DengueNCT03465254
Dengue Serostatus Study in the Philippines
An observational study of Dengue and Severe Dengue, run by University of the Philippines.
Trial summary
This is an observational study for 5 years, and aims to determine the risk of developing dengue among Philippine children who are eligible to receive the dengue vaccine during the DOH mass dengue vaccination, by dengue serostatus at baseline. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue, Severe Dengue, Dengue Fever
- Type of treatment
- Vaccines
- How many people
- 2,996 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children in selected study areas in Region 7, aged 9-14 years old who are considered eligible to be included in the DOH dengue mass vaccination
Who may be able to join
- Provide signed informed consent and assent (as applicable)
- Be a child belonging to the specified age group and resident of the targeted communities of the DOH dengue mass immunization
- Be eligible to receive dengue vaccine during the DOH dengue mass immunization in 2017
Who cannot join
- Any subject whose parent/guardian refuse to provide informed consent and/or assent
- Children who do not belong to the specified age groups and not residents of the targeted communities
- Children <9 years old
- Children with history of bleeding disorder
- Any subject previously enrolled in a dengue vaccine clinical trial
About this study
Official title: Effect of Baseline Dengue Serostatus Among Tetravalent Dengue Vaccine CYDTDV (Dengvaxia®) Recipients on Subsequent Virologically Confirmed Dengue in the Philippines
This is an observational study for 5 years, and aims to determine the risk of developing dengue among Philippine children who are eligible to receive the dengue vaccine during the DOH mass dengue vaccination, by dengue serostatus at baseline.
Read the detailed description
This is a cohort study that aims to determine the relative risk of developing virologically-confirmed dengue among Philippine children who are eligible to receive dengue vaccine during the DOH Mass Dengue Vaccination. Additionally, it also aims to determine the relative risk of developing severe and/or hospitalized virologically-confirmed dengue among Philippine children who received the Dengue vaccine, describe the epidemiologic trends and characteristics of virologically-confirmed dengue among these children, and assess the performance of simpler tests such as dried blood spots and serum IgG for the assessment of dengue seroprevalence at the population level. We will enroll children who are residents of selected areas in Region 7, Philippines. Children should be eligible to participate in the Department of Health mass dengue vaccination. They will be prospectively venipunctured for baseline dengue serologic status. The blood samples will be stored for serologic testing using neutralization tests and commercial IgG tests. Children in the cohort will be followed up, and those who present with <5 days of fever will be identified and blood drawn for dengue LAMP and RT-PCR.
- Conditions
- Dengue, Severe Dengue, Dengue Fever, Virologically-confirmed Dengue
- Medical subject headings
- Dengue, Severe Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Recruited members of the cohort are children aged 9-14 years old and eligible to receive the dengue vaccine at the time of the initiation of community-based dengue immunization program of the Department of Health. |
What is being measured
The primary outcome is the main question the study is designed to answer.
virologically-confirmed dengue (VCD)
The primary outcome measure is virologically confirmed dengue by RT-PCR
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study startNov 2016
- Primary completion31 Oct 2022
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DengueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,996 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Philippines, World Health Organization, Research Institute for Tropical Medicine, Philippines, University of North Carolina, La Jolla Institute for Allergy & Immunology, International Vaccine Institute
- Responsible party
- Sponsor
- Investigators
- Jacqueline L. Deen, MD, Principal investigator, UPM-NIH, Institute of Child Health and Human Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465254
- Sponsor's protocol ID
- UPM REB 2016-435-01
- Status last verified
- May 2023
- First submitted
- 6 Mar 2018
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Mpingabo PI, Ylade M, Aogo RA, Crisostomo MV, Thiono DJ, Daag JV, Agrupis KA, Escoto AC, Raimundi-Rodriguez GL, Odio CD, Fernandez MA, White L, de Silva AM, Deen J, Katzelnick LC. Protective envelope dimer epitope-like antibodies are elicited against dengue virus in children after infection and vaccination. Sci Transl Med. 2025 Jul 23;17(808):eadq0571. doi: 10.1126/scitranslmed.adq0571. Epub 2025 Jul 23.
PubMed 40700517Lopez AL, Adams C, Ylade M, Jadi R, Daag JV, Molloy CT, Agrupis KA, Kim DR, Silva MW, Yoon IK, White L, Deen J, de Silva AM. Determining dengue virus serostatus by indirect IgG ELISA compared with focus reduction neutralisation test in children in Cebu, Philippines: a prospective population-based study. Lancet Glob Health. 2021 Jan;9(1):e44-e51. doi: 10.1016/S2214-109X(20)30392-2. Epub 2020 Nov 16.
PubMed 33212030
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Baseline Dengue Serostatus Among Tetravalent Dengue Vaccine CYDTDV (Dengvaxia®) Recipients on Subsequent Virologically Confirmed Dengue in the Philippines
- ClinicalTrials.gov ID
- NCT03465254
- Acronym / sponsor ID
- UPM REB 2016-435-01
- Conditions
- Dengue, Severe Dengue, Dengue Fever, Virologically-confirmed Dengue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,996 participants (actual)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Collaborators
- Department of Health, Philippines, World Health Organization, Research Institute for Tropical Medicine, Philippines, University of North Carolina, La Jolla Institute for Allergy & Immunology, International Vaccine Institute
- Study start
- Nov 2016 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- Jun 2023 (estimated)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study for 5 years, and aims to determine the risk of developing dengue among Philippine children who are eligible to receive the dengue vaccine during the DOH mass dengue vaccination, by dengue serostatus at baseline.
Detailed description
This is a cohort study that aims to determine the relative risk of developing virologically-confirmed dengue among Philippine children who are eligible to receive dengue vaccine during the DOH Mass Dengue Vaccination. Additionally, it also aims to determine the relative risk of developing severe and/or hospitalized virologically-confirmed dengue among Philippine children who received the Dengue vaccine, describe the epidemiologic trends and characteristics of virologically-confirmed dengue among these children, and assess the performance of simpler tests such as dried blood spots and serum IgG for the assessment of dengue seroprevalence at the population level. We will enroll children who are residents of selected areas in Region 7, Philippines. Children should be eligible to participate in the Department of Health mass dengue vaccination. They will be prospectively venipunctured for baseline dengue serologic status. The blood samples will be stored for serologic testing using neutralization tests and commercial IgG tests. Children in the cohort will be followed up, and those who present with <5 days of fever will be identified and blood drawn for dengue LAMP and RT-PCR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –Recruited members of the cohort are children aged 9-14 years old and eligible to receive the dengue vaccine at the time of the initiation of community-based dengue immunization program of the Department of Health. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children in selected study areas in Region 7, aged 9-14 years old who are considered eligible to be included in the DOH dengue mass vaccination
Key inclusion criteria (3 listed)
- Provide signed informed consent and assent (as applicable)
- Be a child belonging to the specified age group and resident of the targeted communities of the DOH dengue mass immunization
- Be eligible to receive dengue vaccine during the DOH dengue mass immunization in 2017
Key exclusion criteria (5 listed)
- Any subject whose parent/guardian refuse to provide informed consent and/or assent
- Children who do not belong to the specified age groups and not residents of the targeted communities
- Children <9 years old
- Children with history of bleeding disorder
- Any subject previously enrolled in a dengue vaccine clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
virologically-confirmed dengue (VCD)
Time frame: 5 years
The primary outcome measure is virologically confirmed dengue by RT-PCR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Derived from this study: PubMed 40700517Mpingabo PI, Ylade M, Aogo RA, Crisostomo MV, Thiono DJ, Daag JV, Agrupis KA, Escoto AC, Raimundi-Rodriguez GL, Odio CD, Fernandez MA, White L, de Silva AM, Deen J, Katzelnick LC. Protective envelope dimer epitope-like antibodies are elicited against dengue virus in children after infection and vaccination. Sci Transl Med. 2025 Jul 23;17(808):eadq0571. doi: 10.1126/scitranslmed.adq0571. Epub 2025 Jul 23.
- Derived from this study: PubMed 33212030Lopez AL, Adams C, Ylade M, Jadi R, Daag JV, Molloy CT, Agrupis KA, Kim DR, Silva MW, Yoon IK, White L, Deen J, de Silva AM. Determining dengue virus serostatus by indirect IgG ELISA compared with focus reduction neutralisation test in children in Cebu, Philippines: a prospective population-based study. Lancet Glob Health. 2021 Jan;9(1):e44-e51. doi: 10.1016/S2214-109X(20)30392-2. Epub 2020 Nov 16.
- Individual participant dataSharing planned: Undecided
Related trials for Dengue
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline L. Deen, MD principal investigator
UPM-NIH, Institute of Child Health and Human Development
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue and Severe Dengue, run by University of the Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
virologically-confirmed dengue (VCD) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03465254, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.