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CTRI Number  CTRI/2024/10/074656 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 06/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To evaluate the efficacy and safety of Pneumococcal vaccine in Healthy Indian Subjects. 
Scientific Title of Study   A Prospective, Randomized, Double-Blind, Multi-Center, Phase III Study To Assess And Compare The Immunogenicity And Safety Of The 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine In Healthy Indian Subjects. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CRNI/CTP/018; Version number 2.0, dated 04 Nov 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr. Virendra Nath Tripathi 
Designation  Senior Consultant Pediatrician 
Affiliation   
Address  New Leelamani Hospital near 14/116 C-1 parade chauraha Civil Lines Kanpur Uttar Pradesh 208001

Kanpur Nagar
UTTAR PRADESH
208001
India 
Phone  09415050777  
Fax    
Email  dr.vntripathicr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nidhi Singh 
Designation  Head Clinical Research  
Affiliation  Clinical Research Network India 
Address  B-806, 807, Advant Navis Business Park, Plot 7, Noida-Greater Noida Expressway, Sector 142, Noida, Delhi-NCR

Gautam Buddha Nagar
UTTAR PRADESH
201305
India 
Phone  09695237796  
Fax    
Email  nidhisingh@crnindia.org  
 
Details of Contact Person
Public Query  
Name  Dr Nidhi Singh 
Designation  Head Clinical Research  
Affiliation  Clinical Research Network India 
Address  B-806, 807, Advant Navis Business Park, Plot 7, Noida-Greater Noida Expressway, Sector 142, Noida, Delhi-NCR

Gautam Buddha Nagar
UTTAR PRADESH
201305
India 
Phone  09695237796  
Fax    
Email  nidhisingh@crnindia.org  
 
Source of Monetary or Material Support  
Novo Medi Sciences Pvt Ltd. Royal Status Building, Pandit Wamanrao Sadolikar Marg, Lokmanya Tilak Colony, Dadar, Mumbai, Maharashtra- 400014  
 
Primary Sponsor  
Name  Novo Medi Sciences Pvt Ltd. 
Address  Royal Status Building, Pandit Wamanrao Sadolikar Marg, Lokmanya Tilak Colony, Dadar, Mumbai, Maharashtra- 400014 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anand Mohan Dixit   All India Institute of Medical Science  All India Institute of Medical Science, Gorakhpur Opp Army Public School Kunraghat Gorakhpur Uttar Pradesh 273008 India
Gorakhpur
UTTAR PRADESH 		 09917750046

dnana2791@gmail.com 
Dr Sanjay Pandey  All India Institute of Medical Sciences,  Dept. of Community Medicine, All India Institute of Medical Sciences, Patna Bihar- 801507
Patna
BIHAR 		 7783892746

drsanjaypanday72@gmail.com 
Dr Shailesh Patil  Belagavi Institute of Medical Sciences  Department of Pediatrics Belagavi Institute of Medical Sciences Dr B R Ambedkar Road Belagavi 590001 Karnataka India
Belgaum
KARNATAKA 		 9480454944

shaileshpt@yahoo.com 
Dr Srikanth Tripathy  Dr. D.Y. Patil Medical College, Hospital & Research Centre  Director office, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA 		 9500779797

director.medicalresearch@dpu.edu.in 
Dr Manish Narang   Guru Teg Bahadur Hospital  Guru Teg Bahadur Hospital Dilshad Garden Delhi East Delhi 110095
North East
DELHI 		 09811036569

manish_2710@yahoo.com 
Dr Virendra Nath Tripathi  New Leelamani Hospital  New Leelamani Hospital near 14/116 C-1 parade chauraha Civil Lines Kanpur Uttar Pradesh 208001
Kanpur Nagar
UTTAR PRADESH 		 09415050777

