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CTRI Number  CTRI/2023/08/056078 [Registered on: 03/08/2023] Trial Registered Prospectively
Last Modified On: 08/06/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Surveillance Study 
Study Design  Other 
Public Title of Study   Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers 
Scientific Title of Study   A Multi-center, Multi-national, Prospective Surveillance Study of Respiratory Syncytial Virus Disease in Infants & Toddlers 6 to less than 22 Months of Age 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
VAD00019, Ver 1.0 dated 21Feb2023   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 Pvt Ltd. 
Address  PPD Pharmaceutical development Pvt Ltd. 101, A Wing, Fulcrum Hiranandani Business Park

Mumbai
MAHARASHTRA
400099
India 
Phone  02266022900  
Fax    
Email  rashmi.chitgupi@ppd.com  
 
Details of Contact Person
Public Query  
Name  Rashmi Chitgupi 
Designation  Country Head - Clinical Management 
Affiliation  PPD Pharmaceutical development Pvt Ltd. 
Address  PPD Pharmaceutical development Pvt Ltd. 101, A Wing, Fulcrum Hiranandani Business Park

Mumbai
MAHARASHTRA
400099
India 
Phone  02266022900  
Fax    
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     Colombia
Finland
Ghana
Honduras
India
Spain
Thailand
United States of America  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ravi M Dhati  JSS Medical College Hospital  Department of Pediatrics, M G Road, Mysuru-570004, India
Mysore
KARNATAKA 		 0821-2335555

ravimdped@gmail.com 
Dr Anand Kawade   KEM Hospital Research Centre, Vadu Rural Health Program  Department : Vadu Rural Heath Program (VHRP) Taluka- Shirur, District-Pune-412216, Maharashtra, India
Pune
MAHARASHTRA 		 8888891174

anand.kawade@kemhrcvadu.org 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, JSS Medical College  Approved 
KEM Hospital Research Centre, Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  N/A 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  It is an observational study. Intervention or comparator agent is not applicable. 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  22.00 Month(s)
Gender  Both 
Details  Participants are eligible for the study only if all of the following criteria are met:
Age
I01: Aged 6 months to < 22 months on the day of inclusion


Type of participant and disease characteristics
I02: Participants who are healthy as determined by medical evaluation including medical
history
I03: 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, based on the
following definition: “Medically stable” refers to the condition of premature infants who
do not require significant medical support or ongoing management for debilitating
disease and who have demonstrated a clinical course of sustained recovery by the time
they are enrolled in the study

Informed Consent
I04:
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)

OTHER INCLUSIONS
I05: Participant and parent/LAR are able to attend all scheduled visits and to comply with all
study procedures  
 
ExclusionCriteria 
Details  Participants are not eligible for the study if any of the following criteria are met:
Medical conditions
E01: 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)
E02: Chronic illness that, in the opinion of the investigator, is at a stage where it might
interfere with study conduct or completion.

E03: 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
E04: Member of a household that contains an immunocompromised individual, including, but
not limited to:
• a person who is human immunodeficiency virus (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
Prior/concomitant therapy
E05: Participant’s mother previous receipt or planned administration of an investigational
RSV vaccine during pregnancy and/or breastfeeding
E06: Receipt or planned receipt of any of the following vaccines:
• Any intranasal live attenuated vaccine within the 28 days prior to enrollment
• Any injectable live attenuated vaccine within the 28 days prior to and after
enrollment
E07: Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product
(such as ribavirin or RSV immune globulin or RSV monoclonal antibody) less than
6 months before enrollment
E08: Receipt of immune globulins, blood or blood-derived products in the past 3 months

Prior/concurrent clinical study experience
E09: 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

Other exclusions
E10: Deprived of freedom in an emergency setting, or hospitalized involuntarily
E11: Identified as a natural or adopted child of the Investigator or employee with direct
involvement in the proposed study

If the participant has a primary physician who is not the investigator, the site should contact this
physician with the participant’s parents / LAR’s consent to inform this physician of the
participant’s participation in the study. In addition, the site should ask this primary physician to
verify exclusion criteria relating to previous therapies, such as receipt of blood products or
previous vaccines. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To assess the baseline RSV
seroprevalence, overall & by country
2. To assess the incidence during the study of
RT PCR confirmed RSV ARD & LRTD, overall and by country  		 At Day 01 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the baseline RSV
seroprevalence for each age group (overall & by country)

2. To assess the incidence during the study of
RT-PCR confirmed RSV ARD & LRTD by month, by age group, by baseline serostatus, & by severity (overall & by
country)

3. To assess the incidence during the study of
RT-PCR confirmed RSV ARD & LRTD for each strain (overall & by country)

4. To describe the incidence during the study of clinically diagnosed RSV ARD & LRTD

5. To describe the incidence during the study of all-cause acute otitis media (AOM)

6. To describe the association between RTPCR confirmed
RSV ARD & LRTD & RSV
antibodies at baseline
 		 At Day 01 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   31/08/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  11/07/2023 
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)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  
The objective of this study is to prepare for the global Phase III vaccine efficacy VAD00004 study. VAD00019 study will test the processes and case definitions planned for the VAD00004 study. The purpose is to generate seroprevalence data to estimate the proportion of infants and toddlers who had been previously exposed to RSV or RSV antibodies (monoclonal or maternal), to test the RSV illness definitions, and to evaluate the incidence of lower respiratory tract disease (LRTD) and ARD cases associated with reverse transcription polymerase chain reaction (RTPCR) confirmed RSV in the targeted population (incidence over
the study duration of approximately one RSV season), and the proportion of LRTD among ARD cases . 
 
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