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Monoclonal Antibodies

MEDI8897 for Respiratory Syncytial Virus

Phase 2 & 3

Waitlist Available

Research Sponsored by MedImmune LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 15, day 31, day 151 post first dose in season 1 and season 2

Awards & highlights

Study Summary

This trial will compare the safety and tolerability of two drugs given to prevent RSV infection in high-risk groups: preterm infants and children with lung or heart conditions.

Eligible Conditions

Respiratory Syncytial Virus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 15, day 31, day 151 post first dose in season 1 and season 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 15, day 31, day 151 post first dose in season 1 and season 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 15, day 31, day 151 post first dose in season 1 and season 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD)

Secondary outcome measures

Incidence of Anti-drug Antibody (ADA) to MEDI8897 and Palivizumab in Serum

Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose

Serum Concentrations of MEDI8897 and Palivizumab

Side effects data

From 2023 Phase 2 & 3 trial • 925 Patients • NCT03959488

21%

Upper respiratory tract infection

21%

Nasopharyngitis

17%

Diarrhoea

14%

Pyrexia

14%

Rhinitis

12%

Covid-19

Vomiting

Conjunctivitis

Constipation

Otitis media acute

Gastroenteritis

Roseola

Viral upper respiratory tract infection

Vaccination complication

Rhinorrhoea

Otitis media

Ear infection

Speech disorder developmental

Hand-foot-and-mouth disease

Sars-cov-2 test positive

Bronchiolitis

Teething

Tympanic membrane perforation

Dry skin

Abdominal pain

Food allergy

Enterovirus infection

Dermatitis contact

Rash

Flatulence

Adenoiditis

Adenovirus infection

Lice infestation

Pneumonia

Rhinitis allergic

Tonsillar hypertrophy

Dermatitis diaper

Skin irritation

Phimosis

Bronchitis

Otitis media chronic

Tracheitis

Hypothyroidism

Lower respiratory tract infection viral

Enteritis

Molluscum contagiosum

Tonsillitis

Otitis externa

Rotavirus infection

Dermatitis atopic

Tongue injury

Laryngitis

Feeding disorder

Sars-cov-2 test negative

Eczema

Nasal obstruction

100%

80%

60%

40%

20%

Study treatment Arm

Palivizumab/Palivizumab

MEDI8897

MEDI8897/MEDI8897

Palivizumab

Palivizumab/MEDI8897

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MEDI8897Experimental Treatment1 Intervention

anti-RSV monoclonal antibody with an extended half-life

Group II: PalivizumabActive Control1 Intervention

anti-RSV monoclonal antibody

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MEDI8897

2016

Completed Phase 3

~5390

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MedImmune LLCLead Sponsor

347 Previous Clinical Trials

792,984 Total Patients Enrolled

AstraZenecaLead Sponsor

4,257 Previous Clinical Trials

288,592,861 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you list any other times when MEDI8897 was trialed before?

"Right now, there are 6 different clinical trials underway that are researching MEDI8897. Of those 6, 4 are in Phase 3. Although most of the trials for MEDI8897 are based in Pozuelo de Alarcon, North carolina, there are a total of 616 research sites for this medication."

Answered by AI

On how many continents is this experiment being conducted?

"At the moment, there are 33 clinical trial sites open for enrollment. Some notable locations include Columbus, Seattle and Columbia. If it is possible, selecting a clinical trial site close to your home can minimize travel-related difficulties."

Answered by AI

Does this research allow people who are over 20 years old to participate?

"The age range for individuals eligible to enroll in this study is 0 to 1 year old."

Answered by AI

How does one become eligible to participate in this experiment?

"In order for an infant to join this clinical trial, they must have contracted respiratory syncytial virus and be between 0 and 1 years old. Right now, the study is trying to enroll 925 patients."

Answered by AI

Are investigators still looking for volunteers for this experiment?

"This study is not recruiting patients currently. The trial was first posted on 2019-07-30 and was last updated on 2022-08-18. 882 other studies are actively recruiting participants with respiratory syncytial virus infections and 6 studies are actively recruiting participants for MEDI8897."

Answered by AI

Is this research study novel in design?

"There are currently 6 ongoing clinical trials for MEDI8897 in 40 different countries. The first study was conducted in 2019 and completed Phase 3 drug approval in 3013 participants. There have been 15 completed studies since then."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity

Domachowske, Joseph, Shabir A. Madhi, Eric A.F. Simões, Victoria Atanasova, Fernando Cabañas, Kenji Furuno, Maria L. Garcia-Garcia, et al.. 2022. “Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmc2112186.

clinicaltrials.govStudy

A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children

2019. "A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03959488.