| CTRI Number |
CTRI/2022/05/042363 [Registered on: 04/05/2022] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to check Safety and Immune response of SII Inactivated Salk Polio Vaccine (Adsorbed) in comparison with Sii Licensed Inactivated Poliovirus Vaccine (IPV) |
|
Scientific Title of Study
|
A Phase II/III study, Multicenter, Double-Blind, Randomized, Active Controlled
Study to evaluate Safety and Immunogenicity of SII Inactivated Salk Polio
Vaccine (Adsorbed) in comparison with Sii Licensed Inactivated Poliovirus
Vaccine (IPV) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IPV:01 Version: 2.0 dated 03 September 2021 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
|
| Address |
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| Phone |
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| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad Kulkarni |
| Designation |
Executive Director |
| Affiliation |
Serum Institute of India Pvt Ltd. |
| Address |
Serum Institute of India Pvt. Ltd. 212 / 2, Off Soli Poonawalla Road, Hadapsar - Pune – 411028, India
Pune
MAHARASHTRA
411028
India |
| Phone |
|
| Fax |
|
| Email |
drpsk@seruminstitute.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajjad Desai |
| Designation |
Deputy Medical Director |
| Affiliation |
Serum Institute of India Pvt Ltd. |
| Address |
Serum Institute of India Pvt. Ltd. 212 / 2, Off Soli Poonawalla Road, Hadapsar - Pune – 411028, India
Pune
MAHARASHTRA
411028
India |
| Phone |
|
| Fax |
|
| Email |
sajjad.desai@seruminstitute.com |
|
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Source of Monetary or Material Support
|
| Serum Institute of India Pvt Ltd, Pune |
|
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Primary Sponsor
|
| Name |
Serum Institute of India Pvt Ltd |
| Address |
Serum Institute of India Pvt. Ltd.
212 / 2, Off Soli Poonawalla Road,
Hadapsar - Pune – 411028, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hira Lal Bhalla |
All India Institute of Medical Sciences |
OPD Block, Room No.206 and 207, Kunraghat, Gorakhpur, Uttar Pradesh 273008
Gorakhpur
UTTAR PRADESH |
9761715236
hirabhalla@gmail.com |
| Dr Sonali Palkar |
Bharati Vidyapeeth Medical College Hospital and Research Centre |
room no 211, pediatric research cell, department of pediatrics, Bharati Vidyapeeth (Deemed to be University) medical college hospital and research center Pune
Pune
MAHARASHTRA |
9881008717
palkarsh@gmail.com |
| Dr Pradeep N |
Cheluvamba Hospital, Mysore Medical College and Research Institute Mysuru |
Cheluvamba Hospital, Mysore Medical College and Research Institute, Irwin Road, Next to Railway Station, Mysuru, Karnataka 570001, India
Mysore
KARNATAKA |
00918212520512
drpradeepn80@yahoo.com |
| Dr Shanta Dutta |
ICMR-National Institute of Cholera and Enteric Disease (ICMR-NICED) |
P33 C.I.T road, scheme- XM, Beliaghata, Kolkata-700010 West Bengal
Kolkata
WEST BENGAL |
9830152971
Shanta.niced@icmr.gov.in |
| Dr Sandeep Kumar Panigrahi |
IMS and SUM Hospital, Bhubaneshwar |
Preventive and Therapeutic Clinical Trial Unit, Department of Community Medicine, IMS and SUM Hospital, K8, Kalinga Nagar, Ghatikia, Bhubaneshwar, Odisha - 751003
Khordha
ORISSA |
00919040069093
sandeepkumarpanigrahi@soa.ac.in |
| Dr Bheemisetti S Chakravarthy |
King George Hospital |
Pediatric ward, Department of pediatric, Andhra medical college, King George Hospital, Maharanipeta, Visakhapatnam- 530002
Visakhapatnam
ANDHRA PRADESH |
9848253535
chakravarthy.kghamc@gmail.com |
| Dr B Vijai Anand Babu |
Kurnool Medical College/Govt. Hospital,Kurnool |
New MCH Block, O.P.No:17, Department of Pediatrics, Ground floor, Room No:3, Govt. General Hospital, Budhawara Peta, Kurnool-518002, Andhra Pradesh, India.
