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1 Clinical Trial Details (PDF Generation Date :- Sun, 07 Oct :20:17 GMT) CTRI Number Last Modified On 13/02/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/09/ [Registered on: 23/09/2013] - Trial Registered Retrospectively No Interventional Vaccine Randomized, Parallel Group, Active Controlled Trial This study will evaluate the immunogenicity and tolerability of V503 i preadolescent and adolescent subjects between 9 and 15 years old an demonstrate the consistency of the manufactured vaccine through assessment of 3 different final manufacturing process lots of V503. A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, an Manufacturing Consistency of V503 (A Multivalent Human Papillomav [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women to 26 Year Olds) Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) NCT V dated 15-Jan-2010 Designation Affiliation Address ClinicalTrials.gov Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Anirban Roychowdhury Head Clinical Research India MSD Pharmaceuticals Pvt Ltd Address 6th Floor, Vatika Towers - B, Golf Course Road Sector 54, Gurgaon HARYANA India Phone Fax Designation Affiliation anirban.roychowdhury@merck.com Details Contact Person (Public Query) Anirban Roychowdhury Head Clinical Research India Address 6th Floor, Vatika Towers - B, Golf Course Road Sector 54, HARYANA India page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > Merck Sharp and Dohme One Merck Drive P.O. Box 100 Whitehouse Station, NJ USA Primary Sponsor Details Merck Sharp and Dohme Address One Merck Drive P.O. Box 100 Whitehouse Station, NJ USA Type of Sponsor NIL List of Countries Austria Belgium Brazil Chile Colombia Costa Rica Croatia Democratic People's Republic of Korea Denmark Finland France Hong Kong India Lithuania Netherlands Norway Peru Poland Russian Federation South Africa Spain Sweden Taiwan Thailand Turkey United Kingdom of Principal Investigator Dr Neerja Bhatla Pharmaceutical industry-global Address NIL of Site Site Address Phone/Fax/ All India Institute of Medical Sciences Department of Obs and Gynae Ansari Nagar,, New Delhi DELHI com Dr Sanjay Lalwani Bharati Hospital Department of page 2 / 6

3 Details of Ethics Committee Dr Hemant Jain Dr Daljit Singh AndResearch Center Chacha Nehru BalChikitsalaya and MGM Dayanand Medical College and Hospital Pediatrics Katraj Dhankawadi, Pune Pune MAHARASHTRA Department of Pediatrics Medical College (CNBC & MGM,Chacha Nehru Bal Chikitsalaya Indore Indore MADHYA PRADESH Department fo Pediatrics Tagore nagar, civil lines, Ludhiana Ludhiana PUNJAB Dr Swapna Chakraborty Medical CollegeKolkata Department of Pediatrics 88, College Street Kolkata WEST BENGAL Dr Amaresh Adyar Nilofer Hospital Department fo Pediatrics Red Hills, Hyderabad ANDHRA PRADESH Dr Sudha Marwah Spectrum Healthcare 81-84, Lady Ratan Tata Medical Centre, M. Karve Road, Cooperage, Mumbai MAHARASHTRA iffmail.com om com althcare.co.in of Committee Approval Status Date of Approval Is Independent Ethics Committee? CLINXXL Independent Ethics Committee_Spectrum healthcare Pvt Ltd_Mumbai Ethics and scientificreview CommitteeMGM Medical Collegeand M.Y. Ethics Committee,AIIMS IEC Dayanand Medical College IEC Medical College Kolkata Institutional Ethics Committee _Osmania Medical College Approved 21/06/2010 Yes Approved 30/06/2010 No Approved 14/01/2011 No Approved 30/08/2010 No Approved 28/09/2010 No Approved 18/10/2010 No Institutional Approved 04/11/2010 No page 3 / 6

