| CTRI Number |
CTRI/2013/06/003722 [Registered on: 07/06/2013] Trial Registered Prospectively |
| Last Modified On: |
17/11/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparition of immunity and reaction of bOPV vaccine and tOPV vaccine in routine immunization schedule, with or without IPV vaccine administration at DTP3 vaccine contact: A controlled trial |
|
Scientific Title of Study
|
Comparative evaluation of immunogenicity and reactogenicity of bivalent oral poliovirus vaccine (bOPV) and trivalent oral poliovirus vaccine (tOPV) in the standard EPI schedule, with or without inactivated polio vaccine (IPV) administration at DTP3 contact: A randomized controlled trial |
| Trial Acronym |
WHO EPI Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PBL/CR/2012/04/CT/bOPV version 03 dated 28-03-2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr T Jacob John |
| Designation |
Principal Investigator |
| Affiliation |
Member, SAGE working group on polio |
| Address |
(Retired) Prof. & Head, Dept. of Clinical Virology, Christian Medical College, Vellore, TN, India
Vellore
TAMIL NADU
632002
India |
| Phone |
|
| Fax |
|
| Email |
tjacobjohn@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arani Chatterjee |
| Designation |
Senior vice president-Clinical research |
| Affiliation |
Panacea Biotec Ltd |
| Address |
Panacea Biotec Ltd, B1-Ext-G3,Mohan Co-operative Estate,Mathura Road
New Delhi
DELHI
110044
India |
| Phone |
011-41679000 |
| Fax |
011-41578085 |
| Email |
aranichatterjee@panaceabiotec.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arani Chatterjee |
| Designation |
Senior vice president-Clinical research |
| Affiliation |
Panacea Biotec Ltd |
| Address |
Panacea Biotec Ltd, B1-Ext-G3,Mohan Co-operative Estate,Mathura Road
New Delhi
DELHI
110044
India |
| Phone |
011-41679000 |
| Fax |
011-41578085 |
| Email |
aranichatterjee@panaceabiotec.com |
|
|
Source of Monetary or Material Support
|
| World health Organization |
|
|
Primary Sponsor
|
| Name |
World health Organization |
| Address |
20 avenue Appia Geneva Switzerland |
| Type of Sponsor |
Other [World health Organization] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Panacea Biotec Ltd |
B1 G3 Mohan Cooperative Industrial Estate Mathura Road New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P Venugopal |
Andhra Medical college |
Department of Pediatrics,Maharanipeta-530002
Visakhapatnam
ANDHRA PRADESH
Visakhapatnam
ANDHRA PRADESH |
09848027203
venugopal_kgh@yahoo.com |
| Dr Sanjay Kewalchand Lalwani |
Bharti Vidyapeeth Deemed University medical college |
Katraj-Dhankawadi,Pune - Satara road-411043
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
919373314322
sanjaylalwani2007@rediffmail.com |
| Dr Sharad Agarkhedkar |
Dr. DY Patil Medical College |
Prof. & Head, Department of Pediatrics ,DY Patil Medical College, Sant Tukaram Nagar, Pimpri -411018
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
09822030122
ashalaka@gmail.com |
| Dr J Venkateswara Rao |
Gandhi medical college and Hospital |
Dept. of Paediatrics,Musheerabad-500048
Secunderabad
ANDHRA PRADESH
Hyderabad
ANDHRA PRADESH |
919848027709
dr_jvrao@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bharti Vidyapeth University, Pune |
Approved |
| Institutional Ethics Committee, Dr DY Patil Medical College, Pune |
Approved |
| Institutional Ethics Committee, gandhi Hospital, Secundrabad |
Approved |
| Institutional Ethics Committee, King George Hospital, Visakhapatnam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Poliomyelitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Bivalent type 1 and 3 oral poliovirus vaccine (bOPV) containing at least 106 CCID50 of Sabin poliovirus type 1 and at least 105.8 CCID50 of Sabin poliovirus type 3 of Panacea Biotec Ltd and
2 dose Inactivated poliovirus vaccine (IPV) formulated to contain 40 8 32 D antigen of Panacea Biotec Ltd
|
4 doses of 2 drops oral bOPv will be administered at birth,6,10,14 weeks
2 dose of 0.5 ml intramuscular IPV will be administered 14 weeks and 18 weeks. |
| Comparator Agent |
1.Standard trivalent oral poliovirus vaccine (tOPV), in a 10:1:6 formulation, containing at least 106 CCID50 of Sabin-strain poliovirus type 1, at least 105 CCID50 of Sabin-strain poliovirus type 2, and at least 105.8 CCID50 of Sabin-strain poliovirus type 3.
|
1. 2 drops of oral tOPV, 4 doses will be administered at birth,6,10,14 weeks.
