Prospective, Study for the Use of Palivizumab (Synagis) in High Risk Children in Germany

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by AbbVie
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier:
First received: March 2, 2010
Last updated: February 20, 2015
Last verified: February 2015

Evaluation of Respiratory Syncytial Virus (RSV) Hospitalization and the impact of risk factors on preterm infants, infants with congenital heart disease and infants with bronchopulmonary abnormality of development immunized with Synagis.

Respiratory Syncytial Virus Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Documentation of Safety and Efficacy of Synagis in Preterm Infants

Resource links provided by NLM:

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Determination of Synagis usage patterns in infants under risk of RSV (when [which month] and where [hospital or community based pediatrician] drug is administered [ Time Frame: Once per month during Respiratory Syncytial Virus-season ] [ Designated as safety issue: No ]
  • Determination of RSV hospitalization rates among Synagis infants (for any reason and RSV-related) [ Time Frame: Once per month during Respiratory Syncytial Virus-season ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determination and evaluation of risk factors of the individual patient for complicated RSV disease [ Time Frame: Once per month during Respiratory Syncytial Virus-season ] [ Designated as safety issue: No ]
  • Determination of parental compliance with the palivizumab administration schedule [ Time Frame: Once per month during Respiratory Syncytial Virus-season ] [ Designated as safety issue: No ]
  • Determination of the Synagis usage in the german health care system [ Time Frame: Once per month during Respiratory Syncytial Virus-season ] [ Designated as safety issue: No ]

Estimated Enrollment: 20000
Study Start Date: November 2007
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Children with risk for Respiratory Syncytial Virus Infection
The study population will consist of preterm infants and children born with hemodynamically significant congenital heart disease

Detailed Description:

The Synagis Post-Marketing Observational Study (PMOS) will provide information:

  • when and where the drug is administered
  • how the risk factors are distributed in the investigated population
  • how often RSV-related hospitalization and ICU admission occur
  • on the compliance rate among parents of Synagis® infants

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Each community Pediatrician in care of preterm infants and/or children with congenital heart disease can participate in this study.


Inclusion Criteria:

  • Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the Respiratory syncytial virus season
  • Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.
  • Children less than 2 years of age and with hemodynamically significant congenital heart disease.

Exclusion Criteria:

  • Children with known hypersensitivity to Palivizumab or any component of the formulation, or other humanized monoclonal antibodies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01155193

Contact: Susanne Gehrmann #49 6122581168
Contact: Elisabeth Glaser-Caldow #49 6122 581235

  Show 1551 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Bianca Wittig, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier: NCT01155193     History of Changes
Other Study ID Numbers: P10-410
Study First Received: March 2, 2010
Last Updated: February 20, 2015
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by AbbVie:
Respiratory syncytial virus
Congenital heart disease
Pre-term infants

Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Mononegavirales Infections
Paramyxoviridae Infections
Pneumovirus Infections
RNA Virus Infections
Virus Diseases processed this record on March 26, 2015