Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers

A Multi-center, Multi-national, Prospective Surveillance Study of Respiratory Syncytial Virus Disease in Infants and Toddlers 6 to < 22 Months of Age

The study is a multi-center, multi-national, prospective surveillance study in which the study participants will not receive a study vaccine but will provide a baseline blood sample and be followed for acute respiratory disease during 6 months. The 6-month follow-up will occur for the most part during the Respiratory Syncytial Virus(RSV) season (based on enrollment timing and as per feasibility). A maximum of 1000 children from 6 to < 22 months of age are planned to be enrolled in 5 to 10 countries, 1 to 2 sites per country, targeting approximately 100 participants per country. The purpose of the study is to assess the seroprevalence and incidence of RSV disease during the study period in the targeted countries and sites for a Phase III vaccine study.

Study Overview

• Status: Active, not recruiting
• Conditions: Respiratory Syncytial Virus Infections

Detailed Description

The duration of the study will be 6 months for each participant.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00100
    • Investigational Site Number : 2460002
  • Järvenpää, Finland, 04400
    • Investigational Site Number : 2460001
  • Kokkola, Finland, 67100
    • Investigational Site Number : 2460004
  • Tampere, Finland, 33100
    • Investigational Site Number : 2460003
• Ghana
  • Kintampo, Ghana, 200
    • Investigational Site Number : 2880002
  • Navrongo, Ghana, 114
    • Investigational Site Number : 2880001
• Honduras
  • San Pedro Sula, Honduras, 21104
    • Investigational Site Number : 3400002
  • Tegucigalpa, Honduras, 11101
    • Investigational Site Number : 3400001
• India
  • Mysuru, India, 570004
    • Investigational Site Number : 3560001
  • Pune, India, 412216
    • Investigational Site Number : 3560002
• Spain
  • Madrid
    • Mostoles, Madrid, Spain, 28938
      • Investigational Site Number : 7240001
• Thailand
  • Ratchathewi, Thailand, 10400
    • Investigational Site Number : 7640001
  • Songkla, Thailand, 90110
    • Investigational Site Number : 7640002
• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68114-3755
      • Quality Clinical Research - 10040 Regency Cir - HyperCore - PPDS Site Number : 8400001
  • Ohio
    • Cleveland, Ohio, United States, 44121-4243
      • Senders Pediatrics Site Number : 8400002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

Description

Inclusion Criteria:

• Aged 6 months to < 22 months on the day of inclusion (means the day of the 6-month birthday to the day before the 22-month birthday)
• Participants who are healthy as determined by medical evaluation including medical history
• 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

Exclusion Criteria:

• 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)
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
• 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

• 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
• Participant's mother previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding

• 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
• 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
• Receipt of immune globulins, blood or blood-derived products in the past 3 months
• 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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy children aged 6 months to < 22 months; No vaccine will be administered. All enrolled participants will have a blood sample collected at enrollment (visit 01) and a nasal swab collected each time they have an RSV-like illness visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RSV A serum neutralizing antibody (Nab) titers	To assess RSV A serum Nab titers overall	At Day 1
RSV A serum neutralizing antibody (Nab) titers	To assess RSV A serum Nab titers by country	At Day 1
RSV B serum Nab titers	To assess RSV B serum Nab titers overall	At Day 1
RSV B serum Nab titers	To assess RSV B serum Nab titers overall by country	At Day 1
Anti-F immunoglobulin A (IgA) and G (IgG) enzyme linked immunosorbant assay (ELISA) titers	To assess Anti-F IgA and IgG ELISA titers overall	At Day 1
Anti-F immunoglobulin A (IgA) and G (IgG) enzyme linked immunosorbant assay (ELISA) titers	To assess Anti-F IgA and IgG ELISA titers by country	At Day 1
Baseline serostatus	To assess baseline serostatus overall	At Day 1
Baseline serostatus	To assess baseline serostatus by country	At Day 1
Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study	To assess to incidence of ARD confirmed by RT PCR overall	Throughout study, approximately 6 months
Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study	To assess to incidence of ARD confirmed by RT PCR by country	Throughout study, approximately 6 months
Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study	To assess to incidence of LRTD confirmed by RT PCR overall	Throughout study, approximately 6 months
Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study	To assess to incidence of LRTD confirmed by RT PCR by country	Throughout study, approximately 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RSV A serum Nab titers	To assess RSV A serum Nab titers for each age group overall	At Day 1
RSV A serum Nab titers	To assess RSV A serum Nab titers for each age group by country	At Day 1
RSV B serum Nab antibody titers	To assess RSV B serum Nab titers for each age group overall	At Day 1
RSV B serum Nab antibody titers	To assess RSV B serum Nab titers for each age group by country	At Day 1
Anti-F IgA and IgG ELISA titers	To assess Anti-F IgA and IgG ELISA titers for each age group overall	At Day 1
Anti-F IgA and IgG ELISA titers	To assess Anti-F IgA and IgG ELISA titers for each age group by country	At Day 1
Baseline serostatus by age group	To assess baseline serostatus for each age group overall	At Day 1
Baseline serostatus by age group	To assess baseline serostatus for each age group by country	At Day 1
Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study	To assess to incidence of ARD confirmed by RT PCR for each age group overall	Throughout study, approximately 6 months
Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study	To assess to incidence of ARD confirmed by RT PCR for each age group by country	Throughout study, approximately 6 months
Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study	To assess to incidence of LRTD confirmed by RT PCR for each age group overall	Throughout study, approximately 6 months
Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study	To assess to incidence of LRTD confirmed by RT PCR for each age group by country	Throughout study, approximately 6 months
Occurrence of ARD associated with each RT-PCR confirmed RSV strain (A/B) during the study	To assess to incidence of ARD confirmed by RT PCR for each strain overall	Throughout study, approximately 6 months
Occurrence of ARD associated with each RT-PCR confirmed RSV strain (A/B) during the study	To assess to incidence of ARD confirmed by RT PCR for each strain by country	Throughout study, approximately 6 months
Occurrence of severe LRTD associated with any RT PCR confirmed RSV strain during the study	To assess the severity of LRTD confirmed by any RT PCR for each strain	Throughout study, approximately 6 months
Occurrence of LRTD associated with each RT-PCR confirmed RSV strain (A/B) during the study	To assess to incidence of LRTD confirmed by RT PCR for each strain overall	Throughout study, approximately 6 months
Occurrence of LRTD associated with each RT-PCR confirmed RSV strain (A/B) during the study	To assess to incidence of LRTD confirmed by RT PCR for each strain by country	Throughout study, approximately 6 months
Occurrence of clinically diagnosed RSV ARD according to routine practice (with or without RT-PCR RSV confirmation) during the study		Throughout study, approximately 6 months
Occurrence of clinically diagnosed RSV LRTD according to routine practice (with or without RT-PCR RSV confirmation) during the study		Throughout study, approximately 6 months
Occurrence of AOM episodes during the study		Throughout study, approximately 6 months
Occurrence of ARD and LRTD associated with any RT PCR confirmed RSV strain during the study, RSV A and RSV B serum neutralizing antibody titers, anti-F IgA and IgG ELISA antibody titers	To assess the association between RT-PCR confirmed RSV ARD and LRTD and RSV A, B, anti-G IgA an IgG ELISA antibodies at baseline	At Day 1

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Estimated): June 28, 2024
• Study Completion (Estimated): June 28, 2024

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Virus Diseases; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: VAD00019 (Sanofi Identifier); U1111-1281-0204 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No