PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Fri, 24 Sep 2021 14:38:34 GMT) CTRI Number CTRI/2012/02/002430 [Registered on: 16/02/2012] - Trial Registered Retrospectively Last Modified On 15/02/2012 Post Graduate Thesis No Type of Trial Interventional Type of Study Vaccine Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study A Multicenter, Open Label, Comparative Study to Evaluate a Fully Liquid Pentavalent DTwP-HepB-Hib Vaccine (EasyfiveTM, Panacea Biotec Ltd.) with Pentavalent DTwP-HepB/Hib Vaccine (Tritanrix-HBTM Reconstituted With HiberixTM, GSK) in Healthy Infants. Scientific Title of A Randomized, Multicenter, Open Label, Comparative Study to Evaluate the Immunogenicity and Study Reactogenicity of a Fully Liquid Pentavalent DTwP-HepB-Hib Vaccine (EasyfiveTM, Panacea Biotec Ltd.) with Pentavalent DTwP-HepB/Hib Vaccine (Tritanrix-HBTM Reconstituted With HiberixTM, GSK) in Healthy Infants. Secondary IDs if Any Secondary ID Identifier PBL/CR/0142008/CT Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Arani Chatterjee Trial Coordinator (multi-center study) Designation senior vice president-clinical research Affiliation Panacea biotec ltd Address B-1 Extn, G-3 Mohan co-op Industrial Estate Mathura Road New Delhi DELHI 110044 India New Delhi DELHI 110044 India Phone 01141679000 Fax 01141578085 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Arani Chatterjee Query) Designation senior vice president-clinical research Affiliation Panacea biotec ltd Address B-1 Extn, G-3 Mohan co-op Industrial Estate Mathura Road New Delhi DELHI 110044 India New Delhi DELHI 110044 India Phone 01141679000 Fax 01141578085 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Arani Chatterjee Designation senior vice president-clinical research Affiliation Panacea biotec ltd Address B-1 Extn, G-3 Mohan co-op Industrial Estate Mathura Road New Delhi DELHI 110044 India New Delhi DELHI page 1 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in 110044 India Phone 01141679000 Fax 01141578085 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Panacea Biotec Ltd Primary Sponsor Primary Sponsor Details Name Panacea Biotec Ltd Address B-1 Extn, G-3 Mohan co-op Industrial Estate Mathura Road New Delhi DELHI 110044 India Type of Sponsor Pharmaceutical industry-Indian Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment Chile Egypt Thailand Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Daniela Gonzlez CESFAM Carol Urzua, Dept. of Pediatrics, 5625761288 Santiago, Chile CESFAM Carol Urzua Calle Mendoza 0855, [email protected] San Bernardo Santiago, Chile Not Applicable N/A DrMohamed AEL Menoufiya University, Prof of Pediatrics., 20223590074 Guindi Egypt Menoufiya University, Egypt [email protected] Not Applicable N/A Dr Tawee Queen Sirikit National Queen Sirikit National 66818198172 Chotpitayasunondh Institute of Child Health Institute of Child Health, Dept. of Pediatrics, [email protected] 420/8 Rajavithi Rd., o.th Payathai, Rajthevi Bangkok 10400, Thailand Not Applicable N/A Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? ethical scientific Approved 31/01/2012 Yes committee, Santiago Menoufiya university Approved 10/10/2011 Yes national Liver Institute IRB Ministry of Health Egypt Approved 01/03/2010 No Ministry of Public health Approved 26/01/2011 No Thailand National Drug Agency Approved 01/11/2011 No page 2 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in Institute of Public Health of Chile the research ethics Approved 24/02/2011 Yes committee of Queen Sirikit National Institute of Child Health (Renewal applied for) Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers Vaccination Of infants at 2,4,6 and 18 months of age by pentavalent vaccine as per their national immunization schedule of respective country Intervention / Type Name Details Comparator Agent Intervention Fully Liquid Pentavalent 0.5 ml of vaccine at 2, 4, 6 DTwP-HepB-Hib Vaccine months of age and a booster (EasyfiveTM, Panacea Biotec dose of DTwP-Hib (EasyfourTM, Ltd.) Panacea Biotec Ltd.)will also be administered at 18 months of subject age, in the anterolateral aspect of thigh intramuscularly Comparator Agent Pentavalent DTwP-HepB/Hib 0.5 ml of vaccine at 2, 4, 6 Vaccine (Tritanrix-HBTM months of age and a booster Reconstituted With HiberixTM, dose of DTwP-Hib (EasyfourTM, GSK) Panacea Biotec Ltd.)will also be administered at 18 months of subject age, in the anterolateral aspect of thigh intramuscularly Inclusion Criteria Inclusion Criteria Age From 2.00 Month(s) Age To 14.00 Day(s) Gender Both Details 1. Infants of 2 months (+2 weeks) of age whose parents/LAR give written informed consent prior to the study entry.