dr.vntripathicr@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee. Dr. D. Y. Patil Vidyapeeth  Approved 
Guru Teg Bahadur Hospital Ethics Committee  Approved 
Institutional Ethic Committee   Approved 
Institutional Ethic Committee   Approved 
Institutional Ethics Committee Leelamani Hospital  Approved 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  PCV-13 (TT/DT)- 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (TT/DT) (1,3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) developed by Beijing Minhai Biotechnology Co., Ltd  For Cohort 1 & 2: All subjects will receive a single dose (0.5 mL) of Investigational vaccine intramuscularly into the deltoid muscle of the nondominant arm For Cohort 3: All subjects will be administered 3 dose series of Investigational Vaccine as 0.5 mL per dose by deep intramuscular injection in the anterolateral aspect of right thigh, with an interval of 4 weeks between each vaccination. 
Comparator Agent  PREVENAR 13® [Pneumococcal Polysaccharide Conjugate Vaccine (13- valent, adsorbed; Diphtheria CRM197 Protein)] of Pfizer Inc.  For Cohort 1 & 2: All subjects will receive a single dose (0.5 mL) of comparator vaccine intramuscularly into the deltoid muscle of the nondominant arm. For Cohort 3: All subjects will be administered 3 dose series of comparator Vaccine as 0.5 mL per dose by deep intramuscular injection in the anterolateral aspect of right thigh, with an interval of 4 weeks between each vaccination. 
 
Inclusion Criteria  
Age From  42.00 Day(s)
Age To  65.00 Year(s)
Gender  Both 
Details  For Cohort 1 & 2
1. Healthy subjects aged 6 – 65 years (both inclusive) on the day of enrolment & subjects/ parents/ LARs are willing to participate and give written informed consent prior to the study entry.
2. Children & adolescents who have history of primary immunization with Pneumococcal vaccine or Adult who are pneumococcal vaccine naïve.
3. Subjects with good health as determined by:
a) Medical history.
b) Physical examination.
c) Clinical judgment of the investigator
4. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is
sexually active.
5. Negative urine pregnancy test for all female subjects who are of childbearing potential.

For Cohort 3
1. Healthy subjects aged 6 - 8 weeks (both inclusive) on the day of enrolment & parents/LARs are willing to participate and give written informed consent prior to the study entry.
2. Subjects with good health as determined by:
a) Medical history
b) Physical examination
c) Clinical judgment of the investigator
3. Subject’s parents/LARs must be able to comprehend and comply with study requirements and procedures, and willing to complete subject diary and to return with the subject for all scheduled follow up visits.
4. Subjects must have been born full-term, at randomization.
5. Weight of the infant at enrolment visit ≥ 3.2 kg.
6. Subjects who have not received any Pneumococcal vaccine prior to enrolment.
7. Subjects with an up-to-date minimal vaccination status (includes, BCG vaccine, first dose of OPV, IPV and first dose of vaccine against Hep B, DPT and Hib that could be administered as pentavalent vaccine) at the time of enrolment as per UIP schedule (per local/regional protocols) 
 
ExclusionCriteria 
Details  Exclusion Criteria for the first dose (for all cohorts):
1. The subjects/parents or LARs are unwilling or unable to give written informed consent to participate in the study.
2. Subjects who have participated in another trial of an investigational agent within 30 days prior to enrolment.
3. Planned participation in another clinical trial during the present trial period.
4. Subjects who/whose families are planning to leave the area of the study site before the end of the study period.
5. History of culture-proven invasive disease caused by S. pneumoniae.
6. Bleeding disorder, contraindicating IM vaccination, or receipt of
anticoagulants in the 3 weeks preceding screening.
7. History of infections with HIV, HBV, or HCV in the infant or mother.
8. Presence of evolving or changing neurological disorder.
9. Subjects with history of seizures.
10. Axillary temperature ≥40.0°C in past 3 days.
11. Any evidence of acute illness or infection requiring systemic
antibiotic therapy within past 3 days
12. Planned or elective surgery during the course of the study.
13. Subjects with a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or having received immunosuppressive therapy within 1 month prior to study entry (including systemic corticosteroids) or those who have received a parenteral immunoglobulin preparation.
14. Subjects who have received any blood products, cytotoxic agents or radiotherapy.
15. Vaccination with any licensed or investigational pneumococcal vaccine within the last year
16. Subjects with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component. This includes such reactions in older siblings and also includes all components of the UIP vaccines.
17. Subjects with any serious chronic disease or with any condition that in the opinion of the investigator might interfere with the
evaluation of the study objectives or compromise the safety of the subject.