Kurnool
ANDHRA PRADESH |
9000718884
bangivijaianandbabu@gmail.com |
| Dr Madhu Gupta |
Post Graduate Institute of Medical Education and Research, Chandigarh |
Department of Community Medicine & School of Public Health, Post Graduate Institute of Medical Education and Research, Chandigarh- 160012
Chandigarh
CHANDIGARH |
00911722755223
madhugupta21@gmail.com |
| Dr Sushma Save |
T N Medical College and B Y L Nair Hospital, Mumbai |
Department of Pediatrics,
T N Medical College and B Y L Nair Hospital, Dr A L Nair Road, Mumbai Central 400008
Mumbai
MAHARASHTRA |
008369818898
sushmasave73@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IMS and SUM Hospital, Bhubaneshwar |
Approved |
| Institutional Ethics Committee Bharati Vidyapeeth (Deemed to be University), Pune |
Approved |
| Institutional Ethics Committee ICMR Kolkata |
Approved |
| Institutional Ethics Committee KGH Visakhapatnam |
Approved |
| Institutional Ethics Committee Kurnool Medical College |
Approved |
| Institutional Ethics Committee, K.R. Hospital, Mysore Medical College and Research Institute, Mysore |
Approved |
| Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research, Chandigarh |
Approved |
| Institutional Ethics Committee, TNMC Nair Hospital T N Medical college and BYL Nair Hospital, Mumbai |
Approved |
| Institutional Human Ethics Committee AIIMS, Gorakhpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of poliomyelitis caused by poliovirus Types 1, 2, and 3 |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SII Inactivated Salk Polio Vaccine (Adsorbed) |
SII Inactivated Salk Polio Vaccine (Adsorbed), produced by Serum Institute
of India Pvt. Ltd., is a sterile suspension of three types of inactivated
poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). It is a
highly purified, adjuvanted reduced antigen content of inactivated poliovirus
vaccine.
Store at 2 - 8°C
Dose: 0.5 ml by intramuscular injection;
3 doses of SII Inactivated Salk Polio Vaccine (Adsorbed)
will be administered 4 weeks apart, with the first administration given at 6-
8 weeks of age. |
| Comparator Agent |
Sii Licensed IPV |
Poliomyelitis Vaccine (Inactivated), produced by Serum Institute of India
Pvt. Ltd., is a sterile suspension of three types of inactivated poliovirus: Type
1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). Poliomyelitis Vaccine
(Inactivated) is a highly purified, inactivated poliovirus vaccine.
Dose: 0.5 ml by intramuscular injection
Store at 2 - 8°C;
3 doses of Sii licensed IPV will be administered 4 weeks apart, with the first administration given at 6-
8 weeks of age |
|
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Inclusion Criteria
|
| Age From |
42.00 Day(s) |
| Age To |
56.00 Day(s) |
| Gender |
Both |
| Details |
1. Healthy infants as established by medical history and clinical examination before entering the study
2. Age: 6-8 weeks at the time of enrollment
3. Parental ability and willingness to provide informed consent
4. Parent who intends to reside in the area with the child during the study period
5. Receipt of birth dose of OPV (within 14 days of birth) |
|
| ExclusionCriteria |
| Details |
1. Presence of fever on the day of enrollment [Temporary exclusion criteria].
2. Acute disease at the time of enrollment [Temporary exclusion criteria].
3. Prior receipt or intent to receive OPV/IPV/IPV containing vaccines
during the study period. (except birth dose of OPV and on national/subnational immunization days)
4. Presence of significant malnutrition (weight-for-height z-score < -3SD median)
5. Known or suspected impairment of immunological function based on medical history and physical examination.
6. Receipt of immunoglobulin therapy and / or blood products since birth or planned administration during the study period
7. Planned concurrent participation in another clinical study at any point throughout the entire study period
8. Any clinically significant congenital malformation or genetic defect which may interfere with the evaluation of safety or immunogenicity of
the IP |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of participants with type-specific seroconversion for SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV. |
28 days after third vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Type-specific geometric mean titers of SII Inactivated
Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV. |
Prevaccination and 28 days after third vaccination |
| Percentage of participants with type-specific seroprotection (titers ≥ 8) of SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV. |
Day 28 after the third vaccination |
|
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Target Sample Size
|
Total Sample Size="648"
Sample Size from India="648"
Final Enrollment numbers achieved (Total)= "648"
Final Enrollment numbers achieved (India)="648" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/05/2022 |
| Date of Study Completion (India) |
13/04/2024 |
| 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
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The study is designed as a multicenter, double-blind, randomized, active controlled Phase II/III study with two groups of infants (n=324 per group) receiving either SII Inactivated Salk Polio Vaccine (Adsorbed) or Sii licensed IPV.
Participants will be screened for eligibility with their parental consent and will be selected for the study according to inclusion and exclusion criteria. Three doses of either SII Inactivated Salk Polio Vaccine (Adsorbed) or Sii licensed IPV will be administered as a 0.5 mL intramuscular injection in mid-lateral aspect of the thigh, 4 weeks apart (minimum interval of 4 weeks and maximum of 6 weeks), with the first administration given at 6-8 weeks of age.
Safety will be evaluated by active surveillance for solicited adverse events over the 4-day period after each vaccination in all participants. In addition, surveillance for unsolicited AEs and SAEs will be carried out over the period from first vaccination and 28 days after the third vaccination in all participants. |