2. 2 drops of mOPV2 will be administered at 18 weeks. |
| Intervention |
Bivalent type 1 and 3 oral poliovirus vaccine (bOPV) containing at least 106 CCID50 of Sabin poliovirus type 1 and at least 105.8 CCID50 of Sabin poliovirus type 3 of Panacea Biotec Ltd and 1 dose Inactivated poliovirus vaccine (IPV) formulated to contain 40 8 32 D antigen of Panacea Biotec Ltd |
4 doses of 2 drops oral bOPv will be administered at birth,6,10,14 weeks . 1 dose of 0.5 ml intramuscular IPV will be administered at 14 weeks |
| Intervention |
Bivalent type 1 and 3 oral poliovirus vaccine (bOPV) containing at least 106 CCID50 of Sabin poliovirus type 1 and at least 105.8 CCID50 of Sabin poliovirus type 3 of Panacea Biotec Ltd. |
4 doses of 2 drops oral bOPv will be administered at birth,6,10,14 weeks in bOPV.2 dose of IPV will be administered at 18 and 22 weeks. |
| Comparator Agent |
Standard trivalent oral poliovirus vaccine (tOPV), in a 10:1:6 formulation, containing at least 106 CCID50 of Sabin-strain poliovirus type 1, at least 105 CCID50 of Sabin-strain poliovirus type 2, and at least 105.8 CCID50 of Sabin-strain poliovirus type 3 and 1 dose Inactivated poliovirus vaccine (IPV) formulated to contain 40 8 32 D antigen of Panacea Biotec Ltd |
2 drops of oral tOPV, 4 doses will be administered at birth,6,10,14 weeks. 0.5 ml intramuscular IPV at 14 weeks and 2 drops of mOPV2 will be administered at 18 weeks. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
0.00 Day(s) |
| Gender |
Both |
| Details |
1.Full term (>37 weeks) healthy newborn delivered by a normal vaginal delivery or LSCS at the study site hospital
2.Birth weight of >2.5 kg and Apgar score >9 at 5 min
3.Residing within a relatively short and easily accessible distance (< 30 km)
4.Judged to be able to attend all scheduled study visits and comply with the study procedures
5.Parent or Legally Acceptable Representative (LAR) provides written informed consent or oral witnessed consent for the baby’s inclusion |
|
| ExclusionCriteria |
| Details |
1.Preterm (gestation age 37 weeks) baby or high risk delivery
2.Birth weight 2.5 kg or Apgar score at 5 min 9
3.Any diagnosed/suspected medical condition or congenital defect which requires active management or hospitalization; as judged by the investigator
4.Residence 30 km from study site
5.Baby and the family expected not to be available for the study visits during the study period
6.Parent/LAR does not consent for their baby’s participation
7.A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family)
8.Thrombocytopenia or a bleeding disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The seroconversion 28 days after 4 doses of bOPV compared to 4 doses of tOPV given in the routine immunization schedule |
At Birth, cord blood sample collection
Blood sample collection at 14 and 18 week in all 5 arms
Stool sample collection at 18, 19 and 22 week in 4 arms and blood sample collection at 19 wk and 22 wk in one arm |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary endpoints are
•Seroconversion after one dose of IPV added to the tOPV or bOPV at 14 weeks (DPT3 contact) in the EPI schedule
•Rapid boosting between 18 and 19 week visit to assess priming following the first dose of IPV (only in the bOPV and IPV arm)
Rest in summary section
|
At Birth, cord blood sample collection
Blood sample collection at 14 and 18 week in all 5 arms
Stool sample collection at 18, 19 and 22 week in 4 arms and blood sample collection at 19 wk and 22 wk in one arm
|
|
|
Target Sample Size
|
Total Sample Size="900"
Sample Size from India="900"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/06/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Comparative evaluation of immunogenicity and reactogenicity of bivalent oral poliovirus vaccine (bOPV) and trivalent oral poliovirus vaccine (tOPV) in the standard EPI schedule, with or without inactivated polio vaccine (IPV) administration at DTP3 contact. The primary endpoint is seroconversion 28 days after 4 doses of bOPV compared to 4 doses of tOPV given in the routine immunization schedule. The secondary endpoints are: · Seroconversion after one dose of IPV added to the tOPV or bOPV at 14 weeks (DPT3 contact) in the EPI schedule · Rapid boosting between 18 and 19 week visit to assess priming following the first dose of IPV (only in the bOPV + IPV arm) · Seroconversion after two doses of IPV added to the bOPV in the EPI schedule (only in the bOPV + IPV arm) · Boosting of antibody titres to any of the three poliovirus types by IPV, one or two doses · Comparing shedding of virus in the tOPV only, tOPV with IPV and bOPV with IPV arms after mOPV2 challenge at 18 weeks · Detecting any interference on the immunological endpoints accepted for clinical protection due to concomitant administration of IPV and pentavalent vaccine Safety: • To monitor and evaluate adverse events (AEs) following vaccine administration. Study visits, procedures & follow up Immediately after birth, 3-3.5 ml. cord blood will be collected. Newborn babies fulfilling eligibility criteria and whose parents have provided informed consent will be assigned in to one of the 5 study arms (A-E) as per the randomization list. A dose of tOPV or bOPV will be given within 24 hours of birth as per the study arm. Where the newborn is not eligible or parents do not consent to participate, the cord blood will be discarded as per usual hospital procedures.
At 6 and 10 week visits, a dose of the study vaccine will be administered as per the study arm. At 14 weeks, 1 ml. blood will be collected from each study participant by venepuncture followed by administration of vaccine/s as per the study arm. IPV will be given in addition to the tOPV/bOPV in the arms B, D, E as per the study arm. IPV will be given intramuscularly using AD syringe in the anterolateral side of the right thigh. At 18 weeks, 3-3.5 ml. blood will be collected by venepuncture from infants in all the study arms. In arms A-D a stool sample will be collected at week 18, followed by administration of a challenge dose of mOPV2/tOPV except in arm C, where instead IPV will be administered IM to compensate for the loss of type 2 vaccination. After this, a stool sample from each infant in arms A-D will be collected after 7 days (week 19) and 28 days (week 22). Arm E will have a second dose of IPV at 18 weeks, followed by blood sample, 1 ml. each at 19 and 22 weeks. In arm C, a second dose IPV will be given at 22 weeks to compensate for the type 2 vaccination. The study subjects will continue getting other (than polio) EPI vaccines concurrently. BCG and HepB will be given at birth as per EPI recommendation. Instead of DPT, these infants will be given pentavalent vaccine (DTP + Hep B + Hib) at 6, 10 and 14 weeks. After having fulfilled the study requirements at 22 weeks, infants will exit the study, and will be referred to the routine vaccination program |