Clinical trial NCT06252285: Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Official title: Phase III, Randomized, Observer-blind, Placebo-controlled, Multi-center, Multinational Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers (PEARL)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: RSV Immunisation
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-02-09
Enrollment: 6300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a phase III, randomized, observer-blind, placebo-controlled, multinational, multi-center study to be conducted in approximately 6300 children 6 months to \< 22 months of age. The purpose of the study is to evaluate the efficacy, immunogenicity, and safety of Respiratory Syncytial Virus Toddler (RSVt) vaccine administered by intranasal route compared to placebo.

Eligible participants will be randomized in a 1:1 ratio to receive 2 intranasal administrations of either the RSVt vaccine or placebo.

Study duration will be 24 months for each participant. The safety follow-up will start after the first vaccination and up to the end of the study.

Detailed description: Study duration will be 24 months for each participant. The safety follow-up will start at inclusion and up to the end of the study.

Eligibility criteria: Inclusion Criteria: -Aged 6 months to \< 22 months on the day of inclusion (means the day of the 6-month birthday to the day before the 22-month birthday)

* Participants who are healthy as determined by medical evaluation including medical history
* Born at full term of pregnancy (≥ 37 weeks)

Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
* History of medically diagnosed wheezing
* Any acute febrile illness in the past 48 hours that according to investigator judgment is significant enough to interfere with successful inoculation on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
* Probable or confirmed ongoing case of viral respiratory infection (including COVID-19, influenza, rhinovirus, etc.) at the time of enrollment. A prospective participant should not be included in the study until the respiratory infection has resolved.
* Member of a household that contains an immunocompromised individual, including, but not limited to:

  * a person who is HIV infected
  * a person who has received chemotherapy within the 12 months prior to study enrollment
  * a person who has received (within the past 6 months) or is receiving (at the time of enrollment) immunosuppressant agents
  * a person living with a solid organ or bone marrow transplant
* Potential close contact with other immunocompromised individual within 30 days after each vaccination as per investigator's discretion
* Participant's biological mother's previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding.
* Receipt or planned receipt of any of the following vaccines prior to enrollment or after the first study intervention administration:

  * Any other intranasal live attenuated vaccine within the 28 days prior to and after Dose 1 study administration
  * Unless given on the day of Dose 1 study administration, any other injectable live attenuated vaccines within the 28 days prior to and after. Concomitant receipt on the day of Dose 1 study administration is allowed.
* Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV immune globulin) at the time of enrollment. Previous receipt of an RSV monoclonal antibody within 6 months prior to the first study vaccine administration.
* Receipt of immune globulins, blood or blood-derived products in the past 3 months
* Receipt of intranasal and intra-ocular medications within 3 days prior to study enrollment
* Participation at the time of study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Occurrence of lower respiratory tract disease (LRTD) (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2
timeFrame: from 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
Secondary outcomes:
measure: Occurrence of upper respiratory tract disease (URTD) (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2
timeFrame: from 22 days post-dose 2 up to the start date of first occurrence of URTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
measure: Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain leading to hospitalization > 21 days post-dose 2
timeFrame: from 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT PCR confirmed RSV strain leading to hospitalization, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
measure: Occurrence of severe LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2
timeFrame: from 22 days post-dose 2 up to the start date of first occurrence of severe LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
measure: Occurrence of urgent care visits, associated with an episode of LRTD over RSV Season 1, associated with any RT-PCR confirmed RSV strain > 21 days post-dose 2
timeFrame: from 22 days post-dose 2 up to the start date of first occurrence of urgent care visit associated with an episode of LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
measure: Occurrence of acute respiratory disease (ARD) (during RSV Season 1) associated with any RT-PCR confirmed RSV strain > 21 days post-dose 2
timeFrame: from 22 days post-dose 2 up to the start date of first occurrence of ARD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
measure: Occurrence of hospitalizations, associated with an episode of ARD over RSV Season 1, associated with any RT-PCR confirmed RSV strain > 21 days post dose 2
timeFrame: from 22 days post-dose 2 up to the start date of first occurrence of hospitalizations associated with an episode of ARD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
measure: Occurrence of urgent care visits, associated with an episode of ARD over RSV Season 1, associated with any RT-PCR confirmed RSV strain > 21 days post-dose 2
timeFrame: from 22 days post-dose 2 up to the start date of first occurrence of urgent care visit associated with an episode of ARD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1
measure: Occurrence of LRTD (during RSV Season 1) associated with an RT-PCR confirmed RSV A or B strain > 21 days post-dose 2
timeFrame: from 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with an RT PCR confirmed RSV A or B, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
measure: Occurrence of URTD (during RSV Season 1) associated with an RT-PCR confirmed RSV A or B strain > 21 days post-dose 2
timeFrame: from 22 days post-dose 2 up to the start date of first occurrence of URTD associated with an RT-PCR confirmed RSV A or B, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
measure: Occurrence of ARD (during RSV Season 1) associated with an RT PCR confirmed RSV A or B strain > 21 days post-dose 2
timeFrame: from 22 days post-dose 2 up to the start date of first occurrence of ARD associated with an RT-PCR confirmed RSV A or B, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
measure: Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 1
timeFrame: from 22 days post-dose 1 up to the start date of first occurrence of LRTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
measure: Occurrence of URTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 1
timeFrame: from 22 days post-dose 1 up to the start date of first occurrence of URTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
measure: Occurrence of ARD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 1
timeFrame: from 22 days post-dose 1 up to the start date of first occurrence of ARD associated with any RT-PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
measure: Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2, in RSV-exposed participants
timeFrame: from 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1
measure: Occurrence of URTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2, by baseline serostatus
timeFrame: from 22 days post-dose 2 up to the start date of first occurrence of URTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
measure: Occurrence of ARD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2, by baseline serostatus
timeFrame: from 22 days post-dose 2 up to the start date of first occurrence of ARD associated with any RT-PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1)
measure: Occurrence of LRTD (during RSV Season 2), associated with any RT-PCR confirmed RSV strain
timeFrame: from 12 months post-dose 1 up to the start date of first occurrence of LRTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of the study (ie. up to 24 months post-dose 1)
measure: Occurrence of URTD (during RSV Season 2), associated with any RT-PCR confirmed RSV strain
timeFrame: from 12 months post-dose 1 up to the start date of first occurrence of URTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of the study (ie. up to 24 months post-dose 1)
measure: Occurrence of ARD (during RSV Season 2), associated with any RT PCR confirmed RSV strain
timeFrame: from 12 months post-dose 1 up to the start date of first occurrence of ARD associated with any RT-PCR confirmed RSV strain, assessed up to the end of the study (ie. up to 24 months post-dose 1
measure: Occurrence of LRTD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus
timeFrame: from 12 months post-dose 1 up to the start date of first occurrence of LRTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of the study (ie. up to 24 months post-dose 1)
measure: Occurrence of URTD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus
timeFrame: from 12 months post-dose 1 up to the start date of first occurrence of URTD associated with any RT-PCR confirmed RSV strain, assessed up to the end of the study (ie. up to 24 months post-dose 1)
measure: Occurrence of ARD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus
timeFrame: from 12 months post-dose 1 up to the start date of first occurrence of ARD associated with any RT-PCR confirmed RSV strain, assessed up to the end of the study (ie. up to 24 months post-dose 1)
measure: Presence of solicited administration site reactions within 21 days after each vaccination
timeFrame: Within 21 days after each vaccination
measure: Presence of solicited systemic reactions within 21 days after each vaccination
timeFrame: Within 21 days after each vaccination
measure: Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination
timeFrame: Within 30 minutes after each vaccination
measure: Presence of unsolicited AEs within 28 days after each vaccination
timeFrame: Within 28 days after each vaccination
measure: Presence of medically attended adverse events MAAEs throughout the study
timeFrame: Throughout the study (approximately 24 months)
measure: Presence of serious adverse events (SAEs) throughout the study
timeFrame: Throughout the study (approximately 24 months)
measure: Presence of adverse events of special interest (AESIs) throughout the study
timeFrame: Throughout the study (approximately 24 months)
measure: RSV A serum neutralizing antibody titers at D01
timeFrame: Day 01
measure: RSV B serum neutralizing antibody titers at D01
timeFrame: Day 01
measure: RSV A serum neutralizing antibody titers at 28 days post-dose 2
timeFrame: 28 days post-dose 2
measure: RSV B serum neutralizing antibody titers at 28 days post-dose 2
timeFrame: 28 days post-dose 2
measure: RSV serum anti-F Immunoglobulin A (IgA) Electrochemiluminescence (ECL) antibody titers at D01
timeFrame: Day 01
measure: RSV serum anti-F IgG ECL antibody titers at D01
timeFrame: Day 01
measure: RSV serum anti-F Immunoglobulin A (IgA) ECL antibody titers at 28 days post-dose 2
timeFrame: 28 Days post-dose 2
measure: RSV serum anti-F IgG ECL antibody titers at 28 days post-dose 2
timeFrame: 28 Days post-dose 2
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates - Flourish - PPDS- Site Number : 8400009
state: Alabama
city: Guntersville
country: United States
facility: Lakeview Clinical Research- Site Number : 8400024
state: Alabama
city: Tucson
country: United States
facility: Novak Clinical Research- Site Number : 8400069
state: Arizona
city: Madera
country: United States
facility: Madera Family Medical Group- Site Number : 8400029
state: California
city: Tarzana
country: United States
facility: Integrated Clinical Research- Site Number : 8400056
state: California
city: Victorville
country: United States
facility: National Institute of Clinical Research - Victorville - ClinEdge - PPDS- Site Number : 8400040
state: California
city: Coconut Creek
country: United States
facility: Invictus Clinical Research Group- Site Number : 8400035
state: Florida
city: Doral
country: United States
facility: Site Number : 8400031
state: Florida
city: Orlando
country: United States
facility: Accel Research - Nona Pediatric Center- Site Number : 8400068
state: Florida
city: Tampa
country: United States
facility: TrueBlue Clinical Research- Site Number : 8400065
state: Florida
city: Tampa
country: United States
facility: Teena Hughes Pediatrics- Site Number : 8400042
state: Florida
city: Atlanta
country: United States
facility: Morehouse School of Medicine - Atlanta- Site Number : 8400037
state: Georgia
city: Atlanta
country: United States
facility: Emory-Children's Center- Site Number : 8400001
state: Georgia
city: Atlanta
country: United States
facility: Agile Clinical Research Trials- Site Number : 8400015
state: Georgia
city: Chamblee
country: United States
facility: Tekton Research, LLC - 4961 Buford Hwy - Georgia - PPDS- Site Number : 8400064
state: Georgia
city: Macon
country: United States
facility: Velocity Clinical Research - (Macon - Georgia) - PPDS- Site Number : 8400041
state: Georgia
city: Savannah
country: United States
facility: iResearch Savannah - CenExel - PPDS- Site Number : 8400032
state: Georgia
city: Ammon
country: United States
facility: Medical Research Partners - Ammon- Site Number : 8400059
state: Idaho
city: Idaho Falls
country: United States
facility: Clinical Research Prime- Site Number : 8400013
state: Idaho
city: Idaho Falls
country: United States
facility: Leavitt Women's Healthcare- Site Number : 8400033
state: Idaho
city: Idaho Falls
country: United States
facility: Snake River Research- Site Number : 8400046
state: Idaho
city: Allen Park
country: United States
facility: Michigan Institute of Research- Site Number : 8400055
state: Michigan
city: Dearborn Heights
country: United States
facility: Vida Clinical Studies - Dearborn Heights- Site Number : 8400072
state: Michigan
city: Southfield
country: United States
facility: Great Lakes Research Institute- Site Number : 8400060
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute - Minneapolis- Site Number : 8400011
state: Minnesota
city: Great Falls
country: United States
facility: Boeson Research - Great Falls- Site Number : 8400008
