KLE UNIVERSITY ~~

KLE UNIVERSITY [Established under Section3of theUGCAct, 1956videMHRD, G.O.I Notification NO.F9-19/2000-U.3{A) dl 13" April2006j

Office of the Registrar , KLE University, JNMC Campus, Nehru Nagar, Belgaum-590 010, Karr:ataka State, India

tr: 0831-2472777 FAX: 0831-2493777 Web: http://www.kleuniversity.edu.in E-mail : registrar@kahe.edu.in

Ref: KLEU/EC/2012-13/D- Date: 18/0612012

From, Chairperson, Ethics Committee ofKLE University, Belgaum

To, Dr. S M Dhaded, Professor & Head, Department of Pediatrics, J.N. Medical College, KLE Deemed University. Consultant, KLES Dr Prabhakar Kore Hospital & MRC, Nehrn Nagar, Belgaum- 590010

Ref: Protocol Study:"Safety, Immune Lot-to-Lot Consistency and Non-Inferiority of Shan 5

(DTwP-HepB-Hib) Vaccine in Comparison to Pentavac SD when administered as a Single Booster

Dose at 15-18 months and Three Dose at 6-8,10-12 and 14-16 Weeks of Age in Healthy Indian

Children and Infants" (protocol Number: SH501 Version 1.0, dated 14th April 2012)".

Sub: Ap~roval of Study Documents for the conduct of study Protocol Number: SH501, Version 1.0, Dated 14t April 2012.

Dear Dr. S. M. Dhaded,

The Ethics Committee, KLE University, Belgaum has received from you 12 Copies of each of following study related documents.

1. Research Protocol (Protocol Number: SH501, Version 1.0, dated 14th April 2012).

2. Investigator's.Brochure (Version 2, Dated 17th April 2012, which replaces Version 1, dated 24th

December 2007).

3. Case Report Form (Cohort 1&2)(Version 0.3, Dated 13.04.2012 Cohort 1), (Version 0.3, dated

13.04.2012, Cohort 2).

4. Inform Consent Form (Cohort 1&2) English, Kannada, Marathi & Hindi (Version 1.0, dated 14th

April 2012).

KL E UN IVERSITY ~PlICfEl:IQW.l

KLE UNIVERSITY [Establishedunder Section 3oftheUGCAct, 1956videMHRD, G,O.I Notification No,F.9-19/2000-U.3(A) dl 1311April 2006]

Office of the Registrar, KLE University, JNMC Campus, Nehru Nagar, Belgaum-590 010, Kamataka State , India

II : 0831-2472777 FAX: 0831-2493777 Web: http://www.kleuniversity.edu.in E-mail: registrar@kahe.edu.in

5. Symptoms Dairy Card (Cohort 1&2) English, Kannada, Marathi & Hindi.

6. CV of Investigator's.

7. Investigator' s undertaking.

8. Insurance Policy, 14-MAY-2012 to 30-APR-2013.

9. DCGI Approval submission letter Dated 13th April 2012 .

10. Translation Certificates:

• English to Hindi (cohortl) Dated 14th April 2012.

• English to Hindi (cohort2) Dated 14th April 2012.

• English to Marathi (cohort 1) Dated 14th April 2012.

• English to Marathi (cohort 2) Dated 16th April 2012.

• English to Kannada (cohortl) Dated 14th April 2012.

• English to Kannada (cohort2) Dated 14th April 2012.

At the Ethics Committee meeting held on Saturday 09th June, 2012 at 03:00pm at Site

Management Office, KLES Dr Prabhakar Kor e Hospital & MRC, Belgaum.

Your referenced letter and the above submitted documents were examined and discussed. Discussion Points ­

The study is approved through 08/June/2013.

But the Investigator has to comply with the following prior to initiation of enrollment ­

• The study can be initiated only after the submission ofDCGI approval.

The members who attended the meeting held on Saturday 09th June, 2012 at 03:00pm at Site

Management Office, KLES Dr Prabhakar Kore Hosp ital & MRC, Belgaum.

KLE U N IVER SITY ~PIlCmlOWS

KLE UNIVERSITY [Established under Section 3 ofthe UGC Act, 1956videMHRD, G.O.INotificationNO.F.9-1912000-U.3IAl dt 1311April 2006]

Office of the Registrar, KLE University, JNMC Campus, Nehru Nagar, Belgaum-590 010, Karnataka State, India

.: 0831-2472777 FAX: 0831-2493777 Web: http://www.kleuniversity.edu.in E-mail: registrar@kahe.edu.in

Following Members of the Committee were present:

1. Dr. Sanjiva Kholkute, Officer-in-Charge, RMRC, Belgaum Chairman

2. Dr. Subarna.Roy, Scientist'D'Officer-in-charge, RMRC, Belgaum Officiating

3. Dr. P. A. Pati!, Joint Director, KLE University Research Foundation Member

4. Dr. Ashok C. Pangi, Prof of Surgery, JNMC, Belgaum Member

5. Dr. S.M.Dhaded, Professor & HOD Dept of Pediatric, J.N.M.C, Bgm Member

6. Mrs. Maki N. Kapadia, Social Worker, Havelock Road, Camp, Belgaum Member

7. Mr. N.D.Kunne, Advocate & Receiver Bgm Dist.Court, Belgaum Member

8. Mr. B.N.Metagudmath, Retd. Dy.SPs, Vigilance Officer, KLESH, Belgaum Member

9. Dr. S.S.Goudar, Prof of Physiology, JNMC, Belgaum Member - Secretary

Following Members of the committee who expressed their inability to attend / had not attended the

meeting were:

1. Dr. M. B. Bellad, ProfOBGYN, JNMC, Belgaum Member

2. Dr. Sunita. Y. Patil, Associate Professor, Dept of Pathology, J.N.M.C, Bgm Member

You are expected to report to the Ethics committee the following:

• All deviations from, or changes to, the protocol to eliminate immediate hazards to the study

subjects

• Changes that increase the risk to participating subjects and/or those that significantly affect the

conduct of the study

• All serious adverse events

• New information that may affect adversely the safety of the subjects or the conduct of the study

• Any changes in the study document

• Progress of the study.

Also please provide a report to the Ethics Committee on the completion of the study.

KLE� UNIV ERSITY EIoI'OIoBlf(;~

KLE UNIVERSITY� [Establishedunder Section 3ofthe UGCAct, 1956 videMHRD, G.O.INotification No.F.9-19/2000-U.3(A) dt. 13111 April 2006)

Office of the Registrar , KLE University,� JNMC Campus, Nehru Nagar, Belgaum-590 010, Karnataka State, India�

II :0831-2472777 FAX: 0831-2493777 Web: http://www.kleuniversity.edu.in E-mail: registrar@kahe.edu.in�

Neither the PI nor any of the proposed study team members were present during the decision-making procedures of the Ethics Committee.

Note: Phannacogenomic study in any form is not approved by the Ethics Committee.

Yours truly,

k: 4 dA\1­(Dr. S. S. ~u~~~) (Name & Signature of Ethics Committee� Cha lilt}')�

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