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CTRI Number  CTRI/2017/06/008776 [Registered on: 07/06/2017] Trial Registered Prospectively
Last Modified On: 25/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine
Biological
Preventive 
Study Design  Single Arm Study 
Public Title of Study   A first in human clinical trial to assess safety and antibody protection against pneumonia and meningitis caused by streptococcus pneumoniae bacteria with single dose of BE’s 14-antigen Pneumococcal conjugate vaccine with preservative in 18-45 year-old healthy adult male volunteers. 
Scientific Title of Study   A single arm open label non-comparative Phase-I study to evaluate safety, reactogenicity and immunogenicity of single intramuscular dose of 14-valent pneumococcal polysaccharide conjugate vaccine (with thiomersal as preservative) of Biological E. Limited in 18-45 year-old healthy adults.  
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
BECT042/PCV-Phase-I/CTP-01 Version:1.0 dated:20.04.17  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R Vasudev 
Designation  Assistant Professor- Department of General Medicine 
Affiliation  King George Hospital 
Address  King George Hospital, Collectorate Junction, Maharanipeta, Visakhapatnam-530002, Andhra Pradesh, India.

Hyderabad
ANDHRA PRADESH
530002
India 
Phone  09866739808  
Fax    
Email  vasudev.kgh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr TSA Kishore 
Designation  Associate Vice President- Clinical Affairs & Pharmacovigilance 
Affiliation  Biological E.Limited 
Address  18/1&3, Azamabad, Hyderabad, Telangana

Hyderabad
ANDHRA PRADESH
500020
India 
Phone  4030214046  
Fax  04030214046  
Email  kishore.turaga@biologicale.co.in  
 
Details of Contact Person
Public Query  
Name  Dr TSA Kishore 
Designation  Associate Vice President- Clinical Affairs & Pharmacovigilance 
Affiliation  Biological E.Limited 
Address  18/1&3, Azamabad, Hyderabad, Telangana

Hyderabad
ANDHRA PRADESH
500020
India 
Phone  4030214046  
Fax  04030214046  
Email  kishore.turaga@biologicale.co.in  
 
Source of Monetary or Material Support  
Biological E.Limited, 18/1&3, Azamabad, Hyderabad, Telangana India 500020.  
 
Primary Sponsor  
Name  Biological E Limited  
Address  18/1&3, Azamabad, Hyderabad, Telangana India 500020.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R Vasudev  King George Hospital  Dept. of General Medicine, King George Hospital, Collectorate Junction, Maharanipeta, Visakhapatnam-530002, Andhra Pradesh, India.
Visakhapatnam
ANDHRA PRADESH 		 09866739808

vasudev.kgh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- King George Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
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 
Comparator Agent  None  None 
Intervention  Pneumococcal Conjugate Vaccine (Adsorbed) (14 Valent) with Thiomersal as preservative- Multi Human dose.  1. Dose:0.5 mL Single dose 2. Frequency: One dose only 3. Route of administration: Intramuscular injection in deltoid muscle of the non-dominant arm. 4.Total duration of therapy: 35 days (post single dose administration)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1.Healthy male 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.
5.No clinically significant abnormal laboratory parameters at baseline as judged by the investigator.
6.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, 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 substance 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 adverse reactions.
2.Proportion of subjects with unsolicited local and systemic adverse events (AEs)
3.Any clinically significant abnormal haematology and biochemistry laboratory parameters
4.Serious adverse events (SAEs), if any,  		 1. Duration: 7 consecutive days (Day 0-6) post vaccination.
2. Duration: 28 days post vaccination.
3. Duration: 28 day post vaccination (once at baseline and again 28th day)
4. Duration: 28 days post vaccination
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Proportion of subjects achieving seroconversion
2.Proportion of subjects achieving ≥2 fold and ≥4 fold increase in anti-PnCPS IgG antibody titre
3.Geometric mean titre (GMT)  		 1. Duration: 28 days post vaccination.
2. Duration: 28 days post vaccination.
3. Duration: 28 days post vaccination.
 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   12/06/2017 
Date of Study Completion (India) 28/07/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
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)?  

Brief Summary  

This is a single arm, open label Phase-I study to demonstrate safety, reactogenicity & Immunogenicity of Biological E’s 14-valent pneumococcal conjugate vaccine with thiomersal as preservative in 18-45 year-old adult male subjects.A total of 24 adult male 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. This is a single centre study.

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 schedule Y, ICH and Indian good clinical practice guidelines in force. 

 
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