FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/096132 [Registered on: 16/10/2025] Trial Registered Prospectively
Last Modified On: 10/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine
Biological
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A phase-I clinical study to assess the safety of Biological Es Meningococcal vaccine in 18-45 year old healthy adults.  
Scientific Title of Study   A prospective, open label, randomized, controlled Phase-I clinical study to evaluate the safety and immunogenicity of single intramuscular dose of Biological E’s Meningococcal Conjugate Vaccine, administered to 18-45 years-old healthy adults. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
BECT091/MCV-Phase-I/CTP-01 VersionNo:1.0 dated 13.09.24   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- 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  Plot No 1, Phase 11, Kolthur Village, Shameerpet, Medchal-Malkajgiri District, Telangana -500 078. 
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 Shiva Narang  GTB Hospital  Department of General Medicine, 6th Floor, Room No::26B,Tahirpur Road, GTB Enclave, Dilshad Garden
East
DELHI 		 09899838807

shivanarang@gmail.com 
Dr A Venkateshwar Rao  St.Theresas Hospital  Department of Internal Medicine, Ground floor of OPD, Room no:05, Erragadda Raitu Bazar Main Road, Sanath Nagar
Hyderabad
TELANGANA 		 09440040662

drvenkateshwarraoavula@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics committee, St Theresas Hospital  Approved 
Guru Teg Bahadur Hospital Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z23||Encounter for immunization,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BE’s Meningococcal Conjugate Vaccine (adjuvanted)  Each 0.5 mL dose of the vaccine administered intramuscularly, preferably in the deltoid muscle on Day 0 
Intervention  BE’s Meningococcal Conjugate Vaccine (non-adjuvanted)  Each 0.5 mL dose of the vaccine administered intramuscularly, preferably in the deltoid muscle on Day 0 
Comparator Agent  Meningococcal Group A, C, W, Y, X Conjugate Vaccine (MenFive®)  Each 0.5 mL dose of the vaccine administered intramuscularly, preferably in the deltoid muscle on Day 0 
 
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 (both inclusive) years of age at the time of vaccination;
2. Subject, in the opinion of the investigator, has ability to communicate 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).
3. Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the subject prior to performing any study specific procedure.
4. Subjects considered of stable health as judged by the principal investigator based on personal medical history, protocol specific laboratory parameters and clinical examination findings before entering into the study.
5. Negative urine pregnancy test for female subjects of childbearing potential at screening
6.Female participants of non-childbearing potential.
7. No clinically significant abnormal laboratory parameters at baseline as judged by the investigator.
8. Subjects willing to avoid consumption (ingestion) of chronic herbal medication during the course of the study. 
 
ExclusionCriteria 
Details  1. Individuals with body temperature greater than or equal to 100.4°F within 3 days of intended study vaccine administration;
2. History of any meningococcal vaccine administration and/or disease caused by N. meningitides;
3. Household contact with and or intimate exposure to N. meningitides infections over the last 90 days;
4. Individuals with any progressive unstable or uncontrolled clinical conditions according to judgment of the investigator (e.g., neurological, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease);
5. Subject inability to understand and follow required study procedures, keep appointments, or are planning to relocate during the study period;
6. Individuals with history of any illness or any laboratory abnormality that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
7.Subject with suspected or known history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids in the previous 30 days;
8. Subject with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time or history of receipt of anti-coagulants in the past 3 weeks;
9. Subjects that have received immunoglobulins and/or any other blood products in the 90 days preceding the vaccination visit
10. History of allergy, hypersensitivity or allergic reaction to any vaccine-related component;
11. Individuals participating in any other clinical trial within 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study;
12. Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study objectives. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
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 (AEs)
3. 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. during the total study period of 28 days’ post-vaccination. 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of subjects achieving a greater than or equal to 4-fold increase in serum bactericidal activity titres for Meningococcal Polysaccharide A, C, Y, W, and X specific antibodies  At day 28 compared to baseline after a single dose vaccination. 
Percentage of subjects achieving greater than or equal to 1:8 SBA titres for Meningococcal Polysaccharide A, C, Y, W, and X specific antibodies  at 28 days’ post single dose vaccination 
Meningococcal Polysaccharide A, C, Y, W, and X specific SBA GMTs  at day 28 post single dose vaccination 
Geometric Mean Fold Rise (GMFR) in Meningococcal Polysaccharide A, C, Y, W, and X specific GMTs  at day 28 post single dose vaccination from baseline 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 1 
Date of First Enrollment (India)   28/11/2025 
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="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 prospective, open label, randomized, comparative, first-in-human, Phase-I study to evaluate the safety, tolerability, reactogenicity and immunogenicity of a single intramuscular dose of adjuvanted and non-adjuvanted formulations of Biological E’s Meningococcal Conjugate Vaccine (MCV) in 18-45-year-old healthy adult subject. 

A total of 90 adult subjects will be recruited to one of the three treatment arms in 1:1:1 ratio to receive a single 0.5 mL dose of BE’s Meningococcal Conjugate Vaccine either adjuvanted or non-adjuvanted or a licensed comparator, intramuscularly.

The study will be conducted in compliance with NDCT Rules, ICH and Indian good clinical practice guidelines in force at the time of study conduct.


 
Close