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A Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to <24 Month-old Children and in 2 Month-old Infants

A Phase 1/2a, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-old Children and in 2 Month-old Infants

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00686075
Enrollment
1338
Registered
2008-05-29
Start date
2008-06-30
Completion date
2012-08-31
Last updated
2014-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Respiratory Syncytial Virus (RSV), Parainfluenza Virus Type 3 (PIV3), MEDI-534

Brief summary

Primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 in children 6 to less than (\<) 24 months of age and in infants 2 months of age.

Detailed description

This is a Phase 1/2a, randomized, double-blind, placebo-controlled, dose-escalation, multicenter study to evaluate the safety and tolerability of multiple doses of MEDI-534 at 10\^5 or 10\^6 median tissue culture infectious dose (TCID50) in RSV and PIV3 seronegative children 6 to \<24 months of age and at dosages of 10\^4, 10\^5 or 10\^6 TCID50 in unscreened infants 2 months of age.

Interventions

BIOLOGICALMEDI-534, Cohort 1

Participants aged 6 to less than (\<) 24 months will receive MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.

OTHERPlacebo, Cohort 1

Participants aged 6 to \<24 months will receive placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.

BIOLOGICALMEDI-534, Cohort 2

Participants aged 6 to \<24 months will receive MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.

OTHERPlacebo, Cohort 2

Participants aged 6 to \<24 months will receive placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.

BIOLOGICALMEDI-534, Cohort 3

Participants aged 2 months will receive MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.

OTHERPlacebo, Cohort 3

Participants aged 2 months will receive placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.

BIOLOGICALMEDI-534, Cohort 4

Participants aged 2 months will receive MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.

OTHERPlacebo, Cohort 4

Participants aged 2 months will receive placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.

BIOLOGICALMEDI-534, Cohort 5

Participants aged 2 months will receive MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.

OTHERPlacebo, Cohort 5

Participants aged 2 months will receive placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.

Sponsors

MedImmune LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
2 Months to 23 Months
Healthy volunteers
Yes

Inclusion criteria

* Male or female whose age on the day of randomization falls within one of the two age groups: 6 to less than (\<) 24 months (more than \[\>\] 6 months of age and not yet reached their 2nd year birthday), Cohorts 1 and 2 2 months (+/- 4 weeks), Cohorts 3, 4, and 5 * Cohorts 1 and 2 only: Subject is seronegative to both Respiratory Syncytial Virus (RSV) and human Parainfluenza Virus Type 3 (hPIV3) at Screening * Subject whose gestational age was greater than or equal to (\>=) 36 weeks * Subject is in general good health with normal growth (that is, body weight greater than (\>) third percentile per world health organization \[WHO\] simplified weight-per-age field tables * Subject's legal representative is available by telephone * Written informed consent and Health Insurance Portability and Accountability Act (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 1-year after receipt of the first dose of study vaccine * 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 (\>=100.4 degrees Fahrenheit \[\>=38.0 degrees Celsius\], regardless of route) or lower respiratory illness within 7 days prior to randomization * Moderate or severe nasal congestion that in the investigator's opinion could interfere with intranasal delivery of study vaccine * Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization * 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 for the systemic treatment of common childhood symptoms (that is, pain relievers, decongestants or cough suppressants) are permitted according to the judgment of the investigator * Any current or expected receipt of immunosuppressive agents including steroids (\>=2 milligram per kilogram \[mg/kg\] per day of prednisone or its equivalent, or \>=20 milligram per day \[mg/day\] if the subject weighs \>10 kilogram \[kg\], given daily or on alternate days for \>=14 days); children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for \>=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 the protocol-specified blood collection at 28 days after final study dosing * History of receipt of immunoglobulin products or expected receipt through the protocol-specified blood collection at 28 days after final study dosing * Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 180 days after final study dosing * Receipt of any live virus vaccine (excluding oral polio vaccine and 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 (that is, non-live) vaccine or oral polio 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 human immunodeficiency virus (HIV) infection * Expected to be living in the same home or enrolled in the same classroom at day care with infants \<6 months within 28 days after each dose * Living in a household with another child who is concurrently enrolled in a study of a live viral vaccine (including this study) * Expected contact with a pregnant caregiver within 28 days after each dose * A household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 28 days after any study vaccine dose * Expected household contact within 28 days after each dose with a health care provider for immunocompromised subjects 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 for respiratory illness (excludes elective mechanical ventilation during surgery for subjects in Cohorts 1 and 2) * 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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 3Within 28 days after Dose 3An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 3Within 28 days after Dose 3An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 3 are events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 3 were reported.
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 1Within 28 days after Dose 1An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 1 were reported.
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 2Within 28 days after Dose 2An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 2 were reported.
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 3Within 28 days after Dose 3An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 3 were reported.
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1Within 28 days after Dose 1An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 2Within 28 days after Dose 2An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.
Number of Participants With Solicited Symptoms After Dose 1Within 28 days after Dose 1Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever greater than or equal to (\>=) 100.4 degrees Fahrenheit (F), runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Number of Participants With Solicited Symptoms After Dose 2Within 28 days after Dose 2Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever \>=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Number of Participants With Solicited Symptoms After Dose 3Within 28 days after Dose 3Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever \>=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1Within 28 days after Dose 1An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) for Dose 1 are events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 1 were reported.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 2Within 28 days after Dose 2An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 2 are events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 2 were reported.

Secondary

MeasureTime frameDescription
Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3Day 28 after Dose 3Seroresponse was defined as a \>=4-fold rise from Baseline in neutralizing antibody titer, regardless of Baseline serostatus. Respiratory Syncytial Virus (RSV) and hPIV3 antibody titers were determined by using microneutralization assay and hemagglutination inhibition assay, respectively. Clopper-pearson exact confidence interval was reported.
Genotypic Stability of Recovered Vaccine-Type VirusWithin 28 days after any doseNasal wash samples with vaccine-type virus were evaluated for genotypic stability, defined as the presence of the entire RSV-Fusion (RSV F) insert based on the RSV F sequence results. If the insert was absent or truncated, the recovered virus was counted as genotypically unstable. Nasal wash samples were categorized as genotypically stable, genotypically unstable or undetermined genotypic stability.
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationDay 0 to Day 365An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea. MA-LRIs occurring within 28 days post any dose and after 28 days post any dose were summarized separately.
Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After RandomizationDay 0 to Day 365An SNMC was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of SNMCs include diabetes, asthma, autoimmune disease (for example, lupus, rheumatoid arthritis), and neurological disease (for example, epilepsy, autism).
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After RandomizationDay 0 to Day 365An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events after administration of drug which were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) within 365 days after randomization were reported.
Number of Participants Who Shed Vaccine-Type Virus7, 12 and 28 days after Dose 1, 2 and 3Nasal wash specimens were collected to assess vaccine virus recovery in the upper respiratory tract on 7, 12 and 28 days after each dosing.

Countries

Australia, Brazil, Canada, Finland, Germany, Israel, South Africa, Spain, United States

Participant flow

Recruitment details

A total of 720 participants were randomized in the study. An additional 618 participants were screened but not randomized in the study.

Participants by arm

ArmCount
MEDI-534, Cohort 1
Participants aged 6 to less than (\<) 24 months received MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
79
Placebo, Cohort 1
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
81
MEDI-534, Cohort 2
Participants aged 6 to \<24 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
80
Placebo, Cohort 2
Participants aged 6 to \<24 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
80
MEDI-534, Cohort 3
Participants aged 2 months received MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
40
Placebo, Cohort 3
Participants aged 2 months received placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.
40
MEDI-534, Cohort 4
Participants aged 2 months received MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
82
Placebo, Cohort 4
Participants aged 2 months received placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.
78
MEDI-534, Cohort 5
Participants aged 2 months received MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
81
Placebo, Cohort 5
Participants aged 2 months received placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
79
Total720