Exclusion Criteria for the Second / Third Dose (For cohort 3 only)
1. Generalized allergic reaction in past 3 days
2. Seizures
3. Encephalopathy
4. Axillary temperature ≥40.0°C in past 3 days
5. Inconsolable persisting crying (more than 3 hours in past 3 days)
6. Generalized cyanosis within past 3 days
7. Any serious reaction after previous dose which can compromise the safety of the subject if continued in the trial. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Cohort 1 & 2
Serotype-specific IgG GMCs alone & in comparison to PREVENAR 13® 4 weeks after single dose.
GMFRs in serotype-specific IgG alone & in comparison to PREVENAR 13® from before vaccination to 4 weeks after single dose.
Percentage of subjects achieving serotype-specific pneumococcal IgG concentrations ≥ 0.35 μg/mL alone & in comparison to PREVENAR 13® from before vaccination to 4 weeks after single dose.



 		 Cohort 1 & 2
4 weeks after single dose.

Cohort 3:
4 weeks after the 3rd dose  
 
Secondary Outcome  
Outcome  TimePoints 
Immunogenicity Endpoints
For Infants (Cohort 3)

OPA responses: alone and in comparison, to Prevenar 13®

Percentage of subjects with OPA titer ≥ 1:8 measured 4 weeks post 3rd dose of study vaccine.

OPA geometric mean titer (GMT) measured 4 weeks post 3rd dose of study vaccine.


Safety Endpoints
For Infants (Cohort 3)
Incidences of solicited local and systemic events collected at 30 minutes and through Day 0 to Day 7 after each vaccination.
Incidences of unsolicited AEs through 28 days post primary series.
Incidences of SAEs during the entire study period.

For children, adolescents & adults (Cohort 1 & 2)
Incidences of solicited local and systemic events collected at 30 minutes and through Day 0 to Day 7 after vaccination.
Incidences of unsolicited AEs through 28 days post vaccination.
Incidences of SAEs during the entire study period.
 		 4 weeks post 3rd dose of study vaccine

Safety throughout the study 
 
Target Sample Size   Total Sample Size="950"
Sample Size from India="950" 
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 3 
Date of First Enrollment (India)   14/10/2024 
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)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Pneumococcal disease remains a burden with a large unmet medical need in all age groups with changes in pneumococcal serotype prevalence observed globally, in part driven by antibiotic resistance. The prevention of risk factors assumes vital importance. The measures consist of reducing childhood wasting, lessening indoor and ambient air pollution, infection control practices and attempts at mitigating the susceptibility to pneumococcal diseases by vaccination. Vaccination against pneumococcal disease is a crucial preventive strategy and should be regarded as the key focus.

This study will be conducted in following phases:
For Cohort 1 & 2: After obtaining consent/assent, subjects will be screened, enrolled and randomized to one of the two study arms (A and B).  Post study/visit specific evaluations, subjects will receive 1 dose of investigational vaccine, test vaccine (13-valent Pneumococcal Polysaccharide Conjugate Vaccine TT/DT) (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) developed by Beijing Minhai Biotechnology Co., Ltd or PREVENAR 13®, Pfizer Inc at Visit 1. The subjects’ condition will be followed up for 7 days post vaccination after dose to account for any AEs.
Follow-up phase: This phase will comprise of on-site follow-ups of the subjects 28 days after the vaccination (Visit 2). 

For Cohort 3:
Primary immunization phase of the study (3+0): Subjects 6-8 weeks of age will be screened, enrolled and randomized to one of the two study arms (A and B), upon receipt of written informed consent from Parents/LARs. Subjects will receive 1 dose of investigational vaccine, test vaccine (13-valent Pneumococcal Polysaccharide Conjugate Vaccine TT/DT) (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) developed by Beijing Minhai Biotechnology Co., Ltd or PREVENAR 13®, Pfizer Inc at Visit 1 (6-8 weeks), Visit 2 (10-12 weeks) and Visit 3 (14-16 weeks), respectively (3 doses in total) with an interval of 4 weeks and a window period of +1 week. The subjects’ condition will be followed up for 7 days post vaccination after each dose (i.e., after Visit 1, 2 and 3) to account for any AEs
Follow-up phase: This phase will comprise of on-site follow-ups of the subjects 28 days after the 3rd dose (Visit 4).
 
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