Clinical trial NCT06534892: An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study
Official title: A Phase 3b, Randomized, Open Label, Multicountry, Multi-center, Extension and Crossover Vaccination Study to Evaluate the Immunogenicity and Safety of Different Revaccination Schedules and Persistence of a Single Dose of the RSVPreF3 OA Vaccine in Adults Aged 60 Years and Above Who Participated in the RSV OA=ADJ-006 Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory syncytial virus (RSV)
Older adults
RSVPreF3 OA vaccine
Immunogenicity
Safety
RSV Season
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2024-08-02
Enrollment: 10356
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an extension and crossover study.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is:

* To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose,
* To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine,
* To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.


Eligibility criteria: Inclusion Criteria:

* Male or female participants who were previously enrolled in the RSV OA=ADJ-006 study and received placebo (Placebo group) or a single dose of the RSVPreF3 OA vaccine (RSV_1dose group).
* Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, attend regular phone calls/study site visits, ability to access and utilize a phone or other electronic communications).
* Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure.
* Participants who are medically stable in the opinion of the investigator at study entry. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study.

Exclusion Criteria:

Medical Conditions:

* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy based on medical history and physical examination.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
* Hypersensitivity to latex.
* Serious or unstable chronic illness.
* Recurrent or un-controlled neurological disorders or seizures.
* Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
* Any other medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
* Any history of dementia or any medical condition that moderately or severely impairs cognition and understanding of the informed consent form and/or study procedures.
* Participants who experienced an SAE or pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study that was considered to be possibly or probably related to the study vaccine or non-study concomitant vaccines, either by the investigator or the sponsor, including hypersensitivity reactions.
* Participants with a new onset of a pIMD or exacerbation of a pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study, that, in the opinion of the investigator, exposes the participant to unacceptable risk from subsequent vaccination.

Prior/Concomitant Therapy:

• 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. • Previous vaccination with an RSV vaccine (investigational or licensed vaccine) and/or planned administration of an RSV vaccine during the study period other than the RSVPreF3 OA vaccine administered during the RSV OA=ADJ-006 study.

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 Exclusion Criteria:

* 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.
* Participation of any study personnel or their immediate dependents, family, or household members.
* Bedridden participants.

Specific exclusion criteria for Crossover group:

• Planned or administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after study intervention administration, with the exception of COVID vaccines which can be administered up to 14 days before or from 14 days after study vaccination. Inactivated seasonal influenza vaccines can be co-administered or administered at any time.

Specific exclusion criteria for RSV_PreS4, RSV_PreS5 and RSV_1Dose groups:

* Planned or administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after study intervention administration, with the exception of COVID vaccines and inactivated seasonal influenza vaccines which can be administered up to 14 days before or from 14 days after study intervention administration.
* Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first study visit or planned administration during the study period.
* Chronic administration of immunosuppressants or other immunemodifying drugs during the period starting 90 days prior to the first study visit or planned administration during the study period. For corticosteroids, this will mean prednisone \>= 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.

