| CTRI Number |
CTRI/2011/12/002243 [Registered on: 15/12/2011] Trial Registered Retrospectively |
| Last Modified On: |
18/09/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Epidemiology |
| Study Design |
Other |
|
Public Title of Study
|
Prospective dengue seroprevalence study in 5 to 10 year-old children |
|
Scientific Title of Study
|
Prospective dengue seroprevalence study in 5 to 10 year-old children in India |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| DNG10 |
Protocol Number |
| U1111-1124-7423 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suneela Garg |
| Address |
Department of Community Medicine,
Maulana Azad Medical College,
Bahadur Shah Zafar Marg
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
911123234939 |
| Fax |
|
| Email |
suneela.garg@yahoo.com |
|
Details Contact Person
Scientific Query
|
| Name |
Dr Rohit Arora |
| Address |
Sanofi Pasteur India Pvt. Ltd.
Aventis House 54/A
Sir Mathuradas Vasanji Road,
Andheri (East) Mumbai
Mumbai
MAHARASHTRA
400093
India |
| Phone |
91-2228278083 |
| Fax |
912228278000 |
| Email |
drrohit.arora@sanofipasteur.com |
|
Details Contact Person
Public Query
|
| Name |
Dr Rohit Arora |
| Address |
Sanofi Pasteur India Pvt. Ltd.
Aventis House 54/A
Sir Mathuradas Vasanji Road,
Andheri (East) Mumbai
Mumbai
MAHARASHTRA
400093
India |
| Phone |
91-2228278083 |
| Fax |
912228278000 |
| Email |
drrohit.arora@sanofipasteur.com |
|
|
Source of Monetary or Material Support
|
| Sanofi Pasteur SA
2 Avenue Pointe Pasteur
F-69367 Lyon Cedex
France |
|
|
Primary Sponsor
|
| Name |
Sanofi Pasteur SA |
| Address |
2 Avenue Pointe Pasteur
F-69367 Lyon Cedex
France |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sanofi Pasteur India Pvt Ltd |
Aventis House 54/A Sir Mathuradas Vasanji Road, Andheri (East) Mumbai |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suneela Garg |
Department of Community Medicine, Maulana Azad Medical College |
Department of Community Medicine, Maulana Azad Medical College,
New Delhi, 110 002
New Delhi
|
911123234939
gargsuneela@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| College of Medicine & J.N.M Hospital, West Bengal University of Health Sciences, Kalyani, Nadia West Bengali, 741235 |
Approved |
| Institutional Ethical Committee, Maulana Azad Medical College & Associated Lok Nayak, Govind Ballabh Hospital, Guru Nanak Eye Centre, New Delhi, 110002 |
Approved |
| Institutional Ethics Committee, Datta Meghe Institute of Medical Sciences (Deemed University), Atrey Layout, Pratap Nagar, NAGPUR - 442 022, Maharashtra, India. |
Approved |
| Kempegowda Institute of Medical Sciences, Banashankari 2nd Stage, Banglore-560 070 |
Approved |
| Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital Staff Research Society, LTM Medical College Building, 2nd Floor, Moom No. 17, Sion, Mumbai - 400 022 |
Approved |
| Mediciti Ethics Committee, Mediciti Hospitals, Mediciti Institute of Medical Sciences & Share Organizations, 5-9-22, Near Sarovar Hotel, Secretariat Road, Hyderabad - 500063 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dengue |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
- 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. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of participants with dengue specific IgG antibodies in serum samples |
Day 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of positive samples with dengue specific serotype DENV 1, 2,3 and/or 4 |
Day 0 |
| Prevalence of positive serum samples with JEV specific IgG antibodies |
Day 0 |
|
|
Target Sample Size
|
Total Sample Size="3230"
Sample Size from India="3230" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
22/09/2011 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
Brief Summary
Modification(s)
|
This is a descriptive prospective community-based seroprevalence study in a sample of children registered in the health centers to assess the prevalence of dengue-specific antibodies in order to assess if there has been dengue transmission in the community in recent years. |
