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CTRI Number  CTRI/2022/03/041495 [Registered on: 30/03/2022] 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  Single Arm Study 
Public Title of Study   A clinical study to assess the safety, tolerability, reactogenicity & immunogenicity of pneumococcal polysaccharide conjugate vaccine in 18 to 45 years old healthy adults.  
Scientific Title of Study   A prospective open label non-comparative Phase-I clinical study to evaluate safety, tolerability, reactogenicity and immunogenicity of single intramuscular dose of Biological E’s 24-valent pneumococcal polysaccharide conjugate vaccine in 18-45 years-old healthy adults.  
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
BECT075/PCV-Phase-I/CTP-01 Version :1.0 dated:01.09.21   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


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 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  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anil Kumar Pandey  ESIC Medical College & Hospital  Department of Physiology, ESIC Medical College & Hospital, Room No. 440, 4th Floor, NH-3 behind BK Hospital New Industrial Town-121001
Faridabad
HARYANA 		 07042918222

drpandeyak@yahoo.co.in 
DrGupta Hemant Ramsharan  Grant Medical College & Sir J.J Hospital  Department of Medicine, Grant Medical College & Sir J.J Hospital, 2nd Floor, J J Marg, Nagpada, Mumbai Central-400008
Mumbai
MAHARASHTRA 		 09870456888

drhemantgupta@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee - Grant Medical College & Sir J.J Hospital  Submittted/Under Review 
Institutional Ethics Committee for ESIC Medical College And Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Preventive protection against Pneumococcal diseases.  
Patients  (1) ICD-10 Condition: Z23||Encounter for immunization,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Biological Es Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (24 Valent) - Single Human Dose – 0.5 mL  1. Dose: 0.5 mL single dose 2. Frequency: One dose only 3. Route of administration: Intra-muscular injection in deltoid muscle of the non-dominant arm. 4. Total duration of therapy: 35 days (post single dose administration)  
Comparator Agent  None  None 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Healthy male and non-pregnant female subjects between 18-45 years of age at the time of vaccination;
2. Subjects who provide voluntary written informed consent to participate in the study and are capable of comprehending and complying with study requirements and procedures, able and willing to complete subject diary and to return for all scheduled follow-up visits, and have expressed availability for the required study period, with access to a consistent means of telephone contact, either residential land line or mobile.
3. Free of obvious health problems [with no significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, mental or haematological functional abnormalities or illness that require medical therapy] as established by medical history and clinical assessment;
4. Adult male subjects willing to follow acceptable methods of contraception (e.g. condom, with or without spermicide) or practice abstinence and agreeing not to make their female partners pregnant from the time of vaccination until the end of the study. Male subject should also agree to avoid semen donation or providing semen for in-vitro fertilization during the study duration.
5. Female subject of child bearing potential must have a negative urine pregnancy test (UPT), and willingness to avoid becoming pregnant through use of an effective method of contraception or abstinence from the time of study enrolment until six weeks after the dose of vaccination in the study
6. No clinically significant abnormal laboratory parameters at baseline as judged by the investigator.
7. Subjects willing to avoid consumption (ingestion) of chronic herbal medication during the course of the study.
 
 
ExclusionCriteria 
Details  1. Previous history of pneumococcal vaccination;
2. 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;
3. History of allergic or anaphylactic reaction to any vaccine or vaccine-related component or known hypersensitivity to any component of the study vaccine.
4. Any acute or serious infection needing systemic antibiotics or antiviral treatment in last 7 days;
5. 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.
6. Epilepsy, a history of seizures or convulsions, or a family history of mental illness;
7. 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;
8. Subjects who have received any blood products, cytotoxic agents or radiotherapy within the last 3 months;
9. Any licensed or investigational drug or 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;
10. Known or suspected immunosuppression or immunodeficiency;
11. Any laboratory abnormality that could increase the risk associated with study participation or interfere with the interpretation of study results;
12. Inability or unwillingness to abide by the requirements of the study;
13. Any participant who cannot be adequately followed for safety, tolerability, reactogenicity and immunogenicity according to the study plan;
14. Participant is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study;
15. Suspicion or recent history (within the past year) of alcohol or drug abuse.
16. An employee (or first-degree relative of employee) of the Sponsor, the CRO, or any investigator or site personnel.
17. Any medical or social condition that in the opinion/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   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Proportion of subjects with solicited local and systemic adverse reactions
2.Proportion of subjects with unsolicited local and systemic adverse events
3.Any clinically significant abnormal haematology and biochemistry laboratory parameters.
4.Serious adverse events (SAEs) and medically attended adverse events (MAAE) 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 till day 28.
3.until day 28 post single dose vaccination.
4. During the study period 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of subjects achieving seroconversion   At day 28 post vaccination 
Proportion of subjects achieving ≥2-fold and ≥4-fold increase in serotype specific anti-PnCPS IgG antibody titre   At day 28 
Geometric mean titre (GMT) of serotype specific anti-PnCPS IgG antibodies   at day 28 post vaccination. 
Geometric Mean Fold Rise (GMFR) in serotype specific anti-PnCPS IgG titres   At Day 28 post vaccination. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   15/04/2022 
Date of Study Completion (India) 27/10/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a single arm, open label Phase-I study to demonstrate safety, tolerability, reactogenicity & Immunogenicity of Biological E’s 24-valent pneumococcal polysaccharide conjugate vaccine in 18-45 year-old adult healthy subjects. A total of 60 subjects will be administered a single 0.5 mL dose of the test vaccine by Intra-muscular injection in deltoid muscle of the non-dominant arm.

Blood sample will be collected once at screening and again 28 days after the single dose, for routine haematology, biochemistry parameters and for serotype specific anti-pneumococcal IgG antibody assay. Vital signs will be recorded at all protocol specified visits for all subjects.

The total duration of the study is 35 days for each subject (7 days for screening time and 28 days for follow up post single dose).

The study will be conducted in compliance with G.S.R.227(E) New Drugs and Clinical Trials Rules, ICH and Indian good clinical practice guidelines in force at the time of study conduct.

 
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