Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers

NCT ID: NCT05964582

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 344 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-11
• Study Completion Date: 2024-07-02

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.

Conditions

Respiratory Syncytial Virus Infections

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 21 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences &amp; Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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

Omaha, Nebraska, United States

Senders Pediatrics Site Number : 8400002

Cleveland, Ohio, United States

Investigational Site Number : 2460002

Helsinki, , Finland

Investigational Site Number : 2460001

Järvenpää, , Finland

Investigational Site Number : 2460004

Kokkola, , Finland

Investigational Site Number : 2460003

Tampere, , Finland

Investigational Site Number : 2880002

Kintampo, , Ghana

Investigational Site Number : 2880001

Navrongo, , Ghana

Investigational Site Number : 3400002

San Pedro Sula, , Honduras

Investigational Site Number : 3400001

Tegucigalpa, , Honduras

Investigational Site Number : 3560001

Mysuru, , India

Investigational Site Number : 3560002

Pune, , India

Investigational Site Number : 7240001

Móstoles, Madrid, Spain

Investigational Site Number : 7640001

Ratchathewi, , Thailand

Investigational Site Number : 7640002

Songkhla, , Thailand

Countries

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

Other Identifiers

U1111-1281-0204

Identifier Type: REGISTRY

Identifier Source: secondary_id

VAD00019

Identifier Type: -

Identifier Source: org_study_id