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CTRI Number  CTRI/2021/09/036860 [Registered on: 27/09/2021] Trial Registered Prospectively
Last Modified On: 20/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical trial to demonstrate the immunogenicity of 23-Valent Pneumococcal Polysaccharide Vaccine (PPSV23) in healthy adults  
Scientific Title of Study   A Randomized, Double-blinded, Multicenter Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Adults 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chandramani Singh 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  All India Institute of Medical Sciences, Dept. of Community & Family Medicine, Patna Bihar- 801507

Patna
BIHAR
801507
India 
Phone  0612-2451105  
Fax    
Email  cmaiims57@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nidhi Singh 
Designation  Head Clinical operations 
Affiliation  Clinical Research Network India  
Address  B-812, Advant Navis Business Park, Plot #7, Noida-Greater Noida Expressway, Sector 142,
B-812, Advant Navis Business Park, Plot #7, Noida-Greater Noida Expressway, Sector 142,
Gautam Buddha Nagar
UTTAR PRADESH
201305
India 
Phone  9695237796  
Fax    
Email  nidhisingh@crnindia.org  
 
Details of Contact Person
Public Query  
Name  Dr Nidhi Singh 
Designation  Head Clinical operations 
Affiliation  Clinical Research Network India  
Address  B-812, Advant Navis Business Park, Plot #7, Noida-Greater Noida Expressway, Sector 142,
B-812, Advant Navis Business Park, Plot #7, Noida-Greater Noida Expressway, Sector 142,
Gautam Buddha Nagar
UTTAR PRADESH
201305
India 
Phone  9695237796  
Fax    
Email  nidhisingh@crnindia.org  
 
Source of Monetary or Material Support  
G C Chemie Pharmie Ltd 
 
Primary Sponsor  
Name  GCChemie Pharmie Ltd 
Address  5/C, Shree Laxmi Indl. Estte, New Link Road, Andheri (West), Mumbai – 400053, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Clinical Research Network India CRO  B-812, Advant Navis Business Park, Plot #7, Noida-Greater Noida Expressway, Sector 142, Noida, Delhi-NCR, Uttar Pradesh 201305  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chintan B Patel   Aatman Hospital   Aatman Hospital, 5, Anveshan row house, Bopal Gam BRTS, Bopal- Ghuma Road, Bopal, Ahmedabad:- 380058 Gujarat, India
Ahmadabad
GUJARAT 		 9825182251

cr.aatman@gmail.com 
Dr Chandramani Singh   All India Institute of Medical Sciences Patna  All India Institute of Medical Sciences, Dept. of Community & Family Medicine, Phulwari sarif, Patna Bihar- 801507
Patna
BIHAR 		 9695237796

cmaiims57@gmail.com 
Dr Amit S Bhate  Jeevan Rekha Hospital   Jeevan Rekha Hospital, Dr. B R Ambedkar Road, Belagavi, Karnataka- 590010
Belgaum
KARNATAKA 		 9155661151

dr.amitsureshbhate@gmail.com 
Dr N Ravi Kumar  Niloufer Hospital  Dept. of Pediatrics, Niloufer Hospital,Affiliated to Osmania Medical College, Red Hills, Lakdikapool, Hyderabad-500004
Hyderabad
TELANGANA 		 7893561444

ravik1961@yahoo.com 
Dr Jitendra Singh Kushwaha  Prakhar Hospital   Prakhar Hospital Pvt Ltd, 8/219 Arya Nagar, Kanpur, Uttar Pradesh-208002
Kanpur Nagar
UTTAR PRADESH 		 7880668537

dr.jskushwahacr@gmail.com 
Dr Ajeet Pratap Singh  Rana Hospital  Rana Hospital Pvt. Ltd., Rail Vihar Medical College Road Chargawa Gorakhpur- 273001
Gorakhpur
UTTAR PRADESH 		 8287679687

