MedImmune, Inc. Single-stranded, nonsegmented RNA virus in the paramyxoviridae...

MedImmune, Inc.

• Single-stranded, Single-stranded, nonsegmentednonsegmentedRNA virus in the RNA virus in the paramyxoviridae paramyxoviridae familyfamily– Attachment (G) Attachment (G)

proteins assist with proteins assist with viral adherence to the viral adherence to the host cellshost cells

– Fusion (F) proteins Fusion (F) proteins aid with viral aid with viral penetrationpenetration

Randhawa J. www.template.bio.warwick.ac.uk/staff/easton/

RSV FeaturesRSV FeaturesRSV FeaturesRSV Features

MedImmune, Inc.

Leader S, Kohlhase K. Pediatr Infect Dis J. 2002;21:629-32.

73,250

87,826

121,558

181,662

220,379

0 50,000 100,000 150,000 200,000 250,000

Dehydration

Jaundice

Pneumonia(cause unspecified)

Bronchiolitis(cause unspecified)

RSV Bronchiolitis

Based on National Hospital Discharge Survey, 1997-1999

Top Causes of Infant Top Causes of Infant HospitalizationHospitalization

Top Causes of Infant Top Causes of Infant HospitalizationHospitalization

MedImmune, Inc.

Thompson WW, et al. JAMA. 2003;289:179-86.

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RSV: A Leading Viral Cause of RSV: A Leading Viral Cause of Infant DeathInfant Death

RSV: A Leading Viral Cause of RSV: A Leading Viral Cause of Infant DeathInfant Death

• CDC viral surveillance data and mortality data were analyzed from CDC viral surveillance data and mortality data were analyzed from 1990-19991990-1999

• RSV was found to be a leading viral cause of infant death*, with RSV was found to be a leading viral cause of infant death*, with nearly 9 times the mortality of influenzanearly 9 times the mortality of influenza

MedImmune, Inc.

Shay DK, et al. JAMA. 1999;282:1440-6.

Among U.S. Children Less Than 1-Year Old, 1980-1996

Annual Bronchiolitis Annual Bronchiolitis HospitalizationsHospitalizations

Annual Bronchiolitis Annual Bronchiolitis HospitalizationsHospitalizations

40,000

50,000

60,000

70,000

80,000

90,000

100,000

110,000

120,000

130,000

140,000

1980

1982

1984

1986

1988

1990

1992

1994

1996

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20,000

30,000

MedImmune, Inc.

Palivizumab (SynagisPalivizumab (Synagis®®): ): Mechanism of ActionMechanism of Action

Palivizumab (SynagisPalivizumab (Synagis®®): ): Mechanism of ActionMechanism of Action

• Palivizumab is a monoclonal Palivizumab is a monoclonal antibody that binds the F antibody that binds the F (fusion) protein of RSV(fusion) protein of RSV

• Palivizumab prevents Palivizumab prevents infection of the host cellinfection of the host cell

• Palivizumab reduces viral Palivizumab reduces viral replication and spread of RSV replication and spread of RSV to other susceptible cellsto other susceptible cells

• Protective levels need to be Protective levels need to be achieved prior to exposure to achieved prior to exposure to RSVRSV

Palivizumab

RSV

MedImmune, Inc.

Respiratory Syncytial VirusRespiratory Syncytial VirusRespiratory Syncytial VirusRespiratory Syncytial Virus

• Major viral respiratory pathogen in children Major viral respiratory pathogen in children worldwideworldwide– ~ 50% of infants infected in the first year of life ~ 50% of infants infected in the first year of life

– >>95% infected by 2 years of age 95% infected by 2 years of age

• Most common lower respiratory tract Most common lower respiratory tract pathogen of infants and young childrenpathogen of infants and young children– 25-40% of first infections have signs or symptoms 25-40% of first infections have signs or symptoms

of LRI, bronchiolitis or pneumonia of LRI, bronchiolitis or pneumonia

MedImmune, Inc.

