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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
12,000
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
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
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Jatinegara Primary Health Center ( Site 0102)
East Jakarta, Jakarta Special Capital Region, Indonesia
Cipayung Primary Health Center ( Site 0105)
East Jakarta, Jakarta Special Capital Region, Indonesia
Dr Cipto Mangunkusumo Hospital-Pediatrics ( Site 0101)
Jakarta, Jakarta Special Capital Region, Indonesia
Kelapa Gading Primary Health Center ( Site 0104)
North Jakarta, Jakarta Special Capital Region, Indonesia
Pasar Minggu Primary Health Center ( Site 0103)
South Jakarta, Jakarta Special Capital Region, Indonesia
Hospital Pakar Kanak - Kanak UKM (HPKK) ( Site 0024)
Cheras, Kuala Lumpur, Malaysia
University Malaya Medical Centre-Department of Paediatrics ( Site 0025)
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Sibu ( Site 0021)
Sibu, Sarawak, Malaysia
Hospital Ampang ( Site 0028)
Ampang, Selangor, Malaysia
Hospital Al-Sultan Abdullah - Universiti Teknologi MARA ( Site 0029)
Bandar Puncak Alam, Selangor, Malaysia
...and 31 more locations
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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