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CTRI Number  CTRI/2025/09/094840 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 16/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to assess the safety and overall immune response of Serum Institute of India’s 21-valent Pneumococcal Conjugate Vaccine when administered as single dose in healthy Indian Adult participants 
Scientific Title of Study   A Phase 1, Prospective, Randomized, Two-Arm, Active-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of Serum Institute of India’s 21-valent Pneumococcal Conjugate Vaccine (SIIPCV21) in Healthy Indian Adults. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
PCV-21-001, Version 1.0, dated 06/03/2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nithya Gogtay 
Designation  Professor and Head Department of Clinical Pharmacology 
Affiliation  Seth GS Medical College & KEM Hospital 
Address  Department of Clinical Pharmacology 1st Floor New MS Building Seth GS Medical College & KEM Hospital Acharya Donde Marg Parel Mumbai 400012 Maharashtra India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224136051  
Fax    
Email  nithyagogtay@kem.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Vistasp J Sethna 
Designation  Medical Director 
Affiliation  Serum Institute of India Pvt Ltd 
Address  Serum Institute of India Pvt Ltd 212 2 Hadapsar Off Soli Poonawalla Road Pune 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  02026602506  
Fax    
Email  vistasp.sethna@seruminstitute.com  
 
Details of Contact Person
Public Query  
Name  Dr Vistasp J Sethna 
Designation  Medical Director 
Affiliation  Serum Institute of India Pvt Ltd 
Address  Serum Institute of India Pvt Ltd 212 2 Hadapsar Off Soli Poonawalla Road Pune 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  02026602506  
Fax    
Email  vistasp.sethna@seruminstitute.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Serum Institute of India Pvt Ltd 
Address  Serum Institute of India Pvt. Ltd. 212/2, Hadapsar, Off Soli Poonawalla Road, Pune-411028. India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pradeep DCosta  KEM Hospital Research Centre  Department of Medicine, KEM Hospital Research Centre, TDH Building 3rd floor, Sardar Moodliar Road, Rasta Peth, Pune 411011, Maharashtra, India
Pune
MAHARASHTRA 		 02066037336

pradeepdcosta6@gmail.com 
Dr Madhu Gupta  Postgraduate Institute of Medical Education and Research  Clinical Pharmacology Unit under Department of Pharmacology, and Department of Community Medicine and School of Public Health, Postgraduate Institute of Medical Education and Research, Sector - 12, Chandigarh -160012, India
Chandigarh
CHANDIGARH 		 01722755901

madhugupta21@gmail.com 
Dr Nithya Gogtay  Seth GS Medical College & KEM Hospital  1st Floor, New MS Building Seth GS Medical College & KEM Hospital Parel, Mumbai - 400012 Maharashtra, India
Mumbai
MAHARASHTRA 		 02224136051

nithyagogtay@kem.edu 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee Post Graduate Institute of Medical Education and Research  Approved 
Institutional Ethics Committee-l Seth GS Medical College and KEM Hospital, Mumbai.  Submittted/Under Review 
KEM Hospital Research Centre Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Active immunization for prevention of invasive disease, and pneumonia caused by Streptococcus pneumoniae. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pneumococcal 20-valent (Prevenar 20) vaccine   0.5 mL IM, non-dominant upper arm, single administration 
Intervention  Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (21-Valent) – SIIPCV21  0.5 mL IM, non-dominant upper arm, single administration  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Both 
Details  1. Pneumococcal vaccine naive adult who is 18–49 years of age (both inclusive).
2. Healthy as judged by medical history, physical and other examination or investigations and in the clinical opinion of the Investigator may affect the safety of the participant or the trial endpoints.
3. Participant should be capable and willing to give voluntary written informed consent prior to inclusion in the trial.
4. Able to comprehend and comply with trial requirements and procedures and be able and willing to complete participant diary.
5. Male participants who are sexually active or married and female participants who are sexually active or married and are of childbearing potential should be willing to follow effective birth control methods for duration of the trial.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Safety and Tolerability following IM injection of SIILPCV21 vaccine versus Active Comparator for occurrence, severity, and relationship to vaccination of solicited, unsolicited Adverse Events, SAEs.  Solicited adverse events (local and systemic) during the 7 day follow-up period post vaccination.

Unsolicited adverse events up to 28-Day follow-up period post vaccination.

SAEs during the entire trial period. 
 
Secondary Outcome  
Outcome  TimePoints 
Functional antibodies will be measured by OPA & IgG conc. by ELISA will be evaluated for all serotypes contained in SIIPCV21.  Immunogenicity:

Serotype-specific OPA GMTs measured 28 days post vaccination

Percentage of participants with serotype-specific serum OPA titers greater than or equal to 1:8 measured 28 days post vaccination

Serotype-specific IgG GMCs measured 28 days post vaccination
 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   27/09/2025 
Date of Study Completion (India) 26/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 Phase 1 Safety, Tolerability and Immunogenicity trial in healthy Indian adults. The study is based on the objective that intramuscular administration of SIIPCV21 in healthy Indian participants will be safe, well tolerated and immunogenic. On successful completion, this early safety study will lead to later phase,  safety and immunogenicity trials in the target population, i.e. adult, children, and infants, aimed at licensure of SIIPCV21. 
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