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Active, not recruitingNCT07013487Updated Sep 22, 2026

A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)

A Phase 3 interventional study of V181 and Placebo in Healthy, sponsored by Merck Sharp & Dohme LLC. Active, not recruiting at 41 sites in 7 countries. Open to participants aged 2 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
12,000
Allocation
Randomized
Ages
2 Years to 17 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

The key Inclusion Criteria include but are not limited to:

  • Is generally healthy based on medical history and physical examination.

The key Exclusion Criteria include but are not limited to:

  • Has a known or suspected impairment of immunological function.
  • Has a history of congenital or acquired immunodeficiency.
  • Has a documented human immunodeficiency virus (HIV) infection or is breastfeeding from a mother with documented HIV infection.
  • Has a documented history of hepatitis B or C infection.
  • Has a bleeding disorder contraindicating subcutaneous vaccination or repeated venipuncture.
  • Has a serious or progressive disease, including but not limited to cancer, uncontrolled diabetes, severe cardiac, renal or hepatic insufficiency, or systemic autoimmune or neurologic disorders.
  • Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders.
  • Previous receipt of a dengue vaccine or plans to receive any dengue vaccine (investigational or approved) for the duration of the study (other than the study vaccine).
  • Received systemic corticosteroids \<30 days before receipt of study intervention or is expected to require systemic corticosteroids ≤28 days after receipt of study intervention.
  • Has received a blood transfusion or blood products, including immunoglobulins, ≤6 months before receipt of study intervention or plans to receive a blood transfusion or blood products (including immunoglobulins) ≤28 days after receipt of study intervention.
  • Has received immunosuppressive therapies, including chemotherapeutic agents used to treat cancer or other conditions, treatments associated with organ or bone marrow transplantation, or autoimmune disease, ≤6 months before receipt of study intervention or plans to receive immunosuppressive therapies ≤28 days after receipt of study intervention.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
12,000 participants (estimated)

Study arms

  • Experimental
    V181

    Participants will receive a single 0.5 mL subcutaneous (SC) dose of V181 on Day 1.

    Biological: V181

  • Placebo comparator
    Placebo

    Participants will receive a single 0.5 mL SC dose of placebo on Day 1.

    Biological: Placebo

Interventions

  • BiologicalV181

    Participants will receive a single 0.5 mL SC dose of V181 on Day 1.

  • BiologicalPlacebo

    Participants will receive a single 0.5 mL SC dose of placebo on Day 1.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to approximately 6 months postvaccination

  2. 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.

    Time frame: Up to approximately 5 years postvaccination

  3. 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.

    Time frame: Up to approximately 5 days postvaccination

  4. 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).

    Time frame: Up to approximately 28 days postvaccination

  5. 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

    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).

    Time frame: Up to approximately 3 years postvaccination

Secondary outcomes

  1. 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.

    Time frame: Up to approximately 3 years postvaccination

  2. 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.

    Time frame: Up to approximately 3 years postvaccination

  3. 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.

    Time frame: Up to approximately 5 years postvaccination

  4. 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.

    Time frame: Up to approximately 5 years postvaccination

  5. 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.

    Time frame: Up to approximately 3 years postvaccination

  6. 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.

    Time frame: Up to approximately 3 years postvaccination

  7. 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.

    Time frame: Up to approximately 5 years postvaccination

  8. 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.

    Time frame: Up to approximately 5 years postvaccination

  9. 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.

    Time frame: Up to approximately 3 years postvaccination

  10. 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.

    Time frame: Up to approximately 3 years postvaccination

  11. 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.

    Time frame: Up to approximately 5 years postvaccination

  12. 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.

    Time frame: Up to approximately 5 years postvaccination

  13. 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.

    Time frame: Up to approximately 3 years postvaccination

  14. 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.

    Time frame: Up to approximately 3 years postvaccination

  15. 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.

    Time frame: Up to approximately 5 years postvaccination

  16. 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.

    Time frame: Up to approximately 5 years postvaccination

  17. 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.

    Time frame: Up to approximately 3 years postvaccination

  18. 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.

    Time frame: Up to approximately 3 years postvaccination

  19. 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.

    Time frame: Up to approximately 5 years postvaccination

  20. 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.

    Time frame: Up to approximately 5 years postvaccination

  21. 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.

    Time frame: Up to approximately 3 years postvaccination

  22. 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.

    Time frame: Up to approximately 3 years postvaccination

  23. 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.

    Time frame: Up to approximately 5 years postvaccination

  24. 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.

    Time frame: Up to approximately 5 years postvaccination

  25. 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.

    Time frame: Up to approximately 28 days postvaccination

  26. 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.

    Time frame: Up to approximately 28 days postvaccination

  27. 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.

    Time frame: Up to approximately 28 days postvaccination

  28. 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.

    Time frame: Up to approximately 28 days postvaccination

  29. 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.

    Time frame: Up to approximately 28 days postvaccination

  30. 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.

    Time frame: Up to approximately 28 days postvaccination

  31. 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.

    Time frame: Baseline (Day 1) and up to approximately 28 days postvaccination

  32. 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.

    Time frame: Baseline (Day 1) and up to approximately 28 days postvaccination

  33. 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.

    Time frame: Up to approximately 5 years postvaccination

  34. 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.

    Time frame: Up to approximately 5 years postvaccination

  35. 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.

    Time frame: Up to approximately 5 years postvaccination

  36. 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.

    Time frame: Up to approximately 5 years postvaccination

  37. 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.

    Time frame: Up to approximately 5 years postvaccination

  38. 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.

    Time frame: Up to approximately 5 years postvaccination

07

Study locations

41 sites
  • Jatinegara Primary Health Center ( Site 0102)
    East Jakarta, Jakarta Special Capital Region 13310, Indonesia
  • Cipayung Primary Health Center ( Site 0105)
    East Jakarta, Jakarta Special Capital Region 13840, Indonesia
  • Dr Cipto Mangunkusumo Hospital-Pediatrics ( Site 0101)
    Jakarta, Jakarta Special Capital Region 10430, Indonesia
  • Kelapa Gading Primary Health Center ( Site 0104)
    North Jakarta, Jakarta Special Capital Region 14240, Indonesia
  • Pasar Minggu Primary Health Center ( Site 0103)
    South Jakarta, Jakarta Special Capital Region 12620, Indonesia
  • Hospital Pakar Kanak - Kanak UKM (HPKK) ( Site 0024)
    Cheras, Kuala Lumpur 56000, Malaysia
  • University Malaya Medical Centre-Department of Paediatrics ( Site 0025)
    Lembah Pantai, Kuala Lumpur 59100, Malaysia
  • Hospital Sibu ( Site 0021)
    Sibu, Sarawak 96000, Malaysia
  • Hospital Ampang ( Site 0028)
    Ampang, Selangor 68000, Malaysia
  • Hospital Al-Sultan Abdullah - Universiti Teknologi MARA ( Site 0029)
    Bandar Puncak Alam, Selangor 42300, Malaysia
  • Sunway Medical Centre ( Site 0027)
    Petaling Jaya, Selangor 47500, Malaysia
  • Hospital Tunku Azizah-Paediatric ( Site 0022)
    Kuala Lumpur, 50300, Malaysia
  • Health Index Multispecialty And Lying-In Clinic ( Site 0042)
    Bacoor, Cavite 4102, Philippines
  • Chong Hua Hospital ( Site 0051)
    Cebu City, Cebu 6000, Philippines
  • Norzel Medical and Diagnostic Clinic Foundation Corp ( Site 0044)
    Cebu City, Central Visayas (Region VII) 6000, Philippines
  • West Visayas State University Medical Center ( Site 0045)
    Iloilo City, Iloilo 5000, Philippines
  • Philippine General Hospital ( Site 0041)
    Manila, National Capital Region 1000, Philippines
  • University of the Philippines Manila ( Site 0047)
    Metro Manila, National Capital Region 1000, Philippines
  • Clinical Research Investigator Group ( Site 0110)
    Bayamón, 00960, Puerto Rico
  • San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0114)
    Caguas, 00726, Puerto Rico
  • Ponce Medical School Foundation Inc./CAIMED Center ( Site 0112)
    Ponce, 00716, Puerto Rico
  • Latin Clinical Trial Center ( Site 0113)
    San Juan, 00909, Puerto Rico
  • Wellness clinical Research Vega Baja ( Site 0116)
    Vega Baja, 00693, Puerto Rico
  • National University Hospital-Paediatrics ( Site 0001)
    Singapore, Central Singapore 119074, Singapore
  • KK Women's and Children's Hospital ( Site 0002)
    Singapore, Central Singapore 229899, Singapore
  • Tan Tock Seng Hospital ( Site 0003)
    Singapore, Central Singapore 308433, Singapore
  • Chulalongkorn University-Pediatrics ( Site 0063)
    Bangkok, Bangkok 10330, Thailand
  • Faculty of Tropical Medicine, Mahidol University ( Site 0062)
    Bangkok, Bangkok 10400, Thailand
  • Queen Sirikit National Institute of Child Health-Pediatric Infectious Disease ( Site 0071)
    Bangkok, Bangkok 10400, Thailand
  • Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0065)
    Bangkok, Bangkok 10700, Thailand
  • Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 0067)
    Ratchathewi, Bangkok 10400, Thailand
  • Kamphaeng Phet-AFRIMS Virology Research Unit KAVRU ( Site 0070)
    Muang, Changwat Kamphaeng Phet 62000, Thailand
  • Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0064)
    Amphoe Mueang, Changwat Khon Kaen 40002, Thailand
  • Thammasat University Hospital-Department of Pediatrics ( Site 0068)
    Khong Luang, Changwat Pathum Thani 12120, Thailand
  • Songklanagarind hospital-Department of Pediatrics ( Site 0061)
    Hat Yai, Changwat Songkhla 90110, Thailand
  • Maharaj Nakorn Chiang Mai Hospital ( Site 0066)
    Muang, Chiang Mai 50200, Thailand
  • Kien Giang Women's and Children hospital ( Site 0091)
    Rach Gia, An Giang 920 000, Vietnam
  • Cai Lay Regional General Hospital ( Site 0093)
    Cai Lậy, Tien Giang 860 000, Vietnam
  • Quang Nam Hospital for Women and Children ( Site 0094)
    Da Nang, 550000, Vietnam
  • Dong Thap General Hospital ( Site 0092)
    Dong Thập, 810000, Vietnam
  • Pasteur Institute in Ho Chi Minh city ( Site 0089)
    Ho Chi Minh City, 70000, Vietnam
08

References and documents

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07013487
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jun 10, 2025
Start date
Jun 11, 2025
Primary completion
Oct 24, 2031 (estimated)
Completion
Oct 24, 2031 (estimated)
Last update
Sep 22, 2026

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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