Safety and Tolerability Study to Evaluate MEDI-534 in Chi... | NCT00493285

Label	Type	Description	Intervention Names
1	Active Comparator	MEDI-534 at 10^4 TCID50 at 0, 2, and 4 months (Nasal spray)	Biological: MEDI-534
2	Active Comparator	MEDI-534 at 10^5 TCID50 at 0, 2, and 4 months (Nasal Spray)	Biological: MEDI-534
3	Active Comparator	MEDI-534 at 10^6 TCID50 at 0, 2, and 4 months (Nasal Spray)	Biological: MEDI-534

Name	Type	Description	Arm Group Labels	Other Names
MEDI-534	Biological	Multiple doses of MEDI-534 or Placebo at 10^4 TCID50	1

Measure	Description	Time Frame
Number of Participants With Solicited Adverse Events (SEs) After Dose 1	The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.	Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With SEs After Dose 2	The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.	Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With SEs After Dose 3	The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.	Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants With Adverse Events (AEs) After Dose 1	Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.	Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With AEs After Dose 2	Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.	Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With AEs After Dose 3	Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.

Measure	Description	Time Frame
Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation	Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.	Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 28-34 days post each dose.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female whose age on the day of randomization is 6 to <24 months (reached 6th month birthday and not yet reached 2nd year birthday)
Subject is seronegative to both RSV and PIV3 at screening
Subject was the product of normal full term pregnancy (defined as >36 weeks gestation)
Subject is in general good health
Subject's legal representative is available by telephone
Written informed consent and HIPAA authorization (if applicable) obtained from the subject's legal representative
Subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator
Subject is available to complete the follow-up period, which will be through the end of RSV season (provisionally defined as 01/Apr for the United States) or 180 days after the final dose of study vaccine, whichever is later
Subject's legal representative must be willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol

Exclusion Criteria:

Any fever (equal to or greater than 100.4°F [equal to or greater than 38.0°C], regardless of route) or lower respiratory illness (Section 4.1.2) within 7 days prior to randomization
Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of vaccine
Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt through the protocol-specified blood collection 28 days after each study vaccine dosing, except that infrequent use of over-the-counter medications such as pain relievers are permitted according to the judgment of the investigator
Any current or expected receipt of immunosuppressive agents including steroids (2 mg/kg per day of prednisone or its equivalent, or equal to or greater than 20 mg/day if the subject weighs >10 kg, given daily or on alternate days for equal to or greater than 14 days); children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for equal to or greater than 30 days; the use of topical steroids is permitted according to the judgment of the investigator
History of receipt of blood transfusion or expected receipt through 30 days following final study vaccine dosing
History of receipt of immunoglobulin products or expected receipt through 30 days after study vaccine dosing
Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 30 days after final study vaccine dosing
Receipt of any live virus vaccine (excluding rotavirus vaccine) within 28 days prior to randomization or expected receipt within a 28-day window around any study vaccine dose
Receipt of any inactivated (i.e., non-live) vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any study vaccine dose
Known or suspected immunodeficiency, including HIV
Living in the same home or enrolled in the same classroom at day care with infants <24 months of age (only one child per household may be enrolled into the study)
Contact with pregnant caregiver
A household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 30 days after any study vaccine dose
A household contact who is a health care provider in contact with immunocompromised patients or who is a day care provider for infants under the age of 6 months
History of allergic reaction to any component of the study vaccine
Previous medical history, or evidence, of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the subject
Known or suspected active or chronic hepatitis infection
History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation
Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study
Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation

Name	Affiliation	Role
Elissa Malkin, D.O.	MedImmune LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Pediatric Research Division		Conway	Arkansas	72033	United States
Arkansas Pediatric Clinic

PubMed Identifier	Type	Citation	Retractions
21926667	Result	Bernstein DI, Malkin E, Abughali N, Falloon J, Yi T, Dubovsky F; MI-CP149 Investigators. Phase 1 study of the safety and immunogenicity of a live, attenuated respiratory syncytial virus and parainfluenza virus type 3 vaccine in seronegative children. Pediatr Infect Dis J. 2012 Feb;31(2):109-14. doi: 10.1097/INF.0b013e31823386f1.

ID	Title	Description
FG000	10^4 MEDI-534
FG001	10^4 PLACEBO
FG002	10^5 MEDI-534

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 Participants With Solicited Adverse Events (SEs) After Dose 1

The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.

Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose

Posted

Number

participants

Days 0-28 after Dose 1 (Dose 1 was on Day 0)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG004	10^6 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG005	10^6 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.

Units	Counts
Participants	OG00013 OG0016 OG0029 OG003

Title

Denominators

Categories

Title	Measurements
	OG00012 OG0015 OG0028 OG003

Primary

Number of Participants With SEs After Dose 2

The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.

Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose.

Posted

Number

participants

Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003

Primary

Number of Participants With SEs After Dose 3

The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.

Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose

Posted

Number

participants

Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003

Primary

Number of Participants With Adverse Events (AEs) After Dose 1

Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.

The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.

Posted

Number

participants

Days 0-28 after Dose 1 (Dose 1 was on Day 0)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo

Primary

Number of Participants With AEs After Dose 2

Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.

The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.

Posted

Number

participants

Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo

Primary

Number of Participants With AEs After Dose 3

Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.

The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.

Posted

Number

participants

Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo

Primary

Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs)

An MA-LRI was a healthcare provider-confirmed diagnosis of 1 or more of the following: wheezing, pneumonia, croup, rhonchi (not cleared with cough or suctioning), rales, bronchitis, bronchiolitis, apnea.

The safety population for MA-LRIs included randomized participants who received investigational product and had any safety follow-up.

Posted

Number

participants

Days 0 to 180 days after final dose or the end of the RSV season, whichever was later

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.

Primary

Number of Participants With Serious Adverse Events (SAEs)

Events resulting in death; were life-threatening; resulted in inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and may have jeopardized the participant and required medical/surgical intervention to prevent one of the above outcomes.

The safety population included all subjects who received investigational product for the specified dose and had any safety follow-up.

Posted

Number

participants

Days 0-28 after any dose

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.

Primary

Number of Participants With Significant New Medical Conditions (SNMCs)

A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.

Safety population was participants who received investigational product and had any safety follow-up for ≥ 1 day after dosing (ie, did not discontinue on Day 0 after receiving Dose 1).

Posted

Number

participants

Day 0 through 180 days after the final dose or through the end of the RSV season, whichever was later

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.

Secondary

Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation

Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.

The shedding population included all subjects who received investigational product and had any valid shedding data.

Posted

Number

participants

Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 28-34 days post each dose.

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.

Secondary

Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1

Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.

The shedding population included all subjects who received investigational product and had any valid shedding data.

Posted

Number

participants

Days 7-10 after Dose 1 (Dose 1 was on Day 0)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo

Secondary

Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1

Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.

The shedding population included all subjects who received investigational product and had any valid shedding data.

Posted

Number

participants

Days 12-18 after Dose 1 (Dose 1 was on Day 0)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo

Secondary

Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1

Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.

The shedding population included all subjects who received investigational product and had any valid shedding data.

Posted

Number

participants

Days 28-34 after Dose 1 (Dose 1 was on Day 0)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo

Secondary

Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1

Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.

The shedding population included all subjects who received investigational product and had any valid shedding data.

Posted

Number

participants

Days 0-34 after Dose 1 (Dose 1 was on Day 0)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo

Secondary

Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2

Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.

The shedding population included all subjects who received investigational product and had any valid shedding data.

Posted

Number

participants

Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo

Secondary

Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2

Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.

The shedding population included all subjects who received investigational product and had any valid shedding data.

Posted

Number

participants

Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo

Secondary

Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2

Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.

The shedding population included all subjects who received investigational product and had any valid shedding data.

Posted

Number

participants

Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo

Secondary

Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2

Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.

The shedding population included all subjects who received investigational product and had any valid shedding data.

Posted

Number

participants

Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo

Secondary

Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3

Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.

The shedding population included all subjects who received investigational product and had any valid shedding data.

Posted

Number

participants

Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo

Secondary

Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3

Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.

The shedding population included all subjects who received investigational product and had any valid shedding data.

Posted

Number

participants

Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo

Secondary

Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3

Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.

The shedding population included all subjects who received investigational product and had any valid shedding data.

Posted

Number

participants

Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo

Secondary

Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3

Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.

The shedding population included all subjects who received investigational product and had any valid shedding data.

Posted

Number

participants

Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo

Secondary

Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline

Pre-dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.

The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.

Posted

Mean

95% Confidence Interval

GMT

Baseline (Day 0 prior to Dose 1)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003

Secondary

Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1

Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.

The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.

Posted

Mean

95% Confidence Interval

GMT

Day 28-34 after Dose 1 (Dose 1 was on Day 0)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.

Secondary

Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2

Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.

The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.

Posted

Mean

95% Confidence Interval

GMT

Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.

Secondary

Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3

Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.

The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.

Posted

Mean

95% Confidence Interval

GMT

Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.

Secondary

Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline

Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.

The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.

Posted

Mean

95% Confidence Interval

GMT

Baseline (Day 0 prior to Dose 1)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.

Secondary

Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1

Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.

The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.

Posted

Mean

95% Confidence Interval

GMT

Day 28-34 after Dose 1 (Dose 1 was on Day 0)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.

Secondary

Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2

Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.

The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.

Posted

Mean

95% Confidence Interval

GMT

Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.

Secondary

Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3

Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.

The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.

Posted

Mean

95% Confidence Interval

GMT

Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.

Secondary

Number of Participants With Seroresponse to RSV 28 Days After Dose 1

Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.

The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.

Posted

Number

participants

Days 28-34 after Dose 1 (Dose 1 was on Day 0)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo

Secondary

Number of Participants With Seroresponse to RSV 28 Days After Dose 2

Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.

The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.

Posted

Number

participants

Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003	10^5 Placebo

Secondary

Number of Participants With Seroresponse to RSV 28 Days After Dose 3

Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.

The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.

Posted

Number

participants

Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG003

Secondary

Number of Participants With Seroresponse to PIV3 28 Days After Dose 1

Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.

The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.

Posted

Number

participants

Days 28-34 after Dose 1 (Dose 1 was on Day 0)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.

Secondary

Number of Participants With Seroresponse to PIV3 28 Days After Dose 2

Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.

Posted

Number

participants

Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.

Secondary

Number of Participants With Seroresponse to PIV3 28 Days After Dose 3

Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.

Posted

Number

participants

Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

ID	Title	Description
OG000	10^4 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
OG001	10^4 Placebo	Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
OG002	10^5 MEDI-534	MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG0031 events1 affected6 at risk EG0040 events0 affected10 at risk EG0051 events1 affected5 at risk
Tachycardia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Middle ear effusion	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Tympanic membrane disorder	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0022 events1 affected9 at risk EG003
Tympanic membrane hyperaemia	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0023 events3 affected9 at risk EG003
Eye discharge	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected6 at risk EG0020 events0 affected9 at risk EG003
Eye disorder	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Eye swelling	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Eyelid margin crusting	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0008 events5 affected13 at risk EG0014 events3 affected6 at risk EG0026 events3 affected9 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Faeces discoloured	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0011 events1 affected6 at risk EG0020 events0 affected9 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Infantile spitting up	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Teething	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00013 events6 affected13 at risk EG0010 events0 affected6 at risk EG0025 events3 affected9 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected13 at risk EG0012 events2 affected6 at risk EG0025 events3 affected9 at risk EG003
Pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected6 at risk EG0020 events0 affected9 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Body tinea	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected6 at risk EG0020 events0 affected9 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected13 at risk EG0011 events1 affected6 at risk EG0020 events0 affected9 at risk EG003
Candidiasis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Croup infectious	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected13 at risk EG0011 events1 affected6 at risk EG0020 events0 affected9 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events2 affected6 at risk EG0020 events0 affected9 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Otitis media	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected13 at risk EG0011 events1 affected6 at risk EG0022 events2 affected9 at risk EG003
Otitis media acute	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected13 at risk EG0011 events1 affected6 at risk EG0020 events0 affected9 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected6 at risk EG0020 events0 affected9 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Pharyngotonsillitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Pneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Rhinitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Roseola	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Skin candida	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Tonsillitis streptococcal	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Viral rhinitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Scratch	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0021 events1 affected9 at risk EG003
Body temperature increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected13 at risk EG0011 events1 affected6 at risk EG0024 events3 affected9 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Decreased activity	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Middle insomnia	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0025 events2 affected9 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected6 at risk EG0020 events0 affected9 at risk EG003
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0023 events2 affected9 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0021 events1 affected9 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected13 at risk EG0010 events0 affected6 at risk EG0021 events1 affected9 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected6 at risk EG0020 events0 affected9 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0011 events1 affected6 at risk EG0020 events0 affected9 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected6 at risk EG0020 events0 affected9 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003
Pallor	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected6 at risk EG0020 events0 affected9 at risk EG003

ID	Title	Description
BG000	10^4 MEDI-534
BG001	10^4 PLACEBO
BG002	10^5 MEDI-534
BG003	10^5 PLACEBO
BG004	10^6 MEDI-534
BG005	10^6 PLACEBO
BG006	TOTAL	Total of all reporting groups

ID	Term
D018186	Pneumovirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections

ID	Title	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	10^4 MEDI-534	1	13	11	13
EG001	10^4 PLACEBO	0	6	5	6
EG002	10^5 MEDI-534	0	9	8	9
EG003	10^5 PLACEBO	1	6	5	6
EG004	10^6 MEDI-534	0	10	9	10
EG005	10^6 PLACEBO	0	5	3	5