ajeetpsingh1177@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee Prakhar Hospital Kanpur  Approved 
Institute Ethics Committee All India Institute of Medical Sciences Patna  Approved 
Institute Ethics Committee Osmania Medical college Hyderabad  Approved 
Institutional Ethics Committee Aatman Hospital  Approved 
Institutional Ethics Committee at Jeevan Rekha Hospital Belagavi  Approved 
Institutional Ethics Committee Rana Hospital, Gorakhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Prevention of pneumococcal disease 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  PNEUMOVAX® 23  23-Valent Pneumococcal Vaccine, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc. A single dose (0.5 mL) of PNEUMOVAX® 23 vaccine will be administered to the subject on Day 0 by an intramuscular injection into the deltoid muscle of the lateral upper arm 
Intervention  PPSV23  23-valent Pneumococcal polysaccharide vaccine, PPSV23 (Yuxi Walvax Biotechnology Co. Ltd.) A single dose (0.5 mL) of PPSV23 vaccine will be administered to the subject on Day 0 by an intramuscular injection into the deltoid muscle of the lateral upper arm 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects aged between 18 to 65 years;

Subjects willing to give written informed consent prior to the study entry;

Subjects with good health as determined by:
Medical history;
Physical examination;
Clinical judgment of the investigator.

Subjects able to attend all scheduled visits and comply with all study procedures.  
 
ExclusionCriteria 
Details  Subjects administered with any pneumococcal vaccine before vaccination;

Subjects with history of pneumococcal infection;
Women in pregnancy or lactation period in trial period;

Subjects with allergic history or any SAE after vaccination,such as allergy, urticaria, dyspnoea, angioedema

Subjects with known or suspected immune dysfunction, including persons with congenital immunodeficiency or persons with HIV positive;

Subjects with functional or anatomic asplenia;

Patients treated with chemotherapy in past 5 years or administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in 6 months preceding the vaccine trial;

Subjects with receipt of blood or blood-derived products in 3 months preceding vaccination;

Subjects participating in another clinical study investigating a vaccine or drug in 30 days preceding vaccination;

Subjects with receipt of any live virus vaccine in 30 days preceding vaccination;

Subjects with receipt of any subunit vaccine and inactivated vaccine in the 14 days before vaccination;

Subjects with thrombocytopenia or bleeding disorder;

Subjects with history of asthma, angioneurotic edema, diabetes mellitus or malignancy tumour;

Subjects with history of thyroid gland excision or treatment for thyroid gland disease in last 12 months.

Subjects with hypertension or whose blood pressure is still above 145/95mmHg even with drug treatment;

Subjects with history of eclampsia, epilepsia or psychosis;

Subjects with febrile illness (temperature ≥ 38°C) in 3 days or any acute illness/infection in 7 days preceding vaccination;

Subjects with anti-tuberculosis prophylaxis or therapy in progress;

Those who cannot fulfil the protocol or cannot sign the informed consent form for any medical, psychological, social, occupational and other reasons, according to investigator judgment 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage of subjects exhibiting a ≥ 2-fold increase in antipneumococcal IgG antibody level for all included 23 serotypes after vaccination in each group.

Geometric mean fold increase (GMFI) and geometric mean concentration/titer (GMCs/GMTs) of IgG after vaccination in each group.  		 Antibody response at Day 28 post-vaccination 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of systemic and local adverse reactions in healthy subjects after vaccination (up to 30 minutes) and in 7
subsequent days  		 Day 0-7 post-vaccination 
Incidence of unsolicited adverse events  Day 28 post-vaccination 
Incidence of SAE during the entire study period  During the entire study period 
 
Target Sample Size   Total Sample Size="268"
Sample Size from India="268" 
Final Enrollment numbers achieved (Total)= "268"
Final Enrollment numbers achieved (India)="268" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   04/10/2021 
Date of Study Completion (India) 02/03/2022 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Pneumococcal infection is a leading cause of death throughout the world and a major cause of pneumonia, bacteremia, meningitis, and otitis media. It has been established that purified pneumococcal capsular polysaccharides induce antibody production and such antibody is effective in preventing pneumococcal disease. Clinical studies have demonstrated the immunogenicity of each of the 23 capsular serotypes when tested in polyvalent vaccines. Studies of 23-valent pneumococcal vaccine in children aged two years and above as well as adults of all ages have showed immunogenic response. In order to provide more evidence for the immunogenicity and the safety of the vaccine on Indian population, a phase III clinical trial is planned for for 23-Valent Pneumococcal Polysaccharide Vaccine manufactured by Yuxi Walvax Biotechnology Co., Ltd 
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