| CTRI Number |
CTRI/2023/08/055993 [Registered on: 01/08/2023] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine
Biological
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Biological E’s Polio vaccine clinical study for protection against Polio disease in 6-8 weeks old infants. |
|
Scientific Title of Study
|
A prospective multicentre open label randomized active controlled Phase-II study to evaluate safety, tolerability and immunogenicity of inactivated poliomyelitis vaccine (Adsorbed) of Biological E Limited in 6-8 weeks old infants. |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BECT077/IPV-S19-Phase-II/CTP-01 Version :1.1 dated:26.12.22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subhash Thuluva |
| Designation |
Sr.Vice President- Clinical Development |
| Affiliation |
Biological E.Limited |
| Address |
Clinical Development Dept, 2nd floor, Road No.35,Jubilee Hills
Hyderabad
TELANGANA
500033
India |
| Phone |
04071216248 |
| Fax |
|
| Email |
subhash.thuluva@biologicale.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhash Thuluva |
| Designation |
Sr.Vice President- Clinical Development |
| Affiliation |
Biological E.Limited |
| Address |
Clinical Development Dept, 2nd floor, Road No.35,Jubilee Hills
Hyderabad
TELANGANA
500033
India |
| Phone |
04071216248 |
| Fax |
|
| Email |
subhash.thuluva@biologicale.com |
|
Details of Contact Person
Public Query
|
| Name |
Subba Reddy GV |
| Designation |
General Manager- Clinical Development |
| Affiliation |
Biological E.Limited |
| Address |
Clinical Development Dept, 2nd floor, Road No.35,Jubilee Hills
Hyderabad
TELANGANA
500033
India |
| Phone |
04071216240 |
| Fax |
|
| Email |
subbareddy.gunneri@biologicale.com |
|
|
Source of Monetary or Material Support
|
| Biological E.Limited, 18/1&3, Azamabad, Hyderabad - 500020, Telangana, India. |
|
|
Primary Sponsor
|
| Name |
Biological E.Limited |
| Address |
18/1&3, Azamabad, Hyderabad - 500020, Telangana, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Prashanth |
Cheluvamba Hospital |
Department of Paediatrics, 2nd Floor, Irwin Rd, Devraj Mohalla-570001
Mysore
KARNATAKA |
09606352062
drsp2013@rediffmail.com |
| Dr Manish Narang |
Guru Teg Bahadur Hospital & UCMS |
Department of Paediatrics,
4th Floor, Tahirpur Rd, GTB Enclave, Dilshad Garden-110095
North East
DELHI |
09811036569
manish_2710@yahoo.com |
| Dr N S Mahantshetti |
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre |
Department of Paediatrics, 2nd Floor, J N Medical College, Nehru Nagar – 590010
Belgaum
KARNATAKA |
09448157237
niranjanakle@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee - Guru Teg Bahadur Hospital |
Approved |
| IEC-Mysore Medical College and Research Institute |
Approved |
| Institutional Ethics Committee- KLE University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Vaccination against Polio diseases. |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biological E’s inactivated poliomyelitis vaccine (Adsorbed) |
1. Dose: 0.5 mL single dose 2. Frequency: Three doses 3. Route of administration: Intramuscular injection in the anterolateral aspect of thigh 4. Total duration of therapy: 84 days |
| Comparator Agent |
Licensed IPV vaccine |
1. Dose: 0.5 mL single dose 2. Frequency: Three doses 3. Route of administration: Intramuscular injection in the anterolateral aspect of thigh 4. Total duration of therapy: 84 days |
|
|
Inclusion Criteria
|
| Age From |
42.00 Day(s) |
| Age To |
56.00 Day(s) |
| Gender |
Both |
| Details |
1. Subjects’ parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, with access to a consistent means of telephone contact, either residential land line or mobile).
2. Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
3. A male or female healthy infant of either gender between 6-8 weeks of age at the time of 1st vaccination.
4. Healthy infants with body weight ≥ 3300 gms at the time of 1st vaccination
5. Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature) as judged by the principal investigator.
6. Subjects not participating in any other clinical trials.
7. Receipt of single birth dose of OPV (within 14 days of birth).
8. Infants without contraindications or precautionary circumstances for participating in the trial.
|
|
| ExclusionCriteria |
| Details |
1.Prior immunization or intent to receive oral/injectable polio vaccine (OPV/IPV) within the study period with an exception of birth dose of oral polio vaccine.
2. Current illness (especially fever) or any acute or congenital illness or disability.
3. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the administration of study vaccine (Day -29 to Day 0), or planned use during the study period.
4.Subjects receiving immunosuppressive therapy
5.Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
6.Known or suspected allergy to any of the vaccine components. History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity likely to be exacerbated by any component of the study vaccines.
7. Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS)
8. Known family history of SIDS (Sudden Infant Death Syndrome).
9. Planned or elective surgery during the course of the study.
10. Infants who have received any blood products, any dose of corticosteroids, cytotoxic agents or radiotherapy.
11. Subjects and / or their mothers who have participated in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course.
12. Inability or unwillingness of the parent to abide by the requirements of the protocol.
13. Family history of congenital or hereditary immunodeficiency.
14. Any criteria, which in the judgement of the Investigator, suggests that the subject would not be compliant with the study protocol.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Seroprotection rates (SPR%) in each treatment arm, defined as proportion of subjects with anti-Polio antibodies against poliovirus serotype 1, poliovirus serotype 2 and poliovirus serotype 3.
2. Anti-Polio IgG antibody titres against each vaccine serotype. |
1. At 28 days’ post third dose of vaccination.
2. At Day 28 post third dose of vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects with solicited local adverse reactions and systemic adverse events |
During first 60 minutes of post vaccination observation period and for 7 consecutive days |
| Proportion of subjects with unsolicited local and systemic adverse events (AEs) |
during the total study period until 28 days’ post third dose of vaccination |
| Serious adverse events (SAEs), Medically attended adverse events and AEs of special interest (AESI), if any |
during the total study period until 28 days’ post third dose of vaccination |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/08/2023 |
| Date of Study Completion (India) |
24/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an open label comparative, Phase-II study to demonstrate safety, tolerability and immunogenicity of BE’s inactivated poliomyelitis vaccine (Adsorbed), in 6-8 weeks old infants. A total of 120 healthy 6-8 weeks old infants will be enrolled into the study based on recruitment criteria set.
All subjects assigned to Investigational/control arm as per the randomization will be administered a single 0.5mL intramuscular dose of the investigational BE’s inactivated poliomyelitis vaccine (Adsorbed)/Licensed IPV vaccine as three dose schedule at 6, 10, 14 weeks of age for assessing the safety, tolerability and immunogenicity. The overall safety follow-up will be 91 days (84+7 days’ window period), all adverse events (AE) will be collected and documented for the entire duration of the study (i.e., 84+7 days’ window period for each subject).
The study will be conducted in compliance with GSR 227(E), ICH and Indian good clinical practice guidelines in force at the time of study conduct. |