Primary outcomes:
measure: RSV-A neutralizing titers expressed as Geometric mean titers (GMTs) in RSV_PreS4 group at Day 1
timeFrame: At Day 1
measure: RSV-A neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 31
timeFrame: At Day 31
measure: RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 1
timeFrame: At Day 1
measure: RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 31
timeFrame: At Day 31
measure: RSV-A neutralizing titers expressed as Mean geometric increase (MGI) in RSV_PreS4 group
timeFrame: From Day 1 to Day 31
measure: RSV-B neutralizing titers expressed as MGI in RSV_PreS4 group
timeFrame: From Day 1 to Day 31
measure: Percentage of participants with RSV-A neutralizing titers greater than or equal to (>=) cut-off in RSV_PreS4 group at Day 1
timeFrame: At Day 1
measure: Percentage of participants with RSV-A neutralizing titers >= cut-off in RSV_PreS4 group at Day 31
timeFrame: At Day 31
measure: Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS4 group at Day 1
timeFrame: At Day 1
measure: Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS4 group at Day 31
timeFrame: At Day 31
measure: Percentage of participants with seroresponse rate (SRR) for RSV-A neutralizing titers in RSV_PreS4 group
timeFrame: At Day 31
measure: Percentage of participants with SRR for RSV-B neutralizing titers in RSV_PreS4 group
timeFrame: At Day 31
measure: RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Day 1
timeFrame: At Day 1
measure: RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 12
timeFrame: At Month 12
measure: RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 13
timeFrame: At Month 13
measure: RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 24
timeFrame: At Month 24
measure: RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Day 1
timeFrame: At Day 1
measure: RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 12
timeFrame: At Month 12
measure: RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 13
timeFrame: At Month 13
measure: RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 24
timeFrame: At Month 24
measure: RSV-A neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 13
timeFrame: From Month 12 to Month 13
measure: RSV-A neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 24
timeFrame: From Month 12 to Month 24
measure: RSV-B neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 13
timeFrame: From Month 12 to Month 13
measure: RSV-B neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 24
timeFrame: From Month 12 to Month 24
measure: Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Day 1
timeFrame: At Day 1
measure: Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Month 12
timeFrame: At Month 12
measure: Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Month 13
timeFrame: At Month 13
measure: Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Month 24
timeFrame: At Month 24
measure: Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Day 1
timeFrame: At Day 1
measure: Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Month 12
timeFrame: At Month 12
measure: Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Month 13
timeFrame: At Month 13
measure: Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Month 24
timeFrame: At Month 24
measure: Percentage of participants with seroresponse rate (SRR) for RSV-A neutralizing titers in RSV_PreS5 group
timeFrame: At Month 13
measure: Percentage of participants with SRR for RSV-B neutralizing titers in RSV_PreS5 group
timeFrame: At Month 13
Secondary outcomes:
measure: RSV-A neutralizing titers expressed as GMTs in RSV_1Dose group
timeFrame: At Day 1, Month 12 and at Month 24
measure: RSV-B neutralizing titers expressed as GMTs in RSV_1Dose group
timeFrame: At Day 1, Month 12 and at Month 24
measure: Percentage of participants with RSV-A neutralizing titers >= cut-off in RSV_1Dose group
timeFrame: At Day 1, Month 12 and at Month 24
measure: Percentage of participants with RSV-B neutralizing titers >= cut-off in RSV_1Dose group
timeFrame: At Day 1, Month 12 and at Month 24
measure: Number of participants with unsolicited adverse events
timeFrame: At Day 30 post vaccination
measure: Number of participants with any serious adverse events (SAEs)
timeFrame: From day of vaccination and up to 6 months post each vaccine administration
measure: Number of participants with SAEs related to study intervention
timeFrame: From Day 1 and up to end of study
measure: Number of participants with any potential immune-mediated disease (pIMDs)
timeFrame: From day of vaccination and up to 6 months post each vaccine administration
measure: Number of participants with pIMDs related to study intervention
timeFrame: From Day 1 and up to end of study
measure: Number of participants with fatal SAEs
timeFrame: From Day 1 and up to end of study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Huntsville
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state: Alabama
city: Phoenix
country: United States
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state: Arizona
city: Tucson
country: United States
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state: Arizona
city: Cerritos
country: United States
facility: GSK Investigational Site
state: California
city: Coral Gables
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Lake City
country: United States
facility: GSK Investigational Site
state: Florida
city: Melbourne
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
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state: Florida
city: Orlando
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state: Florida
city: Pinellas Park
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state: Florida
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state: Florida
city: West Palm Beach
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state: Florida
city: Atlanta
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facility: GSK Investigational Site
state: Georgia
city: Savannah
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state: Georgia
city: Chicago
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state: Illinois
city: Evansville
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state: Indiana
city: Mishawaka
country: United States
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state: Indiana
city: El Dorado
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state: Kansas
city: Newton
country: United States
facility: GSK Investigational Site
state: Kansas
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
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state: Kentucky
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state: Missouri
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state: Nebraska
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state: North Carolina
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state: Pennsylvania
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state: Texas
city: Salt Lake City
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state: Utah
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state: Virginia
city: Botany
country: Australia
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state: New South Wales
city: Coffs Harbour
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state: New South Wales
city: Darlinghurst
country: Australia
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state: New South Wales
city: Taringa
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state: Queensland
city: Tarragindi
country: Australia
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state: Queensland
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state: Victoria
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state: Western Australia
city: Diepenbeek
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city: Edegem
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city: Erpent
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city: Genk
country: Belgium
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city: Gent
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city: Ieper
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city: Kluisbergen
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city: Linkebeek
country: Belgium
facility: GSK Investigational Site
city: Linkebeek
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facility: GSK Investigational Site
city: Mechelen
country: Belgium
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city: Tremelo
country: Belgium
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city: Edmonton
country: Canada
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state: Alberta
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country: Canada
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state: British Columbia
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state: British Columbia
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state: British Columbia
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state: British Columbia
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country: Canada
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state: British Columbia
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Truro
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: London-Ontario
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Chicoutimi
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Mirabel
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: St-Charles-Borromee
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: GSK Investigational Site
city: Paide
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
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: Seinajoki
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Weinheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Freiberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Dachau
country: Germany
facility: GSK Investigational Site
city: Dippoldiswalde
country: Germany
facility: GSK Investigational Site
city: Dresden
country: Germany
facility: GSK Investigational Site
city: Essen
country: Germany
facility: GSK Investigational Site
city: Essen
country: Germany
facility: GSK Investigational Site
city: Frankfurt
country: Germany
facility: GSK Investigational Site
city: Freital
country: Germany
facility: GSK Investigational Site
city: Goch
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hannover
country: Germany
facility: GSK Investigational Site
city: Hochheim am Main
country: Germany
facility: GSK Investigational Site
city: Koeln
country: Germany
facility: GSK Investigational Site
city: Leipzig
country: Germany
facility: GSK Investigational Site
city: Mainz
country: Germany
facility: GSK Investigational Site
city: Schenefeld
country: Germany
facility: GSK Investigational Site
city: Wallerfing
country: Germany
facility: GSK Investigational Site
city: Wangen
country: Germany
facility: GSK Investigational Site
city: Witten
country: Germany
facility: GSK Investigational Site
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
city: Alessandria
country: Italy
facility: GSK Investigational Site
city: Bari
country: Italy
facility: GSK Investigational Site
city: Belluno
country: Italy
facility: GSK Investigational Site
city: Ferrara
country: Italy
facility: GSK Investigational Site
city: Napoli
country: Italy
facility: GSK Investigational Site
city: Negrar Verona
country: Italy
facility: GSK Investigational Site
city: Palermo
country: Italy
facility: GSK Investigational Site
city: Pessione - Chieri TO
country: Italy
facility: GSK Investigational Site
city: Pisa
country: Italy
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
city: Siena
country: Italy
facility: GSK Investigational Site
city: Hiroshima
country: Japan
facility: GSK Investigational Site
city: Ibaraki
country: Japan
facility: GSK Investigational Site
city: Kumamoto
country: Japan
facility: GSK Investigational Site
city: Okinawa
country: Japan
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city: Saitama
country: Japan
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city: Shizuoka
country: Japan
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city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
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city: Tokyo
country: Japan
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city: Tokyo
country: Japan
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city: Yamagata
country: Japan
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city: Yamaguchi
country: Japan
facility: GSK Investigational Site
city: Ansan
country: Korea, Republic of
facility: GSK Investigational Site
city: Bucheon-si Kyunggi-do 14584
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Jeonju
country: Korea, Republic of
facility: GSK Investigational Site
city: Kangwon-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Chihuahua
country: Mexico
facility: GSK Investigational Site
city: Leon
country: Mexico
facility: GSK Investigational Site
city: Merida
country: Mexico
facility: GSK Investigational Site
city: Mexico City
country: Mexico
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city: Monterrey
country: Mexico
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city: Oaxaca
country: Mexico
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city: Queretaro
country: Mexico
facility: GSK Investigational Site
city: RM Pharmamexico CITY
country: Mexico
facility: GSK Investigational Site
city: San Luis PotosI
country: Mexico
facility: GSK Investigational Site
city: Grafton Auckland
country: New Zealand
facility: GSK Investigational Site
city: Hawke's Bay
country: New Zealand
facility: GSK Investigational Site
city: Kapiti
country: New Zealand
facility: GSK Investigational Site
city: Palmerston North
country: New Zealand
facility: GSK Investigational Site
city: Tauranga
country: New Zealand
facility: GSK Investigational Site
city: Wellington
country: New Zealand
facility: GSK Investigational Site
city: Czestochowa
country: Poland
facility: GSK Investigational Site
city: Elblag
country: Poland
facility: GSK Investigational Site
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country: Poland
facility: GSK Investigational Site
city: Gdynia
country: Poland
facility: GSK Investigational Site
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country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
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country: Poland
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country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
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country: Poland
facility: GSK Investigational Site
city: Warsaw
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Barnaul
country: Russian Federation
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Gatchina
country: Russian Federation
facility: GSK Investigational Site
city: Kemerovo
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: StPetersburg
country: Russian Federation
facility: GSK Investigational Site
city: StPetersburg
country: Russian Federation
facility: GSK Investigational Site
city: Bloemfontein
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
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country: South Africa
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country: South Africa
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country: South Africa
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country: Spain
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city: Barcelona
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city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Bebington
country: United Kingdom
facility: GSK Investigational Site
city: Belfast
country: United Kingdom
facility: GSK Investigational Site
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Bradford On Avon Wiltsh
country: United Kingdom
facility: GSK Investigational Site
city: Cardiff
country: United Kingdom
facility: GSK Investigational Site
city: Corby
country: United Kingdom
facility: GSK Investigational Site
city: Eynsham
country: United Kingdom
facility: GSK Investigational Site
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
city: Hexham
country: United Kingdom
facility: GSK Investigational Site
city: Lancashire
country: United Kingdom
facility: GSK Investigational Site
city: Leamington Spa
country: United Kingdom
facility: GSK Investigational Site
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Orpington
country: United Kingdom
facility: GSK Investigational Site
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
city: Peterborough
country: United Kingdom
facility: GSK Investigational Site
city: Thetford
country: United Kingdom
facility: GSK Investigational Site
city: Witney
country: United Kingdom
facility: GSK Investigational Site
Study officials:
References: