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CTRI Number  CTRI/2024/08/072726 [Registered on: 20/08/2024] Trial Registered Prospectively
Last Modified On: 19/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Other 
Public Title of Study   Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers 
Scientific Title of Study   Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus vaccine in infants and toddlers (PEARL)  
Trial Acronym  PEARL 
Secondary IDs if Any  
Secondary ID  Identifier 
VAD00004_Protocol Ver 2.0 dated 30Jun2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Rashmi Chitgupi  
Designation  Country Head - Clinical Management 
Affiliation  PPD Pharmaceutical Development India Private Limited  
Address  102, A Wing, Fulcrum, Hiranandani Business Park, Sahar Road, Andheri East,

Mumbai
MAHARASHTRA
400099
India 
Phone  02266022900  
Fax  912266022999  
Email  rashmi.chitgupi@ppd.com  
 
Details of Contact Person
Public Query  
Name  Rashmi Chitgupi  
Designation  Country Head - Clinical Management 
Affiliation  PPD Pharmaceutical Development India Private Limited  
Address  102, A Wing, Fulcrum, Hiranandani Business Park, Sahar Road, Andheri East,


MAHARASHTRA
400099
India 
Phone  02266022900  
Fax  912266022999  
Email  rashmi.chitgupi@ppd.com  
 
Source of Monetary or Material Support  
Sanofi Pasteur Inc. Discovery Drive, Swiftwater, PA 18370-0187, USA 
 
Primary Sponsor  
Name  Sanofi Pasteur Inc. 
Address  Discovery Drive, Swiftwater, PA 18370-0187, USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Brazil
Chile
China
Colombia
Finland
Germany
Ghana
Honduras
India
Japan
Kenya
Mexico
Nepal
Republic of Korea
South Africa
Spain
Thailand
United Kingdom
United States of America  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jitendra Oswal  Bharati Vidyapeeth (Deemed To Be University) Medical College Hospital & Research Centre  Pediatric Research cell, Pune-Satara Road, Dhankawadi, Pune
Pune
MAHARASHTRA 		 9822296180

jsoswal@gmail.com 
Dr Mandyam Dhati Ravi  JSS Hospital  JSS Hopsital, Mahatma Gandhi Road(MG Road), Mysore
Mysore
KARNATAKA 		 9880629506

ravimdped@gmail.com 
Dr Sonali Kar  Kalinga Institute of Medical Sciences,  Department of Community Medicine, Campus 5, KIIT, University, Patia,
Khordha
ORISSA 		 9438423273

sonsam72@yahoo.co.uk 
Dr Anand Kawad  KEM Hospital Research CentrVadu Rural Health Program  At Post Vadu Budruk, Taluka- Shirur,
Pune
MAHARASHTRA 		 8888891174

anand.kawade@kemhrcvadu.org 
Dr Sangappa Dhaded  KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre  Nehrunagar Belagavi-590010,
Belgaum
KARNATAKA 		 8312471350

drdhadedsm@gmail.com 
Dr Sunil Sazawal  LRM Medical College   Department of Pediatrics, Visiting Senior Research Associate, Department of Paediatrics, Garh Road,
Meerut
UTTAR PRADESH 		 9899310632

ssazawal@jhu.edu 
Dr Ashwani Sood  Maharshi Markandeshwar Institute of Medical Science and Research  Mullana, Ambala, Haryana
Ambala
HARYANA 		 9418300888

doc.aksood@gmail.com 
Dr Anurag Agarwal  Maulana Azad Medical College  Maulana Azad Medical College Campus, Balmiki Basti,
New Delhi
DELHI 		 9810409625

anurag_dr@rediffmail.com 
Dr Nirmal Choraria  Nirmal Hospital Pvt. Ltd.  Ring Road
Surat
GUJARAT 		 9737178471

drnirmalchoraria@gmail.com 
Dr Rummankhan Pathan  Seth Vadilal Sarabhai General Hospital  Madalpur Gam, Paldi Road, Ellisbridge,
Ahmadabad
GUJARAT 		 8866484464

