
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Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
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Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure.
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Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Patients with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.
Exclusion Criteria:
Medical conditions
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Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.
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History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
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Hypersensitivity to latex.
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Serious or unstable chronic illness.
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Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol.
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Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
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Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
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Any history of dementia or any medical condition that moderately or severely impairs cognition.
Prior/Concomitant therapy
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Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine, or planned use during the study period.
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Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study vaccine administration, with the exception of inactivated, split virion and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study vaccination.
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Previous vaccination with an RSV vaccine.
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Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
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Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first dose of study vaccine or planned administration during the study period.
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Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first vaccine dose or planned administration during the study period. For corticosteroids, this will mean prednisone ≥ 20 mg/day, 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 participant has been or will be exposed to an investigational or a non-investigational vaccine/product.
Other exclusions
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History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
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Bedridden participants.
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Planned move during the study period that will prohibit participation in the trial until the study end. This includes:
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Planned move during the study period to another LTCF that will prohibit participation in the trial until study end.
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Planned move from the community to a LTCF that will prohibit participation in the trial until study end.
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Participation of any study personnel or their immediate dependants, family, or household members.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Mobile | Alabama | United States | 36608 |
| 2 | GSK Investigational Site | Phoenix | Arizona | United States | 85020 |
| 3 | GSK Investigational Site | Riverside | California | United States | 92503 |
| 4 | GSK Investigational Site | San Diego | California | United States | 92103 |
| 5 | GSK Investigational Site | Coral Gables | Florida | United States | 33134 |
| 6 | GSK Investigational Site | Fort Myers | Florida | United States | 33912 |
| 7 | GSK Investigational Site | Sarasota | Florida | United States | 34243 |
| 8 | GSK Investigational Site | The Villages | Florida | United States | 32162 |
| 9 | GSK Investigational Site | Evansville | Indiana | United States | 47714 |
| 10 | GSK Investigational Site | Wichita | Kansas | United States | 67207 |
| 11 | GSK Investigational Site | Richfield | Minnesota | United States | 55423 |
| 12 | GSK Investigational Site | Kansas City | Missouri | United States | 64114 |
| 13 | GSK Investigational Site | Rochester | New York | United States | 14609 |
| 14 | GSK Investigational Site | Mount Pleasant | South Carolina | United States | 29464 |
| 15 | GSK Investigational Site | Spartanburg | South Carolina | United States | 29303 |
| 16 | GSK Investigational Site | San Antonio | Texas | United States | 78229 |
| 17 | GSK Investigational Site | Norfolk | Virginia | United States | 23502 |
| 18 | GSK Investigational Site | Wenatchee | Washington | United States | 98801 |
| 19 | GSK Investigational Site | Espoo | Finland | 02230 | |
| 20 | GSK Investigational Site | Helsinki | Finland | 00100 | |
| 21 | GSK Investigational Site | Helsinki | Finland | 00930 | |
| 22 | GSK Investigational Site | Jarvenpaa | Finland | 04400 | |
| 23 | GSK Investigational Site | Kokkola | Finland | 67100 | |
| 24 | GSK Investigational Site | Oulu | Finland | 90220 | |
| 25 | GSK Investigational Site | Pori | Finland | 28100 | |
| 26 | GSK Investigational Site | Seinajoki | Finland | 60100 | |
| 27 | GSK Investigational Site | Tampere | Finland | 33100 | |
| 28 | GSK Investigational Site | Turku | Finland | 20520 | |
| 29 | GSK Investigational Site | Muenchen | Bayern | Germany | 80339 |
| 30 | GSK Investigational Site | Wallerfing | Bayern | Germany | 94574 |
| 31 | GSK Investigational Site | Wuerzburg | Bayern | Germany | 97074 |
| 32 | GSK Investigational Site | Essen | Nordrhein-Westfalen | Germany | 45355 |
| 33 | GSK Investigational Site | Essen | Nordrhein-Westfalen | Germany | 45359 |
| 34 | GSK Investigational Site | Goch | Nordrhein-Westfalen | Germany | 47574 |
| 35 | GSK Investigational Site | Mainz | Rheinland-Pfalz | Germany | 55116 |
| 36 | GSK Investigational Site | Hamburg | Germany | 22143 | |
| 37 | GSK Investigational Site | Fukuoka | Japan | 812-0025 | |
| 38 | GSK Investigational Site | Kumamoto | Japan | 861-4157 | |
| 39 | GSK Investigational Site | Tokyo | Japan | 160-0017 | |
| 40 | GSK Investigational Site | Changhua | Taiwan | 500 | |
| 41 | GSK Investigational Site | Taichung | Taiwan | 40447 | |
| 42 | GSK Investigational Site | Taichung | Taiwan | 407 | |
| 43 | GSK Investigational Site | Taipei | Taiwan | 100 | |
| 44 | GSK Investigational Site | Taipei | Taiwan | 104 | |
| 45 | GSK Investigational Site | Taipei | Taiwan | 112 | |
| 46 | GSK Investigational Site | Taoyuan County | Taiwan | 333 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 212496
- 2019-004680-51