CTRI

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CTRI Number

CTRI/2017/09/009844 [Registered on: 19/09/2017] Trial Registered Prospectively

Last Modified On:

30/10/2021

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Follow Up Study

Study Design

Single Arm Study

Public Title of Study

Safety Surveillance Study of BCG vaccine

Scientific Title of Study

An Open Label, Prospective, Multicentre, Single Arm, Single Treatment, Single Dose Post Marketing Surveillance Study to Evaluate the Safety And Tolerability of BCG Vaccine Freeze Dried IP Of GreenSignal Bio Pharma Ltd, Chennai, India

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
AHC/VAC/039/16 Version 02 24-Jul-17	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr VT Sriraam
Designation	Chief Medical Research Coordinator
Affiliation	Aurous HealthCare Research and Development India Private Limited
Address	#180/109, G1 & G2, RR Villa, Rangarajapuram Main Road, Kodambakkam, Chennai â€“ 600024 Chennai TAMIL NADU 600024 India
Phone	9840909155
Fax
Email	md@auroushealthcare.com

Details of Contact Person
Scientific Query

Name	Dr VT Sriraam
Designation	Chief Medical Research Coordinator
Affiliation	Aurous HealthCare Research and Development India Private Limited
Address	#180/109, G1 & G2, RR Villa, Rangarajapuram Main Road, Kodambakkam, Chennai â€“ 600024 Chennai TAMIL NADU 600024 India
Phone	9840909155
Fax
Email	md@auroushealthcare.com

Details of Contact Person
Public Query

Name	Dr VT Sriraam
Designation	Chief Medical Research Coordinator
Affiliation	Aurous HealthCare Research and Development India Private Limited
Address	#180/109, G1 & G2, RR Villa, Rangarajapuram Main Road, Kodambakkam, Chennai â€“ 600024 Chennai TAMIL NADU 600024 India
Phone	9840909155
Fax
Email	md@auroushealthcare.com

Source of Monetary or Material Support

GreenSignal Bio Pharma Limited No.49, Pappankuppam village, Gummidipoondi, Chennai â€“ 601201. Tamil Nadu. India.

Primary Sponsor

Name	GreenSignal BioPharma Private Limited
Address	No.49, Pappankuppam village, Gummidipoondi, Chennai â€“ 601201, Tamil Nadu. India.
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
Aurous HealthCare Research and Development India Private Limited	#180/109, G1 & G2, RR Villa, Rangarajapuram Main Road, Kodambakkam, Chennai â€“ 600024 Tamil Nadu, India

