PDF of Trial CTRI Website URL -

Transcription

1 Clinical Trial Details (PDF Generation Date :- Sun, 06 Jan :39:39 GMT) CTRI Number Last Modified On 15/02/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/02/ [Registered on: 16/02/2012] - Trial Registered Retrospectively No Interventional Vaccine Randomized, Parallel Group, Active Controlled Trial 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. A Randomized, Multicenter, Open Label, Comparative Study to Evaluate the Immunogenicity and 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 Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) PBL/CR/ /CT Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee > Panacea Biotec Ltd Type of Sponsor NIL List of Countries Chile of Principal Investigator Dr Daniela Gonzlez DrMohamed AEL Guindi Dr Tawee Chotpitayasunondh Source of Monetary or Material Support Primary Sponsor Details Panacea Biotec Ltd Pharmaceutical industry-n NIL of Site Site Phone/Fax/ CESFAM Carol Urzua, Santiago, Chile Menoufiya University, Queen Sirikit National Institute of Child Health Dept. of Pediatrics, CESFAM Carol Urzua Calle Mendoza 0855, San Bernardo Santiago, Chile Prof of Pediatrics., Menoufiya University, Queen Sirikit National Institute of Child Health, Dept. of Pediatrics, 420/8 Rajavithi Rd., Payathai, Rajthevi Bangkok 10400, o.th of Committee Approval Status Date of Approval Is Independent Ethics Committee? ethical scientific committee, Santiago Menoufiya university national Liver Institute IRB Approved 31/01/2012 Yes Approved 10/10/2011 Yes Ministry of Health Approved 01/03/2010 No Ministry of Public health Approved 26/01/2011 No National Drug Agency Approved 01/11/2011 No page 2 / 5

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Institute of Public Health of Chile the research ethics committee of Queen Sirikit National Institute of Child Health (Renewal applied for) Status Health Type Healthy Human Volunteers Approved 24/02/2011 Yes Date No Date Specified Condition Vaccination Of infants at 2,4,6 and 18 months of age by pentavalent vaccine as per their national immunization schedule of respective country Type Details Intervention Comparator Agent Age From Age To Gender Details Fully Liquid Pentavalent DTwP-HepB-Hib Vaccine (EasyfiveTM, Panacea Biotec Ltd.) Pentavalent DTwP-HepB/Hib Vaccine (Tritanrix-HBTM Reconstituted With HiberixTM, GSK) 2.00 Month(s) Day(s) Both Inclusion Criteria 0.5 ml of vaccine at 2, 4, 6 months of age and a booster dose of DTwP-Hib (EasyfourTM, Panacea Biotec Ltd.)will also be administered at 18 months of subject age, in the anterolateral aspect of thigh intramuscularly 0.5 ml of vaccine at 2, 4, 6 months of age and a booster dose of DTwP-Hib (EasyfourTM, Panacea Biotec Ltd.)will also be administered at 18 months of subject age, in the anterolateral aspect of thigh intramuscularly 1. Infants of 2 months (+2 weeks) of age whose parents/lar give written informed consent prior to the study entry. 2. Infants with good health as determined by: Medical history Physical examination Clinical judgment of the investigator 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. Exclusion Criteria Details Exclusion Criteria 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. 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 page 3 / 5

4 antibiotic therapy within past 7 days. 8. Planned or elective surgery during the course of the study. 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 Random Sequence Method of Concealment Blinding/Masking Stratified block randomization Open Label Primary Outcome Outcome Timepoints Proportion of subjects achieving seroprotection against diphtheria, tetanus, Hepatitis B and Hib and seroresponsiveness against pertussis, 1 month after three dose vaccination series of DTwP-HB-Hib vaccine in each of the two Proportion of subjects achieving seroprotection against diphtheria, tetanus, Hepatitis B and Hib and seroresponsiveness against pertussis, 1 month after three dose vaccination series of DTwP-HB-Hib vaccine in each of the two Secondary Outcome Outcome Timepoints Safety Endpoint vaccination of solicited symptoms reported during the 4-day (Day 0-3) follow-up period after vaccination. vaccination of unsolicited adverse events (AEs) reported during the 30 day (Day 0-29) follow-up period after completion of vaccination series. vaccination of Serious Adverse Events (SAEs) throughout the study period. Immunological Endpoint Mean Concentrations or Geometric Mean Titres (GMTs) for Anti-diphtheria, Anti-tetanus, Anti-HBs, Anti-PRP, anti-pertussis toxoid (anti-pt), and IgG Bordetella pertussis antibodies one month after completion of primary vaccination series. 3 doses of 0.5 ml test and comparator at 2 months interval is administered by deep intramuscular injection in the anterolateral aspect of thigh. A booster dose of DTwP-Hib (EasyfourTM, Panacea Biotec Ltd.)at 18 months of age. OPV is given as concomitant vaccination.blood samples are collected at visit 1, visit 4 (1 month after completion of primary immunization series), at 18 months of age (follow up visit 2) and at 1 month following booster immunization. primary vaccination series comprises of vaccination at 2,4,6 months of age page 4 / 5

5 Powered by TCPDF ( PDF of Trial Immunological Endpoint Proportion of subjects maintaining seroprotective levels of antibodies against diphtheria, tetanus, Hepatitis B and Hib and seroresponsiveness against pertussis, at 18 months of age (before booster vaccination) in the booster dose of DTwP-Hib (EasyfourTM, Panacea Biotec Ltd.)will be administered to all subjects at 18 months of age. Proportion of subjects achieving seroprotection Blood sample will be collected at 1 month against diphtheria, tetanus and Hib and following booster immunization seroresponsiveness against pertussis one month after booster vaccination. Mean Concentrations or Geometric Mean Titres (GMTs) for Anti-diphtheria, Anti-tetanus, Anti-PRP, anti-pertussis toxoid (anti-pt), and IgG Bordetella pertussis antibodies one month after booster vaccination. Proportion of subjects achieving seroprotection against all three serotypes of Polio one month after concomitant administration of topv vaccine at 2, 4 and 6 months of age. Seroprotection, GMT and maintenance of seroprotection at 18 months of age for Hepatitis B will be compared among the subjects who have received three doses versus four doses of Hepatitis B vaccine, as primary vaccination schedule..seroprotection against all three serotypes of Polio virus, one month after concomitantly administered topv vaccine (at 2, 4 and 6 months of age) will also be estimated at visit 1(prior to immunization) and visit 4 (one month after completion of primary immunization series)..zero dose of Hepatitis B vaccine will be allowed for subjects who are enrolled in Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Total Sample Size=600 Sample Size from =0 No Date Specified 01/06/2011 Years=2 Months=6 Days=0 Open to Recruitment NA page 5 / 5