DengueNCT01477671
Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children
An observational study of Dengue and Dengue Fever, run by Sanofi Pasteur, a Sanofi Company at 4 sites in India.
Trial summary
This is a descriptive prospective community-based seroprevalence study. Primary objective: To determine the prevalence of specific antibodies (immunoglobulin G [IgG]) against dengue in healthy 5 to 10 year-old children in India. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue, Dengue Fever, Dengue Hemorrhagic Fever
- How many people
- 667 participants
- Where
- 4 sitesIndia
- Study dates
- Sep 2011to Dec 2013
- 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants aged between 5 and 10 year-old that are registered in health centers in India.
Who may be able to join
- Aged between 5 and 10 year-old on the day of inclusion
- Healthy child as reported by the parent or legally qualified guardian
- Being registered in selected study site
- Provision of the informed consent form signed by at least one parent or legally qualified guardian
- For children between 8 and 10 years old, provision of the assent form signed.
Who cannot join
- N/A
Trial locations and contacts
4 sites in 1 country.
India4 sites
Study site
Bangalore, 560070
Study site
Hyderabad, 500063
Study site
Kalyani, West Bengali, 741235
Study site
New Delhi, 110002
About this study
Official title: Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children in India
This is a descriptive prospective community-based seroprevalence study.
Primary objective:
- To determine the prevalence of specific antibodies (immunoglobulin G [IgG]) against dengue in healthy 5 to 10 year-old children in India.
Secondary objectives:
- To determine the dengue virus serotype (DeNV-1,2,3 and /or 4) specific to the antibodies in positive (IgG) samples
- To estimate the prevalence of specific antibodies (IgG) against Japanese encephalitis in healthy 5 to 10 year-old children in India.
- Conditions
- Dengue, Dengue Fever, Dengue Hemorrhagic Fever
- Keywords
- Dengue, Dengue Fever, Dengue Hemorrhagic Fever
- 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 |
|---|---|---|
| Study Group | Participants aged between 5 and 10 year-old on day of inclusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of positive samples with dengue specific serotype DENV 1, 2,3 and/or 4
Measured: Baseline
Secondary outcomes (1)
Prevalence of positive serum samples with JEV specific IgG antibodies
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionDec 2013
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.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477671
- Sponsor's protocol ID
- DNG10
- Other IDs
- U1111-1124-7423
- Status last verified
- Jan 2018
- First submitted
- 18 Nov 2011
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Garg S, Chakravarti A, Singh R, Masthi NR, Goyal RC, Jammy GR, Ganguly E, Sharma N, Singh MM, Ferreira G, Moureau A, Ojha S, Nealon J; DNG10 study group. Dengue serotype-specific seroprevalence among 5- to 10-year-old children in India: a community-based cross-sectional study. Int J Infect Dis. 2017 Jan;54:25-30. doi: 10.1016/j.ijid.2016.10.030. Epub 2016 Nov 4.
PubMed 27825949Bhavsar A, Tam CC, Garg S, Jammy GR, Taurel AF, Chong SN, Nealon J. Estimated dengue force of infection and burden of primary infections among Indian children. BMC Public Health. 2019 Aug 14;19(1):1116. doi: 10.1186/s12889-019-7432-7.
PubMed 31412836
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children in India
- ClinicalTrials.gov ID
- NCT01477671
- Acronym / sponsor ID
- DNG10
- Conditions
- Dengue, Dengue Fever, Dengue Hemorrhagic Fever
- Keywords
- Dengue, Dengue Fever, Dengue Hemorrhagic Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Nov 2011 (estimated)
- 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 a descriptive prospective community-based seroprevalence study.
Primary objective:
- To determine the prevalence of specific antibodies (immunoglobulin G [IgG]) against dengue in healthy 5 to 10 year-old children in India.
Secondary objectives:
- To determine the dengue virus serotype (DeNV-1,2,3 and /or 4) specific to the antibodies in positive (IgG) samples
- To estimate the prevalence of specific antibodies (IgG) against Japanese encephalitis in healthy 5 to 10 year-old children in India.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –Participants aged between 5 and 10 year-old on day of inclusion. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants aged between 5 and 10 year-old that are registered in health centers in India.
Key inclusion criteria (5 listed)
- Aged between 5 and 10 year-old on the day of inclusion
- Healthy child as reported by the parent or legally qualified guardian
- Being registered in selected study site
- Provision of the informed consent form signed by at least one parent or legally qualified guardian
- For children between 8 and 10 years old, provision of the assent form signed.
Key exclusion criteria (1 listed)
- N/A
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
Prevalence of positive samples with dengue specific serotype DENV 1, 2,3 and/or 4
Time frame: Baseline
1 secondary outcome
Prevalence of positive serum samples with JEV specific IgG antibodies
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Results publication: PubMed 27825949Garg S, Chakravarti A, Singh R, Masthi NR, Goyal RC, Jammy GR, Ganguly E, Sharma N, Singh MM, Ferreira G, Moureau A, Ojha S, Nealon J; DNG10 study group. Dengue serotype-specific seroprevalence among 5- to 10-year-old children in India: a community-based cross-sectional study. Int J Infect Dis. 2017 Jan;54:25-30. doi: 10.1016/j.ijid.2016.10.030. Epub 2016 Nov 4.
- Derived from this study: PubMed 31412836Bhavsar A, Tam CC, Garg S, Jammy GR, Taurel AF, Chong SN, Nealon J. Estimated dengue force of infection and burden of primary infections among Indian children. BMC Public Health. 2019 Aug 14;19(1):1116. doi: 10.1186/s12889-019-7432-7.
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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.
Medical Director study director
Sanofi Pasteur SA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue and Dengue Fever, run by Sanofi Pasteur, a Sanofi Company at 4 sites in India.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of positive samples with dengue specific serotype DENV 1, 2,3 and/or 4 (time frame: Baseline). 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 NCT01477671, 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 11 Jan 2018.