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 47
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Guruswamy N T MD Paed	General Hospital, Tiptur Dt	Department of Pediatrics, General Hospital Tiptur Dt Tumkur KARNATAKA	9448988990 guru254888@gmail.com
Dr KS Kulkarni MBBS MS Gen Sur	General Hospital, Tumkur Dt	Department of Pediatrics, General Hospital Tumkur Dt Tumkur KARNATAKA	9448552976 amotusuvekere@gmail.com
Dr BM Jagadbesh MBBS D Ortho	Government Hospital	Department of Pediatrics Government Hospital Malur Talil Kolar KARNATAKA	9845438119 addghmalur@gmail.com
Dr Malini	Government Hospital	Government Hospital SIRA Bangalore KARNATAKA	9740105999 malinikrish19@gmail.com
Dr Sreenivasan MA MBBS	Government Hospital	Department of Pediatrics Government Hospital Mulbagal Kolar KARNATAKA	9449238439 amomulbagal@gmail.com
Dr Srinivas G MBBS DPH	Government Hospital	Department of Pediatrics Government Hospital Srinivasapura Taluk Kolar KARNATAKA	9480643439 hosrinivaspura@gmail.com
Dr Althaf Ahmed	Primary Health Centre	Primary Health Centre Kolar Karnatak Kolar KARNATAKA	9840643394 phckyalanur29@gmail.com
Dr Anitha Rani V	Primary Health Centre	Primary Health Centre, Madderi, Karnataka Bangalore KARNATAKA	9480643395 madderipsu@gmail.com
Dr Arun Kumar	Primary Health Centre	Primary Health Centre Bethamangala Kolar KARNATAKA	9448985124 chcbethamangala@gmail.com
Dr Charan Raj T K	Primary Health Centre	Primary Health Centre Birakur Bijapur KARNATAKA	9480643412 phc.phcbyrakur@gmail.com
Dr CM Ravi Kishore	Primary Health Centre	Primary Health Centre, Bangalore Bangalore KARNATAKA	7259126535 drkishorecm@gmail.com
Dr CM Ravi Kishore MBBS	Primary Health Centre	Department of Pediatrics Primary Health Centre Vemagal Kolar KARNATAKA	7259126535 drkishorecm@gmail.com
Dr Dattatreya	Primary Health Centre	Primary Health Centre Madhyagiri Mandya KARNATAKA	9636355501 ghmadhugiri@gmail.com
Dr G Sunitha MBBS	Primary Health Centre	Department of Pediatrics Primary Health Centre Srinivasapura Taluk Kolar KARNATAKA	9481827554 m.o.phc.nambihalli@gmail.com
Dr Geetha MK	Primary Health Centre	Primary Health Centre Thoralakki Malur, Kolar Kolar KARNATAKA	9535821201 thoralakkiphc@gmail.com
Dr Hari Krishna MBBS	Primary Health Centre	Department of Pediatrics Primary Health Centre Koladevi Mulbagal Kolar KARNATAKA	9480643418 phckoladevi@gmail.com
Dr Hemalatha	Primary Health Centre	Primary Health Centre Tumkur Tumkur KARNATAKA	9986168178 drhemalatharamesh@gmail.com
Dr Jagadesh Naik	Primary Health Centre	Primary Health Centre Bangalore Bangalore KARNATAKA	7259681029 jana2601mbbs@gmail.com
Dr K Chandana BAMS	Primary Health Centre	Department of Pediatrics Primary Health Centre Huliyur Tumkur KARNATAKA	9481248992 doctorchandana@gmail.com
Dr K R Prakash	Primary Health Centre	Primary Health Centre Takal Bangalore KARNATAKA	9901029544 phctekal@gmail.com
Dr Kavitha KR MBBS	Primary Health Centre	Department of Pediatrics Primary Health Centre Addagal Srinivasapura Taluk Kolar KARNATAKA	9480650290 phcaddagal@gmail.com
Dr Khena MBBS	Primary Health Centre	Department of Pediatrics Primary Health Centre Yediyur Tumkur KARNATAKA	9980621648 drkhene.u@gmail.com
Dr M Devanand	Primary Health Centre	Primary Health Centre Bangalore KARNATAKA	8277507021 amogubbi@gmail.com
Dr Malathi D	Primary Health Centre	Primary Health Centre Nittur Tumkur Tumkur KARNATAKA	9535508740 mophcnittur@gmail.com
Dr Manjula R	Primary Health Centre	Primary Health Centre, Kolur Bangalore Rural KARNATAKA	9480643401 doddashivaraphc@gmail.com
Dr Pradeep C MBBS	Primary Health Centre	Department of Pediatrics Primary Health Centre Kandikere Halli Tumkur KARNATAKA	8277507172 phc09kandikere@gmail.com
Dr Pradeep Kumar M MBBS PGDDM	Primary Health Centre	Department of Pediatrics Primary Health Centre Yeldur Srinivasapura Taluk Kolar KARNATAKA	8277832311 phcyeldur123@gmail.com
Dr Prakash N A Anaes Sp	Primary Health Centre	Department of Pediatrics Primary Health Centre Kolar Kolar KARNATAKA	9845819752 drmidnightsun75@gmail.com
Dr Raja HR	Primary Health Centre	Primary Health Centre Hebbar Bangalore KARNATAKA	9740234584 phchebbur@gmail.com
Dr Rakesh GS	Primary Health Centre	Primary Health Centre Thayalur Kolar Kolar KARNATAKA	9480643424 phcthayalur@gmail.com
Dr Rakshita NP	Primary Health Centre	Primary Health Centre Nagavalli Tumkur KARNATAKA	8105498979 rakshith.indiafirst@gmail.com
Dr Ramya Deepika YR MBBS	Primary Health Centre	Department of Pediatrics Primary Health Centre Kolar KARNATAKA	9900499182 yrramyadeepika@gmail.com
Dr Ramya MS MBBS	Primary Health Centre	Department of Pediatrics Primary Health Centre Lakkur Village, Malur Taluk Kolar KARNATAKA	9036424976 lakkurphc@gmail.com
Dr Samskrithi N	Primary Health Centre	Primary Health Centre Budikote Bagalkot KARNATAKA	9480603381 amobudhikote@gmail.com
Dr Saraswathi R	Primary Health Centre	Primary Health Centre Bangalpet Kolar Kolar KARNATAKA	9480643382 amododdachinnahalli@gmail.com
Dr Shanthala B N MBBS MD	Primary Health Centre	Department of Pediatrics Primary Health Centre Taluk Health Office Karnataka Tumkur KARNATAKA	9449272190 shanthalanarayanachar@gmail.com
Dr Shivanag K MBBS	Primary Health Centre	Department of Pediatrics Primary Health Centre Yediyur Tumkur KARNATAKA	9535577720 shivnag.babu@yahoo.com
Dr Shobha SG MBBS	Primary Health Centre	Department of Pediatrics Primary Health Centre Kallambela Tumkur KARNATAKA	9972797848 shobhasg25@gmail.com
Dr Sudhakar V MBBS	Primary Health Centre	Department of Pediatrics Primary Health Centre Nangali, Mulbagal Kolar KARNATAKA	8970882223 phcnangali@gmail.com
Dr Sunil Kumar B	Primary Health Centre	Primary Health Centre Kolar Kolar KARNATAKA	9880049855 amokyasambally@gmail.com
Dr Thejaswini K C MBBS	Primary Health Centre	Department of Pediatrics Primary Health Centre Kolar Kolar KARNATAKA	9986819324 theju46@gmail.com
Dr Varalakshmi N MBBS	Primary Health Centre	Department of Pediatrics Primary Health Centre Kolar Kolar KARNATAKA	9480643431 phckolar@gmail.com
Dr Venu	Primary Health Centre	Primary Health Centre Karnataka Bangalore KARNATAKA	8277507101 venurd492@gmail.com
Dr Venu RD MBBS	Primary Health Centre	Department of Pediatrics Primary Health Centre Vemagal Kolar KARNATAKA	9449622010 venurd49@gmail.com
Dr Vijaya MC MBBS	Primary Health Centre	Department of Pediatrics Primary Health Centre Ronur Srinivaspur Taluk Kolar KARNATAKA	9886699123 drvijayamc@gmail.com
Dr Yamini R	Primary Health Centre	Primary Health Centre Guttahalli Bangarpetta Taluk Bangalore KARNATAKA	9480643383 amoguttahalli@gmail.com
DrMallika M M	Primary Health Centre	Primary Health Centre Sugattur Kolar Kolar KARNATAKA	9686619377 phcsugatur@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 2
Name of Committee	Approval Status
ACE Independent Ethics Committee	Approved
ACE Independent Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied
Modification(s)

