| CTRI Number |
CTRI/2015/11/006384 [Registered on: 26/11/2015] Trial Registered Prospectively |
| Last Modified On: |
05/01/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This is phase one study with healthy adult participants to be enrolled to receive study product to check the safety and tolerability of liquid rotavirus vaccine in healthy adults |
|
Scientific Title of Study
|
An Open Label Clinical Trial To Assess The Safety And Tolerability Of A Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) Formulation In Healthy Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ROTA : 05 Version: 2.0 dated 13 Aug 2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil K |
| Designation |
Principal Investigator |
| Affiliation |
Syngene International Limited |
| Address |
Human Pharmacology Unit
Syngene International Limited
Clinical Development
Tower – 1, Semicon Park
Electronics City Phase II
Bangalore – 560 100, India.
Bangalore
KARNATAKA
560100
India |
| Phone |
080-28082771 |
| Fax |
|
| Email |
Anil.Dr@syngeneintl.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad Kulkarni |
| Designation |
Medical Director |
| Affiliation |
Serum Institute of India Limited |
| Address |
Serum Institute of India Limited
212/2, Off Soli Poonawalla Road,
Hadapsar, Pune-411028. India
Pune
MAHARASHTRA
411028
India |
| Phone |
020-26602384 |
| Fax |
020-26993921 |
| Email |
drpsk@seruminstitute.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajjad Desai |
| Designation |
Deputy Medical Director |
| Affiliation |
Serum Institute of India Limited |
| Address |
Serum Institute of India Limited
212/2, Off Soli Poonawalla Road,
Hadapsar, Pune-411028. India
Pune
MAHARASHTRA
411028
India |
| Phone |
020-26602781 |
| Fax |
020-26993921 |
| Email |
sajjad.desai@seruminstitute.com |
|
|
Source of Monetary or Material Support
|
| Serum Institute of India Limited
212/2, Off Soli Poonawalla Road,Hadapsar, Pune-411028 India |
|
|
Primary Sponsor
|
| Name |
Serum Institute of India Limited |
| Address |
Serum Institute of India Limited
212/2, Off Soli Poonawalla Road,Hadapsar, Pune-411028 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Dr Anil K |
Syngene International Limited |
Human Pharmacology Unit
Syngene International Limited
Clinical Development
Tower – 1, Semicon Park
Electronics City Phase II
Bangalore – 560 100, India.
Bangalore
KARNATAKA |
080-28082780
080-28082722
Anil.Dr@syngeneintl.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwara Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Gastroenteritis caused by Rotavirus in Indian
infants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Liquid formulation of live Attenuated pentavalent rotavirus vaccine (LBRV-
PV) |
Liquid formulation of live Attenuated pentavalent rotavirus vaccine (LBRV-PV).
Dose of 2.0 ml |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy adult male or non-pregnant female subjects aged between 18-45 years and normal Body Mass Index (18.5 to 24.9 kg/m2) with minimum of
50 kg weight.
2. Normal health as determined by medical history, clinical examination and
laboratory assessment.
3. Subjects willing to adhere to the protocol requirements and to provide
written informed consent
4. Availability for clinical follow up through period of the study. |
|
| ExclusionCriteria |
| Details |
1. Investigator site personnel directly affiliated with this study and their immediate families.
2. Fever or any acute infection at time of immunization.
3. History of diarrhea or blood in stool or abnormal stool pattern in past one week.
4. A known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccine or a vaccine containing the same substances.
5. History or presence of asthma, urticaria or other allergic reaction.
6. History of chronic gastrointestinal disease, intussusceptions, gastrointestinal malformation or abdominal surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Occurrence of immediate adverse events within 60 minutes.
2. Occurrence of solicited reactions within 7-day post-vaccination follow-up
period.
3. Occurrence of unsolicited adverse events, including serious adverse events
within 28 days after vaccination. |
within 60 minutes;
within 7-day post-vaccination follow-up period;
within 28 days after vaccination. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Occurrence of unsolicited adverse events, including serious adverse
events within 28 days after vaccination. |
28 days after vaccination |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
27/11/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a phase I, open labelled study to assess the safety and tolerability of a Liquid formulation of Bovine Rotavirus Pentavalent Vaccine (LBRV-PV), in healthy adults.
A total of 20 subjects will be enrolled in the study at single site to receive LBRV-PV. Active surveillance for vaccine reactogenicity (solicited reactions) over the 7-day period after vaccination will be conducted on all subjects. In addition, surveillance for unsolicited AEs and SAEs will be carried out over the period between enrollment and four weeks after vaccination on all subjects. |