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CTRI Number  CTRI/2022/10/046401 [Registered on: 12/10/2022] Trial Registered Prospectively
Last Modified On: 03/01/2023
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 clinical trial to know about effects of 15-valent pneumococcal conjugate vaccine in healthy infants given in a Reduced Dosing Schedule with Routine Pediatric Vaccinations. 
Scientific Title of Study   A Phase 3, Observer blind, Randomized, Active-Controlled Trial Evaluating the Immunologic Non-inferiority, Safety and Tolerability of a 15-valent Pneumococcal Conjugate Vaccine Compared to a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given in a Reduced Dosing Schedule with Routine Pediatric Vaccinations. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
CBCC/2021/029 Version 2.0 dated 30/Jun/2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research LLP 
Address  CBCC Global Research LLP India Address: Second Floor, Skoda House, Opposite L J Campus S G Highway, Sarkhej, Ahmedabad, GUJARAT – 382210, India

Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax    
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arpitkumar Prajapati 
Designation  Assistant General Manager, Clinical Sciences  
Affiliation  CuraTeQ Biologics Private Ltd (subsidiary of Aurobindo Pharma Limited).  
Address  Clinical Development Sy No. 77 & 78|Indrakaran (V) | Kandi (M) Sangareddy, District Hyderabad – 502320 India.

Hyderabad
TELANGANA
502320
India 
Phone  8455255222   
Fax    
Email  Arpitkumar.Prajapati@curateqbio.com  
 
Details of Contact Person
Public Query  
Name  Dr M Kuppusamy 
Designation  Managing Director  
Affiliation  Tergene Biotech Pvt. Ltd. 
Address  Suite 121 & 122, Building 450, Genome Valley, Turkapally Village, Shamirpet Mandal, Rangareddy District, Hyderabad, Telangana – 500078, India

Hyderabad
TELANGANA
500078
India 
Phone  9987648486  
Fax    
Email  mks@tergene.com  
 
Source of Monetary or Material Support  
Tergene Biotech Pvt. Ltd. (A Subsidiary of Aurobindo Pharma Ltd) Suite 121 & 122, Building 450 Genome Valley, Turkapally (V), Shamirpet (M) RR Dist, Hyderabad 500078, India  
 
Primary Sponsor  
Name  Tergene Biotech Pvt Ltd  
Address  A Subsidiary of Aurobindo Pharma Ltd) Suite 121 & 122, Building 450 Genome Valley, Turkapally (V), Shamirpet (M) RR Dist, Hyderabad 500078, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NA  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pradeep N  Cheluvamba Hospital  Department of Paediatrics, Mysore, Karnataka, India.
Mysore
KARNATAKA 		 9611898080

drpradeepn80@gmail.com 
Dr Mahantesh Patil  KLEs Dr. Prabhakar Kore Hospital and MRC  NH Service Road, Basava Circle, Chikodi, Nehru Nagar, Belgavi - 590010, Karnataka, India
Belgaum
KARNATAKA 		 9483561674

patilmv1@gmail.com 
Dr N Ravi Kumar  Niloufer Hospital  Red hills, Lakdikapul, Hyderabad – 500004, Telangana, India.
Hyderabad
TELANGANA 		 9490919293

ravik1961@yahoo.com 
Dr Reena Rathi  Suyog Hospital  2nd Floor, Krushi Utpanna Bazar, Samiti Sankul, Dindori Road, Panchavati, Nashik - 422003, Maharashtra, India.
Nashik
MAHARASHTRA 		 9420590111

drreenarathi@yahoo.in 
Dr Deepali Ambike  Yashwantrao Chavan Memorial Hospital  Sant Tukaram Nagar, Pimpri, Pune-411018, Maharashtra, India.
Pune
MAHARASHTRA 		 9373002072

ambikedeepa@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
IEC-MMC and RI and Associated Hospital  Submittted/Under Review 
Institutional Ethics Committee Osmania Medical College  Submittted/Under Review 
Institutional Ethics Committee, KLE University  Approved 
Institutional Ethics Committee, Yashwantrao Chavan Memorial Hospital  Approved 
Suyog Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Infants/ Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  13-Valent Pneumococcal conjugate vaccine (Prevnar 13®)   Dosage: 0.5 ml (A single dose), Frequency: Given as two primary doses at 6 & 14 weeks of age followed by a booster dose at 9 months of age, Route of Administration: Intramuscular route , Duration of Therapy: 10 Months  
Intervention  15-Valent Pneumococcal conjugate vaccine   Dosage: 0.5 ml (A single dose ), Frequency: Given as two primary doses at 6 & 14 weeks of age followed by a booster dose at 9 months of age, Route of Administration: Intramuscular route, Duration of Therapy: 10 Months  
 
Inclusion Criteria
Modification(s)  
Age From  42.00 Day(s)
Age To  69.00 Day(s)
Gender  Both 
Details  Subjects will be considered eligible for the study based on the following criteria:

1. Able to follow all the study requirements and voluntarily obtained informed consent from Parent/legal guardian/ LAR of the infant
2. Infant aged 6-10 weeks (42-69 days) at enrollment
3. Healthy infant as determined by medical history, physical exam, and judgment of the investigator
4. Parent/ legal guardian/ LAR must be able to complete all relevant study procedures during study participation
 
 
ExclusionCriteria 
Details  Subjects will be excluded from the study based on the following criteria:

1. Subject with administration history of pneumococcal vaccine
2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis or rotavirus vaccines
3. Known hypersensitivity or anaphylactic reaction to any vaccine or vaccine-related component
4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, rotavirus or pneumococcal vaccines
5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection
6. Known or suspected immune deficiency or suppression
7. Receipt of blood or gamma-globulin products (including hepatitis B immunoglobulin and monoclonal antibodies). Local anesthetic cream may be applied before blood draws.
8. History of cytotoxic therapy, inhaled corticosteroids (not including allergic rhinitis corticosteroid spray treatment, acute uncomplicated dermatitis surfaces corticosteroid therapy). Topical and inhaled corticosteroids may be permitted as per PI’s discretion.
9. History of culture-proven invasive disease caused by S. pneumoniae or H. influenzae type b (Hib)
10. Any congenital malformation, developmental disorder, genetic defects or severe malnutrition
11. Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb’s palsy.
12. Participation in another investigational trial. Participation in purely observational studies is acceptable.
13. Any co-existing condition which in the opinion of investigator may interfere with the study participation
14. Direct descendant (i.e. child, grandchild) of study site personnel
15. Infants with known Coronavirus infection (COVID-19)

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage of subjects achieving WHO-predefined serotype-specific antibody threshold (Greater than or equal to 0.35 microgram per ml).
serotype-specific IgG GMC ratio

 		 28 days after completion of 2nd Dose
 
 
Secondary Outcome  
Outcome  TimePoints 
Ratio of the post-booster value to the post-primary value for the IgG GMCs,
Serotype-specific Reverse Cumulative Distribution (RCD) plots for IgG.
Safety Endpoints: Percentage of subjects reporting pre-specified local reactions.
Percentage of subjects reporting pre-specified systemic events

 		 28 days after completion of 2nd Dose & 28 days after booster dose.
Safety Time points Th the study roughout 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   17/10/2022 
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="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NONE 
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 3, Observer blind, Randomized, Active-Controlled Trial Evaluating the Immunologic Non-inferiority, Safety and Tolerability of a 15-valent Pneumococcal Conjugate Vaccine Compared to a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given in a Reduced Dosing Schedule with Routine Pediatric Vaccinations.

 
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