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1 Clinical Trial Details (PDF Generation Date :- Sat, 13 Oct :57:54 GMT) CTRI Number Last Modified On 21/06/2011 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/04/ [Registered on: 18/04/2011] - Trial Registered Prospectively No Interventional Vaccine Biological Preventive Randomized, Parallel Group, Active Controlled Trial A post licensure clinical trial to evaluate the immunogenicity & safety of BEs combined liquid pentavalent DTwP-rHepB-HIB vaccine (Combe Five) administered to healthy n infants in comparison with a licensed Pentavac SD vaccine available in n market A multicentric, single blind, parallel, randomized, phase-iv non-inferiority study to evaluate the immunogenicity & safety of BEs combined liquid pentavalent DTwP-rHepB-HIB vaccine administered to 6-8 week old healthy n infants at weeks schedule in comparison with a marketed SIILs Pentavac SD vaccine Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) BECT011/DTwP-rHepB-HIB-PIV/CTP-01 Designation Affiliation Protocol Number Details of Principal Investigator DrTSA Kishore Overall Trial Coordinator Biological E Limited Phone Fax Designation Affiliation Biological E.Limited, 18/1&3, Azamabad Hyderabad kishore.tsa@biologicale.co.in Details Contact Person (Scientific Query) DrTSA Kishore Overall Trial Coordinator Biological E Limited Biological E.Limited, 18/1&3, Azamabad Details Contact Person (Public Query) Phone Fax Designation Affiliation kishore.tsa@biologicale.co.in Details Contact Person (Public Query) MrShekhar Gupta Chief Operating Officer D2L Pharma Research Solutions D2L Pharma Research Solutions 1615, 5th Main, E Block, AECS Layout, Kundalahalli, Bangalore Bangalore page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Biological E.Limited (self) Type of Sponsor None List of Countries of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details Biological ELimited Biological E.Limited 18/1&3, Azamabad, Hyderabad Pharmaceutical industry-n of Site Site Phone/Fax/ DrBKrishna Murthy Cheluvamba Hospital Dept of Paediatrics, Cheluvamba Hospital, Irwin Road, Mysore , Karnataka, Mysore DrJampana Venkateswara Rao Gandhi Hospital Dept of Paediatrics, Gandhi Hospital, Musheerabad, Secunderabad , Andhra Pradesh, Hyderabad DrDNarayanappa JSS Medical college Department of Paediatrics, Jagadguru Sri Shivarathreeshwara Medical College & Hospital, Mahatma Gandhi Road, Mysore , Karnataka, Mysore Dr Mallikarjunaiah K.C General Hospital Dept of Paediatrics, K.C General Hospital, 5th Cross,Malleshwaram, Nr Malleswaram Police Station, Bangalore , Karnataka, Bangalore Dr Pandit Anand Nilkanth KEM Hospital Research Centre bkm6@rediffmail.com dr_jvrao@yahoo.co.in sinchabhi@yahoo.com lakshmipathysr@gmail. com Dept of Paediatrics, KEM Hospital Research Centre, Sardar Moodliar kemhrc@vsnl.com page 2 / 6

3 Details of Ethics Committee Road, Rasta Peth, Pune , Maharashtra, Pune MAHARASHTRA DrPVenugopal King George Hospital Dept of Paediatrics, King George Hospital (KGH), Near Collectorate Maharanipeta, Visakhapatnam , Andhra Pradesh, Visakhapatnam Dr Jain Manish Ajeet Dr Deokule Amita Shrikrishna Mahatma Gandhi institute of Medical Sciences Oyster and Pearl Hospital Dept of Paediatrics, Mahatma Gandhi institute of Medical Sciences, PO Sewagram , Wardha District, Maharashtra, Wardha MAHARASHTRA Dept of Paediatrics, Oyster and Pearl Hospital, Ganesh Khind Road, Near Hotel Pride, Pune , Maharashtra, Pune MAHARASHTRA venugopal_kgh@yahoo.com dr_manishjain@rediffm ail.com aap.phadnis@gmail.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee MGIMS, Sewagram Approved 19/04/2011 No Ethics Committee of Mysore Medical College, Research Institute and Associated Hospital(Cheluvamba Hospital) Approved 16/04/2011 No Human Ethics Committee, Gandhi Hospital Independent Ethics Committee Consultants (K.C General Hospital) Institute Ethics Committee,Padmashre e Dr.D.Y.Patil Medical College, Pimpri, Pune. Institutional Ethics Committee King George Hopital, Visakhapatnam Approved 02/05/2011 No Approved 20/04/2011 Yes Approved 21/04/2011 No Approved 19/03/2011 No JSS Institutional Ethical Approved 25/04/2011 No page 3 / 6

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Committee O & P Institutional Ethics Committee(Oyster and Pearl Hospital) Status Not Applicable Health Type Healthy Human Volunteers Approved 19/04/2011 No Date No Date Specified Condition Type Details Intervention Comparator Agent Age From Age To Gender Details BEs combined Liquid pentavalent DTwP-rHepB-HIB vaccine (Combe Five) SIILs Pentavac SD vaccine (DTwP-rHepB-Hib vaccine) Day(s) Day(s) Both Inclusion Criteria Preventive protection against Diphtheria, Tetanus, Petussis, Hepatitis-B and Haemophilus Influenzae type B diseases 0.5 ml per dose administered intramuscularly 3 dose schedule in the anterolateral aspect of thigh. The duration is 56 days ( schedule) with 28 day interval between doses. 0.5 ml per dose administered intramuscularly 3 dose schedule in the anterolateral aspect of thigh. The duration of treatment is 56 days ( schedule) with 28 day interval between doses. Healthy infants between 6-8 weeks of age (i.e. 42 to 56 days of age, both days inclusive) of either gender at the time of 1st vaccination. Written informed consent obtained from the subjects parent(s) or legally acceptable representative / guardian. Healthy infants with weight equal to or more than 3300 gms at the time of screening. Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature). Healthy infants born to mothers seronegative to HBV and HIV as confirmed by laboratory tests on the mother or based on maternity discharge summary. Infants or their mothers not participating in any other clinical trials. Infants without contraindications or precautionary circumstances for participating in the trial Ability of the infants parent or legally acceptable representative/guardian to understand and comply with the requirements of the protocol. Exclusion Criteria Details Exclusion Criteria Prior immunization with DTP, Hepatitis-B or HIB vaccine with the exception of BCG &/or oral &/or Inactivated polio vaccine. Current illness (especially fever) or any acute or congenital illness or disability. Subjects receiving immunosuppressive therapy. Known or suspected allergy to any of the vaccine components. Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS). page 4 / 6

5 Known family history of SIDS (Sudden Infant Death Syndrome). Planned or elective surgery during the course of the study. Infants who have received any blood products, any dose of corticosteroids, cytotoxic agents or radiotherapy. Subjects and their mothers who have participated in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course. Inability or unwillingness to abide by the requirements of the protocol. Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Sequentially numbered, sealed, opaque envelopes Participant Blinded Primary Outcome Outcome Timepoints 1.Seroprotection rates (SPR) as defined by percentage of subjects with anti-diphtheria, anti-pertussis, anti-tetanus, anti-hbsag and anti-prp antibody titres above their seroprotective cut off values. 1.At Day 84. Secondary Outcome Outcome Timepoints 1.Proportion of subjects achieving 4-fold rise in antibody titres. 2.Geometric mean titres(gmts)estimation. 3.Solicited local and systemic AEs. 4.Solicited and unsolicited AEs. 5.Rate of SAEs and medically attended AEs. 6.Vital signs. 1.At day 84 2.At screening & day minutes post vaccination till day 7. 4.During the subsequent Followup period up to 28th day 5.Until 84th day after 1st vaccination 6.At each visit Target Sample Size Phase of Trial Phase 4 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=408 Sample Size from =408 19/04/2011 No Date Specified Years=0 Months=6 Days=0 Not Applicable Completed None A multicentric, single blind, parallel, randomized, phase-iv non-inferiority study to evaluate the immunogenicity & safety of BE s combined liquid pentavalent DTwP-rHepB-HIB vaccine administered to 6-8 week old healthy n infants at weeks schedule in comparison with a marketed SIIL s Pentavac SD vaccine. This study to be conducted at 08 study sites.all the study sites will be located in. There will be a total of 408 healthy subjects of either sex randomised into two groups in 2:1 page 5 / 6

6 Powered by TCPDF ( PDF of Trial ratio. The primary outcome measure is to evaluate non-inferiority of BE s combined pentavalent DTwP-rHepB-HIB liquid vaccine with SIIL s Pentavac SD in terms of difference in proportion of subjects achieving seroprotection with anti-diphtheria, anti-pertussis, anti-tetanus, anti-hbsag and anti-prp antibody titres at day 84. The secondary outcome measures are to a) compare proportion of subjects achieving fold rise in anti-diphtheria, anti-pertussis, anti-tetanus, anti-hbsag and anti-prp antibody titres, above the seroprotection cut off value, between BE s combined pentavalent DTwP-rHepB-HIB liquid vaccine and Pentavac SD at Day 84; b) To compare immunogenicity in terms of GMTs for anti-diphtheria, anti-pertussis, anti-tetanus, anti-hbsag and anti-prp antibody titres of BE s combined pentavalent DTwP-rHepB-HIB vaccine with that of Pentavac SD at 84; c) To assess the safety and tolerability of BE s combined pentavalent DTwP-rHepB-HIB liquid vaccine in comparison with Pentavac SD for the entire study period of 84 days after the first vaccination. page 6 / 6