Respiratory Syncytial VirusRespiratory Syncytial Virus

Respiratory Syncytial VirusRespiratory Syncytial Virus

• Leading cause of hospitalization in first year Leading cause of hospitalization in first year of life of life – Overall RSV hospitalization rates are 1-2%Overall RSV hospitalization rates are 1-2%

• Annual mortality due to RSV in hospitalized Annual mortality due to RSV in hospitalized infants and children is 0.1 - 5% infants and children is 0.1 - 5% – Dependent on risk factorsDependent on risk factors

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Risk for Serious RSV Disease Risk for Serious RSV Disease Risk for Serious RSV Disease Risk for Serious RSV Disease

• Primary populations at high riskPrimary populations at high risk– Premature infants (Premature infants (<< 35 weeks gestation) 35 weeks gestation)

– Chronic lung disease of prematurityChronic lung disease of prematurity

– Complicated congenital heart diseaseComplicated congenital heart disease

• Hospitalization rates ~8-10x full-term infantsHospitalization rates ~8-10x full-term infants

• Increased intensive care supportIncreased intensive care support– 30% require ICU care30% require ICU care

– 17% require mechanical ventilation 17% require mechanical ventilation

• Mortality rates ~2-6x full-term infantsMortality rates ~2-6x full-term infants

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Envelope Spikes

Respiratory Syncytial VirusRespiratory Syncytial VirusRespiratory Syncytial VirusRespiratory Syncytial Virus

G [298]F [574]

Inner Envelope

M [256]M2 [194]

Nucleocapsid

N [391]P [241]L [nd]

Surface ofInfected Cell

SH [64]

Electron photomicrograph of budding virion (Peter Collins, 1989; Fields Virology 2nd Edition, 1990.)

Efficacy/EffectivenessMedImmune, Inc.

SynagisSynagis®® (palivizumab) (palivizumab)SynagisSynagis®® (palivizumab) (palivizumab)

• Humanized Mab specifc to conserved F Humanized Mab specifc to conserved F protein epitopeprotein epitope

• Broad neutralization vs A and B isolatesBroad neutralization vs A and B isolates

• Active in cotton rat model of RSVActive in cotton rat model of RSV

– 50-100x more active than RSV-IGIV50-100x more active than RSV-IGIV

– Serum levels of 30 ug/mL produce a 99% Serum levels of 30 ug/mL produce a 99% reduction of RSV in cotton rat lungreduction of RSV in cotton rat lung

– Increased potency translated to a dose Increased potency translated to a dose reduction (15 mg/kg) compared to RespiGamreduction (15 mg/kg) compared to RespiGam

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CDR1

CDR2

CDR3

CDR1

CDR2

CDR3

Heavy Chain CDRs

Light Chain CDRs

Numax13 aa differences compared to Synagis

T A G M S V G

D I W W D D K K H Y N P S L K D

D M I F N F Y F D V

S A S S R V G Y M H

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MedImmune, Inc.Control Synagis Numax

Vir

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RSV Lung Replication

Virus Challenge Dose

2

3

4

5

6

7

8

105 107

3 mg/kg MAb Doses3 mg/kg MAb Doses

ND*ND*

*ND: none detected

RSV titer reduction in lungs and upper RSV titer reduction in lungs and upper respiratory tract is enhancedrespiratory tract is enhancedCotton Rat Challenge StudiesCotton Rat Challenge Studies

MAb Dose (mg/kg)

RSV Nasal Replication

2

2

3

4

5

6

101055 Virus Challenge Dose Virus Challenge Dose

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MedImmune, Inc.

Numax Enhanced Potency Numax Enhanced Potency Summary Summary

• Numax has ~40-fold increased binding affinityNumax has ~40-fold increased binding affinity

• Numax is 20-fold more potent than Synagis in Numax is 20-fold more potent than Synagis in neutralizing RSV in tissue cultureneutralizing RSV in tissue culture

• At the same serum concentration level of ~30 At the same serum concentration level of ~30 ug/Ml Numax can:ug/Ml Numax can:

– Reduce RSV in theReduce RSV in the lungslungs of cotton rats better than of cotton rats better than Synagis by 100-foldSynagis by 100-fold

– Reduce RSV in the Reduce RSV in the upper respiratory tractupper respiratory tract of cotton of cotton rats better than Synagis by 100-foldrats better than Synagis by 100-fold

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Clinical Potential of the Enhanced Potency of Numax

Clinical Potential of the Enhanced Potency of Numax

• At same dose as SynagisAt same dose as Synagis®®, should observe , should observe further reductions in RSV hospitalizationsfurther reductions in RSV hospitalizations

