Promotion of RSV Immunization Through Multiple Efforts

Phase 3

Not yet recruiting

• Conditions: Pregnancy; Vaccination

• Registration Number: NCT06640868
• Lead Sponsor: Washington University School of Medicine

Brief Summary

Central hypothesis: a multimodal approach is needed to enhance RSV vaccine uptake in pregnancy rather than the current standard of care that relies solely on physician recommendations at routine prenatal visits and/or mass messaging to the public. The investigators propose a pilot sequential multiple assignment randomized trial (SMART) to evaluate the effect...

Detailed Description

Respiratory syncytial virus (RSV) is the leading cause of hospitalization and death among infants. Each year, up to 80,000 children are hospitalized due to RSV-associated lower respiratory tract infection, with infants having the highest risk. 50% of childhood deaths from RSV are in infants \<6 months old. 1 in every 28 deaths among children aged 28 days to ...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-30
• Study First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-11
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14
• Study Start: 2024-10-30
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. Confirmed intrauterine pregnancy (IUP) at 28-30 weeks.
2. No contraindications to the RSV vaccine: history of severe allergic reaction to any vaccine component or active moderate/severe acute illness with or without fever or receipt of RSV vaccine during the pregnancy

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Exclusion Criteria

• Those who do not have confirmed IUP at 28-30 weeks, or who have a contraindication to the RSV vaccine (history of severe allergic reaction to any vaccine component or active moderate/severe acute illness with or without fever or receipt of RSV vaccine during the pregnancy) will be excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Vaccinated for RSV by delivery	Between 32 weeks and delivery, usually around 40 weeks gestation	Vaccinated for RSV by delivery

Secondary Outcome Measures

Name	Time	Method
Vaccinated for RSV by 34 weeks	Pregnancy by 34 weeks	Vaccinated for RSV by 34 weeks
Receipt of Tdap during pregnancy	Between 27 weeks and delivery, usually around 40 weeks gestation	Receipt of Tdap during pregnancy
Receipt of Flu vaccine during pregnancy	During pregnancy, usually 40 weeks long	Receipt of Flu vaccine during pregnancy
Receipt of COVID vaccine during pregnancy	During pregnancy, usually 40 weeks long	Receipt of COVID vaccine during pregnancy

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 St Louis, Missouri, United States