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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
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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