• Inhibition of nasal RSV replication may also:Inhibition of nasal RSV replication may also:

– Decrease incidence of medically attended LRIsDecrease incidence of medically attended LRIs

Via RSV specific LRI reductionsVia RSV specific LRI reductions

– Decrease incidence/frequency of medically Decrease incidence/frequency of medically attended otitis mediaattended otitis media

• ? decrease in RSV associated wheezing and ? decrease in RSV associated wheezing and asthmaasthma

PharmacokineticsPharmacokineticsPhase IIPhase II

PharmacokineticsPharmacokineticsPhase IIPhase II

• Healthy adults– Mean half-life 15-18 daysMean half-life 15-18 days

– Consistent with an IgG1 and SynagisConsistent with an IgG1 and Synagis

– Dose proportionalityDose proportionality

• Children

– Mean serum trough after first and second 15 mg/kg doses 34.5- and 59.6, respectively

– Comparable to Synagis

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Primary Study ObjectivesPrimary Study ObjectivesPrimary Study ObjectivesPrimary Study Objectives

• To compare the efficacy of Numax to Synagis when administered monthly IM for reduction in incidence of RSV hospitalization in high risk children

Assumption is that the Numax treatment group will Assumption is that the Numax treatment group will have an additional 45% decrease in hospitalizations have an additional 45% decrease in hospitalizations compared to the Synagis treatment groupcompared to the Synagis treatment group

• To compare the safety of Numax to Synagis in high risk children

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Phase III DesignPhase III DesignPhase III DesignPhase III Design

• Randomized (1:1) double-blind Synagis Randomized (1:1) double-blind Synagis controlled trialcontrolled trial

– Liquid formulation of Synagis and NumaxLiquid formulation of Synagis and Numax

LIQ Synagis approved by FDA July 2004LIQ Synagis approved by FDA July 2004

• Sample size of 5750Sample size of 5750

• Northern and southern hemispheresNorthern and southern hemispheres – 2 sequential N hemisphere RSV seasons2 sequential N hemisphere RSV seasons

• Safety oversight by Data Monitoring CommitteeSafety oversight by Data Monitoring Committee

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Phase III SchemaPhase III SchemaPhase III SchemaPhase III Schema

Synagis-LQ IM 15 mg/kg

Numax-LQ IM 15 mg/kg

30 days afterlast scheduledinfusion visit

(Efficacy and Safety)

RANDOMIZE

1st Injection Last Injection

Injections q 30 days

End of Follow-up

Study period = 150 days

Primary Endpoint – RSV Hospitalization

Premature < 6 mos

BPD < 24 mos. with recent Rx

CHD Excluded

Secondary Medically attended LRI (RSV subset)OMAntibiotic UsePK, IM


EligibilityEligibilityWho Who DoDo We Want In the Trial? We Want In the Trial?


• 24 months of age or younger with a diagnosis of chronic lung disease (CLD) of prematurity – requiring medical intervention/management (e.g.,

supplemental oxygen, steroids, bronchodilators, or diuretics) within the previous 6 months

• Key point– CLD is diagnosed by a physician qualified to make

this diagnosis

– Document in records




• 35 weeks gestation or less at birth 35 weeks gestation or less at birth andand 6 6 months of age or youngermonths of age or younger

• Key pointKey point– GA determined by review of birth record

– Hierarchy:

Qualified pediatric assessment

Ultrasound

Dates

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Primary EndpointPrimary EndpointRSV HospitalizationsRSV Hospitalizations

Primary EndpointPrimary EndpointRSV HospitalizationsRSV Hospitalizations

• There are three ways to meet endpoint:There are three ways to meet endpoint:– Primary RSV hospitalizationPrimary RSV hospitalization

– ““Nosocomial” RSV hospitalizationNosocomial” RSV hospitalization

– Death proven to be RSV relatedDeath proven to be RSV related

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Primary RSV HospitalizationsPrimary RSV Hospitalizations (section 3.4.2)(section 3.4.2)


• A Primary RSV hospitalization is defined as: A Primary RSV hospitalization is defined as:

– A respiratory hospitalization with a positive RSV test A respiratory hospitalization with a positive RSV test within 48 hours of hospitalizationwithin 48 hours of hospitalization

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• Key pointsKey points

– A respiratory hospitalization is an admission for a A respiratory hospitalization is an admission for a respiratory cause as determined by the admitting respiratory cause as determined by the admitting physicianphysician

Actively follow childActively follow child

– A nasal secretion specimen must be obtained for A nasal secretion specimen must be obtained for central lab testing for RSV for all such events within central lab testing for RSV for all such events within 48 hours of hospitalization48 hours of hospitalization

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Nosocomial RSV HospitalizationsNosocomial RSV Hospitalizations (section 3.4.2)(section 3.4.2)

Nosocomial RSV HospitalizationsNosocomial RSV Hospitalizations (section 3.4.2)(section 3.4.2)

• A nosocomial RSV hospitalization is defined A nosocomial RSV hospitalization is defined as: as:

– New onset of LRI in an already hospitalized child, New onset of LRI in an already hospitalized child,

– with an objective measure of worsening with an objective measure of worsening respiratory status respiratory status ANDAND

– a positive RSV test within 48 hours of the a positive RSV test within 48 hours of the deteriorationdeterioration

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Nosocomial RSV HospitalizationsNosocomial RSV HospitalizationsNosocomial RSV HospitalizationsNosocomial RSV Hospitalizations• ““New LRI”New LRI”

– Child must have resolved or be clearly resolving any Child must have resolved or be clearly resolving any previous respiratory illnessprevious respiratory illness

– Must have illness thought to be an infection of the Must have illness thought to be an infection of the lower respiratory tractlower respiratory tract

includes symptoms such as cough, retractions, includes symptoms such as cough, retractions, rhonchi, wheezing, crackles or rales rhonchi, wheezing, crackles or rales andand

associated symptoms of fever, coryza, apneaassociated symptoms of fever, coryza, apnea

• ““Objective Worsening”Objective Worsening”– New or increase in supplemental oxygenNew or increase in supplemental oxygen

– New or increase in mechanical ventilationNew or increase in mechanical ventilation

Additional support is not transientAdditional support is not transient

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RSV Related DeathsRSV Related Deaths (section 3.4.2)(section 3.4.2)

RSV Related DeathsRSV Related Deaths (section 3.4.2)(section 3.4.2)

• Deaths which can be demonstrated to be Deaths which can be demonstrated to be caused by RSV caused by RSV

– by autopsy or clinical history by autopsy or clinical history

– AND virologic evidenceAND virologic evidence

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Secondary ObjectivesSecondary ObjectivesSecondary ObjectivesSecondary Objectives

• To compare the incidence of medically-attended (MA) To compare the incidence of medically-attended (MA) lower respiratory tract infections (LRIs)lower respiratory tract infections (LRIs)

– To compare the incidence of RSV-specific MA LRI in a To compare the incidence of RSV-specific MA LRI in a subset of patientssubset of patients

• To compare the frequency and incidence of MA OM To compare the frequency and incidence of MA OM infections infections

• To compare the frequency of prescribed antibiotics for To compare the frequency of prescribed antibiotics for MA LRI and MA OM infectionsMA LRI and MA OM infections

• To determine serum trough drug levels and To determine serum trough drug levels and immunogenicityimmunogenicity

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MA-LRI EventsMA-LRI Events(section 3.5.3.1)(section 3.5.3.1)

MA-LRI EventsMA-LRI Events(section 3.5.3.1)(section 3.5.3.1)

• A qualified investigator determines the LRI eventA qualified investigator determines the LRI event

– By record review or by direct patient assessmentBy record review or by direct patient assessment

• LRI definitionLRI definition

– Bronchiolitis Bronchiolitis

– Pneumonia, or Pneumonia, or

– LRI LRI

wheezing, rhonchi/crackles/rales, respiratory wheezing, rhonchi/crackles/rales, respiratory distress/retractionsdistress/retractions

associated symptoms of fever, coryza, or apnea associated symptoms of fever, coryza, or apnea

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RSV Specific MA-LRI EventsRSV Specific MA-LRI EventsRSV Specific MA-LRI EventsRSV Specific MA-LRI Events

• Extremely important efficacy endpointExtremely important efficacy endpoint

• May be more likely to succeed than May be more likely to succeed than effectiveness endpoint effectiveness endpoint

• Based on assumption that Numax is superior Based on assumption that Numax is superior to Synagisto Synagis

