Clinical trial NCT05964582: Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers
Official title: A Multi-center, Multi-national, Prospective Surveillance Study of Respiratory Syncytial Virus Disease in Infants and Toddlers 6 to < 22 Months of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-07-28
Enrollment: 344
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: RSV A serum neutralizing antibody (Nab) titers
timeFrame: At Day 1
measure: RSV A serum neutralizing antibody (Nab) titers
timeFrame: At Day 1
measure: RSV B serum Nab titers
timeFrame: At Day 1
measure: RSV B serum Nab titers
timeFrame: At Day 1
measure: Anti-F immunoglobulin A (IgA) and G (IgG) enzyme linked immunosorbant assay (ELISA) titers
timeFrame: At Day 1
measure: Anti-F immunoglobulin A (IgA) and G (IgG) enzyme linked immunosorbant assay (ELISA) titers
timeFrame: At Day 1
measure: Baseline serostatus
timeFrame: At Day 1
measure: Baseline serostatus
timeFrame: At Day 1
measure: Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
timeFrame: Throughout study, approximately 6 months
measure: Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
timeFrame: Throughout study, approximately 6 months
measure: Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
timeFrame: Throughout study, approximately 6 months
measure: Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
timeFrame: Throughout study, approximately 6 months
Secondary outcomes:
measure: RSV A serum Nab titers
timeFrame: At Day 1
measure: RSV A serum Nab titers
timeFrame: At Day 1
measure: RSV B serum Nab antibody titers
timeFrame: At Day 1
measure: RSV B serum Nab antibody titers
timeFrame: At Day 1
measure: Anti-F IgA and IgG ELISA titers
timeFrame: At Day 1
measure: Anti-F IgA and IgG ELISA titers
timeFrame: At Day 1
measure: Baseline serostatus by age group
timeFrame: At Day 1
measure: Baseline serostatus by age group
timeFrame: At Day 1
measure: Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
timeFrame: Throughout study, approximately 6 months
measure: Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
timeFrame: Throughout study, approximately 6 months
measure: Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
timeFrame: Throughout study, approximately 6 months
measure: Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
timeFrame: Throughout study, approximately 6 months
measure: Occurrence of ARD associated with each RT-PCR confirmed RSV strain (A/B) during the study
timeFrame: Throughout study, approximately 6 months
measure: Occurrence of ARD associated with each RT-PCR confirmed RSV strain (A/B) during the study
timeFrame: Throughout study, approximately 6 months
measure: Occurrence of severe LRTD associated with any RT PCR confirmed RSV strain during the study
timeFrame: Throughout study, approximately 6 months
measure: Occurrence of LRTD associated with each RT-PCR confirmed RSV strain (A/B) during the study
timeFrame: Throughout study, approximately 6 months
measure: Occurrence of LRTD associated with each RT-PCR confirmed RSV strain (A/B) during the study
timeFrame: Throughout study, approximately 6 months
measure: Occurrence of clinically diagnosed RSV ARD according to routine practice (with or without RT-PCR RSV confirmation) during the study
timeFrame: Throughout study, approximately 6 months
measure: Occurrence of clinically diagnosed RSV LRTD according to routine practice (with or without RT-PCR RSV confirmation) during the study
timeFrame: Throughout study, approximately 6 months
measure: Occurrence of AOM episodes during the study
timeFrame: Throughout study, approximately 6 months
measure: 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
timeFrame: At Day 1
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Quality Clinical Research - 10040 Regency Cir - HyperCore - PPDS Site Number : 8400001
state: Nebraska
city: Cleveland
country: United States
facility: Senders Pediatrics Site Number : 8400002
state: Ohio
city: Helsinki
country: Finland
facility: Investigational Site Number : 2460002
city: Järvenpää
country: Finland
facility: Investigational Site Number : 2460001
city: Kokkola
country: Finland
facility: Investigational Site Number : 2460004
city: Tampere
country: Finland
facility: Investigational Site Number : 2460003
city: Kintampo
country: Ghana
facility: Investigational Site Number : 2880002
city: Navrongo
country: Ghana
facility: Investigational Site Number : 2880001
city: San Pedro Sula
country: Honduras
facility: Investigational Site Number : 3400002
city: Tegucigalpa
country: Honduras
facility: Investigational Site Number : 3400001
city: Mysuru
country: India
facility: Investigational Site Number : 3560001
city: Pune
country: India
facility: Investigational Site Number : 3560002
city: Mostoles
country: Spain
facility: Investigational Site Number : 7240001
state: Madrid
city: Ratchathewi
country: Thailand
facility: Investigational Site Number : 7640001
city: Songkla
country: Thailand
facility: Investigational Site Number : 7640002
Study officials:
affiliation: Sanofi
name: Clinical Sciences &amp; Operations
role: STUDY_DIRECTOR
References: