| CTRI Number |
CTRI/2024/07/071627 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine
Biological
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
A long term safety follow-up study for subjects who received 3 doses of Pneumococcal Vaccine. |
|
Scientific Title of Study
|
A Phase-IV multicentre follow-up study to assess the continued safety of Biological E’s 14-valent pneumococcal polysaccharide conjugate vaccine in subjects, who received 3-dose (3 plus 0) primary PCV vaccination as part of BECT051 and BECT061 studies. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BECT087/PCV-Phase-IV_SF/CTP-01VersionNo:1.0 dated 16.01.24 |
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, Room no:5,2nd 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, Room no:5,2nd floor,Road No.35,Jubilee Hills
TELANGANA
500033
India |
| Phone |
04071216248 |
| Fax |
|
| Email |
subhash.thuluva@biologicale.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Subba Reddy GV |
| Designation |
General Manager- Clinical Development |
| Affiliation |
Biological E.Limited |
| Address |
Clinical Development Dept, Room no:2, 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
|
| Name |
Address |
| MS Biological ELimited |
Plot No 1,
Phase 11, Kolthur Village, Shameerpet,
Medchal-Malkajgiri District, Telangana -500 078. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 13 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shailesh Patil |
Belgavi Institute of Medical Sciences |
Department of Paediatrics, Dr B R Ambedkar Rd, Sadashiv Nagar, 2nd Floor,
Belgaum
KARNATAKA |
09480454944
bimsclinicalresearch@gmail.com |
| Dr S Prashanth |
Cheluvamba Hospital |
Department of Paediatrics, 2nd Floor, Irwin Rd, Devraj Mohalla-570001
Mysore
KARNATAKA |
09606352062
drprashanths10@gmail.com |
| Dr Abhishek TChavan |
Jeevan Rekha Hospital |
Department of Paediatrics, 3rd floor, Dr. B R Arnbedkar Road- 590002
Belgaum
KARNATAKA |
09113222185
dr.abhishektchavan@gmail.com |
| Dr Jai Prakash Narayan |
JLN Medical College |
Department of Paediatrics, 2nd Floor, Kala Bagh-305001
Ajmer
RAJASTHAN |
09314294402
narayan_jaiprakash@yahoo.com |
| Dr MD Ravi |
JSS Hospital |
Department of Paediatrics,
1st Floor, Mahatma Gandhi Road, Fort Mohalla-570004
Mysore
KARNATAKA |
09886629506
ravimdped@gmail.com |
| Dr Vasant Khalatkar |
Khalatkar Hospital |
Department of Paediatrics, ground floor,
R-29, Reshimbag Umred Road- 440024
Nagpur
MAHARASHTRA |
09823044438
vasant.khalatkar@gmail.com |
| Dr B S Chakravarthy |
King George Hospital |
Department of Paediatrics,
1st Floor, Room No. 09, Collectorate Junction, Maharani Peta-530002
Visakhapatnam
ANDHRA PRADESH |
09848253535
chakravarthy.kghamc@gmail.com |
| Dr Niranjana S Mahantshetti |
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre |
Department of Paediatrics,
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre, 2nd Floor, Nehru Nagar-590010
Belgaum
KARNATAKA |
09448157237
niranjanakle@gmail.com |
| Dr Virendra Nath Tripathi |
Prakhar Hospital Pvt. Ltd |
Department of Paediatrics, ground floor,
8/219 Arya Nagar - 208002
Kanpur Nagar
UTTAR PRADESH |
09415050777
dr.vntripathicr@gmail.com |
| Dr Savita Verma |
Pt. BD Sharma Postgraduate Institute of Medical Sciences (PGIMS) |
Department of Pharmacology, 2nd Floor-124001
Rohtak
HARYANA |
09812283746
savita_verma@hotmail.com |
| Dr Ashish Dhongade |
Sant Dnyaneshwar Medical Education & Research Centre, |
Department of Paediatrics,ground floor, 695-a, sadashiv peth, laxmi road, opp. vijay
talkies - 411030
Pune
MAHARASHTRA |
09011095436
adhongade1@gmail.com |
| Dr GBalakishor |
St Theresas Hospital |
Department of Paediatrics, 1st floor, Sanathnagar, Opp. Erragadda Raitu Bazar- 500018
Hyderabad
TELANGANA |
0994906236
baki2004@gmail.com |
| Dr Srimukhi Anumolu |
Vignesh Women & Children Hospital, |
