GOVERNMENT OF WEST BENGALDEPARTMENT OF HEALTH & FW

INSTITUTIONAL ETHICS COMMITTEEMEDICAL COLLEGE & HOSPITALS, KOLKATA

20/08/09

To,

Dr. Sukanta ChatterjeeProfessor and Head Department,Department of Pediatrics,Medical College, Kolkata, 88, College Street,Kolkata - 700 073

Ref: Study Name & No.: MMRV-053 PRI

Dear .Sukanta,

The Institutional Ethics Committee of Medical College Kolkata reviewed and

discussed your application dated 11 August 2009 to conduct the clinical trial entitled

A phase IIIb, open, randornised, multicentre, primary study in healthy children, to

establish the non-inferiority of GlaxoSmithKline (GSK) Biologicals' MeMuRu-OKA

vaccine (administered at 9 and 15 months of age) versus Priorix" (9 months of age)

and Priorix" co-administered with Varilrix ™ at 15months of age (comparator) and

also to evaluate the non-inferiority of Priorix" (9 months of age) and MeMuRu-OKA

vaccine (15 months of age) versus the comparator, all administered subcutaneously as

two-dose primary vaccination course" on August 20. 2009.

The following documents were reviewed and approved:

Sr._No Documents Version l1 Final Protocol Version 12.4 Final dated 23 May 2008I

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2 Investigator Brochure 6th Edition dated final 1OJune 2009.I

.3 Prescribing information of -------

. Varilrixf'M and PriorixTM

4 Informed Consent Form (ICF)- Final Local India English Version 1.0 dated 28-En~lish July-09

Diary Cards for MMRV 0531Dose 1 Group, MeMuRu-OKA .& MeMuRu-OKA group OR

5 Priorix" & MeMuRu-OKA Version 12.4 dated 20-Mar-09Dose 2 Group, Priorix" & I

Priorix" + Varilrix'P'Dose 2 -

Group In English

6 Patient card-English Version October 24, 2008

Informed Consent Form (ICF)- Final Local India English Version 1.0 dated 28-7

HindiJuly-09 translated from English to Hindi on 31-

Jul-09Diary Cards for MMRV 0531 IDose 1 Group, MeMuRu-OKA& MeMuRu-OKA group OR Version 12.4 dated 20-Mar-09 translated from I8 Priorix" & MeMuRu-OKADose 2 Group, Priorix" &

English to Hindi on 22-Apr-2009IPriorix ™ + Varilrix ™ Dose 2 I

Group in Hindi

9 Patient card-Hindi Translated from English to Hindi on 19-Dee-. . 2?08. -i

10 Informed Consent Form (ICF)- FinalLocal India English VerSIOn 1.0 dated 28- i

BengaliJuly-09 translated horn English to Bengali on I1O-Aug-09 I

Diary Cards for MMRV 0531Dose 1 Group, MeMuRu-OKA& MeMuRu-OKA group OR Version 12.4 dated 20-Mar-09 translated from I

11 Priorix" & MeMuRu-OKA I

Dose 2 Group ~Priorix ™ &English to Bengali on 06 August 2009 I

IPriorix" + Varilrix" Dose 2 I

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Group in Bengali Ii

Translated from English to Bengal i on 06 i12 Patient card-Bengali

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iAugust 2009 !

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·13 Workbook Version 12.4 dated l7-Jull-2008 !14 , SAE Report Form Version 12.4 dated 08-Dec-2006 I15 Use of Human Samples Form Version 12.4 dated l3-Aug-2007 i16 Insurance Certificate -

- ;..

We have also received the following documents:,~

1. A copy of Undertaking by the Investigator of site PI (Dr. Sukanta Chatterjee)2. CV of Dr. Sukanta Chatterjee3. English Model rCF Version 2.0 dated 28-Jul-09 with summary changes in version

2.0 Model reF4. PSRIs of MMR (Priorix), Varicella (Varilrix) and MMRV (Priorix-Tetra) from

period 01 May 09 to 31 Jul 095. DCGr approval leiter dated 21-Nov-2008 i

6. Ethics Committee approval from other participating sites

The following members of the ethics committee were present at the meeting held on20108/09 at 12.00P.M at Council Room, MCH Building, l " Floor, MCH, Kolkata

--_._.----- - -Name Designation I

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~--~--"------Prof. Pranab Bhowmick Ex - Prof.& Head 'of Paediatric medicine, Chairperson IMedical College & Hospitals, Kolkata , .._--_...__._- !Prof. Utpal Kumar Datta Principal, Medical College & Hospitals, Member Secretary

Kolkata ~i--·-~i

Prof. Anup Roy Medical Supdt, Cum vice Principal, Member( Permanent Invitee)Medical College & Hospitals, Kolkata ------

Prof. Prabir Sur Prof. Depu. of Radiotherapy Member ( Permanent Invitee)

---. c~ Prof. Sukanto Chatterjee Prof & Head Deptt. of Paediatrics Member ( Permanent invitee)

I I Prof S. Batyabyal Dean of Student affairs, Prof. & HOD Member---~---~~-~~----. '1

Deptt, Of FSM ---------- ._._--------~rof. Indranil Chakraborty Prof. & Head Deptt, Of Biochemistry Member

Prof Sikha Datta Prof & Head Deptt, Of Pharmacology Member---------1

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I I Prof. Samir Dasgupta ~------.-.. --- ---

Prof. & Head Deptt. of Community Member ( Permanent" Invitee)H Dr. Loknath ChakrabortyMedicine 1. __ -- ___ .Prof of Philosophy, Sanskrit College- Member/

,,I " TheologistI Dr. Ratna Dey Lecturer Statistics, MCH, Kolkata - Member --~~:_~1Statiscian.

Hon,ble Minister Anadi Sahoo Labour Minister Member II--

Srnt. Krishna Ghosh Advocate, Legal Expert Member

Smt. Vijaya Roy Research Co-ordinator, Institute of MemberDevelopment Study, SociaJ Scientist

, ~Dr. Ranjana Chaterjee Prof. & HOD, Pediatrics;R.G.Kar, MCH ~ Member

1Dr. Vaskar Bose Prof of Medicine,NRS MCH MemberI!

MS. Susmita Nag Assistant Supdt, Medical College & Convenor ( Permanent Invitee) I.Hospitals, Kolkata ~~'---- I

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We approve the trial to be conducted in .its presented form. The IEC has no objections

for the conduct of inspection for the aforementioned study by national and/or foreign --

regulatory authorities.

The given approval is valid for the entire period of the study.

The Institutional Ethics Committee / Independent Ethics Committee expect to be

informed about the progress of the study 6 monthly. The Ethics Committee should be

informed about the progress of the study, any. SAE occurring in the course of the study,

any changes in the protocol or Informed consent form and a copy of the final report.

I hereby certify that this ethics committee is constituted and functions in accordance withICH-Good Clinical Practice, Schedule Y and ICMR guidelines and at the time ofthe _voting the req~ired quorum was present.

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Yours sincerely,

-P/l</k1vvv~~AC-ChairpersonInstitutional Ethics CommitteeMedical College KolkataKolkata-7~ -