| CTRI Number |
CTRI/2025/07/091180 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
India f-IPV Study 2025: Comparing Immune Response to Different Dose Schedules of Inactivated Polio Vaccine in Routine Immunization.
|
|
Scientific Title of Study
|
Comparative evaluation of immunogenicity of variable dose schedules of Inactivated
Poliovirus Vaccine in routine immunization: A multi-centric open label randomized
controlled trial (India f-IPV study-2025) |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PBL/21/01/FIPV, Version 06; dated 07/Apr/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shailesh D Pawar |
| Designation |
Scientist-F & Officer-In-Charge |
| Affiliation |
Indian Council of Medical Research (ICMR)-National Institute of Virology, Mumbai Unit |
| Address |
Indian Council of Medical Research (ICMR)-National Institute of Virology, Mumbai Unit
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9421018275 |
| Fax |
|
| Email |
shaileshpawarniv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammad Ahmad |
| Designation |
National Professional Officer |
| Affiliation |
WHO Country Office, India, New Delhi |
| Address |
WHO Country Office, India, New Delhi
South
DELHI
110002
India |
| Phone |
8800495773 |
| Fax |
|
| Email |
ahmadmoh@who.int |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohammad Ahmad |
| Designation |
National Professional Officer |
| Affiliation |
WHO Country Office, India, New Delhi |
| Address |
WHO Country Office, India, New Delhi
South
DELHI
110002
India |
| Phone |
8800495773 |
| Fax |
|
| Email |
ahmadmoh@who.int |
|
|
Source of Monetary or Material Support
|
| World Health Organization,
537, A Wing, Nirman Bhawan, Maulana Azad Road, New Delhi 110 011, India.
|
|
|
Primary Sponsor
|
| Name |
World Health Organization |
| Address |
WHO Country Office, 537, A Wing, Nirman Bhawan, Maulana Azad Road, New Delhi 110 011, India. |
| Type of Sponsor |
Other [World Health Organization] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chandra Mohan Kumar |
All India Institute of Medical Sciences, Patna |
Department of Paediatrics Medicine, Second Floor OPD Building, All India Institute of Medical Sciences,
Aurangabad Road Phulwari Sharif Patna Bihar 801507 India
Patna
BIHAR |
9810730206
cmkumar@aiimspatna.org |
| Dr S Muhammad Salim Khan |
Government Medical College, Srinagar |
Department of Community Medicine
Room no 204 Main Building Government Medical College, Srinagar Karan Nagar Srinagar 190010 Jammu & Kashmir
Srinagar
JAMMU & KASHMIR |
7006522286
smsalimkhan03@gmail.com |
| Dr Farzana Islam |
Hamdard Institute of Medical Sciences and Research, New Delhi |
Department of Community Medicine Room No B06,
Hamdard Institute of Medical Sciences Research, New Delhi, 110062
New Delhi
DELHI |
9560067059
drfarzanaislam@gmail.com |
| Dr Manish Jain |
Mahatma Gandhi Institute of Medical Sciences, Wardha |
Department of Pediatrics, OPD No 18 Mahatma Gandhi Institute of Medical Sciences Sewagram Wardha 442102
Wardha
MAHARASHTRA |
9822695195
manish@mgims.ac.in |
| Dr Padmasani Venkat Ramanan |
Sri Ramchandra Hospital, Chennai |
Department of Pediatrics Sri Ramchandra Hospital, Porur, Chennai 600116 Tamil Nadu India
Chennai
TAMIL NADU |
9445140200
padmasani2001@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| IEC-AIIMS-P All India Institute of Medical Sciences, Patna Phulwari Sharif Patna Bihar - 801507 India |
Approved |
| Institutional EC Govt. Medical College Government Medical College Institutional EC Govt. Medical College J and K Srinagar Srinagar Jammu And Kashmir - 190010 India |
Submittted/Under Review |
| Institutional Ethics Committee HIMSR And Associated HAH Centenary Hospital Guru Ravidas Marg Hamdard Nagar South West Delhi South West Delhi Delhi -110062 India |
Approved |
| Institutional Ethics Committee Mahatma Gandhi Institute of Medical sciences Department of Biochemistry, Sevagram Wardha Maharashtra, India |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE SRIHER SRIHER No.1 Ramachandra Nagar Porur Chennai Tamil Nadu - 600116 India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All infants of 9 to 12 months of age. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inactivated poliovirus vaccine |
Enrolled infants will be randomized (1:1) into one of the two study arms (A & B).
Arm A: 250 subjects will receive Fractional dose intradermal IPV (dose 3) will be given 0.1 ml in the left upper arm (9-12 months of age) at Baseline Visit.
ARM B: 250 subjects will receive Full dose intramuscular (IM) IPV will be given 0.5 ml in the anterolateral aspect of left mid-thigh (9-12 months of age) at Baseline Visit. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
9.00 Month(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
1.All infants visiting study site immunization clinic for first MR vaccine at 9 to 12 months of age.
2. Infants with documentary evidence having taken 4 bOPV doses and two f-IPV doses per the routine schedule.
3. Judged to be healthy by the investigator for study participation.
4. Parents 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 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 the national EPI schedule or Polio Immunization Campaigns.
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
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Compare the gains in seroconversion and antibody titres against poliovirus serotype 2 after third fractional or full IPV dose given at 9-12 months age at MR vaccination visit in the routine immunization schedule. |
The primary endpoint is the seroconversion against serotype 2 poliovirus, 1 month (30 days) after IPV vaccination in the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assess persistence of serotype 2 antibodies at enrollment after two primary fIPV doses.
2. Assessment of priming response following two primary fIPV doses.
3. To evaluate adverse events following vaccination. |
1. Persistence of serotype 2 antibodies after two primary doses of fIPV from the baseline sample taken at enrollment.
2. Priming effect of the additional f-IPV dose 7 days (1 week) after IPV vaccination, given at 9-12 months of age.
3. The secondary endpoint is the seroconversion against polioviruses serotypes 1 & 3, 1 month (30 days) after IPV vaccination in the study.
4. Number of adverse events (AEs) causally associated to the study vaccine. |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
01/08/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a two arm, multicentric, open label, randomized clinical trial. A total of 3 scheduled physical visits are planned for the study. Visit 1 (Day 0) Screening Visit / baseline blood sample collection /Vaccination. Telephonic Call (Day 3) Study personnel will contact parents/LAR on third day of the vaccine injection to see any local reactions and ask the parents about any ill health. Visit 2 (Day 7) (+4 days window period), Follow-up Visit for blood sample collection. Visit 3 (Day 30 End of study visit) (+7 days window period), Follow-up Visit for blood sample collection. Infants in Arm A will only be given a dose of fractional IPV (0.1 ml, intradermal) while infants in Arm B will be vaccinated with full dose of IPV (0.5 ml, Intramuscular). Both arms will receive the scheduled first MR vaccine along with any other vaccine recommended in the Expanded Programme of Immunization of that state. Baseline 1 ml blood samples will be collected at the first visit. The participants will be followed up next week for another 1 ml blood sample collection (priming effect of IPV). Finally, a second follow up visit will be done one month after the first study visit when another 1 ml blood sample (for seroconversions from additional IPVs given at enrolment) will be collected. No additional follow-up is planned. |