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009
Overall StudyLost to Follow-up3632330023
Overall StudyOther1100000001
Overall StudyWithdrawal by Subject4337100246

Baseline characteristics

CharacteristicTotalMEDI-534, Cohort 1Placebo, Cohort 1MEDI-534, Cohort 2Placebo, Cohort 2MEDI-534, Cohort 3Placebo, Cohort 3MEDI-534, Cohort 4Placebo, Cohort 4MEDI-534, Cohort 5Placebo, Cohort 5
Age, Customized
6 to <24 months
320 participants79 participants81 participants80 participants80 participants0 participants0 participants0 participants0 participants0 participants0 participants
Age, Customized
Less than (<) 6 months
400 participants0 participants0 participants0 participants0 participants40 participants40 participants82 participants78 participants81 participants79 participants
Sex: Female, Male
Female
360 Participants40 Participants36 Participants35 Participants40 Participants21 Participants18 Participants47 Participants41 Participants39 Participants43 Participants
Sex: Female, Male
Male
360 Participants39 Participants45 Participants45 Participants40 Participants19 Participants22 Participants35 Participants37 Participants42 Participants36 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
65 / 7866 / 7959 / 8055 / 8022 / 4027 / 4045 / 8242 / 7750 / 8044 / 78
serious
Total, serious adverse events
6 / 785 / 795 / 801 / 801 / 402 / 403 / 824 / 779 / 803 / 78

Outcome results

Primary

Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1

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

Time frame: Within 28 days after Dose 1

Population: Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.

ArmMeasureValue (NUMBER)
MEDI-534, Cohort 1Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 12 participants
Placebo, Cohort 1Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 12 participants
MEDI-534, Cohort 2Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 14 participants
Placebo, Cohort 2Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 14 participants
MEDI-534, Cohort 3Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 10 participants
Placebo, Cohort 3Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 10 participants
MEDI-534, Cohort 4Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 11 participants
Placebo, Cohort 4Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 10 participants
MEDI-534, Cohort 5Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 10 participants
Placebo, Cohort 5Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 12 participants
Primary

Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 2

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

Time frame: Within 28 days after Dose 2

Population: Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.

ArmMeasureValue (NUMBER)
MEDI-534, Cohort 1Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 23 participants
Placebo, Cohort 1Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 23 participants
MEDI-534, Cohort 2Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 21 participants
Placebo, Cohort 2Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 23 participants
MEDI-534, Cohort 3Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 21 participants
Placebo, Cohort 3Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 22 participants
MEDI-534, Cohort 4Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 20 participants
Placebo, Cohort 4Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 22 participants
MEDI-534, Cohort 5Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 23 participants
Placebo, Cohort 5Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 21 participants
Primary

Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 3

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

Time frame: Within 28 days after Dose 3

Population: Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.

ArmMeasureValue (NUMBER)
MEDI-534, Cohort 1Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 33 participants
Placebo, Cohort 1Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 30 participants
MEDI-534, Cohort 2Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 37 participants
Placebo, Cohort 2Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 33 participants
MEDI-534, Cohort 3Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 32 participants
Placebo, Cohort 3Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 32 participants
MEDI-534, Cohort 4Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 31 participants
Placebo, Cohort 4Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 31 participants
MEDI-534, Cohort 5Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 37 participants
Placebo, Cohort 5Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 34 participants
Primary

Number of Participants With Solicited Symptoms After Dose 1

Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever greater than or equal to (\>=) 100.4 degrees Fahrenheit (F), runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.

Time frame: Within 28 days after Dose 1

Population: Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.