<br/> 2. Infants with good health as determined by:<br/> • Medical history<br/> • Physical examination<br/> • Clinical judgment of the investigator<br/> 3. Infants who are not seroprotected against Diphtheria, tetanus, pertussis, Hepatitis B or H. influenzae type b by virtue of previous immunization and/or antigen exposure. ‘Zero dose’ of Hepatitis B vaccine will be allowed for subjects who are enrolled in Thailand.<br/> Exclusion Criteria Exclusion Criteria Details 1. The parents or LAR are unwilling or unable to give written informed consent to participate in the study. 2. Infants having history of previous immunization or infection with one of the vaccine constituents. ‘Zero dose’ of Hepatitis B vaccine will be allowed for subjects who are enrolled in Thailand. 3. Known HBsAg positivity in mother. 4. Presence of evolving or changing neurological disorder. 5. Infants with history of seizures before receiving the vaccine, initiation or continuation of pertussis vaccination should be deferred until an evolving neurological disorder can be excluded. 6. Fever ? 38°C (Axillary temperature ? 37°C) in past 3 days. 7. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 7 days. 8. Planned or elective surgery during the course of the study. page 3 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in 9. Infants born before the 37th week of gestation. 10. Birth weight less than 2.5 kg. 11. Infants with a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or having received immunosuppressive therapy within 1 month prior to study entry (including systemic or inhaled corticosteroids) or those who have received a parenteral immunoglobulin preparation 12. Any history suggestive of thrombocytopenia or a bleeding disorder. 13. Infants who have received any blood products, cytotoxic agents or radiotherapy. 14. Infants with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component. 15. Infants with any serious chronic disease such as cardiac, autoimmune disease or insulin dependent diabetes or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives. 16. Infants who have participated in another trial of an investigational agent within 30 days of enrolment. 17. Infants whose families are planning to leave the area of the study site before the end of the study period Method of Generating Stratified block randomization Random Sequence Method of Not Applicable Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints • Proportion of subjects achieving seroprotection • Proportion of subjects achieving seroprotection against diphtheria, tetanus, Hepatitis B and Hib against diphtheria, tetanus, Hepatitis B and Hib and seroresponsiveness against pertussis, 1 and seroresponsiveness against pertussis, 1 month after three dose vaccination series of month after three dose vaccination series of DTwP-HB-Hib vaccine in each of the two DTwP-HB-Hib vaccine in each of the two treatment groups. treatment groups. Secondary Outcome Outcome Timepoints Safety Endpoint 3 doses of 0.5 ml test and comparator at 2 • Occurrence, intensity and relationship to months interval is administered by deep vaccination of solicited symptoms reported intramuscular injection in the anterolateral aspect during the 4-day (Day 0-3) follow-up period after of thigh. A booster dose of DTwP-Hib vaccination. (EasyfourTM, Panacea Biotec Ltd.)at 18 months • Occurrence, intensity and relationship to of age. OPV is given as concomitant vaccination of unsolicited adverse events (AEs) vaccination.Blood samples are collected at visit 1 reported during the 30 day (Day 0-29) follow-up , visit 4 (1 month after completion of primary period after completion of vaccination series. immunization series), at 18 months of age (follow • Occurrence, intensity and relationship to up visit 2) and at 1 month following booster vaccination of Serious Adverse Events (SAEs) immunization . throughout the study period. Immunological Endpoint primary vaccination series comprises of •Mean Concentrations or Geometric Mean Titres vaccination at 2,4,6 months of age (GMTs) for Anti-diphtheria, Anti-tetanus, Anti-HBs, Anti-PRP, anti-pertussis toxoid (anti-PT),