– Synagis will reduce RSV MA LRI by 50% and Numax Synagis will reduce RSV MA LRI by 50% and Numax will reduce RSV MA LRI by 75% will reduce RSV MA LRI by 75%

– Requires large subject numbers (~2600)Requires large subject numbers (~2600)

– Requires capturing all events and testing all eventsRequires capturing all events and testing all events

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RSV Specific MA-LRI EventsRSV Specific MA-LRI EventsRSV Specific MA-LRI EventsRSV Specific MA-LRI Events

• ALLALL MA LRI events must have nasal secretions MA LRI events must have nasal secretions collected for RSV testing within 48 hours of collected for RSV testing within 48 hours of medical diagnosismedical diagnosis

• If a visit for a respiratory illness can not be If a visit for a respiratory illness can not be assessed by the site PI within that time frame, assessed by the site PI within that time frame, a nasal secretion sample should be collected a nasal secretion sample should be collected within 48 hours of that visit within 48 hours of that visit

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Medically-Attended Otitis Media Medically-Attended Otitis Media (OM) (OM) section 3.5.3.2section 3.5.3.2

Medically-Attended Otitis Media Medically-Attended Otitis Media (OM) (OM) section 3.5.3.2section 3.5.3.2

• A qualified investigator will determine OM eventA qualified investigator will determine OM event– Either by record review or by direct patient assessmentEither by record review or by direct patient assessment

• OM definition OM definition – Acute otitis media, acute tympanic membrane (TM) Acute otitis media, acute tympanic membrane (TM)

perforation, bulging TM, red TM with fever, otitis media perforation, bulging TM, red TM with fever, otitis media with effusion, or middle ear effusionwith effusion, or middle ear effusion

– Record as “otitis media” Record as “otitis media”

• A diagnosis of persistent middle ear effusion will A diagnosis of persistent middle ear effusion will not be recorded as a new OM eventnot be recorded as a new OM event

• If another event occurs If another event occurs 21 days 21 days– Should have documentation of resolution of previous Should have documentation of resolution of previous

episode (defined by normal ear exam) episode (defined by normal ear exam)

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Overall Participation Overall Participation Overall Participation Overall Participation

• Approximately 5750 children at risk for Approximately 5750 children at risk for serious RSV disease will be randomizedserious RSV disease will be randomized– Northern hemisphere 2004Northern hemisphere 2004 ~2500 patients~2500 patients

– Southern hemisphere 2005Southern hemisphere 2005 ~750 patients~750 patients

– Northern hemisphere 2005Northern hemisphere 2005 ~2500 patients~2500 patients

MedImmune, Inc.

North America MI-CP110 SitesNorth America MI-CP110 SitesNorth America MI-CP110 SitesNorth America MI-CP110 Sites

2

5

10

1

3

1

2 CT

2 DC

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3

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2 NJ

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2

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1

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1

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1 MD

1

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8

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Protocol ProcedureProtocol Procedure Compliance Goals Compliance GoalsProtocol ProcedureProtocol Procedure Compliance Goals Compliance Goals

• All patients to receive 5 doses of study drugAll patients to receive 5 doses of study drug

• All patients to be followed through Day 150 per All patients to be followed through Day 150 per protocol (all visits/procedures conducted)protocol (all visits/procedures conducted)

– If a patient “misses” a visit/declines a procedure/etc., If a patient “misses” a visit/declines a procedure/etc., study drug injections and subsequent follow-up should study drug injections and subsequent follow-up should continue according to the protocolcontinue according to the protocol

• Assessment of endpoints obtained for all patientsAssessment of endpoints obtained for all patients


Schedule of Routine Patient Schedule of Routine Patient EvaluationsEvaluations

Schedule of Routine Patient Schedule of Routine Patient EvaluationsEvaluations

ScreenScreenStudy DayStudy Day

00 3030 6060 9090 120120 150150

Informed ConsentInformed Consent XX

History & PEHistory & PE XX XX

Labs – chemistriesLabs – chemistries XX XX

Study DrugStudy Drug XX XX XX XX XX

IM & PKIM & PK XX (x)(x) (x)(x) (x)(x) XX

Safety AssessmentSafety Assessment XX XX XX XX XX XX

Med-Attended EventsMed-Attended Events XX XX XX XX XX XX

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Respiratory Hospitalization – Respiratory Hospitalization – Now what do I do?Now what do I do?

