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CTRI Number  CTRI/2024/12/077626 [Registered on: 04/12/2024] Trial Registered Prospectively
Last Modified On: 27/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Phase IV study to assess the effect of reduced two dose schedule (1+1) of Pneumococcal Conjugate Vaccines. 
Scientific Title of Study   A Phase IV, Open labelled, Randomized, Controlled Study to Assess the Immunogenicity and Effect on Pneumococcal Nasopharyngeal Carriage of reduced two dose schedule (1+1) of Pneumococcal Conjugate Vaccines 10-valent PNEUMOSIL and 14 valent PNEUBEVAX-14 as compared to their recommended three dose schedule (2+1) in Healthy Indian Infants. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
KEMHRC/PCV/05 Version 1.0 dated 18 May 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashish Bavdekar 
Designation  Director, Pediatric Department 
Affiliation  KEM Hospital Research Centre 
Address  KEM Hospital Research Centre TDH Building, III Floor, Department of Pediatrics Rasta Peth, Pune, Maharashtra, India

Pune
MAHARASHTRA
411012
India 
Phone  02066037342  
Fax    
Email  a.bavdekar@kemhrcpune.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashish Bavdekar 
Designation  Director, Pediatric Department 
Affiliation  KEM Hospital Research Centre 
Address  KEM Hospital Research Centre TDH Building, III Floor, Department of Pediatrics Rasta Peth, Pune, Maharashtra, India

Pune
MAHARASHTRA
411012
India 
Phone  02066037342  
Fax    
Email  a.bavdekar@kemhrcpune.org  
 
Details of Contact Person
Public Query  
Name  Dr Ashish Bavdekar 
Designation  Director, Pediatric Department 
Affiliation  KEM Hospital Research Centre 
Address  KEM Hospital Research Centre TDH Building, III Floor, Department of Pediatrics, Rasta Peth, Pune, Maharashtra, India

Pune
MAHARASHTRA
411012
India 
Phone  02066037342  
Fax    
Email  a.bavdekar@kemhrcpune.org  
 
Source of Monetary or Material Support  
Bill & Melinda Gates Foundation, P. O. Box 23350, Seattle, Washington 98102, USA 
 
Primary Sponsor  
Name  KEM Hospital Research Centre 
Address  KEM Hospital Research Centre TDH Building, III Floor, Rasta Peth, Pune 411011, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashish Bavdekar  KEM Hospital Research Centre-Vadu Rural Health Program  KEM Hospital Research Centre-Vadu Rural Health Program, P.O. Vadu Budruk, Taluka Shirur, District Pune, 412216, India
Pune
MAHARASHTRA 		 9822056174

a.bavdekar@kemhrcpune.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KEM Hospital Research Centre Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  For active immunization against invasive disease & pneumonia caused by Streptococcus pneumoniae serotypes present in the vaccines. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Reduced two dose schedules (1+1) of PCV-10 (PNEUMOSIL) and PCV-14 (PNEUBEVAX-14)  The reduced two dose schedule (1+1) of PNEUMOSIL® and PNEUBEVAX-14® (14 weeks and 9 months) will be administered in healthy Indian infants  
Comparator Agent  WHO recommended 2+1 schedules of PCV-10 (PNEUMOSIL) and PCV-14 (PNEUBEVAX-14)  WHO recommended 2+1 schedules of PNEUMOSIL and PNEUBEVAX-14 will be administered at 6 weeks, 14 weeks, and 9 months in healthy Indian infants. 
 
Inclusion Criteria  
Age From  42.00 Day(s)
Age To  56.00 Day(s)
Gender  Both 
Details  Healthy infants as established by medical history and clinical examination
6-8 weeks (42-56 days) of age at the time of enrolment.
Written informed consent obtained from the parent(s) of infants
Parent who intends to remain in the study area with the child during the study period and will be ready to comply with the protocol. 
 
ExclusionCriteria 
Details  Presence of fever on the day of enrolment (≥38.0oC) (temporary exclusion)
Any acute illness at the time of enrolment (temporary exclusion)
Concurrent participation in another clinical trial during study period.
Weight-for-height z-score ≤-3SD
Presence of significant systemic disorder as determined by medical history and/or physical examination
Prior receipt of any pneumococcal vaccine
Known sensitivity or allergy to any components of the study vaccine
Major congenital or genetic defect
Receipt of any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
History of chronic administration (defined as more than 14 days) of immune-suppressants including corticosteroids.
Any medical or social condition that in the opinion of the PI may interfere with the protocol adherence or pose a risk to the participant. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the immunogenicity response with reduced two dose schedule (1+1) of PNEUMOSIL and PNEUBEVAX-14® as compared to their recommended three dose schedule (2 + 1) at 10 months of age (four weeks after the booster dose) in healthy Indian infants.  10 months of age 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the functional serotype specific antibody response as measured by opsonophagocytic assay (OPA) with reduced two dose schedule (1+1) of PNEUMOSIL® and PNEUBEVAX-14® as compared to their regular three dose (2+1) at 10 months of age (4 weeks after the booster dose) in healthy Indian infants.  At 10 months of age 
To assess the impact of reduced two dose schedule (1+1) of PNEUMOSIL® and PNEUBEVAX-14® on nasopharyngeal carriage of vaccine serotypes (VTs) of S. pneumoniae at 15 months of age (6 months after receipt of the booster dose) as compared to their recommended three dose schedule (2+1) in healthy Indian infants.  At 15 months of age 
 
Target Sample Size   Total Sample Size="1400"
Sample Size from India="1400" 
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 4 
Date of First Enrollment (India)   01/01/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Globally, Pneumococcal Conjugate Vaccines have gained substantial success in reducing invasive pneumococcal disease; however, the high cost of PCV remains one of the major hurdles in its’ programmatic inclusion and sustainability. A reduced two-dose (1+1) schedule of PCV has been shown to offer optimal immune protection in countries with mature PCV programs. This approach not only reduces the vaccination costs including the logistic and operational costs, but also alleviates the complex childhood vaccination program thus facilitating improved coverage.

The reduced dose schedule 1+1 of PCV10 and PCV13 has been evaluated in different regions worldwide. All the sites have shown similar immunogenicity and VT carriage reduction using the 1+1 schedule compared with the three-dose schedules. The UK pivotal trial, the first study evaluating a 1+1 schedule of PCV13 (PREVNAR®), has shown that serotype-specific immune responses following a booster dose at 12 months of age were similar or superior to those after a 2+1 schedule. This immunogenicity study laid the foundation for a reduced-dose 1+1 schedule in countries with mature PCV programs (11).

The 1+1 study in India conducted before the PCV rollout showed that 1+1 schedules of both PCV13 (PREVNAR®) and PCV10 (SYNFLORIX®) achieved immune protection in Indian children during the second year of life which was comparable to WHO- WHO-recommended 3-dose schedules. The study showed that the reduced dose schedule (1+1) of the PCV13 (PREVNAR®) resulted in a significant 13VT-carriage reduction in the second year of life (14).

Presently, there are no data available on immunogenicity or clinical efficacy for the 1+1 schedule of PNEUMOSIL® and PNEUBEVAX-14®. As these vaccines have been rolled out in the government program of India and are likely to be rolled out in other low and middle-income countries, the evidence on the effectiveness of the 1+1 schedule of PNEUMOSIL® and PNEUBEVAX-14® can help the policymakers to implement this reduced dose schedule in the near future. The proposed study plans to assess the effect of PNEUMOSIL® and PNEUBEVAX-14® in a 1+1 schedule compared to the existing 2+1 schedule on immunogenicity and NP carriage in healthy Indian infants. 

 
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