Related Experiment Video

Updated: Aug 12, 2026

Experimental Human Pneumococcal Carriage
07:47

Experimental Human Pneumococcal Carriage

Published on: February 15, 2013

Safety and tolerance of palivizumab administration in a large Northern Hemisphere trial. Northern Hemisphere Expanded

J R Groothuis1

  • 1Abbott International, Abbott Park, IL, USA.

The Pediatric Infectious Disease Journal
|June 23, 2001
PubMed

Insights

Palivizumab is safe for preterm infants during respiratory syncytial virus season. This expanded access study found low adverse events, reaffirming its tolerability for preventing RSV infections.

Area of Science:

  • Pediatrics
  • Immunology
  • Infectious Diseases

Background:

  • Respiratory Syncytial Virus (RSV) is a major cause of lower respiratory tract infections in infants.
  • Bronchopulmonary dysplasia (BPD) is a chronic lung disease that increases infants' risk of severe RSV outcomes.
  • Palivizumab is a monoclonal antibody used for RSV prophylaxis in high-risk infants.

Purpose of the Study:

  • To collect additional safety data on palivizumab in a real-world setting.
  • To evaluate the incidence of adverse events in preterm infants receiving palivizumab.
  • To reaffirm the safety and tolerability profile of palivizumab.

Main Methods:

  • An Expanded Access Study design was utilized.
  • 565 preterm infants, with or without BPD, received palivizumab.
  • Prophylaxis was administered every 30 days throughout the RSV season.

Main Results:

  • The overall incidence of adverse events was low, reported in 6.9% of subjects.
  • Serious adverse events were infrequent, including hospitalizations.
  • One case of RSV bronchiolitis not requiring hospitalization was reported.

Conclusions:

  • Palivizumab demonstrated a favorable safety profile in this large cohort of preterm infants.
  • The study reaffirms the safety and tolerability of palivizumab for RSV prophylaxis.
  • Palivizumab can be safely administered to high-risk infants during the RSV season.

More Related Videos

Development of an IFN-γ ELISpot Assay to Assess Varicella-Zoster Virus-specific Cell-mediated Immunity Following Umbilical Cord Blood Transplantation08:04

Development of an IFN-γ ELISpot Assay to Assess Varicella-Zoster Virus-specific Cell-mediated Immunity Following Umbilical Cord Blood Transplantation

Published on: July 9, 2014

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Allergic Drug Reactions01:27

Allergic Drug Reactions

Allergic reactions related to drugs are hypersensitivity responses driven by the immune system and bear no connection to the drug's therapeutic action. While drugs in isolation do not trigger an immune response, they can interact with endogenous proteins to form antigens. These antigens stimulate lymphocytes to produce antibodies. IgE-type antibodies attach themselves to mast cells. Upon subsequent exposure to the same stimulus, the antigen-antibody interaction is initiated, unleashing numerous...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
Hypersensitivity Reactions: Delayed Hypersensitivity Reactions01:29

Hypersensitivity Reactions: Delayed Hypersensitivity Reactions

Delayed-Type Hypersensitivity (DTH), or Type IV hypersensitivity, is a cell-mediated immune response. It occurs when T cells, rather than antibodies, mediate a reaction to specific antigens. It is characterized by a delayed onset (1-2 days) and involves the recruitment of macrophages to the inflammation site.The initiation of a DTH response begins with the sensitization of T cells. During this phase, which lasts at least 1-2 weeks, antigen-specific T cells are activated, clonally expanded, and...
Respiratory Syncytial Virus Disease01:29

Respiratory Syncytial Virus Disease

Human respiratory syncytial virus (RSV) is a widespread pathogen that primarily targets infants and young children but also poses a serious health risk to elderly and immunocompromised individuals. Belonging to the Pneumoviridae family, RSV is a negative-sense, single-stranded RNA virus within the Pneumovirus genus. Its global health burden is significant, with millions of cases annually resulting in hospitalizations and mortality, particularly in resource-limited settings. Although most...