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CTRI Number  CTRI/2017/02/007793 [Registered on: 07/02/2017] Trial Registered Prospectively
Last Modified On: 06/02/2017
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative evaluation of immunogenicity of various schedules and delivery options to provide fractional Dose Inactivated Poliovirus Vaccine in routine immunization  
Scientific Title of Study   Comparative evaluation of immunogenicity of various schedules and delivery options to provide fractional Dose Inactivated Poliovirus Vaccine in routine immunization in the post tOPV-bOPV period: A multi-centric open label randomized controlled trial” (India fractional dose IPV study) 
Trial Acronym  WHO fIPV study 
Secondary IDs if Any  
Secondary ID  Identifier 
PBL/ CR/2016/02/CT/fIPV Version 01 dated 24/08/2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jagadish M Deshpande 
Designation  Scientific Consultant 
Affiliation  Indian Council of Medical Research (ICMR 
Address  Indian Council of Medical Research P.O. Box No. 4911. Ansari Nagar New Delhi - 110029

South
DELHI
110029
India 
Phone  7506176377  
Fax    
Email  deshpandejm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jagadish M Deshpande 
Designation  Scientific Consultant 
Affiliation  Indian Council of Medical Research (ICMR 
Address  Indian Council of Medical Research P.O. Box No. 4911. Ansari Nagar New Delhi - 110029


DELHI
110029
India 
Phone  7506176377  
Fax    
Email  deshpandejm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Lalitendu Mohanty 
Designation  Senior GM 
Affiliation  Panacea biotec Ltd 
Address  B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road, New Delhi

South
DELHI
110044
India 
Phone  01141679000  
Fax    
Email  lalitendumohanty@panaceabiotec.com  
 
Source of Monetary or Material Support  
World health Organization  
 
Primary Sponsor  
Name  Panacea Biotec Ltd 
Address  B1 G3 Mohan Cooperative Industrial Estate Mathura Road New Delhi  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
World health Organization  20 avenue Appia Geneva Switzerland  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Krishnamurthy Balasundaram  Cheluvamba Hospital  Opp Mysore Medical College, KR Hospital Compound, Irwin Rd, Devraj Mohalla, Mysuru, Karnataka 570001
Mysore
KARNATAKA 
9448057007

bkm876@gmail.com 
Dr NS Mahantashetti  Dr Prabhakar Kore hospital  KLE Universitys J.N Medical College, Belagavi-10 Karnataka
Belgaum
KARNATAKA 
7204345879

nsmahantasheeti@gmail.com 
Dr Dipty Jain  Indira Gandhi Government Medical College and Hospital  Department of Pediatrics Indira Gandhi Government Medical College and Hospital, Nagpur -440018 Maharashtra
Nagpur
MAHARASHTRA 
09373103579

dipty47@rediffmail.com 
Dr Ashish Bavdekar  KEM Hospital Research Centre  Sardar Moodliar, Rasta Peth Pune -411011
Pune
MAHARASHTRA 
9822056174

bavdekar@vsnl.com 
Dr MA Mathew  M.O.S.C. Medical College  Department of Pediatrics, MOSC Medical College Hospital Kolencherry Ernakulum, Kerala Pin code- 682311
Ernakulam
KERALA 
09447234554

drmathew_11@yahoo.com 
Dr Manish Jain  Mahatma Gandhi Institute of Medical Sciences  Department of Pediatrics Mahatma Gandhi Institute of Medical Sciences, Department of Pediatrics, P.O Sewagram, Wardha-442102 Maharashtra
Wardha
MAHARASHTRA 
09822695195

manish@mgims.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethic Committee Indira Gandhi Government Medical College and Hospital  Submittted/Under Review 
Ethic Committee, KLE Universitys J.N Medical College,   Approved 
Ethic Committee, KEM Hospital Research Centre  Submittted/Under Review 
Institutional Ethic Committee, Mahatma Gandhi Institute of Medical Sciences  Submittted/Under Review 
Institutional Ethic Committee, MOSC Medical College Hospital Kolencherry  Approved 
Institutional Ethic Committee, Mysore Medical College and Research Institute  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Poliomyelitis  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  bOPV(Bivalent oral vaccine)  two drop orally  
Intervention  Inactivated poliovirus vaccine (IPV)   Full dose IPV 0.5 ml will be given as deep intramuscular (IM) in the anterolateral side of the right thigh. Fractional dose intradermal IPV 0.1 ml will be given in the right upper arm 
 
