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CTRI Number  CTRI/2022/11/047443 [Registered on: 18/11/2022] Trial Registered Prospectively
Last Modified On: 06/10/2023
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 Phase III Study to check the Safety and efficacy of the PCV 13 Vaccine in Healthy Infants in India in prevention of Pneumococcal disease caused by Streptococcus pneumonia. 
Scientific Title of Study   A Randomized, Double-Blind, Multi-center, Phase III Study to Assess and Compare the Immunogenicity and Safety of the 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-TT) with PREVENAR 13® of Pfizer Inc. in Healthy Infants in India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CRN_India/ 0106/2021, Version number: 2.0, Dated 01-03-2022  Protocol Number 
 
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
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-821, 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-821, Advant Navis Business Park, Plot #7, Noida-Greater Noida Expressway, Sector 142,


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  G C Chemie 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-821, 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
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chandramani Singh   All India Institute of Medical Sciences   Dept. of Community & Family Medicine, All India Institute of Medical Sciences, Phulwari sarif, Patna Bihar- 801507 Patna BIHAR
Patna
BIHAR 		 9695237796

cmaiims57@gmail.com 
Dr Anil K Pandey  ESIC Medical College & Hospital  ESIC Medical College & Hospital NH-3, NIT, Faridabad- 121001
Faridabad
HARYANA 		 0129-2985084

drpandeyak@yahoo.co.in 
Dr Abhishek T Chavan  Jeevan Rekha Hospital   Consultant Pediatrician, Dr. B.R. Ambedkar Road Opp Civil Hospital Belagavi (Belgaum), Karnataka - 590002 India
Belgaum
KARNATAKA 		 9113222185

dr.abhishektchavan@gmail.com 
Dr Raghu Raj Singh   New Leelamani Hospital Pvt Ltd   New Leelamani Hospital Pvt Ltd 14/116, C-1 Parade Chaurahu Civil Lines Kanpur 208001
Kanpur Nagar
UTTAR PRADESH 		 9555989176

drraghurajsingh156@gmail.com 
Dr Vijay Kumar Barge  Rajarshee Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital  Rajarshee Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital, Dasara Chowk, Bhausinghaji Road, Town Hall, Kohlapur- 416012
Kolhapur
MAHARASHTRA 		 7969792775

drvijaybarge12@gmail.com 
Dr Vishal Tripathi  Rana Hospital  Consultant Pediatrician, Rana Hospital Pvt. Ltd., Rail Vihar Medical College Road Chargawa Gorakhpur 273001
Gorakhpur
UTTAR PRADESH 		 8700304154

dr.vishaltripathicr@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Institute Ethics Committee All India Institute of Medical Sciences Patna  Approved 
Institutional Ethics Committee at Jeevan Rekha Hospital Belagavi  Approved 
Institutional Ethics Committee Leelamani Hospital  Approved 
Institutional Ethics Committee Rana Hospital, Gorakhpur  Approved 
Institutional Ethics Committee, ESIC Medical College & Hospital  Approved 
Institutional Ethics Committee, Rajarshee Chhatrapati Shahu Mahraj Govt. Medical College and Chhatrapati Pramila Raje General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy PCV-naïve Indian male and female infants between 6-8 weeks 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  PCV13-TT (13-valent Pneumococcal Polysaccharide Conjugate Vaccine) of Yuxi Walvax Biotechnology Co., Ltd. (Imported by G. C. Chemie Pharmie Ltd.)   Investigational PCV13-TT vaccine will be administered as 0.5 mL per dose by deep intramuscular injection in the anterolateral aspect of right thigh. The 1st vaccination will be on Day 0 at 6 to 8 weeks of age, 2nd vaccination at 10 to 12 weeks of age and 3rd vaccination at 14 to 16 weeks of age, with an interval of 4 weeks between each vaccination. The booster dose will be administered at 15-18 months of age.  
Comparator Agent  PREVENAR 13® [Pneumococcal Polysaccharide Conjugate Vaccine (13-valent, adsorbed; Diphtheria CRM197 Protein)] of Pfizer Inc.  PREVENAR 13 vaccine will be administered as 0.5 mL per dose by deep intramuscular injection in the anterolateral aspect of right thigh. The 1st vaccination will be on Day 0 at 6 to 8 weeks of age, 2nd vaccination at 10 to 12 weeks of age and 3rd vaccination at 14 to 16 weeks of age, with an interval of 4 weeks between each vaccination. The booster dose will be administered at 15-18 months of age.  
 
Inclusion Criteria  
Age From  42.00 Day(s)
Age To  56.00 Day(s)
Gender  Both 
Details  Prospective subjects will only be eligible for randomization if all of the following inclusion criteria, and none of the exclusion criteria, are met at the time of screening:
Inclusion Criteria for Primary Immunization Phase:
1. Healthy PCV-naïve subjects between 6-8 weeks of age (both inclusive) on the day of enrolment, whose 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 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).

Inclusion Criteria for Booster Immunization Phase:
1. Subjects with good health as determined by:
a)Medical history.
b)Physical examination.
c)Clinical judgment of the investigator.
2. Subjects who have completed primary immunization series of the investigational vaccine in the present study.
 
 
ExclusionCriteria 
Details  Exclusion Criteria for the first dose:
1. The 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 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. Subjects who have received any Pneumococcal vaccine prior to
enrolment.
7. Bleeding disorder, contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding screening.
8. History of infections with Human Immunodeficiency Virus (HIV), hepatitis B virus, or hepatitis C virus in the infant or mother.
9. Presence of evolving or changing neurological disorder.
10. Subjects with history of seizures.
11. Axillary temperature ≥ 40.0°C in past 3 days.
12. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 3 days.
13. Planned or elective surgery during the course of the study.
14. 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.
15. Subjects who have received any blood products, cytotoxic agents or radiotherapy.
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
1. Generalized allergic reaction in past 3 days .
2. Seizures.
3. Encephalopathy.
4. Axillary temperature of> 40.0°C in past 3 days. .
5. Inconsolable persisting crying (defined as > 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.

Exclusion Criteria for Booster immunization Phase:
1. Subjects who have participated in another trial after primary immunization.
2. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 3 days.
3. History of culture-proven invasive disease caused by S. pneumonia after primary immunization.
4. Subjects who have already received pneumococcal vaccine booster dose (other than investigational vaccine) from other resources (from different doctor/hospital).
5. Bleeding disorder, contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding booster dose.
6. History of infections with Human Immunodeficiency Virus (HIV),hepatitis B virus, or hepatitis C virus in the infant after primary immunization.
7. Presence of evolving or changing neurological disorder after primary immunization.
8. Axillary temperature ≥ 40.0°C in past 3 days.
9. Any history of elective surgery after primary immunization.
10. 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 booster vaccination (including systemic corticosteroids) or those who have received a parenteral immunoglobulin preparation.
11. Subjects who have received any blood products, cytotoxic agents or radiotherapy.
12. Subjects with history of anaphylaxis, seizures or any serious vaccine reaction, or allergy to any vaccine component.
13. Infant 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.

Note that specific exclusion criteria (e.g., abnormal vital sign, acute illness) will be reassessed at all vaccination visits. Any subject who cannot be vaccinated due to an acute abnormality assessed at the 2nd or 3rd vaccination or booster vaccination visit may return once the acute issue has resolved. A minimum of 48 hours must have passed after a documented fever before a subject can be vaccinated. This safety requirement will not be deemed a protocol deviation should the visit fall outside the vaccination window; however, it will be encouraged to maintain the vaccination window whenever possible in these situations.

 
 
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 
Immunogenicity
IgG responses 4 weeks after the 3rd dose of PCV13-TT or PREVENAR 13®
• Percentage of subjects achieving serotype-specific pneumococcal
immunoglobulin G (IgG) concentrations ≥ 0.35 μg/mL
 		 Immunogenicity
IgG responses 4 weeks after the 3rd dose of PCV13-TT or PREVENAR 13®
• Percentage of subjects achieving serotype-specific pneumococcal
immunoglobulin G (IgG) concentrations ≥ 0.35 μg/mL
 
 
Secondary Outcome  
Outcome  TimePoints 
Immunogenicity and Immune persistence
IgG responses 4 weeks after booster dose of PCV13-TT or PREVENAR 13®
• Percentage of subjects achieving serotype-specific pneumococcal immunoglobulin G (IgG) concentrations ≥ 0.35 μg/mL
• Serotype-specific IgG GMCs.
• Antibodies measured 28 days after primary series and before booster dose (approximately 12 months post primary series) to determine antibody persistence after primary immunization.

OPA responses in 25% subjects (randomly selected) after the three-dose primary series & booster dose of PCV13-TT or PREVENAR 13®
• Percentage of subjects with serotype-specific serum OPA titers ≥ 1:8 (LLOQ)
• Serotype-specific serum OPA GMTs along with their ratios.

 		 IgG responses 4 weeks after booster dose of PCV13-TT or PREVENAR 13® 
 
Target Sample Size   Total Sample Size="344"
Sample Size from India="344" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="344" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   21/11/2022 
Date of Study Completion (India) 17/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Streptococcus pneumonia (S. pneumoniae), also known as pneumococcus, is the leading cause of Invasive Pneumococcal Disease (IPD). Of the estimated 8.8 million global annual deaths amongst children < 5 years of age in 2008, WHO estimated that 476,000 (333,000 to 529,000) were caused by pneumococcal infections.  Pneumococcus is a frequent inhabitant of upper respiratory tract, infants and young children are thought to be the main reservoir of this agent with cross sectional point prevalence range of 27%-85%. Pneumococcus spreads by respiratory droplet and causes pneumonia usually of the lobar type, otitis media, paranasal sinusitis, meningitis (usually secondary to former infections), septicaemia, in addition to IPD. Extreme age groups < 2 years and > 65 years have the highest IPD incidence. The incidence of acute otitis media (AOM) peaks at 6-12 months of age, and declines after 5 years of age. The 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-TT) manufactured by Yuxi Walvax Biotechnology Co., Ltd. is formulated by compounding the capsular polysaccharide antigen of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, individually conjugated to tetanus toxoid carrier protein. The investigational vaccine was approved for used in infants and children aged 6 months through 5 years (before the 6th birthday) and the Certificate of Drug Registration (Approval No. 2019S00755) was issued by the National Medical Products Administration (NMPA) in December 2019. The vaccine elicits immune responses in recipients following immunization, and is indicated for the prevention of invasive diseases caused by 13 serotypes of Streptococcus pneumoniae. The current study aims to develop a safe and effective 13-valent pneumococcal conjugate vaccine to reduce the global disease burden. 
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