Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers

Respiratory Syncytial Virus Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05964582
• Other study ID #: VAD00019
• Secondary ID: U1111-1281-0204
• Status: Active, not recruiting
• Start date: July 11, 2023
• Est. completion date: June 28, 2024

Study information

• Verified date: February 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: June 28, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 21 Months

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Locations

Country	Name	City	State
Finland	Investigational Site Number : 2460002	Helsinki
Finland	Investigational Site Number : 2460001	Järvenpää
Finland	Investigational Site Number : 2460004	Kokkola
Finland	Investigational Site Number : 2460003	Tampere
Ghana	Investigational Site Number : 2880002	Kintampo
Ghana	Investigational Site Number : 2880001	Navrongo
Honduras	Investigational Site Number : 3400002	San Pedro Sula
Honduras	Investigational Site Number : 3400001	Tegucigalpa
India	Investigational Site Number : 3560001	Mysuru
India	Investigational Site Number : 3560002	Pune
Spain	Investigational Site Number : 7240001	Mostoles	Madrid
Thailand	Investigational Site Number : 7640001	Ratchathewi
Thailand	Investigational Site Number : 7640002	Songkla
United States	Senders Pediatrics Site Number : 8400002	Cleveland	Ohio
United States	Quality Clinical Research - 10040 Regency Cir - HyperCore - PPDS Site Number : 8400001	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

United States,  Finland,  Ghana,  Honduras,  India,  Spain,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RSV A serum neutralizing antibody (Nab) titers	To assess RSV A serum Nab titers overall	At Day 1
Primary	RSV A serum neutralizing antibody (Nab) titers	To assess RSV A serum Nab titers by country	At Day 1
Primary	RSV B serum Nab titers	To assess RSV B serum Nab titers overall	At Day 1
Primary	RSV B serum Nab titers	To assess RSV B serum Nab titers overall by country	At Day 1
Primary	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
Primary	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
Primary	Baseline serostatus	To assess baseline serostatus overall	At Day 1
Primary	Baseline serostatus	To assess baseline serostatus by country	At Day 1
Primary	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
Primary	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
Primary	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
Primary	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	RSV A serum Nab titers	To assess RSV A serum Nab titers for each age group overall	At Day 1
Secondary	RSV A serum Nab titers	To assess RSV A serum Nab titers for each age group by country	At Day 1
Secondary	RSV B serum Nab antibody titers	To assess RSV B serum Nab titers for each age group overall	At Day 1
Secondary	RSV B serum Nab antibody titers	To assess RSV B serum Nab titers for each age group by country	At Day 1
Secondary	Anti-F IgA and IgG ELISA titers	To assess Anti-F IgA and IgG ELISA titers for each age group overall	At Day 1
Secondary	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
Secondary	Baseline serostatus by age group	To assess baseline serostatus for each age group overall	At Day 1
Secondary	Baseline serostatus by age group	To assess baseline serostatus for each age group by country	At Day 1
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Occurrence of AOM episodes during the study		Throughout study, approximately 6 months
Secondary	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