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CTRI Number  CTRI/2021/10/037067 [Registered on: 04/10/2021] 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   A clinical study to assess the safety & immune response of BEs Pneumococcal conjugate vaccine when administered in a three dose schedule.  
Scientific Title of Study   A single blind randomised active-controlled Phase-III study to evaluate safety and immunogenicity of a candidate 14-valent pneumococcal polysaccharide conjugate vaccine administered to 6-8 weeks old healthy Indian Infants in 6-10-14 weeks dosing schedule.  
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
BECT061/PCV-Phase-III/CTP-01 Version No: 1.0 dated 14.05.20   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Subhash Thuluva 
Designation  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 TSA Kishore 
Designation  Associate Vice president - Clinical Development 
Affiliation  Biological E.Limited 
Address  Clinical Development Dept, 2nd floor, Road No.35, Jubilee Hills

Hyderabad
TELANGANA
500033
India 
Phone  04071216247   
Fax    
Email  kishore.turaga@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 ELimited 
Address  18/1&3, Azamabad, Hyderabad - 500020, Telangana, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shailesh Patil   Belgavi Institute of Medical Sciences  Ground floor, Dr B R Ambedkar Rd, Sadashiv Nagar, 590019, India.
Belgaum
KARNATAKA 		 9480454944

bimsclinicalresearch@gmail.com 
Dr S Prashanth   Cheluvamba Hospital  Dept. of Paediatrics, ground floor, Cheluvamba Hospital Mysore Medical College & Research Institute, Irwin Road-570001
Mysore
KARNATAKA 		 08105028742

drsp2013@rediffmail.com 
Dr Vasant Madhav Khalatkar  Khalatkar Hospital  1st floor, R29, Reshimbarg, Umred Road- Nagpur,440024, India
Nagpur
MAHARASHTRA 		 09823044438

vasant.khalatkar@gmail.com 
Dr B Ramesh Kumar  King George Hospital  Dept. of Paediatrics, 1st floor, King George Hospital,Collectorate Junction, Maharanipeta– 530002.
Visakhapatnam
ANDHRA PRADESH 		 09248863180

ramesh.kghamc@gmail.com 
Dr N S Mahantshetti   KLES Dr. Prabhakar Kore Hospital & Medical Research Centre   Dept. of Pediatrics, 2nd floor,KLES Dr. Prabhakar Kore Hospital & Medical Research Centre J N Medical College Nehru Nagar,590010
Belgaum
KARNATAKA 		 08312477201

niranjanakle@gmail.com 
Dr Vishal Tripathi  Rana Hospital Pvt. Ltd  Dept. of Paediatrics, 1st floor, Rail Vihar Medical College Road, Chargawan, Gorakhpur
Gorakhpur
UTTAR PRADESH 		 8700304154

nidhiray46@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Institutional Ethics Committee-MMC and RI and Associated Hospital  Approved 
Ethics Committee-Rana Hospital  Approved 
Institutional Ethics Committee, Belagavi Institute Of Medical Sciences  Approved 
Institutional Ethics Committee, KLE University, JN Medical College   Approved 
Institutional Ethics Committee- King George Hospital   Approved 
Kalatkar Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Preventive protection against Pneumococcal disease caused by the vaccine serotypes.  
Patients  (1) ICD-10 Condition: Z23||Encounter for immunization,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pfizer’s 13-valent Pneumococcal Polysaccharide Conjugate Vaccine- Prevenar13®   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: 86 days  
Intervention  Pneumococcal polysaccharide Conjugate Vaccine (Adsorbed) (14 Valent)-MHD   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: 86 days  
 
Inclusion Criteria  
Age From  42.00 Day(s)
Age To  56.00 Day(s)
Gender  Both 
Details  1. Healthy pneumococcal conjugate vaccine-naïve (PCV-naive) infants as established by medical history and clinical assessment before entering into the study. PCV-naïve infants are those who have not been previously vaccinated with any licensed or investigational pneumococcal vaccine.
2. Infants between 6-8 weeks of age (42-56 days, both days inclusive) of either gender, at the time of 1st dose of vaccination.
3. Healthy Infants with weight ≥ 3300 gms at the time of screening.
4. 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 landline or mobile).
5. Subject’s parent(s)/LAR(s) willing to provide written or thumb printed informed consent (including audio visual recording of consent process) prior to performing any study specific procedure
6. Infants with a minimal vaccination status for their age at the time of enrolment (“minimal” defined as single dose of BCG, Hepatitis B &/or Polio vaccine at the time of enrolment).
 
 
ExclusionCriteria 
Details  1. Child in care, defined as a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.
2. Evidence of previous Streptococcus pneumoniae infection or pneumococcal vaccination.
3. Use of any investigational or non-registered product (drug or 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 other than the study vaccine.
4. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe (eg., coagulation abnormalities).
5. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs or any blood products during the period starting 30 days prior to the proposed first vaccine dose or planned administration of the same during the study period.
6. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
7. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
8. Family history of congenital or hereditary immunodeficiency.
9. 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.
10. History of any neurological disorders, meningitis or seizures.
11. Infant who has had a sibling die of sudden infant death syndrome (SIDS) or die suddenly and without apparent other cause or preceding illness in the first year of life.
12. Infant 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).
13. Acute disease and/or fever at the time of vaccination.
Fever is defined as the endogenous elevation of at least one measured body temperature of ≥ 38◦C (≥ 100.4◦F).
14. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination and Principal investigator judgement.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Proportion of subjects with solicited local and systemic adverse reactions/events
2.Proportion of subjects with unsolicited systemic adverse events (AEs)
3.Medically attended adverse events and serious adverse events (SAEs), if any 		 1.during first 60 minutes of post vaccination observation period and for subsequent 7
consecutive days
2. during the total post vaccination follow up period.
3.during the total study period 
 
Secondary Outcome  
Outcome  TimePoints 
The percentage of subjects with anti-PnCPS IgG concentration ≥ 0.35 μg/ml (as measured by ELISA) against each of the vaccine serotype   At 1 month after 3rd dose, against baseline. 
In subjects already baseline seroconverted (≥ 0.35 μg/ml), percentage of subjects with ≥4-fold rise in serotype specific anti-PnCPS IgG antibody concentration   From their baseline  
Anti-PnCPS IgG Geometric Mean Concentrations   At 1 month after 3rd dose, against baseline 
The percentage of subjects with ≥2-fold and ≥4-fold rise in anti-PnCPS IgG Concentrations   From baseline, at 1 month after 3rd dose 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   11/10/2021 
Date of Study Completion (India) 19/01/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
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 a two arm single blind, multicentre randomised active controlled phase-III study to evaluate safety and immunogenicity of three 0.5 mL intramuscular doses of Biological E’s candidate 14-valent pneumococcal polysaccharide conjugate vaccine to be administered to 6-8 weeks old healthy infants in 6-10-14 weeks EPI immunisation schedule in comparison with Pfizer’s Prevenar 13.

A total of 300 healthy Indian infants will be equally randomised to one of the two treatment arms (test and comparator groups) based on the screening and enrolment criteria set in the protocol. Each subject will receive three doses (0.5 mL/dose) of study vaccine intramuscularly based on the group to which they were randomised.The total duration of the study is 86 days for each subject. The study will be conducted in compliance with schedule Y, ICH and Indian good clinical practice guidelines in force.



 
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