| CTRI Number |
CTRI/2025/03/083102 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| 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
|
A clinical study to assess the safety and immunogenicity of BEs Pneumococcal vaccine when administered as a single dose to five years and above of age. |
|
Scientific Title of Study
|
A single blind, randomized, active-controlled, phase-IV study to evaluate immunogenicity and safety of Biological E’s 14-valent pneumococcal polysaccharide conjugate vaccine (PNEUBEVAX-14), administered to healthy children aged ≥5 years to 18 years and healthy adults aged ≥18 years and above. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BECT090/PCV14-Phase-IV/CTP-01 VersionNo:1.0 dated 17.06.24 |
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 |
Associate Vice President |
| 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 = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shreyans Shah |
Aartham Multi Super Speciality Hospital |
Department of Paediatrics, OPD 1st floor, Dr Vikram Sarabhai Marg, near Panjrapole Cross Road, L Colony, Ambawadi- 380015.
Ahmadabad
GUJARAT |
09909977831
drshreyansshahcr@gmail.com |
| Dr R G Viveki |
Belgavi Institute of Medical Sciences |
Department of Community Medicine, OPD 2nd Floor, BIMS Building, Dr B R Ambedkar Rd, Sadashiv Nagar - 590001
Belgaum
KARNATAKA |
09845143860
bimsclinicalresearch@gmail.com |
| Dr Mohan M E |
BGS Global Institute of Medical Sciences |
Department of General Medicine,
OPD 2nd Floor, Uttarahalli Road Kengeri- 560060
Bangalore
KARNATAKA |
08792516793
drmohanbgsresearch@gmail.com |
| Dr Sonali Hemant Palkar |
Bharati Vidyapeeth Medical College Hospital and Research Centre |
Department of Community medicine, OPD Ground floor, Pune-Satara road, Dhankawadi-411043
Pune
MAHARASHTRA |
09881008717
palkarsh@gmail.com |
| Dr Avneet Singh |
Christian Medical College & Hospital |
Department of Community Medicine, OPD block 1st floor, Brown Road, CMC Campus- 141008
Ludhiana
PUNJAB |
07986534701
askdr3@gmail.com |
| Dr Onkar Singh Bhinder |
ESIC Medical College & Hospital |
Department of Pediatrics,
OPD 8th Floor, NH-3 New Industrial
Town- Faridabad- 121001
New Delhi
DELHI |
07529864316
o.bhinder@gmail.com |
| Dr Anjan Jyoti Talukdar |
Gauhati Medical College & Hospital, |
Department of Medicine, 1st floor, OPD block, Narakasur Hilltop, Bhangagarh, Guwahati- 781032
Dibrugarh
ASSAM |
09954658926
anjan110178@gmail.com |
| Dr Manish Narang |
GTB Hospital |
Department of Pediatrics,
OPD 4th Floor, Tahirpur Rd, GTB Enclave, Dilshad Garden-110095
North East
DELHI |
09811036569
manish_2710@yahoo.com |
| Dr Jai Prakash Narayan |
JLN Medical College |
Department of Pediatrics,
OPD 2nd Floor, Kala Bagh-305001
Ajmer
RAJASTHAN |
09314294402
narayan_jaiprakash@yahoo.com |
| Dr B S Chakravarthy |
King George Hospital |
Department of Pediatrics,
OPD 1st Floor, Room No. 09, Collectorate Junction, Maharani Peta- 530002
Visakhapatnam
ANDHRA PRADESH |
09848253535
chakravarthy.kghamc@gmail.com |
| Dr Ramanath Andy Karayalar |
Panimalar Medical College Hospital & Research Institute |
Department of Pediatrics,
OPD 3rd Floor, Varadharajapuram, Chennai Outer Ring Rd, Poonamallee-600123
Chennai
TAMIL NADU |
09884750160
chandra.ramanath82@gmail.com |
| Dr Savita Verma |
PT. B D Sharma Post Graduate Institute of Medical Sciences & Hospital |
Department of Pharmacology,
OPD 2nd Floor-124001
Rohtak
HARYANA |
09812283746
savita_verma@hotmail.com |
| Dr P Umapathy |
Sri Ramachandra Hospital |
Department of Pediatrics, OPD 1st floor of G Block,Porur – 600116
Chennai
TAMIL NADU |
09841663959
umapathy.p@sriramachandra.edu.in |
| Dr Pareshkumar A Thakkar |
SSG General Hospital |
Department of Pediatrics,
OPD 1st floor, ward no:17 Jail Raod, Indra Avenue-390001
Vadodara
GUJARAT |
09426032150
pareshthakkar@yahoo.com |
| Dr G Balakishor |
St.Theresas Hospital |
Department of Pediatrics, OPD 1st Floor, Room No. 05, Erragadda Main Road, Czech Colony Sanath Nagar- 500018
Hyderabad
TELANGANA |
09949046236
baki2004@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Aartham Ethics Committee Aartham Hospitals |
Submittted/Under Review |
| Ethics committee St Theresas Hospital |
Approved |
| Guru Teg Bahadur Hospital Ethics Committee |
Approved |
| IEC King George Hospital, |
Approved |
| Institutional Ethics Committee BVDU Bharati Hospital and Research Centre Bharati Hospital, |
Approved |
| Institutional Ethics Committee Christian Medical College and Hospital |
Submittted/Under Review |
| Institutional Ethics Committee for Human Research, Medical College |
Approved |
| Institutional Ethics Committee SRIHER |
Approved |
| Institutional Ethics Committee, BGS Global Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee, ESIC Medical College And Hospital |
Approved |
| Institutional Ethics Committee, GMCH Gauhati Medical College And Hospital, |
Submittted/Under Review |
| Institutional Ethics Committee, Jawahar Lal Nehru Medical College |
Approved |
| Institutional Ethics Committee, PGIMS UHS |
Approved |
| Institutional Ethics Committee- Belagavi Institute Of Medical Sciences, |
Approved |
| PMCHRI-IHEC Panimalar Medical College Hospital & Research Institute |
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 |
| Intervention |
Pneubevax-14 |
0.5mL of BE’s Pneubevax-14 vaccine administered intramuscularly on Day 0 |
| Comparator Agent |
Prevenar 13 |
0.5mL of Prevenar13® vaccine administered intramuscularly on Day 0 |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy subjects of either gender between 5 years to 18 years old children and 18 years and above aged adults at the time of vaccination.