drrummankhan@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
IEC,KLE Universitys KLE Dr PK Hospital & MRC  Approved 
Institutional Ethics Committee Bharati Vidyapeeth Deemed University  Submittted/Under Review 
Institutional Ethics Committee Maulana Azad Medical College  Submittted/Under Review 
Institutional Ethics Committee, LLRM Medical College  Approved 
Institutional Ethics Committee, JSS Medical College & jSS Hospital,  Submittted/Under Review 
Institutional Ethics Committee, MM Institute of Medical Science and Research  Submittted/Under Review 
Institutional Ethics Committee-KIMS Kalinga Institute of Medical Sciences  Submittted/Under Review 
KEM Hospital Research Centre, Ethics Committee  Approved 
Nirmal Hospital Pvt. Ltd. Ethics Committee  Approved 
Sangini Hospital Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Respiratory Syncytial Virus 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Participants will be randomized to receive either RSVt vaccine or placebo in a 1:1 ratio. Form: Liquid for nasal spray • Composition: buffer, same formulation as that used for the RSVt vaccine, approximately 0.1 mL to be delivered as a fine mist of droplets per nostril, using an intranasal administration device. • Route of administration: intranasal  
Intervention  Respiratory Syncytial Virus vaccine  The RSVt vaccine drug product (DP) consists of a frozen liquid formulation with the same histidine-based formulation buffer as the drug substance. The physical appearance of the RSVt vaccine DP ranges from a clear colorless solution to opalescent suspension with white to pale yellow tint. Each 0.2 mL dose (0.1 mL to be administered per nostrill;) of RSVt vaccine will contain the live-attenuated RSV. 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  22.00 Month(s)
Gender  Both 
Details  1. Aged 6 months to less than 22 months on the day of inclusion

2. Participants who are healthy as determined by medical evaluation including medical
history.

3. Born at full term of pregnancy (≥ 37 weeks) or born after a gestation period of 27 through
36 weeks and medically stable as assessed by the investigator.

4. Informed consent form has been signed and dated by the parent(s) or other LAR (and by
an independent witness if required by local regulations).

5. Participant and parent(s)/LAR are able to attend all scheduled visits and to comply with all
study procedures
 
 
ExclusionCriteria 
Details  1. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
2. Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances
3. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completionc
4. History of medically diagnosed wheezing
5. Any acute febrile illness in the past 48 hours that according to investigator judgment is significant enough to interfere with successful inoculation on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
6. Probable or confirmed ongoing case of viral respiratory infection (including COVID-19, influenza, rhinovirus, etc.) at the time of enrollment. A prospective participant should not be included in the study until the respiratory infection has resolved.
7. Member of a household that contains an immunocompromised individual, including, but not limited to:
• a person who is HIV infected
• a person who has received chemotherapy within the 12 months prior to study enrollment
• a person who has received (within the past 6 months) or is receiving (at the time of enrollment) immunosuppressant agents
• a person living with a solid organ or bone marrow transplant Potential close contact with other immunocompromised individual within 30 days after each vaccination as per investigator’s discretion
8. Participant’s biological mother’s previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding.
9. Receipt or planned receipt of any of the following vaccines prior to enrollment or after the first study intervention administration:
• Any other intranasal live attenuated vaccine within the 28 days prior to and after Dose 1 study administration
• Unless given on the day of Dose 1 study administration, any other injectable live attenuated vaccines within the 28 days prior to and after. Concomitant receipt on the day of Dose 1 study administration is allowed.

10. Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV immune globulin) at the time of enrollment. Previous receipt of an RSV monoclonal antibody within 6 months prior to the first study vaccine administration.
11. Receipt of immune globulins, blood or blood-derived products in the past 3 months
12. Receipt of intranasal and intra-ocular medications within 3 days prior to study enrollment
13. Participation at the time of study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
14. Deprived of freedom in an emergency setting, or hospitalized involuntarily
15. Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To demonstrate the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV LRTD after
2 doses, over RSV Season 1  		 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1). 
 
Secondary Outcome  
Outcome  TimePoints 
1. To demonstrate
the clinical
efficacy of RSVt
vaccine for the
prevention of RT
PCR confirmed
RSV URTD after
2 doses over RSV
Season 1

2. To demonstrate the
clinical efficacy of
RSVt vaccine for
the prevention of
RT-PCR confirmed
RSV associated
with the occurrence
of LRTD, leading to
hospitalization after
2 doses over RSV
Season 1 		 1. 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1).

2. 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1).  
 
Target Sample Size   Total Sample Size="6000"
Sample Size from India="2000" 
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)   06/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/02/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   Infants and young children are at increased risk for respiratory syncytial virus (RSV) infections because of their maturing immune system and lack of prior exposure to RSV. A genetically stable live-attenuated RSV ∆NS2/∆1313/I1314L vaccine (from the US National Institutes of Health) has been shown to be safe and immunogenic in RSV-seronegative children in Phase I studies.  Sanofi is conducting Phase I/II clinical studies with a similar RSV ∆NS2/∆1313/I1314L vaccine (referred to as RSVt vaccine) to assess the vaccine safety, immunogenicity, infectivity of the candidate (VAD00001 study) as well as vaccine virus transmissibility to close contacts of study participants (VAD00014 study). Study VAD00004 will be initiated as part of the Phase III development of the RSVt vaccine. The objective of the study is RSVt clinical efficacy, while also further investigating the safety and immunogenicity of the RSVt vaccine in a global context. Vaccine efficacy against lower respiratory tract disease (LRTD) and upper respiratory tract disease (URTD) will be assessed. 
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