ArmMeasureGroupValue (NUMBER)
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Any solicited symptom65 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Drowsiness26 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Fever: 100.4 to 101.4 degrees F13 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Oropharyngeal inflammation9 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Fever: 103.2 to 104.9 degrees F3 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Irritability/fussiness40 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Cough27 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Fever: greater than (>) 104.9 degrees F0 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Runny/stuffy nose50 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Epistaxis4 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Loss of appetite/decreased urine output22 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Fever: 101.5 to 103.1 degrees F9 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Drowsiness29 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Fever: 103.2 to 104.9 degrees F1 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Any solicited symptom68 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Epistaxis0 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Irritability/fussiness46 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Loss of appetite/decreased urine output26 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Fever: 101.5 to 103.1 degrees F8 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Fever: 100.4 to 101.4 degrees F8 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Oropharyngeal inflammation12 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Cough30 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Runny/stuffy nose51 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 1Fever: greater than (>) 104.9 degrees F0 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Fever: greater than (>) 104.9 degrees F0 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Epistaxis4 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Any solicited symptom61 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Fever: 100.4 to 101.4 degrees F10 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Fever: 101.5 to 103.1 degrees F6 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Fever: 103.2 to 104.9 degrees F1 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Runny/stuffy nose50 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Cough33 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Drowsiness21 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Loss of appetite/decreased urine output21 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Irritability/fussiness41 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Oropharyngeal inflammation7 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Fever: 103.2 to 104.9 degrees F1 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Cough24 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Irritability/fussiness44 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Fever: 101.5 to 103.1 degrees F8 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Oropharyngeal inflammation8 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Loss of appetite/decreased urine output21 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Epistaxis5 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Any solicited symptom59 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Runny/stuffy nose40 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Fever: greater than (>) 104.9 degrees F0 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Fever: 100.4 to 101.4 degrees F8 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 1Drowsiness21 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Drowsiness10 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Cough11 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Fever: 100.4 to 101.4 degrees F4 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Oropharyngeal inflammation2 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Fever: greater than (>) 104.9 degrees F0 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Fever: 103.2 to 104.9 degrees F0 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Irritability/fussiness16 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Any solicited symptom27 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Loss of appetite/decreased urine output7 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Epistaxis1 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Runny/stuffy nose19 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Fever: 101.5 to 103.1 degrees F1 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Oropharyngeal inflammation2 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Fever: 103.2 to 104.9 degrees F1 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Fever: greater than (>) 104.9 degrees F0 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Fever: 100.4 to 101.4 degrees F4 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Runny/stuffy nose15 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Epistaxis1 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Cough8 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Drowsiness9 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Loss of appetite/decreased urine output7 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Any solicited symptom24 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Irritability/fussiness14 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 1Fever: 101.5 to 103.1 degrees F3 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Irritability/fussiness29 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Any solicited symptom50 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Fever: greater than (>) 104.9 degrees F0 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Fever: 100.4 to 101.4 degrees F6 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Fever: 101.5 to 103.1 degrees F1 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Epistaxis2 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Loss of appetite/decreased urine output9 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Cough19 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Drowsiness15 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Oropharyngeal inflammation5 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Fever: 103.2 to 104.9 degrees F0 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Runny/stuffy nose30 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Any solicited symptom48 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Fever: greater than (>) 104.9 degrees F0 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Fever: 103.2 to 104.9 degrees F0 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Irritability/fussiness18 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Fever: 100.4 to 101.4 degrees F1 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Drowsiness13 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Fever: 101.5 to 103.1 degrees F4 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Cough22 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Epistaxis0 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Oropharyngeal inflammation7 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Loss of appetite/decreased urine output6 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 1Runny/stuffy nose36 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Cough17 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Any solicited symptom60 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Fever: 101.5 to 103.1 degrees F2 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Drowsiness16 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Loss of appetite/decreased urine output12 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Fever: greater than (>) 104.9 degrees F0 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Epistaxis0 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Irritability/fussiness41 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Fever: 100.4 to 101.4 degrees F4 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Fever: 103.2 to 104.9 degrees F0 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Oropharyngeal inflammation3 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Runny/stuffy nose30 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Fever: 103.2 to 104.9 degrees F0 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Oropharyngeal inflammation6 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Loss of appetite/decreased urine output12 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Fever: 101.5 to 103.1 degrees F2 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Any solicited symptom53 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Fever: greater than (>) 104.9 degrees F0 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Runny/stuffy nose30 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Cough19 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Irritability/fussiness32 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Fever: 100.4 to 101.4 degrees F3 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Epistaxis1 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 1Drowsiness22 participants
Primary

Number of Participants With Solicited Symptoms After Dose 2

Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever \>=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.

Time frame: Within 28 days after Dose 2

Population: Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.

ArmMeasureGroupValue (NUMBER)
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Cough16 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Fever: 103.2 to 104.9 degrees F2 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Oropharyngeal inflammation9 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Fever: 101.5 to 103.1 degrees F13 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Epistaxis4 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Fever: >104.9 degrees F1 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Any solicited symptom50 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Drowsiness20 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Irritability/fussiness33 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Runny/stuffy nose41 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Fever: 100.4 to 101.4 degrees F16 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Loss of appetite/decreased urine output16 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Irritability/fussiness29 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Cough23 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Drowsiness13 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Epistaxis4 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Fever: 100.4 to 101.4 degrees F17 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Fever: 101.5 to 103.1 degrees F10 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Oropharyngeal inflammation5 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Fever: 103.2 to 104.9 degrees F1 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Fever: >104.9 degrees F0 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Any solicited symptom53 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Loss of appetite/decreased urine output17 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 2Runny/stuffy nose35 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Irritability/fussiness35 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Fever: 100.4 to 101.4 degrees F10 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Epistaxis2 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Fever: >104.9 degrees F0 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Fever: 101.5 to 103.1 degrees F9 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Cough28 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Any solicited symptom53 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Runny/stuffy nose38 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Fever: 103.2 to 104.9 degrees F3 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Oropharyngeal inflammation4 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Drowsiness15 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Loss of appetite/decreased urine output14 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Fever: 101.5 to 103.1 degrees F8 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Any solicited symptom45 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Irritability/fussiness25 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Fever: 100.4 to 101.4 degrees F11 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Fever: 103.2 to 104.9 degrees F1 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Epistaxis4 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Fever: >104.9 degrees F0 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Loss of appetite/decreased urine output17 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Drowsiness15 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Cough22 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Oropharyngeal inflammation3 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 2Runny/stuffy nose34 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Fever: 100.4 to 101.4 degrees F1 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Cough2 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Fever: 101.5 to 103.1 degrees F0 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Fever: 103.2 to 104.9 degrees F0 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Epistaxis1 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Oropharyngeal inflammation2 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Loss of appetite/decreased urine output3 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Runny/stuffy nose10 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Fever: >104.9 degrees F0 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Drowsiness5 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Irritability/fussiness8 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Any solicited symptom12 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Drowsiness4 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Any solicited symptom19 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Fever: 100.4 to 101.4 degrees F2 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Fever: 101.5 to 103.1 degrees F1 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Fever: 103.2 to 104.9 degrees F0 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Fever: >104.9 degrees F0 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Runny/stuffy nose15 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Cough7 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Loss of appetite/decreased urine output4 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Irritability/fussiness6 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Oropharyngeal inflammation1 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 2Epistaxis0 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Irritability/fussiness13 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Oropharyngeal inflammation4 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Fever: 101.5 to 103.1 degrees F3 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Cough15 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Runny/stuffy nose25 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Fever: >104.9 degrees F0 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Any solicited symptom38 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Epistaxis0 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Loss of appetite/decreased urine output9 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Drowsiness11 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Fever: 100.4 to 101.4 degrees F8 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Fever: 103.2 to 104.9 degrees F1 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Drowsiness7 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Irritability/fussiness14 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Runny/stuffy nose30 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Fever: 103.2 to 104.9 degrees F0 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Fever: 101.5 to 103.1 degrees F1 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Epistaxis1 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Fever: 100.4 to 101.4 degrees F4 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Loss of appetite/decreased urine output11 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Cough21 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Oropharyngeal inflammation2 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Fever: >104.9 degrees F0 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 2Any solicited symptom42 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Fever: 103.2 to 104.9 degrees F0 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Runny/stuffy nose25 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Drowsiness7 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Fever: >104.9 degrees F0 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Loss of appetite/decreased urine output9 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Fever: 101.5 to 103.1 degrees F1 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Irritability/fussiness22 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Fever: 100.4 to 101.4 degrees F1 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Epistaxis1 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Oropharyngeal inflammation7 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Any solicited symptom39 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Cough20 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Cough20 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Oropharyngeal inflammation7 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Runny/stuffy nose24 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Any solicited symptom41 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Fever: >104.9 degrees F0 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Loss of appetite/decreased urine output9 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Fever: 103.2 to 104.9 degrees F0 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Epistaxis0 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Fever: 100.4 to 101.4 degrees F3 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Drowsiness10 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Irritability/fussiness21 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 2Fever: 101.5 to 103.1 degrees F0 participants
Primary

