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| ID | Type | Description | Link |
|---|---|---|---|
| MOBILIZE-1 | Other Identifier | MSD | |
| 2022-003483-25 | EudraCT Number |
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The purpose of this study is to demonstrate that V181 is safe and well tolerated, elicits an immune response, and reduces the frequency of virologically confirmed dengue (VCD) of any severity, due to any of the 4 dengue serotypes, regardless of dengue serostatus at baseline in children 2 to 17 years of age.
The Reactogenicity and Immunogenicity Subset consists of approximately 3600 participants who will be followed for immunogenicity and safety through 28 days postvaccination. The Long-term Immunogenicity Subset consists of approximately 620 participants randomly selected from the Reactogenicity and Immunogenicity Subset and will evaluate virus reduction neutralization test (VRNT) at designated timepoints up to 5 years postvaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V181 | Experimental | Participants will receive a single 0.5 mL subcutaneous (SC) dose of V181 on Day 1. |
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| Placebo | Placebo Comparator | Participants will receive a single 0.5 mL SC dose of placebo on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V181 | Biological | Participants will receive a single 0.5 mL SC dose of V181 on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing a Medically Attended Adverse Event (MAAE) | A MAAE is an adverse event (AE) in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an ER visit, office visit, or an urgent care visit with any medical personnel for any reason. | Up to approximately 6 months postvaccination |
| Percentage of Participants Experiencing a Serious Adverse Event (SAE) | An SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. | Up to approximately 5 years postvaccination |
| Reactogenicity and Immunogenicity Subset: Percentage of Participants Experiencing Solicited Injection-site AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. Solicited injection-site AEs will include pain/tenderness, erythema/redness, and swelling. | Up to approximately 5 days postvaccination |
| Reactogenicity and Immunogenicity Subset: Percentage of Participants Experiencing Solicited Systemic AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. Solicited systemic AEs will include rash, headache, tiredness (fatigue), muscle aches all over body (myalgia), joint pain and fever (pyrexia). | Up to approximately 28 days postvaccination |
| Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Due to Any of the 4 Dengue Serotypes, Regardless of Dengue Serostatus at Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Due to Each of the 4 Dengue Serotypes, Regardless of Dengue Serostatus at Baseline | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. | Up to approximately 3 years postvaccination |
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The key Inclusion Criteria include but are not limited to:
The key Exclusion Criteria include but are not limited to:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jatinegara Primary Health Center ( Site 0102) | Recruiting | East Jakarta | Jakarta Special Capital Region | 13310 | Indonesia |
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| Label | URL |
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| Merck Clinical Trials Information | View source |
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| Placebo |
| Biological |
Participants will receive a single 0.5 mL SC dose of placebo on Day 1. |
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Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by wild type (WT) reverse transcription polymerase chain reaction (RT-PCR) or non-structural protein 1 (NS1) enzyme-linked immunosorbent assay (ELISA). |
| Up to approximately 3 years postvaccination |
| Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. | Up to approximately 3 years postvaccination |
| Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. | Up to approximately 5 years postvaccination |
| Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. | Up to approximately 5 years postvaccination |
| Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD Meeting Criteria for Warning Signs or Severe Dengue, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. Clinical evaluation for presence of dengue with warning signs or severe dengue will be conducted by an investigator or medically qualified designee, based on pre-specified criteria. | Up to approximately 3 years postvaccination |
| Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD Meeting Criteria for Warning Signs or Severe Dengue, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. Clinical evaluation for presence of dengue with warning signs or severe dengue will be conducted by an investigator or medically qualified designee, based on pre-specified criteria. | Up to approximately 3 years postvaccination |
| Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD Meeting Criteria for Warning Signs or Severe Dengue, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. Clinical evaluation for presence of dengue with warning signs or severe dengue will be conducted by an investigator or medically qualified designee, based on pre-specified criteria. | Up to approximately 5 years postvaccination |
| Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD Meeting Criteria for Warning Signs or Severe Dengue, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. Clinical evaluation for presence of dengue with warning signs or severe dengue will be conducted by an investigator or medically qualified designee, based on pre-specified criteria. | Up to approximately 5 years postvaccination |
| Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. | Up to approximately 3 years postvaccination |
| Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. | Up to approximately 3 years postvaccination |
| Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. | Up to approximately 5 years postvaccination |
| Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. | Up to approximately 5 years postvaccination |
| Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. | Up to approximately 3 years postvaccination |
| Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. | Up to approximately 3 years postvaccination |
| Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. | Up to approximately 5 years postvaccination |
| Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. | Up to approximately 5 years postvaccination |
| Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD Meeting Criteria for Warning Signs or Severe Dengue, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. Clinical evaluation for presence of dengue with warning signs or severe dengue will be conducted by an investigator or medically qualified designee, based on pre-specified criteria. | Up to approximately 3 years postvaccination |
| Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD Meeting Criteria for Warning Signs or Severe Dengue, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. Clinical evaluation for presence of dengue with warning signs or severe dengue will be conducted by an investigator or medically qualified designee, based on pre-specified criteria. | Up to approximately 3 years postvaccination |
| Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD Meeting Criteria for Warning Signs or Severe Dengue, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. Clinical evaluation for presence of dengue with warning signs or severe dengue will be conducted by an investigator or medically qualified designee, based on pre-specified criteria. | Up to approximately 5 years postvaccination |
| Percentage of Participants Experiencing Symptomatic (Regardless of Fever) VCD Meeting Criteria for Warning Signs or Severe Dengue, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. Clinical evaluation for presence of dengue with warning signs or severe dengue will be conducted by an investigator or medically qualified designee, based on pre-specified criteria. | Up to approximately 5 years postvaccination |
| Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Regardless of Fever) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. | Up to approximately 3 years postvaccination |
| Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Regardless of Fever) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. | Up to approximately 3 years postvaccination |
| Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Regardless of Fever) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. | Up to approximately 5 years postvaccination |
| Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Regardless of Fever) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination | Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by WT RT-PCR or NS1 ELISA. | Up to approximately 5 years postvaccination |
| Reactogenicity and Immunogenicity Subset: Percentage of Participants who are Seropositive as measured by VRNT, by Dengue Serostatus at Baseline | Seropositivity for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported. | Up to approximately 28 days postvaccination |
| Reactogenicity and Immunogenicity Subset: Percentage of Participants who are Seropositive as measured by VRNT, Regardless of Dengue Serostatus at Baseline | Seropositivity for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported. | Up to approximately 28 days postvaccination |
| Reactogenicity and Immunogenicity Subset: Percentage of Participants who Seroconvert as measured by VRNT, by Dengue Serostatus at Baseline | Seroconversion rate for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported. | Up to approximately 28 days postvaccination |
| Reactogenicity and Immunogenicity Subset: Percentage of Participants who Seroconvert as measured by VRNT, Regardless of Dengue Serostatus at Baseline | Seroconversion rate for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported. | Up to approximately 28 days postvaccination |
| Reactogenicity and Immunogenicity Subset: Dengue Virus-Neutralizing Antibody Titers, as Measured by VRNT, by Dengue Serostatus at Baseline | Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported. | Up to approximately 28 days postvaccination |
| Reactogenicity and Immunogenicity Subset: Dengue Virus-Neutralizing Antibody Titers, as Measured by VRNT, Regardless of Dengue Serostatus at Baseline | Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported. | Up to approximately 28 days postvaccination |
| Reactogenicity and Immunogenicity Subset: Geometric Mean Fold Rises (GMFRs) in Dengue Virus-Neutralizing Antibody Titers, by Dengue Serostatus at Baseline | GMFRs for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported. | Baseline (Day 1) and up to approximately 28 days postvaccination |
| Reactogenicity and Immunogenicity Subset: GMFRs in Dengue Virus-Neutralizing Antibody Titers, Regardless of Dengue Serostatus at Baseline | GMFRs for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported. | Baseline (Day 1) and up to approximately 28 days postvaccination |
| Long-term Immunogenicity Subset: Percentage of Participants who are Seropositive, as measured by VRNT, by Dengue Serostatus at Baseline | Seropositivity for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported. | Up to approximately 5 years postvaccination |
| Long-term Immunogenicity Subset: Percentage of Participants who are Seropositive, as measured by VRNT, Regardless of Dengue Serostatus at Baseline | Seropositivity for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported. | Up to approximately 5 years postvaccination |
| Long-term Immunogenicity Subset: Percentage of Participants who Seroconvert, as measured by VRNT, by Dengue Serostatus at Baseline | Seroconversion rate for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported. | Up to approximately 5 years postvaccination |
| Long-term Immunogenicity Subset: Percentage of Participants who Seroconvert as measured by VRNT, Regardless of Dengue Serostatus at Baseline | Seroconversion rate for Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported. | Up to approximately 5 years postvaccination |
| Long-term Immunogenicity Subset: Dengue Virus-Neutralizing Antibody Titers, as Measured by VRNT, by Dengue Serostatus at Baseline | Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported. | Up to approximately 5 years postvaccination |
| Long-term Immunogenicity Subset: Dengue Virus-Neutralizing Antibody Titers, as Measured by VRNT, Regardless of Dengue Serostatus at Baseline | Dengue virus-neutralizing antibody titers for 4 dengue serotypes (DENV-1, DENV-2, DENV-3, DENV-4) as measured by VRNT will be reported. | Up to approximately 5 years postvaccination |
| Cipayung Primary Health Center ( Site 0105) | Recruiting | East Jakarta | Jakarta Special Capital Region | 13840 | Indonesia |
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| Dr Cipto Mangunkusumo Hospital-Pediatrics ( Site 0101) | Recruiting | Jakarta | Jakarta Special Capital Region | 10430 | Indonesia |
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| Kelapa Gading Primary Health Center ( Site 0104) | Recruiting | North Jakarta | Jakarta Special Capital Region | 14240 | Indonesia |
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| Pasar Minggu Primary Health Center ( Site 0103) | Recruiting | South Jakarta | Jakarta Special Capital Region | 12620 | Indonesia |
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| Hospital Pakar Kanak - Kanak UKM (HPKK) ( Site 0024) | Completed | Cheras | Kuala Lumpur | 56000 | Malaysia |
| University Malaya Medical Centre-Department of Paediatrics ( Site 0025) | Recruiting | Lembah Pantai | Kuala Lumpur | 59100 | Malaysia |
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| Hospital Sibu ( Site 0021) | Recruiting | Sibu | Sarawak | 96000 | Malaysia |
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| Hospital Ampang ( Site 0028) | Recruiting | Ampang | Selangor | 68000 | Malaysia |
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| Hospital Al-Sultan Abdullah - Universiti Teknologi MARA ( Site 0029) | Completed | Bandar Puncak Alam | Selangor | 42300 | Malaysia |
| Sunway Medical Centre ( Site 0027) | Recruiting | Petaling Jaya | Selangor | 47500 | Malaysia |
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| Hospital Tunku Azizah-Paediatric ( Site 0022) | Recruiting | Kuala Lumpur | 50300 | Malaysia |
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| Health Index Multispecialty And Lying-In Clinic ( Site 0042) | Recruiting | Bacoor | Cavite | 4102 | Philippines |
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| Chong Hua Hospital ( Site 0051) | Recruiting | Cebu City | Cebu | 6000 | Philippines |
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| Norzel Medical and Diagnostic Clinic Foundation Corp ( Site 0044) | Recruiting | Cebu City | Central Visayas (Region VII) | 6000 | Philippines |
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| West Visayas State University Medical Center ( Site 0045) | Active, not recruiting | Iloilo City | Iloilo | 5000 | Philippines |
| Philippine General Hospital ( Site 0041) | Recruiting | Manila | National Capital Region | 1000 | Philippines |
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| University of the Philippines Manila ( Site 0047) | Recruiting | Metro Manila | National Capital Region | 1000 | Philippines |
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| Clinical Research Investigator Group ( Site 0110) | Recruiting | Bayamón | 00960 | Puerto Rico |
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| San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0114) | Recruiting | Caguas | 00726 | Puerto Rico |
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| Ponce Medical School Foundation Inc./CAIMED Center ( Site 0112) | Recruiting | Ponce | 00716 | Puerto Rico |
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| Latin Clinical Trial Center ( Site 0113) | Recruiting | San Juan | 00909 | Puerto Rico |
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| Wellness clinical Research Vega Baja ( Site 0116) | Recruiting | Vega Baja | 00693 | Puerto Rico |
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| National University Hospital-Paediatrics ( Site 0001) | Active, not recruiting | Singapore | Central Singapore | 119074 | Singapore |
| KK Women's and Children's Hospital ( Site 0002) | Active, not recruiting | Singapore | Central Singapore | 229899 | Singapore |
| Tan Tock Seng Hospital ( Site 0003) | Active, not recruiting | Singapore | Central Singapore | 308433 | Singapore |
| Chulalongkorn University-Pediatrics ( Site 0063) | Recruiting | Bangkok | Bangkok | 10330 | Thailand |
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| Faculty of Tropical Medicine, Mahidol University ( Site 0062) | Recruiting | Bangkok | Bangkok | 10400 | Thailand |
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| Queen Sirikit National Institute of Child Health-Pediatric Infectious Disease ( Site 0071) | Recruiting | Bangkok | Bangkok | 10400 | Thailand |
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| Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0065) | Active, not recruiting | Bangkok | Bangkok | 10700 | Thailand |
| Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 0067) | Recruiting | Ratchathewi | Bangkok | 10400 | Thailand |
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| Kamphaeng Phet-AFRIMS Virology Research Unit KAVRU ( Site 0070) | Recruiting | Muang | Changwat Kamphaeng Phet | 62000 | Thailand |
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| Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0064) | Recruiting | Amphoe Mueang | Changwat Khon Kaen | 40002 | Thailand |
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| Thammasat University Hospital-Department of Pediatrics ( Site 0068) | Recruiting | Khong Luang | Changwat Pathum Thani | 12120 | Thailand |
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| Songklanagarind hospital-Department of Pediatrics ( Site 0061) | Recruiting | Hat Yai | Changwat Songkhla | 90110 | Thailand |
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| Maharaj Nakorn Chiang Mai Hospital ( Site 0066) | Recruiting | Muang | Chiang Mai | 50200 | Thailand |
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| Kien Giang Women's and Children hospital ( Site 0091) | Recruiting | Rach Gia | An Giang | 920 000 | Vietnam |
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| Cai Lay Regional General Hospital ( Site 0093) | Recruiting | Cai Lậy | Tien Giang | 860 000 | Vietnam |
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| Quang Nam Hospital for Women and Children ( Site 0094) | Recruiting | Da Nang | 550000 | Vietnam |
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| Dong Thap General Hospital ( Site 0092) | Recruiting | Dong Thập | 810000 | Vietnam |
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| Pasteur Institute in Ho Chi Minh city ( Site 0089) | Recruiting | Ho Chi Minh City | 70000 | Vietnam |
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