Study A: A placebo-controlled crossover study to assess safety of intranasal administration of palivizumab Study B: Effect of intranasal administration of palivizumab on respiratory syncytial virus-associated infection - a double-blind randomized controlled trial

Phase 2

Completed

Conditions: bronchiolitis
RSV respiratory tract infection
10047438
10024970

Registration Number: NL-OMON55390

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 408

Inclusion Criteria

Study A: Healthy adults 18-60 years of age
Study B: 32-35 weeks gestational age with at least one brother or sister and
less than 6 months old at the start of the RSV season

Exclusion Criteria

Study A: Nasal obstruction, immunocompromised, respiratory symptoms or serious
infection 4 weeks before study start, nasal surgery
Study B: known congenital heart disease, serious congenital disease, Down
Syndrome

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Study A: The main study outcome is self-reported symptoms according to the FDA<br /><br>scorecard and SAE*s. The phase IIb will be initiated based on the overall<br /><br>safety profile. The study will proceed to study B if no serious adverse events<br /><br>occur and other AE are considered non-related to treatment by the investigators<br /><br>and the DSMB.<br /><br>Study B: The primary outcome is RSV infection with lab-confirmed RSV infection.<br /><br>RSV hospitalization is a key secondary outcome. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Study A: Observation of symptoms by a physician will take place for the 10<br /><br>minutes following administration on the first day of intervention. We will test<br /><br>nasal swab samples for a respiratory panel to exclude the possibility of<br /><br>respiratory pathogen as the cause of symptoms when symptoms are present.<br /><br>Study B: RSV hospitalization, medically attended RSV infection without<br /><br>hospitalization, non-medically attended RSV infection, RTI hospitalization,<br /><br>medically attended RTI without hospitalization, non-medically attended RTI, any<br /><br>hospitalization, otitis media, and wheeze in the first year of life. Incidence<br /><br>and total days of RSV-associated ICU stay, mechanical ventilation and<br /><br>supplemental oxygen suppletion, nasal swabs for co-infections by other<br /><br>respiratory pathogens if available, and safety data on local and systemic<br /><br>adverse events and severe adverse events.<br /><br><br /><br>Key secondary endpoint</p><br>