Department of Paediatrics, ground floor,
Kovelamudivari Street Suryaraopet,Vijayawada - 520002
Krishna
ANDHRA PRADESH |
07799867867
dr.srimukhianumolu@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| Ethics Committee Jeevan Rekha Hospital |
Approved |
| Ethics committee- St Theresas Hospital |
Approved |
| Ethics Committee-Sant dnyaneshwar medical education research centre, |
Approved |
| IEC King George Hospital, |
Approved |
| IEC Prakhar Hospital Pvt Ltd |
Approved |
| IEC-Mysore Medical College and Research & Associated Hospital |
Approved |
| Institutional Ethics Committee Anu Hospitals |
Approved |
| Institutional Ethics Committee, Jawahar Lal Nehru Medical College |
Approved |
| Institutional Ethics Committee, KLE University |
Approved |
| Institutional Ethics Committee, PGIMS UHS |
Approved |
| Institutional Ethics Committee,JSS Medical College, |
Approved |
| Institutional Ethics Committee- Belagavi Institute of Medical Sciences, |
Approved |
| Khalatkar Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None |
None |
| Intervention |
Pneumococcal polysaccharide Conjugate Vaccine (Adsorbed) (14 Valent)- Single Human dose- 0.5mL |
1. Dose:0.5 mL three dose schedule 2.Frequency: three doses administered 28 days apart doses, at Day 0, Day 28 & Day 56 respectively. 3. Route of administration: Intramuscular injection in the vastus lateralis muscle on anterolateral aspect of thigh 4.Total duration of therapy: day 86 (30 days post last dose) till the day of the enrolment in the current safety follow-up study |
|
|
Inclusion Criteria
|
| Age From |
24.00 Month(s) |
| Age To |
42.00 Month(s) |
| Gender |
Both |
| Details |
1. All Subjects who participated and completed all study related visits and assessments, part of BECT051 and BECT061 studies.
2. Subjects’ parent(s)or LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
3. Subject’s parent(s)or LAR(s) willing to provide written or thumb printed informed consent prior to performing any study specific procedure or assessments. |
|
| ExclusionCriteria |
| Details |
1. Subjects who dropped out from BECT051 or BECT061 studies.
2. Subjects who participated in another clinical study from the completion of the BECT051 and BECT061 studies until the commencement of current study.
3. Subject is a direct descendant (child or grand-child) of any person employed by the Sponsor, the Contract Research Organization (CRO) or the Study Site (including the PI and study site personnel). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess incidence of adverse events (AEs) in terms of their number and percentage of AEs experienced by BE-PCV14 and PCV-13 vaccinated subjects
2.To assess medically attended adverse events (MAAEs), if any, in terms of their number and percentage of AEs experienced BE-PCV14 and PCV-13 vaccinated subjects |
1.From day 86 (30 days’ post last dose) till the day of the study visit (enrolment) in the current safety follow-up study.
2.From day 86 (30 days’ post last dose) till the day of the study visit (enrolment) in the current safety follow-up study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="1590"
Sample Size from India="1590"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 multicentre phase-IV follow up study to assess continued safety of Biological E’s 14-valent pneumococcal polysaccharide conjugate vaccine among subjects who participated in BECT051 and BECT061 studies. Biological E. has successfully completed PCV Phase-III studies (BECT051 and BECT061) in 6-8 weeks old healthy infants.
Subjects who completed primary vaccination series and the follow-up visit at day 86 as per the study visit schedule in BECT051 and BECT061 studies, will further be followed-up for assessing continued safety of BE-PCV14. All subjects of these two studies have completed at least 24 months after primary vaccination series. |