Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers

NCT05964582 | Completed

• 2 other identifiers: VAD00019U1111-1281-0204
• Study Type: observational
• Target: 344
• Locations: 7 countries
• Sites: 15

Brief Summary

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.

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (21)

• RSV A serum Nab titers

  At Day 1

• RSV A serum Nab titers

  At Day 1

• RSV B serum Nab antibody titers

  At Day 1

• RSV B serum Nab antibody titers

  At Day 1

• Anti-F IgA and IgG ELISA titers

  At Day 1

Study Arms (1)

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

Eligibility Criteria

• Age: 6 Months - 21 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (15)

Quality Clinical Research - 10040 Regency Cir - HyperCore - PPDS Site Number : 8400001

Omaha, Nebraska, 68114-3755, United States

Location

Senders Pediatrics Site Number : 8400002

Cleveland, Ohio, 44121-4243, United States

Location

Investigational Site Number : 2460002

Helsinki, 00100, Finland

Location

Investigational Site Number : 2460001

Jarvenpaa, 04400, Finland

Location

Investigational Site Number : 2460004

Kokkola, 67100, Finland

Location

Investigational Site Number : 2460003

Tampere, 33100, Finland

Location

Investigational Site Number : 2880002

Kintampo, 200, Ghana

Location

Investigational Site Number : 2880001

Navrongo, 114, Ghana

Location

Investigational Site Number : 3400002

San Pedro Sula, 21104, Honduras

Location

Investigational Site Number : 3400001

Tegucigalpa, 11101, Honduras

Location

Investigational Site Number : 3560001

Mysuru, 570004, India

Location

Investigational Site Number : 3560002

Pune, 412216, India

Location

Investigational Site Number : 7240001

Móstoles, Madrid, 28938, Spain

Location

Investigational Site Number : 7640001

Ratchathewi, 10400, Thailand

Location

Investigational Site Number : 7640002

Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Clinical Sciences &amp; Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 28, 2023
• Study Start: July 11, 2023
• Primary Completion: July 2, 2024
• Study Completion: July 2, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

HO (2); IN (2); ES (1); GH (2); FI (4); TH (2); US (2)