state: Montana
city: Hastings
country: United States
facility: Velocity Clinical Research - Hastings- Site Number : 8400017
state: Nebraska
city: Lincoln
country: United States
facility: Be Well Clinical Studies - Lincoln- Site Number : 8400058
state: Nebraska
city: Norfolk
country: United States
facility: Velocity Clinical Research (Norfolk - Nebraska) - PPDS- Site Number : 8400038
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research - Omaha - Regency Circle- Site Number : 8400016
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research - Omaha- Site Number : 8400054
state: Nebraska
city: Bronx
country: United States
facility: Prime Global Research, Inc.- Site Number : 8400043
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center- Site Number : 8400063
state: Ohio
city: South Euclid
country: United States
facility: Senders Pediatrics- Site Number : 8400006
state: Ohio
city: Gresham
country: United States
facility: Cyn3rgy Research- Site Number : 8400014
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8400036
state: South Carolina
city: North Charleston
country: United States
facility: Palmetto Pediatrics- Site Number : 8400012
state: South Carolina
city: Simpsonville
country: United States
facility: Parkside Pediatrics - Simpsonville- Site Number : 8400071
state: South Carolina
city: Nashville
country: United States
facility: Clinical Research Associates Inc- Site Number : 8400005
state: Tennessee
city: Beaumont
country: United States
facility: Tekton Research, LLC - Beaumont - PPDS- Site Number : 8400061
state: Texas
city: Del Rio
country: United States
facility: South Texas Urgent Care - Del Rio- Site Number : 8400062
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group - Fort Worth- Site Number : 8400022
state: Texas
city: Houston
country: United States
facility: Private Practice - Dr. Chinyere N. Awa- Site Number : 8400066
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - CyFair Clinical Research Center- Site Number : 8400044
state: Texas
city: League City
country: United States
facility: Maximos Ob/Gyn- Site Number : 8400023
state: Texas
city: Richmond
country: United States
facility: Pediatric Center - Richmond- Site Number : 8400019
state: Texas
city: San Antonio
country: United States
facility: Tekton Research - FM78- Site Number : 8400067
state: Texas
city: Layton
country: United States
facility: Alliance for Multispecialty Research - Layton - North Robins Drive- Site Number : 8400030
state: Utah
city: Roy
country: United States
facility: Wee Care Pediatrics - Roy- Site Number : 8400002
state: Utah
city: Syracuse
country: United States
facility: Wee Care Pediatrics - Syracuse- Site Number : 8400004
state: Utah
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320006
state: Ciudad De Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320007
state: Ciudad De Buenos Aires
city: Río Cuarto
country: Argentina
facility: Investigational Site Number : 0320003
state: Córdoba
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320005
state: Santa Fe
city: San Miguel de Tucumán
country: Argentina
facility: Investigational Site Number : 0320004
state: Tucumán
city: San Miguel de Tucumán
country: Argentina
facility: Investigational Site Number : 0320002
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
city: Salvador
country: Brazil
facility: AssociaÃ§Ã£o Obras Sociais IrmÃ£ Dulce - Centro de Pesquisa ClÃ-nica (CPEC)- Site Number : 0760009
state: Bahia
city: Belo Horizonte
country: Brazil
facility: Freire Pesquisa Clínica- Site Number : 0760001
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre- Site Number : 0760005
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles- Site Number : 0760007
state: Rio Grande Do Sul
city: Ribeirão Preto
country: Brazil
facility: Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS- Site Number : 0760010
state: São Paulo
city: São José Do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760006
state: São Paulo
city: SÃ£O Paulo
country: Brazil
facility: Hospital SÃ£o Paulo da Universidade Federal de Sao Paulo - Escola Paulista de Medicina UNIFESP-EPM- Site Number : 0760002
state: São Paulo
city: São Paulo
country: Brazil
facility: Centro Paulista de Investigaçăo Clínica - CEPIC- Site Number : 0760004
city: Santiago
country: Chile
facility: Investigational Site Number : 1520004
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Puerto Montt
country: Chile
facility: Investigational Site Number : 1520005
city: Jiangsu
country: China
facility: Investigational Site Number : 1560009
city: Acacías
country: Colombia
facility: Investigational Site Number : 1700004
city: Chía
country: Colombia
facility: Investigational Site Number : 1700002
city: Girardot
country: Colombia
facility: Investigational Site Number : 1700003
city: Espoo
country: Finland
facility: Investigational Site Number : 2460003
city: Helsinki
country: Finland
facility: Investigational Site Number : 2460005
city: Järvenpää
country: Finland
facility: Investigational Site Number : 2460008
city: Kokkola
country: Finland
facility: Investigational Site Number : 2460004
city: Oulu
country: Finland
facility: Investigational Site Number : 2460002
city: Seinäjoki
country: Finland
facility: Investigational Site Number : 2460006
city: Tampere
country: Finland
facility: Investigational Site Number : 2460009
city: Turku
country: Finland
facility: Investigational Site Number : 2460001
city: Sapporo
country: Japan
facility: Investigational Site Number : 3920011
state: Hokkaido
city: Kawagoe
country: Japan
facility: Investigational Site Number : 3920007
state: Saitama
city: Shizuoka-Shi Aoi-Ku
country: Japan
facility: Investigational Site Number : 3920010
state: Shizuoka
city: Edogawa-Ku
country: Japan
facility: Investigational Site Number : 3920006
state: Tokyo
city: Fukui-Shi
country: Japan
facility: Investigational Site Number : 3920002
city: Fukui
country: Japan
facility: Investigational Site Number : 3920001
city: Fukuoka
country: Japan
facility: Investigational Site Number : 3920004
city: Kagoshima
country: Japan
facility: Investigational Site Number : 3920003
city: Kasuga-Shi
country: Japan
facility: Investigational Site Number : 3920005
city: Lizuka-shi
country: Japan
facility: Investigational Site Number : 3920008
city: Osaka
country: Japan
facility: Investigational Site Number : 3920009
city: Butere
country: Kenya
facility: Investigational Site Number : 4040007
city: Kericho
country: Kenya
facility: Investigational Site Number : 4040001
city: Kisumu
country: Kenya
facility: Investigational Site Number : 4040002
city: Kisumu
country: Kenya
facility: Investigational Site Number : 4040003
city: Nairobi
country: Kenya
facility: Investigational Site Number : 4040006
city: Mexico City
country: Mexico
facility: Investigational Site Number : 4840007
city: Monterrey
country: Mexico
facility: Investigational Site Number : 4840008
city: Veracruz
country: Mexico
facility: Investigational Site Number : 4840004
city: Dhulikhel N.p
country: Nepal
facility: Investigational Site Number : 5240003
state: Bagmati
city: Kathmandu
country: Nepal
facility: Investigational Site Number : 5240001
state: Bagmati
city: Nepalgunj
country: Nepal
facility: Investigational Site Number : 5240002
state: Bheri
city: Bayamon
country: Puerto Rico
facility: Clinical Research Investigator Group- Site Number : 6300001
city: Guayama
country: Puerto Rico
facility: Clinical Research Puerto Rico (CRPR), Inc. - Guayama- Site Number : 6300005
city: San Juan
country: Puerto Rico
facility: Caribbean Medical Research Center- Site Number : 6300003
city: San Juan
country: Puerto Rico
facility: Hospital Pediatrico Universitario- Site Number : 6300002
city: Brits
country: South Africa
facility: Investigational Site Number : 7100007
city: City Of Cape Town
country: South Africa
facility: Investigational Site Number : 7100008
city: East London
country: South Africa
facility: Investigational Site Number : 7100001
city: Johannesburg
country: South Africa
facility: Investigational Site Number : 7100005
city: Johannesburg
country: South Africa
facility: Investigational Site Number : 7100004
city: Johannesburg
country: South Africa
facility: Investigational Site Number : 7100003
city: Paarl
country: South Africa
facility: Investigational Site Number : 7100006
city: Pretoria
country: South Africa
facility: Investigational Site Number : 7100002
city: Soshanguve
country: South Africa
facility: Investigational Site Number : 7100009
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240001
state: Barcelona [Barcelona]
city: Mostoles
country: Spain
facility: Investigational Site Number : 7240003
state: Madrid
city: Pamplona
country: Spain
facility: Investigational Site Number : 7240005
state: Navarra
city: Seville
country: Spain
facility: Investigational Site Number : 7240002
state: Sevilla
city: Santiago de Compostela
country: Spain
facility: Investigational Site Number : 7240004
city: Bangkok
country: Thailand
facility: Investigational Site Number : 7640002
city: Bangkok
country: Thailand
facility: Investigational Site Number : 7640005
city: Bangkok
country: Thailand
facility: Investigational Site Number : 7640004
city: Chiang Mai
country: Thailand
facility: Investigational Site Number : 7640001
city: Hat Yai
country: Thailand
facility: Investigational Site Number : 7640006
city: Khon Kaen
country: Thailand
facility: Investigational Site Number : 7640003
city: Hayle
country: United Kingdom
facility: Investigational Site Number : 8260003
state: Cornwall
city: Exeter
country: United Kingdom
facility: Investigational Site Number : 8260005
state: Devon
city: Southampton
country: United Kingdom
facility: Investigational Site Number : 8260007
state: Hampshire
city: Bristol
country: United Kingdom
facility: Investigational Site Number : 8260004
Study officials:
References: