| CTRI Number |
CTRI/2024/06/069168 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Antirabies vaccine using single dose ,intradermal route in children who are not exposed to rabies |
|
Scientific Title of Study
|
Immunogenicity of Single Dose Intradermal Pre-Exposure Rabies Prophylaxis Regimen in Children. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kanvi Sharma |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 19A, Department of Paediatrics,
Maulana Azad Medical College, Bahadur shah zafar marg, New delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
9718966189 |
| Fax |
|
| Email |
kanvi.sharma14ab17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anurag Agarwal |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Paediatrics,
Maulana Azad Medical College, Bahadur shah zafar marg, New delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
9810409625 |
| Fax |
|
| Email |
doctoranuragagarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anurag Agarwal |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Paediatrics,
Maulana Azad Medical College, Bahadur shah zafar marg, New delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
9810409625 |
| Fax |
|
| Email |
doctoranuragagarwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur shah zafar marg, New delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
Bahadur shah zafar marg, New delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kanvi Sharma |
Lok Nayak Hospital |
Room No.516 Pediatrics OPD Fifth Floor, OPD Building Maulana Azad Medical college and Associated Lok Nayak Hospital. New Delhi
DELHI
New Delhi
DELHI |
9718966189
kanvi.sharma14ab17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospitals(Lok Nayak, GB Pant Institute Post Graduate Medical Education (GIPMER) and Research hospital, Guru nanak Eye Centre, New Delhi-110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
None |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anti Rabies Vaccine |
The antirabies vaccine will be administered as a single dose of 0.1 ml on day 0 via the intradermal route at two sites, one over each deltoid, as pre-exposure prophylaxis. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children and adolescents aged 1-18 years from OPD / with minor illnesses. |
|
| ExclusionCriteria |
| Details |
1.History of receipt of any rabies vaccine in the
2.Past History of animal bite.
3. Previous severe allergic reaction to any of the vaccine components.
4.Known history of autoimmune disease, immunodeficiency disorders or chronic diseases.
5.History of receipt of any vaccine within 1 month.
6.History of dog bite during the study period.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of subjects with IgG anti rabies virus glycoprotein titres equal to or more than 0.5 EU/ml 28 days after single dose of Intradermal Pre exposure Rabies Prophylaxis.
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Proportion of subjects with IgG anti rabies virus glycoprotein titres equal to or more than 0.5 EU/ml 180 days after single dose of Intradermal Pre exposure Rabies Prophylaxis..
2.Proportion & profile of adverse effects in children, following single dose intradermal pre-exposure rabies prophylaxis |
Day 180
Where day 0 will be day of administration of vaccine |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a single arm interventional study titled IMMUNOGENICITY OF SINGLE DOSE INTRADERMAL PRE-EXPOSURE RABIES PROPHYLAXIS REGIMEN IN CHILDREN 1-18 years of age in 40 patients and will be conducted at Maulana Azad Medical college, New delhi.
The primary outcome would be to find out the Proportion of subjects with IgG anti rabies virus glycoprotein titres equal to or more than 0.5 EU/ml 28 days after single dose of Intradermal Pre exposure Rabies Prophylaxis.
The Secondary Outcomes would be to find out- - Proportion of subjects with IgG anti rabies virus glycoprotein titres equal to or more than 0.5 EU/ml 180 days after single dose of Intradermal Pre exposure Rabies Prophylaxis.
- Proportion and profile of adverse effects in children, following single dose intradermal pre-exposure rabies prophylaxis.
|