Inclusion Criteria  
Age From  42.00 Day(s)
Age To  48.00 Day(s)
Gender  Both 
Details  1. All infants visiting study site immunization clinic for OPV1/Penta1 immunization
2. The infant should be 6-7 completed weeks of age at OPV1/Penta1 contact
3. Infants with documentary evidence having taken birth dose of bOPV
4. Weight at enrolment visit of ≥ 3.2 Kgs
5. Judged to be healthy by the investigator for study participation
6. Parents judged to be able to attend all scheduled study visits and comply with the study procedures
7. Parent or Legally Acceptable Representative (LAR) provides written informed consent for the baby’s inclusion in the study
 
 
ExclusionCriteria 
Details  1. Not fulfilling any of the inclusion criteria
2. Taken any polio vaccine/s other than birth dose of bOPV
3. Any diagnosed/suspected medical condition which requires active management or hospitalization; as judged by the investigator
4. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family)
5. Thrombocytopenia or a bleeding disorder
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. The primary endpoint is the seroconversion against type 2 poliovirus, four weeks after completion of doses given in the routine immunization schedule in all the study arms.  6, 10 and 14 week 
 
Secondary Outcome  
Outcome  TimePoints 
4. Number of adverse events (AEs) occurred during the study  through out the study 
 
Target Sample Size   Total Sample Size="800"
Sample Size from India="800" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/02/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

All babies who visit study institution for routine vaccination at 6 weeks of age and immunized with birth dose of bOPV will be considered for the enrolment. If a baby fulfils the eligibility criteria, a complete informed consent process will be followed as per the applicable regulatory requirements. As IPV for the study is already licenced and being given to millions of infants in India as per the present routine immunization schedule, it is not proposed to audio-video record the informed consent process

Babies fulfilling eligibility criteria and whose parents have provided informed consent will be randomized into one of the four study arms (A, B1, B2 & C). On enrolment at week six, one millilitre (ml) of blood sample will be collected from each study participant by venepuncture followed by administration of vaccine/s as per the allocated study arm. Parents will be advised to avoid any other vaccine from centres other than the study site. For every study infant, a study specific immunization card will be issued indicating the baby to be a study subject and that all routine vaccinations will be advised and taken care of by the study site investigator during this period. Parents will be informed about the date of next follow visit during the previous visit. Reminder telephone contacts/household visits will be arranged through study staff.

At 10 and 14 week visits, the study vaccine/s will be administered as per the allocated study arm. At 14 week visit one ml blood will be collected from each study participant by venepuncture followed by administration of vaccine/s as per the study arm. At 18 weeks, one ml blood will be collected by venepuncture in all the study arms.

In study arm A, IPV full dose will be given intramuscularly in the anterolateral side of the right thigh using AD syringe. In arm B1 and C, fractional dose IPV will be administered intradermally in right upper arm using BCG needle syringe. In Arm B2, fractional dose IPV will be administered intradermally in right upper arm using West/Helm adapter intradermal device.

The study subjects will continue getting other EPI vaccines concurrently, except polio vaccines which they shall receive as per the study arm. After having fulfilled the study requirements at 18 weeks, infants will exit the study. The infants will be referred to the routine vaccination program for the subsequent vaccination according to the national immunization schedule.

All trial related interventions will be conducted by study personnel; the only subject compliance required is to abide by scheduled visits and fill subject diary cards.

 
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