Nasal administration of palivizumab to prevent respiratory syncytial virus infection

Effect of intranasal administration of palivizumab on respiratory syncytial virus-associated infection – a randomized controlled trial - Narsyn

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002742-37-NL

Enrollment

408

Registered

2018-08-15

Start date

2018-09-12

Completion date

Unknown

Last updated

2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory syncytial virus infection

Interventions

Product Name: Commercial Synagis Pharmaceutical Form: Nasal drops Pharmaceutical form of the placebo: Nasal drops Route of administration of the placebo: Intranasal use (Noncurrent)

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Study A: The main objective of this non-commercial trial is self-reported symptoms (local and systemic AE's) according to the FDA scorecard and SAE’s. The phase IIb will be initiated based on the overall safety profile, there must be no treatment SAE or AE's as determined by the investigator and DSMB. Study B: The primary objective of this non-commercial trial is RSV infection with lab-confirmed diagnosis. ;Secondary Objective: Study A: Observation of symptoms by a physician will take place for the 10 minutes following administration on the first day of intervention. We will test nasal swab samples for a respiratory panel to exclude the possibility of respiratory pathogen as the cause of symptoms when symptoms are present. Study B: RSV hospitalization, medically-attended RSV infection, any hospitalization, any non-hospitalized RSV infection, any respiratory disease, non-tested medically attended respiratory tract infection (RTI), RSV negative RTI admission, non-tested RTI admission, use of respiratory medication, otitis media, and wheeze in the first year of life. Incidence and total days of RSV-associated ICU stay, mechanical ventilation and supplemental oxygen. Nasal swabs for co-infections by other respiratory pathogens. Safety data on local and systemic adverse events and severe adverse events. : Key secondary outcome ;Primary end point(s): Any RSV infection with laboratory-confirmed RSV. ;Timepoint(s) of evaluation of this end point: Follow up for RSV infection will occur only during the first RSV season from initiation of treatment through the end of April.	—

Measure

Time frame

Main Objective: Study A: The main objective of this non-commercial trial is self-reported symptoms (local and systemic AE's) according to the FDA scorecard and SAE’s. The phase IIb will be initiated based on the overall safety profile, there must be no treatment SAE or AE's as determined by the investigator and DSMB. Study B: The primary objective of this non-commercial trial is RSV infection with lab-confirmed diagnosis. ;Secondary Objective: Study A: Observation of symptoms by a physician will take place for the 10 minutes following administration on the first day of intervention. We will test nasal swab samples for a respiratory panel to exclude the possibility of respiratory pathogen as the cause of symptoms when symptoms are present. Study B: RSV hospitalization*, medically-attended RSV infection, any hospitalization, any non-hospitalized RSV infection, any respiratory disease, non-tested medically attended respiratory tract infection (RTI), RSV negative RTI admission, non-tested RTI admission, use of respiratory medication, otitis media, and wheeze in the first year of life. Incidence and total days of RSV-associated ICU stay, mechanical ventilation and supplemental oxygen. Nasal swabs for co-infections by other respiratory pathogens. Safety data on local and systemic adverse events and severe adverse events. *: Key secondary outcome ;Primary end point(s): Any RSV infection with laboratory-confirmed RSV. ;Timepoint(s) of evaluation of this end point: Follow up for RSV infection will occur only during the first RSV season from initiation of treatment through the end of April.

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Secondary

Measure	Time frame
Secondary end point(s): RSV hospitalization, medically-attended RSV infection, any hospitalization, any non-hospitalized RSV infection, any respiratory disease, non-tested medically attended respiratory tract infection (RTI), RSV negative RTI admission, non-tested RTI admission, use of respiratory medication, otitis media, and wheeze in the first year of life. Incidence and total days of RSV-associated ICU stay, mechanical ventilation and supplemental oxygen. Nasal swabs for co-infections by other respiratory pathogens. Safety data on local and systemic adverse events and severe adverse events. : Key secondary outcome ;Timepoint(s) of evaluation of this end point: Follow up for RSV hospitalization, medically-attended RSV infection, any hospitalization, any non-hospitalized RSV infection, any respiratory disease, non-tested medically attended respiratory tract infection (RTI), RSV negative RTI admission, non-tested RTI admission, otitis media, and days ICU admission/ mechanical ventilation/supplemental oxygen will occur only during the first RSV season from initiation of treatment through the end of April. Follow-up for wheeze and respiratory medication use will occur through the first year of life.	—

Measure

Time frame

Secondary end point(s): RSV hospitalization*, medically-attended RSV infection, any hospitalization, any non-hospitalized RSV infection, any respiratory disease, non-tested medically attended respiratory tract infection (RTI), RSV negative RTI admission, non-tested RTI admission, use of respiratory medication, otitis media, and wheeze in the first year of life. Incidence and total days of RSV-associated ICU stay, mechanical ventilation and supplemental oxygen. Nasal swabs for co-infections by other respiratory pathogens. Safety data on local and systemic adverse events and severe adverse events. *: Key secondary outcome ;Timepoint(s) of evaluation of this end point: Follow up for RSV hospitalization, medically-attended RSV infection, any hospitalization, any non-hospitalized RSV infection, any respiratory disease, non-tested medically attended respiratory tract infection (RTI), RSV negative RTI admission, non-tested RTI admission, otitis media, and days ICU admission/ mechanical ventilation/supplemental oxygen will occur only during the first RSV season from initiation of treatment through the end of April. Follow-up for wheeze and respiratory medication use will occur through the first year of life.

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Countries

Netherlands

Contacts

Public ContactNarsyn trial information

University Medical Center Utrecht

narsyn@umcutrecht.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026