Health Type	Condition
Healthy Human Volunteers	No Condition. This is an observational study on subjects who are to routinely receive BCG vaccine as part of their vaccination program.

Intervention / Comparator Agent

Type	Name	Details
Intervention	BCG Vaccine Freeze Dried IP Of GreenSignal Bio Pharma Ltd, Chennai, India	COHORT 1 : Infants and Children, below the age of 1 year (male and female, age not inclusive) Dose : Infants below 1 month : Single Dose 0.05mL On reconstitution, with 1.0mL of 0.9% w/v Sodium Chloride injection, each vaccine dose of 0.05mL contains 1-4 x 105 CFU Dose : Infants & Children above 1 month : Single Dose 0.1mL On reconstitution, with 1.0mL of 0.9% w/v Sodium Chloride injection, each vaccine dose of 0.1mL contains 2-8 x 105 CFU COHORT 2: Adults and Children above the age of 1 year (male and female, age inclusive) Single Dose 0.1mL On reconstitution, with 1.0mL of 0.9% w/v Sodium Chloride injection, each vaccine dose of 0.1mL contains 2-8 x 105 CFU
Comparator Agent	Not Applicable	Not Applicable

Inclusion Criteria

Age From	3.00 Day(s)
Age To	55.00 Year(s)
Gender	Both
Details	1. Cohort 1 : Infants and Children, below the age of 1 year (male and female, age not inclusive) Cohort 2: Adults and Children above the age of 1 year (male and female, age inclusive) 2. Clinically healthy subjects as evaluated by medical history, general and physical examination 3. Subjects who are known/ whose parents are known to be HIV negative 4. Subjects who are negative to the Tuberculin Skin Test 5. Subjects who show no reason to be suspected of having tuberculosis. 6. Subjects who have no scar relatable to previous BCG vaccination. 7. Subjects/Parents or LAR of Subjects who are willing to provide informed consent for the participation in the study.

ExclusionCriteria

Details

1. Subjects who have previously been vaccinated with/ uncertain history of vaccination with BCG.
2. Subjects who are sick, suffering from common cold or other conditions that compromise their immune system at the time of vaccination.
3. Subjects with febrile conditions at the time of or 3 days prior to vaccination.

4. Subjects with congenital immunodeficiency, leukemia or any malignant disease
5. Subjects who are immunocompromised by known diagnosis of viral infections, cancer, surgery, transplants etc.
6. Subjects who are on immunosuppressant inclusive of corticosteroids, alkylating agents, antimetabolites, on radiation treatment and anti tuberculosis medications
7. Subjects who have undergone major surgical procedure 4 weeks prior to randomisation.
8. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
9. Subjects who are known/reported to be pregnant, lactating, planning a pregnancy or unwilling to practice double barrier contraceptive method.
10. Subjects who in the opinion of the investigator are deemed unfit to participate in the study.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
1. Reactogenicity and Safety: Normal presentation with no local and systemic adverse events 2. Scar Formation: Normal Presentation at the site of vaccination.	1. Day 3, Day 45, 6 months, 12 months. 2. Day 3, Day 45, 6 months, 12 months.

Secondary Outcome

Outcome

TimePoints

Part I
1. Injection site abscess
2. Injection site papule

Part I
1. Injection Site Papule
2. Mild Ulceration of Injection Site
3. Lymphadenitis Suppuration
4. Skin Lesions

Part II
1. Lymphadenitis Suppuration
2. Skin Lesions
3. BCG Lymphadenitis
4. Disseminated BCG Diseases
5. Osteitis/Osteomyelitis

Part III
1. Skin Lesions.
2. BCG Lymphadenitis
3. Disseminated BCG Diseases
4. Osteitis/ Osteomyelitis

Day 3, Day 45, 6 months, 12 months.

Target Sample Size

Total Sample Size="5000"
Sample Size from India="5000"
Final Enrollment numbers achieved (Total)= "3500"
Final Enrollment numbers achieved (India)="3500"

Phase of Trial

Post Marketing Surveillance

Date of First Enrollment (India)

01/11/2017

Date of Study Completion (India)

08/08/2019

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="1"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

Not Applicable.

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Open Label, Prospective, Multicentre, Single Arm, Single Treatment, Single Dose Post Marketing Surveillance Study to Evaluate the Safety And Tolerability of BCG Vaccine Freeze Dried IP Of GreenSignal Bio Pharma Ltd, Chennai, India.
This is an OBSERVATIONAL STUDY only. No interventions are planned. The study is observed on subjects who routinely receive BCG vaccine as per of their immunisation program.
The study is observed in three parts for a total duration of 12 months.
The study population is split into 2 cohorts.

Cohort 1 : Infants and Children, below the age of 1 year (male and female, age not inclusive)

Cohort 2: Adults and Children above the age of 1 year (male and female, age inclusive)
A total of 5000 subjects are to be enrolled and observed in this study.
Reactogenicity, Safety and Scar Formation is observed as Efficacy End Points
The following are observed as Safety End Points.

Part I (Visit 1-Day1 ; Visit 2-Day 3)

1. Injection site abscess

2. Injection site papule

Part I (Visit 3 â€“ Day 45)

1. Injection Site Papule

2. Mild Ulceration of Injection Site

3. Lymphadenitis Suppuration

4. Skin Lesions

Part II (Visit 4 â€“ 6 Months)

1. Lymphadenitis Suppuration

2. Skin Lesions

3. BCG Lymphadenitis

4. Disseminated BCG Diseases

5. Osteitis/Osteomyelitis

Part III (Visit 5 â€“ 12 months)

1. Skin Lesions.

2. BCG Lymphadenitis

3. Disseminated BCG Diseases

4. Osteitis/ Osteomyelitis

Safety Monitoring

Mild Adverse events

1. Injection Site Papule

2. Mild Ulceration

3. Scar

Severe Adverse events

1. Local Abscess

2. Keloid

3. Lymphadenitis Suppuration

4. Cutaneous Skin LEsions

5. osteitis/Osteomyelitis

6. Disseminated BCG Diseases.

7. Immune Reconstitution Syndrome.