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent EthicsCommittee BharatiVidyapeeth University Status Date Approved/Obtained 20/07/2010 Health Type Healthy Human Volunteers Condition Cervical Cancers Vulvar Cancer Vaginal Cancer Genital Lesions PAP Test Abnormalities HPV Infections Type Details Intervention Boys 9 to 15 years old: Lot 1 Biological: V503 Multivalent 3. ( Please note that this is an extension study (V which will colle safety and Intervention Experimental: Girls 9 to 15 years old: V503 Lot 1 Intervention Experimental: Girls 9 to 15 years old: V503 Lot 2 Intervention Experimental: Girls 9 to 15 years old: V503 Lot 3 Biological: V503 Multivalent 3.( The patient received the vaccination in the V study ) Please note that this is an extension study (V which will collect safety and Biological: V503 Multivalent 3.( The patient received the vaccination in the V study ) Please note that this is an extension study (V which will collect safety and Biological: V503 Multivalent page 4 / 6

5 Inclusion Criteria Comparator Agent NA NA Age From Age To Gender Details 9.00 Year(s) Year(s) Both Inclusion Criteria 3. ( The patient received the vaccination in the V study ) Please note that this is an extension study (V which will collect safety and Inclusion Criteria: Boys and Girls Age 9 to 15: Participant has not had sexual intercourse prior to the study and does not plan to become sexually active during the study period Day 1 to Month 7 Exclusion Criteria Details Please note that this is an extension study (V EXT1) which will collect safety and through Month 36 for patients in the age group of 9-15 years. No study vaccine will be administered in. Subjects enrolled in the 16- to 26-year-old cohort in the base study will not be included in the EXTENSION STUDY. Exclusion Criteria Exclusion Criteria: Boys and Girls Age 9 to 15: History of allergic reaction that required medical intervention Currently enrolled in any other clinical study Participant is pregnant Participant is immunocompromised or has taken immunosuppressants in the last year Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial Participant has a history of positive test for HPV. Method of Generating Random Sequence Method of Concealment Blinding/Masking Stratified randomization Centralized Participant, Investigator and Outcome Assessor Blinded Only patients in the age group of 9-15 years of age ( Male and female ) would be included in the study. All other age groups are excluded in. Primary Outcome Outcome Timepoints Number of subjects with injection site adverse experiences Number of subjects with elevated temperature 4 weeks after last dose of vaccination page 5 / 6

6 Powered by TCPDF ( PDF of Trial Number of subjects with systemic adverse experiences Geometric mean titers (GMTs) to each of the HPV types contained in the vaccine Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary types contained in the vaccine Geometric mean titers (GMTs) to each of the HPV types contained in the vaccine at 6, 18, and 30 months post dose 3 types contained in the vaccine at 6, 18, and 30 months post dose 3 Number of participants with vaccine-related serious adverse events (SAEs) or death [ Time Frame: Up to 30 months post dose 3 ] [ Designated as safety issue: Yes ] Total Sample Size=2800 Sample Size from India=225 28/09/ /08/2010 Years=2 Months=11 Days=25 Closed to Recruitment of Participants Closed to Recruitment of Participants types contained in the vaccine [ Time Frame: 4 weeks post dose 3 ] [ Designated as safety issue: No ] Geometric mean titers (GMTs) to each of the HPV types contained in the vaccine at 6, 18, and 30 months post dose 3 [ Time Frame: Up to 30 months post dose 3 ] [ Designated as safety issue: No ] types contained in the vaccine at 6, 18, and 30 months post dose 3 [ Time Frame: Up to 30 months post dose 3 ] [ Designated as safety issue: No ] Number of participants with vaccine-related serious adverse events (SAEs) or death [ Time Frame: Up to 30 months post dose 3 ] [ Designated as safety issue: Yes ] This is an optional extension study (V ) which will collect safety and immunogenicity information vaccine was administered in. Subjects that entered into the base study rolled over into the V extension study. Study subjects enrolled in the age group of 9-15 years old cohort rolled into. Subjects enrolled in the 16- to 26-year-old cohort in the base study were not be included in EXTENSION study. The LPLV for the study was achieved on 30 April Data base lock is expected on 24 February Kindly note that the base study V was a 12-month study for collecting safety and for six months following the subjects third dose of study vaccine, the study concluded in The V study is registered on the CTRI website vide registration no CTRI/2009/091/ [Registered on: 02/02/2010] page 6 / 6

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