asal administration of palivizumab to prevent respiratory syncytial virus infectio

Phase 1

• Conditions: respiratory syncytial virus infection; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-002742-37-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-15
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 408

Inclusion Criteria

Study A
Adult men and women between the ages of 18 and 60 in good health based on relevant medical history.

Study B
Healthy preterm infants with gestational age between 32 and 35 weeks and less than 6 months of age at the onset of the RSV season. Children must have a least one sibling. Only children of parents who master the Dutch language are included.

Are the trial subjects under 18? yes
Number of subjects for this age range: 408
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Study A
Adults with a nasal cold or obstructions in the nasal cavity that could interfere with administration of the study vaccine are excluded. History of any respiratory symptoms or clinically significant infectious disease within 4 weeks prior to drug administration or immunocompromised subjects are excluded from the study. Final, nasal surgery prior to or during the trial is an exclusion criterion.

Study B
Children with a known cardiac anomaly, Down syndrome or other serious congenital disorders and children who received surfactant treatment are excluded from the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified