Study of Motavizumab (MEDI-524) and Palivizumab Administe... | NCT00316264

Label	Type	Description	Intervention Names
Motavizumab followed by Palivizumab	Experimental	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)	Biological: Motavizumab, palivizumab
Palivizumab followed by motavizumab	Experimental	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)	Biological: Palivizumab, motavizumab
Motavizumab control	Experimental	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)	Biological: Motavizumab

Name	Type	Description	Arm Group Labels	Other Names
Motavizumab, palivizumab	Biological	Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl.

Measure	Description	Time Frame
Number of Subjects Reporting Serious Adverse Events (SAEs)		Day 0 - Day 150
Number of Subjects Reporting Adverse Events (AEs)		Day 0 - Day 150
Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.	Serum chemistry samples were collected at Day 0, Day 60, and Day 150. Values representing changes in severity according to the AE grading table were recorded as AEs.	Day 0 - Day 150

Measure	Description	Time Frame
The Serum Concentrations of Motavizumab at Day 0		Day 0
The Trough Serum Concentrations of Motavizumab at Day 60		Day 60
The Trough Serum Concentrations of Motavizumab at Day 150

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The child must have been born at less than or equal to 35 weeks gestation and be less than or equal to 6 months of age at the time of entry into the study (child must be entered on or before his/her 6-month birthday); or the child must be less than or equal to 24 months of age at the time of entry into the study (child must be entered on or before his/her 24-month birthday) and diagnosed with chronic lung disease (CLD) of prematurity with stable or decreasing doses of diuretics, steroids, or bronchodilators, or treatment with supplemental oxygen, within the previous 6 months.
The child must be in general good health at the time of study entry.
The child's parent(s)/legal guardian must provide written informed consent.
The child must be able to complete the follow-up visits through 120-150 days from last injection of study drug.
Parent(s)/legal guardian of patient must have available telephone access.

Exclusion Criteria:

Hospitalized at the time of study entry (unless discharge is expected within 10 days after entry into the study)
Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure [CPAP])
Congenital heart disease (CHD) (children with medically or surgically corrected [closed] patent ductus arteriosus and no other CHD may be enrolled)
Evidence of infection with hepatitis A, B, or C virus
Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection (a child of a mother with known HIV infection must be proven to be uninfected at the time of enrollment)
Suspected serious allergic or immune-mediated events with prior receipt of palivizumab
Acute illness or progressive clinical disorder
Active infection, including acute RSV infection, at the time of enrollment
Previous reaction to intravenous immunoglobulin (IGIV), blood products, or other foreign proteins
Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV [RespiGam], IVIG, or palivizumab) or any investigational agents
Previous participation in a clinical trial of motavizumab
Currently participating in any investigational study

Name	Affiliation	Role
Pamela Griffin, M.D.	MedImmune LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Department of Paediatrics and Child Health, The Canberra Hospital		Garran	Australian Capital Territory	2605	Australia

PubMed Identifier	Type	Citation	Retractions
20525274	Result	Fernandez P, Trenholme A, Abarca K, Griffin MP, Hultquist M, Harris B, Losonsky GA; Motavizumab Study Group. A phase 2, randomized, double-blind safety and pharmacokinetic assessment of respiratory syncytial virus (RSV) prophylaxis with motavizumab and palivizumab administered in the same season. BMC Pediatr. 2010 Jun 3;10:38. doi: 10.1186/1471-2431-10-38.

ID	Title	Description
FG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
FG001	Palivizumab Followed by Motavizumab (MEDI-524)

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects Reporting Serious Adverse Events (SAEs)

The safety population included all randomized subjects who received study drug and had any safety follow-up.

Posted

Number

participants

Day 0 - Day 150

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Units	Counts
Participants	OG00083 OG00183 OG00293

Title

Denominators

Categories

Title	Measurements
	OG00019 OG0017 OG00211

Primary

Number of Subjects Reporting Adverse Events (AEs)

The safety population included all randomized subjects who received study drug and had any safety follow-up.

Posted

Number

participants

Day 0 - Day 150

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Units	Counts
Participants

Primary

Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.

Serum chemistry samples were collected at Day 0, Day 60, and Day 150. Values representing changes in severity according to the AE grading table were recorded as AEs.

The safety population included all randomized subjects who received study drug and had any safety follow-up.

Posted

Number

participants

Day 0 - Day 150

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Secondary

The Serum Concentrations of Motavizumab at Day 0

The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.

Posted

Mean

Standard Deviation

μg/mL

Day 0

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Secondary

The Trough Serum Concentrations of Motavizumab at Day 60

Posted

Mean

Standard Deviation

μg/mL

Day 60

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Secondary

The Trough Serum Concentrations of Motavizumab at Day 150

Posted

Mean

Standard Deviation

μg/mL

Day 150

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Secondary

The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose

Posted

Mean

Standard Deviation

μg/mL

120-150 days post final dose

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Secondary

The Serum Concentrations of Palivizumab at Day 0

Posted

Mean

Standard Deviation

μg/mL

Day 0

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Secondary

The Trough Serum Concentrations of Palivizumab at Day 60

Posted

Mean

Standard Deviation

μg/mL

Day 60

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Secondary

The Trough Serum Concentrations of Palivizumab at Day 150

Posted

Mean

Standard Deviation

μg/mL

Day 150

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Secondary

The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose

Posted

Mean

Standard Deviation

μg/mL

120-150 days post final dose

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Secondary

The Immunogenicity of Motavizumab at Day 0

Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.

Posted

Number

participants with detected antibody

Day 0

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Secondary

The Immunogenicity of Motavizumab at Day 60

Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.

Posted

Number

participants with detected antibody

Day 60

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Secondary

The Immunogenicity of Motavizumab at Day 150

Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.

Posted

Number

participants with detected antibody

Day 150

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Secondary

The Immunogenicity of Motavizumab at 120 to 150 Days Post Final Dose

Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.

Posted

Number

participants with detected antibody

120 - 150 days post final dose

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control

Secondary

The Immunogenicity of Motavizumab at Any Time

Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.

Posted

Number

participants with detected antibody

At any time

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Secondary

The Immunogenicity of Palivizumab at Day 0

Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.

Posted

Number

participants with detected antibody

Day 0

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Secondary

The Immunogenicity of Palivizumab at Day 60

Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.

Posted

Number

participants with detected antibody

Day 60

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Secondary

The Immunogenicity of Palivizumab at Day 150

Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.

Posted

Number

participants with detected antibody

Day 150

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Secondary

The Immunogenicity of Palivizumab at 120 to 150 Days Post Final Dose

Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.

Posted

Number

participants with detected antibody

120 - 150 days post final pose

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control

Secondary

The Immunogenicity of Palivizumab at Any Time

Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.

Posted

Number

participants with detected antibody

At any time

ID	Title	Description
OG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
OG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Visual disturbance	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected83 at risk EG0020 events0 affected93 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected83 at risk EG0021 events1 affected93 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected83 at risk EG0020 events0 affected93 at risk
INFANTILE COLIC	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected83 at risk EG0021 events1 affected93 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0012 events2 affected83 at risk EG0021 events1 affected93 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected83 at risk EG0021 events1 affected93 at risk
BRONCHIOLITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected83 at risk EG0011 events1 affected83 at risk EG0023 events3 affected93 at risk
BRONCHITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events1 affected83 at risk EG0010 events0 affected83 at risk EG0020 events0 affected93 at risk
BRONCHITIS VIRAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected83 at risk EG0020 events0 affected93 at risk
CROUP INFECTIOUS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected83 at risk EG0020 events0 affected93 at risk
GASTROENTERITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected83 at risk EG0020 events0 affected93 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected83 at risk EG0020 events0 affected93 at risk
PARAINFLUENZAE VIRUS INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected83 at risk EG0020 events0 affected93 at risk
PNEUMONIA	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0004 events3 affected83 at risk EG0010 events0 affected83 at risk EG0021 events1 affected93 at risk
PNEUMONIA INFLUENZAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected83 at risk EG0020 events0 affected93 at risk
PNEUMONIA PARAINFLUENZAE VIRAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected83 at risk EG0021 events1 affected93 at risk
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected83 at risk EG0021 events1 affected93 at risk
RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLIT	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected83 at risk EG0021 events1 affected93 at risk
RESPIRATORY TRACT INFECTION VIRAL	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected83 at risk EG0020 events0 affected93 at risk
SEPSIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected83 at risk EG0020 events0 affected93 at risk
STAPHYLOCOCCAL SCALDED SKIN SYNDROME	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected83 at risk EG0020 events0 affected93 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0012 events1 affected83 at risk EG0020 events0 affected93 at risk
VIRAL INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected83 at risk EG0020 events0 affected93 at risk
LIVER FUNCTION TEST ABNORMAL	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected83 at risk EG0021 events1 affected93 at risk
APNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected83 at risk EG0021 events1 affected93 at risk
WHEEZING	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected83 at risk EG0020 events0 affected93 at risk
ERYTHEMA MULTIFORME	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected83 at risk EG0020 events0 affected93 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected83 at risk EG0016 events6 affected83 at risk EG0023 events3 affected93 at risk
CONJUNCTIVITIS	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected83 at risk EG00111 events11 affected83 at risk EG00216 events16 affected93 at risk
ANAEMIA NEONATAL	Blood and lymphatic system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected83 at risk EG0024 events4 affected93 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0005 events4 affected83 at risk EG0011 events1 affected83 at risk EG0023 events3 affected93 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0008 events6 affected83 at risk EG0016 events6 affected83 at risk EG00210 events6 affected93 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00013 events12 affected83 at risk EG00115 events13 affected83 at risk EG00213 events11 affected93 at risk
FLATULENCE	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events1 affected83 at risk EG0012 events2 affected83 at risk EG0025 events3 affected93 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected83 at risk EG0019 events7 affected83 at risk EG0027 events7 affected93 at risk
INFANTILE COLIC	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0013 events1 affected83 at risk EG0022 events2 affected93 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0012 events2 affected83 at risk EG0024 events4 affected93 at risk
TEETHING	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00024 events10 affected83 at risk EG00114 events9 affected83 at risk EG00227 events16 affected93 at risk
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0012 events2 affected83 at risk EG0022 events2 affected93 at risk
VOMITING	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected83 at risk EG0012 events2 affected83 at risk EG0021 events1 affected93 at risk
INJECTION SITE ERYTHEMA	General disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events3 affected83 at risk EG0019 events9 affected83 at risk EG00213 events8 affected93 at risk
IRRITABILITY	General disorders	MedDRA (11.1)	Systematic Assessment	EG00027 events10 affected83 at risk EG00132 events11 affected83 at risk EG00243 events11 affected93 at risk
PYREXIA	General disorders	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected83 at risk EG0018 events8 affected83 at risk EG00211 events11 affected93 at risk
IMMUNISATION REACTION	Immune system disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected83 at risk EG0016 events4 affected83 at risk EG0022 events2 affected93 at risk
BRONCHIOLITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0007 events6 affected83 at risk EG0016 events6 affected83 at risk EG0022 events2 affected93 at risk
BRONCHITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00021 events14 affected83 at risk EG00127 events20 affected83 at risk EG00229 events19 affected93 at risk
CANDIDA NAPPY RASH	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected83 at risk EG0013 events3 affected83 at risk EG0022 events2 affected93 at risk
CANDIDIASIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0013 events3 affected83 at risk EG0021 events1 affected93 at risk
EAR INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0013 events2 affected83 at risk EG0021 events1 affected93 at risk
GASTROENTERITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0008 events7 affected83 at risk EG0014 events4 affected83 at risk EG0025 events5 affected93 at risk
GASTROENTERITIS ROTAVIRUS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected83 at risk EG0022 events2 affected93 at risk
GENITAL CANDIDIASIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected83 at risk EG0014 events3 affected83 at risk EG0021 events1 affected93 at risk
LARYNGITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected83 at risk EG0014 events3 affected83 at risk EG0021 events1 affected93 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00012 events7 affected83 at risk EG0018 events6 affected83 at risk EG00211 events6 affected93 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00035 events25 affected83 at risk EG00140 events26 affected83 at risk EG00237 events23 affected93 at risk
ORAL CANDIDIASIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0003 events2 affected83 at risk EG0015 events5 affected83 at risk EG0022 events2 affected93 at risk
OTITIS MEDIA	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0005 events4 affected83 at risk EG0014 events4 affected83 at risk EG0024 events4 affected93 at risk
OTITIS MEDIA ACUTE	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected83 at risk EG0025 events5 affected93 at risk
PHARYNGITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0007 events7 affected83 at risk EG0014 events4 affected83 at risk EG00210 events10 affected93 at risk
RASH PUSTULAR	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected83 at risk EG0010 events0 affected83 at risk EG0022 events2 affected93 at risk
RHINITIS	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00012 events10 affected83 at risk EG00118 events14 affected83 at risk EG0028 events8 affected93 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00028 events17 affected83 at risk EG00122 events15 affected83 at risk EG00225 events18 affected93 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected83 at risk EG0022 events2 affected93 at risk
VARICELLA	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected83 at risk EG0012 events2 affected83 at risk EG0022 events2 affected93 at risk
VIRAL INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected83 at risk EG0012 events2 affected83 at risk EG0024 events3 affected93 at risk
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected83 at risk EG0023 events3 affected93 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0011 events1 affected83 at risk EG0022 events2 affected93 at risk
PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0012 events2 affected83 at risk EG0021 events1 affected93 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected83 at risk EG0025 events5 affected93 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected83 at risk EG0013 events3 affected83 at risk EG0022 events2 affected93 at risk
BLOOD UREA INCREASED	Investigations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0012 events1 affected83 at risk EG0023 events3 affected93 at risk
CARDIAC MURMUR	Investigations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected83 at risk EG0011 events1 affected83 at risk EG0022 events2 affected93 at risk
HYPERTONIA	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0005 events5 affected83 at risk EG0011 events1 affected83 at risk EG0020 events0 affected93 at risk
PSYCHOMOTOR SKILLS IMPAIRED	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected83 at risk EG0022 events2 affected93 at risk
AGITATION	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected83 at risk EG0013 events2 affected83 at risk EG0022 events2 affected93 at risk
BREATH HOLDING	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events2 affected83 at risk EG0010 events0 affected83 at risk EG0020 events0 affected93 at risk
GENITAL RASH	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events1 affected83 at risk EG0011 events1 affected83 at risk EG0022 events2 affected93 at risk
BRONCHIAL HYPERREACTIVITY	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0010 events0 affected83 at risk EG0023 events3 affected93 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0007 events6 affected83 at risk EG0015 events4 affected83 at risk EG0026 events5 affected93 at risk
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0008 events7 affected83 at risk EG0011 events1 affected83 at risk EG0023 events3 affected93 at risk
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG00012 events3 affected83 at risk EG0016 events5 affected83 at risk EG0022 events1 affected93 at risk
WHEEZING	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG00021 events15 affected83 at risk EG00111 events8 affected83 at risk EG00212 events10 affected93 at risk
DERMATITIS ATOPIC	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected83 at risk EG0013 events3 affected83 at risk EG0021 events1 affected93 at risk
DERMATITIS DIAPER	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0005 events5 affected83 at risk EG00112 events10 affected83 at risk EG00216 events10 affected93 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected83 at risk EG0012 events1 affected83 at risk EG0026 events4 affected93 at risk
ECZEMA	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0017 events5 affected83 at risk EG0027 events4 affected93 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0011 events1 affected83 at risk EG0022 events2 affected93 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected83 at risk EG0016 events5 affected83 at risk EG0026 events4 affected93 at risk
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected83 at risk EG0010 events0 affected83 at risk EG0022 events2 affected93 at risk
SEBORRHOEIC DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0005 events4 affected83 at risk EG0011 events1 affected83 at risk EG0025 events5 affected93 at risk

ID	Term
D018357	Respiratory Syncytial Virus Infections
D047928	Premature Birth

ID	Term
D018186	Pneumovirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
BG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
BG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Motavizumab (MEDI-524) Followed by Palivizumab	2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)	19	83	75	83
EG001	Palivizumab Followed by Motavizumab (MEDI-524)	2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)	7	83	74	83
EG002	Motavizumab (MEDI-524) Control	5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)	11	93	83	93