Published Studies Related to Synagis (Palivizumab)
A randomized controlled trial of motavizumab versus palivizumab for the prophylaxis of serious respiratory syncytial virus disease in children with hemodynamically significant congenital heart disease. [2011.08]
Children with hemodynamically significant congenital heart disease (CHD) are at risk for serious respiratory syncytial virus (RSV) disease. This study was designed to assess the safety and tolerability of motavizumab versus palivizumab in children with CHD and was not powered for efficacy... Safety and efficacy were consistent with another study comparing motavizumab with palivizumab in premature infants without CHD.
Tetracaine (ametop) compared to placebo for reducing pain associated with intramuscular injection of palivizumab (synagis). [2009.12]
Infants receive many painful immunizations before they are 2 years old. The purpose of this study was to evaluate if topical tetracaine reduces the pain of intramuscular palivizumab compared to placebo...
Palivizumab prophylaxis, respiratory syncytial virus, and subsequent recurrent wheezing. [2007.07]
OBJECTIVE: Children who experience respiratory syncytial virus (RSV) lower respiratory tract infections (LRTIs) early in life have high rates of subsequent recurrent wheezing. Palivizumab, an anti-RSV monoclonal antibody, has 78% to 80% efficacy in preventing RSV hospitalization in premature infants without chronic lung disease. We hypothesized that palivizumab, by ameliorating or preventing early RSV LRTI in preterm infants, might decrease later recurrent wheezing... CONCLUSIONS: Our study suggests that preventing RSV LRTI with palivizumab may reduce subsequent recurrent wheezing in premature infants.
Palivizumab prophylaxis to prevent respiratory syncytial virus mortality after pediatric bone marrow transplantation: a decision analysis model. [2007.04]
OBJECTIVE: Palivizumab, a monoclonal antibody against respiratory syncytial virus (RSV), has been demonstrated to be safe and effective in young children, but evidence is lacking as to whether palivizumab is effective in preventing RSV-induced morbidity and mortality in children who are immunosuppressed after bone marrow transplantation (BMT). As a randomized, double-blind, placebo-controlled trial is lacking, we chose to examine this issue with the use of decision analysis methodology... CONCLUSIONS: Decision analysis modeling demonstrates a decrease in mortality in pediatric BMT patients with the addition of palivizumab to protect against RSV-related lung disease. A well-designed, randomized controlled trial is necessary.
Safety and immunogenicity of palivizumab (Synagis) administered for two seasons. [2005.11]
To evaluate the safety and immunogenicity of palivizumab, 55 children who received palivizumab in the IMpact-RSV trial received 5 monthly doses of 15 mg/kg palivizumab (Synagis) during the subsequent year. The single child with an antipalivizumab titer of >1/40 had no associated serious adverse events and had expected serum palivizumab trough concentrations.
Clinical Trials Related to Synagis (Palivizumab)
Compliance to Synagis (Palivizumab) Under Daily Pediatrician┬┤s Conditions in Premature Infants 33 - 35 wGA [Recruiting]
Compliance to Synagis (palivizumab) is a key factor to obtain maximal protection against
Respiratory Syncytial Virus (RSV) infection as shown in the Impact study. Many factors as
parent┤s knowledge of burden of RSV disease or physicians satisfaction with Synagis as well
as the appropriate use of the product might influence compliance. The primary objective of
this observational study is to evaluate the compliance to Synagis under daily pediatricians
practice conditions in premature infants 33 - 35 wGA.
A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis) [Completed]
A total of 150 children who meet the entry criteria will be randomized 1: 1 to receive one of
the following treatment sequence A or B.
Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of MEDI-493, Synagis [Active, not recruiting]
Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions [Recruiting]
The purpose of this study is to evaluate safety, efficacy and pharmacokinetics of
palivizumab in children at the age of 24 months or less with immunocompromised medical
Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 30-32 Weeks of Gestation [Not yet recruiting]
Protocol Synopsis: There is a link between early RSV infection and chronic respiratory
Hypothesis: Palivizumab administration may result in decreased AHR and lower respiratory
Primary objective: to evaluate prospectively the effect of palivizumab on airway reactivity
(AHR) and inflammatory parameters in exhaled breath condensate (EBC) in children born at
Secondary objective: to assess prospectively the effect of palivizumab on respiratory
morbidity and allergy in children born at 30-32 weeks.
Inclusion criteria: premature babies 30-32 weeks of gestation born during 2008 and 2009.
Exclusion criteria: Any mechanical ventilation or chronic diseases, e. g., bronchopulmonary
dysplasia (BPD), cystic fibrosis (CF), congenital heart disease, congenital anomalies, known
immunodeficiency, or receipt of other RSV investigative vaccines or therapies.
Primary end points: Airway reactivity as assessed by methacholine challenge test with
determination of PC20 and inflammatory mediators in exhaled breath condensate Secondary end
points: Respiratory morbidity as assessed by questionnaire and telephone interviews.
Additionally, IGE, eosinophil count, and skin tests will be evaluated.
Sample size: 74 participants; Group I - 37 premature babies at 30-32 weeks of gestation born
during 2008 (before approval of Synagis for this group in Israel). Group II - 37 premature
babies 30-32 weeks of gestation born during 2009 (after approval of Synagis for this group
Statistics: A sample size of 37 patients was calculated as necessary to detect a difference
of 0. 5 SD in AHR for a 2-sided tail, with a power of 80%. Demographics and baseline
characteristics will be compared using 1-way analysis of variance for quantitative variables
and Fisher's exact test for categorical variables.
Reports of Suspected Synagis (Palivizumab) Side Effects
Viral Infection (65),
Hypophagia (62), more >>