Respiratory Hospitalization – Respiratory Hospitalization – Now what do I do?Now what do I do?

• Nasal secretions for RSV testing must be obtained Nasal secretions for RSV testing must be obtained within 48 hours (before or after admission)within 48 hours (before or after admission)

– RT-PCR testing will be performed by a Central LabRT-PCR testing will be performed by a Central Lab

• Document Respiratory StatusDocument Respiratory Status

– Physical findings – respiratory signs & symptomsPhysical findings – respiratory signs & symptoms

– Supplemental oxygen / Mechanical ventilation / Supplemental oxygen / Mechanical ventilation / MedicationsMedications

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Secondary EndpointsSecondary EndpointsSecondary EndpointsSecondary Endpoints

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Medically-attended LRIMedically-attended LRIMedically-attended LRIMedically-attended LRI

• All medically-attended LRI events in all patients All medically-attended LRI events in all patients must be capturedmust be captured

– Sites should encourage parents to contact them in the Sites should encourage parents to contact them in the case of an illnesscase of an illness

• If a patient is seen at a doctor’s office, clinic, ER, If a patient is seen at a doctor’s office, clinic, ER, etc., other than the investigational site, then visit etc., other than the investigational site, then visit records must be obtained by the siterecords must be obtained by the site

• The site Investigator will verify LRI by review of the The site Investigator will verify LRI by review of the visit records or by direct patient assessmentvisit records or by direct patient assessment

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Medically-attended LRI – Medically-attended LRI – Subset StudySubset Study

Medically-attended LRI – Medically-attended LRI – Subset StudySubset Study

• For all respiratory illness events, a nasal specimen For all respiratory illness events, a nasal specimen for RSV testing must be obtained within for RSV testing must be obtained within 48 hours48 hours of the visitof the visit

• If the patient is assessed by another medical If the patient is assessed by another medical provider, and a LRI is provider, and a LRI is suspectedsuspected,, a nasal specimen a nasal specimen MUST be obtainedMUST be obtained

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Medically-attended Otitis MediaMedically-attended Otitis MediaMedically-attended Otitis MediaMedically-attended Otitis Media

• All medically-attended OM events in all patients All medically-attended OM events in all patients must be capturedmust be captured

– Sites should encourage parents to contact them in the Sites should encourage parents to contact them in the case of an illnesscase of an illness

• If a patient is seen at a doctor’s office, clinic, ER, If a patient is seen at a doctor’s office, clinic, ER, etc., other than the investigational site, then visit etc., other than the investigational site, then visit records must be obtained by the siterecords must be obtained by the site

• The site Investigator will verify OM by review of the The site Investigator will verify OM by review of the visit records or by direct patient assessmentvisit records or by direct patient assessment

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Pharmacokinetics & ImmunogenicityPharmacokinetics & ImmunogenicityPharmacokinetics & ImmunogenicityPharmacokinetics & Immunogenicity

• Blood will be collected to describe:Blood will be collected to describe:

– Trough serum concentrations of MEDI-524Trough serum concentrations of MEDI-524

– Immunogenicity of MEDI-524Immunogenicity of MEDI-524

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Endpoint GoalsEndpoint GoalsEndpoint GoalsEndpoint Goals

• Nasal secretions collected within 48 hours in order Nasal secretions collected within 48 hours in order to determine endpoints forto determine endpoints for

– All primary respiratory hospitalizationsAll primary respiratory hospitalizations

– All nosocomial respiratory deteriorationsAll nosocomial respiratory deteriorations

– All medically-attended LRIs (Participants in Subset Study)All medically-attended LRIs (Participants in Subset Study)

• When in doubt, collect nasal secretionsWhen in doubt, collect nasal secretions

MedImmune, Inc.

Specimens Collected for RSV Specimens Collected for RSV Diagnostic TestingDiagnostic Testing

Specimens Collected for RSV Specimens Collected for RSV Diagnostic TestingDiagnostic Testing

• RT PCR (Hexaplex) will be performed for RT PCR (Hexaplex) will be performed for RSV detectionRSV detection

• Acceptable specimens include:Acceptable specimens include:

– Nasal wash aspirateNasal wash aspirate

– Nasal aspirateNasal aspirate

– Nasal swabNasal swab

MedImmune, Inc. Single-stranded, nonsegmented RNA virus in the paramyxoviridae...

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