Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers

Not Applicable

• Registration Number: CTRI/2023/08/056078
• Lead Sponsor: Sanofi Pasteur Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Participants are eligible for the study only if all of the following criteria are met:

Age

I01: Aged 6 months to < 22 months on the day of inclusion

Type of participant and disease characteristics

I02: Participants who are healthy as determined by medical evaluation including medical

history

I03: 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: â??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

Informed Consent

I04:

Informed consent form has been signed and dated by the parent(s) or other LAR (and by

an independent witness if required by local regulations)

OTHER INCLUSIONS

I05: Participant and parent/LAR are able to attend all scheduled visits and to comply with all

study procedures

Exclusion Criteria

Participants are not eligible for the study if any of the following criteria are met:

Medical conditions

E01: 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)

E02: Chronic illness that, in the opinion of the investigator, is at a stage where it might

interfere with study conduct or completion.

E03: 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

E04: 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

Prior/concomitant therapy

E05: Participantâ??s mother previous receipt or planned administration of an investigational

RSV vaccine during pregnancy and/or breastfeeding

E06: 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

E07: 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

E08: Receipt of immune globulins, blood or blood-derived products in the past 3 months

Prior/concurrent clinical study experience

E09: 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

Other exclusions

E10: Deprived of freedom in an emergency setting, or hospitalized involuntarily

E11: Identified as a natural or adopted child of the Investigator or employee with direct

involvement in the proposed study

If the participant has a primary physician who is not the investigator, the site should contact this

physician with the participantâ??s parents / LARâ??s consent to inform this physician of the

participantâ??s participation in the study. In addition, the site should ask this primary physician to

verify exclusion criteria relating to previous therapies, such as receipt of blood products or

previous vaccines.

Study & Design

• Study Type: Observational
• Study Design: Not specified