CTRI Number	CTRI/2012/06/002719 [Registered on: 08/06/2012] Trial Registered Prospectively
Last Modified On:	25/11/2013
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Vaccine Preventive
Study Design	Randomized, Parallel Group Trial
Public Title of Study Modification(s)	Incidence of Typhoid fever as observed over 1 year in children aged 6months-12 years after receiving conjugated typhoid vaccine (Peda Typh TM) versus a similar non-vaccinated group in the same locality in Kolkata
Scientific Title of Study	"Open label, randomized, field effectiveness post-marketing trial of Vi-Tetanus toxoid conjugated Typhoid vaccine (Peda Typh TM) in Indian children aged 6 months to 12 years"
Secondary IDs if Any Modification(s)	Secondary ID  Registry  MC/TYVAC/2011/CT-01,Version:1,Dated: 24/05/2011  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr Apurba Ghosh  Address  Institute of Child Health 11, Dr Biresh Guha Street Kolkata WEST BENGAL Kolkata 700017 India  Phone  9830052887   Fax     Email  apurbaghosh@yahoo.com
Details Contact Person Scientific Query	Name  Dr Monjori Mitra  Address  Medclin Research Pvt Ltd, 195/2, Charaborty Para Kolkata WEST BENGAL Kolkata -700 107 India  Phone  03324429413   Fax     Email  monjorim@medclinsearch.com
Details Contact Person Public Query	Name  Dr Monjori Mitra  Address  Medclin Research Pvt Ltd, 195/2, Charaborty Para Kolkata WEST BENGAL Kolkata -700 107 India  Phone  03324429413   Fax     Email  monjorim@medclinsearch.com
Source of Monetary or Material Support	Bio-Med Private Limited,Ghaziabad,UP,India
Primary Sponsor	Name  BioMed Private Limited  Address  C-96, Bulandshahr Road Indl. Area,Ghaziabad-201009 (U.P),India  Type of Sponsor  Pharmaceutical industry-Indian
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Apurba Ghosh  Institute Of Child Health  Research Project Room, 11,Dr. Biresh Guha Street, Kolkata 700017 Kolkata   9830052887 apurbaghosh@yahoo.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Ethics Committee of Institute of Child Health  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Typhoid fever
Intervention / Comparator Agent	Type  Name  Details  Comparator Agent  NIL  NIL  Intervention  Vi-Tetanus toxoid conjugated Typhoid vaccine  Two doses at 6 weeks interval. Each dose of the vaccine containing 5 μg/ 0.5 ml/dose
Inclusion Criteria	Age From  6.00 Month(s) Age To  12.00 Year(s) Gender  Both  Details  1.Healthy children and teenagers from 6 months to 12 years of both sexes residing in ward number 107/108 of Calcutta Municipal Corporation in Kolkata . 2.Parent/ guardian of subjects who have given voluntary written informed consent and should agree to comply with all trial related instructions 3. Are not participating in or planning to participate in any trial or research during the entire study period.
ExclusionCriteria	Details  1. Age out of range 2. Fever (38.5°C) at the time of or in the last 72 hours before vaccination. 3. History of any undiagnosed fever/infection of more than 3 days duration within 1 month prior to vaccination 4. Any established or clinically suspected immunosuppressive or immunocompromised disorder/state (congenital or acquired- drug induced, neoplastic, tuberculosis etc) 5. History of typhoid vaccination in the last 5 years 6. Any other clinical condition considered by the investigator to be unsuitable for study participation 7. Known allergy to any of the components of Pedatyph 8. Any critreria, which in the opinion of the investigator suggests that the subject is likely to be non-complaint with the study protocol
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	Sequentially numbered, sealed, opaque envelopes
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  Incidence of Bactec positive typhoid fever and Paratyphoid fever in the vaccinated and non-vaccinated groups   1 year
Secondary Outcome	Outcome  TimePoints  1.Changes (from baseline to 6 weeks after first, second dose and after one year of vaccination) in the Vi IgG antibody levels and seroconversion rates (≥ 4 fold rise of baseline titre) in a subgroup of vaccinated subjects and to assess booster effect of second vaccination.   1 year  Incidence of treatment emergent adverse events- local and systemic adverse effects   1 year
Target Sample Size	Total Sample Size="2000" Sample Size from India="2000"
Phase of Trial	Phase 4
Date of First Enrollment (India)	02/07/2012
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Closed to Recruitment of Participants
Publication Details
Brief Summary	This study is an  Open label, randomized, field effectiveness post marketing trial of conjugate Vi-TT typhoid ( Peda Typh TM) vaccine in Indian children of age 6 months to 12 years. Two doses of Vi-TT conjugate vaccine Peda Typh™ (manufactured by Biomed Pvt Ltd) will be administered intramuscularly at 6 weeks interval. Each dose of the vaccine containing 5 µg/ 0.5 ml/dose. Subjects aged between 6 months to 12 years of either sex residing in ward number 107/108 of Calcutta Municipal corporation will be initially screened by a field worker and those who have not been vaccinated with any typhoid vaccine will be enrolled in the study if they fulfil other subject recruitment criteria.   Enrolled subjects will be randomized into two study groups. The test group will receive two doses of the test vaccine (0.5 ml by intramuscular route in the upper arm) at 6 weeks interval and the control group will not receive any typhoid vaccine but will receive other vaccines as per the national vaccination guidelines applicable for the age A sample of 2.0 ml of blood will be drawn before vaccination in a subgroup of subjects (100) in the test arm for estimation of the baseline (prevacicination ) Vi IgG antibody titre and repeated after 6 weeks of the first and the second dose, and subsequently 12 months Field workers will follow up all subjects for a period of 1 year post-enrolment. Any case of fever (390 C)  of more than 3 days duration without any focus, in either treatment arm will be brought to the field clinic and examined by the field doctor. If the doctor suspects clinically suspected typhoid fever the subject will be referred to Institute of Child Health for management. Sample of blood will be sent for Bactec culture for Salmonella typhi, Salmonella paratyphi to arrive at a diagnosis of typhoid fever. Widal test would be done at baseline and 7days after to see the titre. Primary end-point: Number of blood culture positive (by Bactec) cases of enteric/typhoid fever and paratyphoid fever detected upto 1 year post-vaccination. Secondary endpoint :  Immunogenicity in a subgroup of vaccinated subjects.  The IgG Vi antibody will be estimated by ELISA technique at baseline and at 6 weeks after administration of the first , second dose of the vaccine and after one year . The post-vaccination GMT will be compared with the pre-vaccination levels and the mean fold rise of antibody titre will be calculated.