2.Subject or Subject’s Parent(s) or LAR who after the nature of the study has been explained to them, have given written informed consent or assent (oral assent applicable to subjects 7 to 12 years of age and written assent applicable to subjects 12 to 18 years of age) according to local regulatory requirements prior to performance of any study specific procedure.
3.Subject or Subject’s Parent(s) or LAR’s ability to understand information relevant to participation in the study and abide with the requirements of the subject diary and other study procedures
4.Individuals in good health as determined by medical history, physical examination and laboratory investigations (only in adults), based on clinical judgment of the investigator.
5.Adult participant seronegative for human immunodeficiency virus, hepatitis B, and hepatitis C at screening.
6.Negative urine pregnancy test for female subjects of childbearing potential at screening and has practiced adequate contraception for 1 month prior to study intervention administration and has agreed to continue adequate contraception during the treatment period and for 1 month after completion of the study intervention administration.
7.Female participants of non-childbearing potential. |
|
| ExclusionCriteria |
| Details |
1.Evidence of previous Streptococcus pneumoniae infection.
2.Child in care
3.History of Invasive Pulmonary Disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or any culture-confirmed invasive disease caused by S. pneumoniae
4.History of allergic or anaphylactic reaction to any vaccine or vaccine-related component or known hypersensitivity to any component of the study vaccine.
5.Acute disease and or fever at the time of vaccination.
6.Fever is defined as the endogenous elevation of at least one measured body temperature of 38°C (100.4°F).
7.Any acute or serious infection needing systemic antibiotics or antiviral treatment in last 7 days;
8.Acute or chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or haematological functional abnormality or major congenital defects or illness that requires medical therapy, as determined by medical history or clinical assessment.
9.Epilepsy, a history of seizures or convulsions, or a family history of mental illness;
10.History of any coagulation or other blood disorder (e.g. thalassemia, thrombocytopenia, disorders of the lymphocytes, anaemias, etc.) or receipt of anti-coagulants in the past 3 weeks;
11.Subjects who have received any blood products, cytotoxic agents or radiotherapy within the last 3 months;
12.Any licensed or investigational vaccine administered within the 90 days prior to receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine;
13.Known or suspected immunosuppression or immunodeficiency;
14.Inability or unwillingness to abide by the requirements of the study;
15.Any participant who cannot be adequately followed for immunogenicity, safety and tolerability assessments according to the study plan;
16.Participant is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study;
17.Suspicion or recent history (within the past year) of alcohol or drug abuse.
18.An employee (or first-degree relative of employee) of the Sponsor, the CRO, or any investigator or site personnel.
19.Any medical or social condition that in the opinion or judgement of the investigator will interfere with the study objectives or pose a risk to the study subject or may prevent the subject from completing the study follow up.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of subjects with anti PnCPS IgG concentration 0.35 microgram per ml against each of the vaccine serotype |
At 28 days post vaccination. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects with solicited local and systemic adverse reactions or events post vaccination, in Pneubevax-14 and Prevenar-13 vaccinated subjects |
During first 30 minutes observation period and for subsequent 7 consecutive day |
| Proportion of subjects with unsolicited adverse events (AEs) during the subsequent follow up period |
28 days post vaccination. |
| Proportion of subjects with serious adverse events (SAEs) and medically attended AEs |
For the total study period. |
| GMFR in anti-PnCPS IgG antibody concentrations against each of the vaccine serotype |
From pre-vaccination levels. |
| Proportion of subjects with 2 and 4-fold rise in serotype specific anti-PnCPS IgG antibody concentration |
From their baseline. |
| Geometric mean concentrations of anti-PnCPS IgG antibodies against each of the vaccine serotype |
From pre-vaccination levels. |
|
|
Target Sample Size
|
Total Sample Size="1200"
Sample Size from India="1200"
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)
|
03/04/2025 |
| 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="10"
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 prospective, single blind, randomized, active-controlled, phase-IV study to evaluate immunogenicity and safety of Pneubevax-14, administered as a single dose to children aged ≥5 years to <10 years (younger children), ≥10 years to <18 years (older children), and adults aged ≥18 years to <50 years and to elderly population (≥50 years and above). Healthy children aged ≥5 to <10 years who are not previously vaccinated or those with incomplete infant series with Pneumococcal vaccines are eligible. Healthy children aged from ≥10 to <18 years (older children) and adults aged ≥18 years and above are eligible if they had never received a dose of pneumococcal vaccine. The total sample size to be enrolled would be 1200 healthy eligible subjects.
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.
|