| 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 trialâ€
(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
|
|
|
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. |