Number of Participants With Solicited Symptoms After Dose 3

Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever \>=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.

Time frame: Within 28 days after Dose 3

Population: Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.

ArmMeasureGroupValue (NUMBER)
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Runny/stuffy nose36 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Cough22 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Drowsiness12 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Loss of appetite/decreased urine output13 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Any solicited symptom41 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Epistaxis2 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Fever: >104.9 degrees F0 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Irritability/fussiness23 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Oropharyngeal inflammation9 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Fever: 101.5 to 103.1 degrees F6 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Fever: 103.2 to 104.9 degrees F0 participants
MEDI-534, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Fever: 100.4 to 101.4 degrees F8 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Runny/stuffy nose35 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Fever: 103.2 to 104.9 degrees F2 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Any solicited symptom45 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Oropharyngeal inflammation4 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Cough14 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Epistaxis1 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Fever: 100.4 to 101.4 degrees F9 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Loss of appetite/decreased urine output15 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Fever: >104.9 degrees F0 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Drowsiness9 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Fever: 101.5 to 103.1 degrees F8 participants
Placebo, Cohort 1Number of Participants With Solicited Symptoms After Dose 3Irritability/fussiness25 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Drowsiness11 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Cough20 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Epistaxis2 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Fever: 100.4 to 101.4 degrees F9 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Oropharyngeal inflammation4 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Fever: 101.5 to 103.1 degrees F6 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Fever: 103.2 to 104.9 degrees F2 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Any solicited symptom48 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Irritability/fussiness29 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Fever: >104.9 degrees F0 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Loss of appetite/decreased urine output8 participants
MEDI-534, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Runny/stuffy nose35 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Drowsiness9 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Fever: 100.4 to 101.4 degrees F9 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Epistaxis4 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Oropharyngeal inflammation2 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Fever: >104.9 degrees F0 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Cough17 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Irritability/fussiness28 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Fever: 101.5 to 103.1 degrees F9 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Any solicited symptom45 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Runny/stuffy nose28 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Fever: 103.2 to 104.9 degrees F1 participants
Placebo, Cohort 2Number of Participants With Solicited Symptoms After Dose 3Loss of appetite/decreased urine output11 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Fever: 103.2 to 104.9 degrees F0 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Any solicited symptom20 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Loss of appetite/decreased urine output8 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Oropharyngeal inflammation1 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Fever: 100.4 to 101.4 degrees F3 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Drowsiness2 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Fever: >104.9 degrees F0 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Epistaxis0 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Cough10 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Irritability/fussiness11 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Fever: 101.5 to 103.1 degrees F1 participants
MEDI-534, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Runny/stuffy nose16 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Any solicited symptom17 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Loss of appetite/decreased urine output4 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Fever: 100.4 to 101.4 degrees F6 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Fever: 101.5 to 103.1 degrees F0 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Fever: 103.2 to 104.9 degrees F0 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Fever: >104.9 degrees F0 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Runny/stuffy nose15 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Cough10 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Drowsiness6 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Irritability/fussiness8 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Oropharyngeal inflammation3 participants
Placebo, Cohort 3Number of Participants With Solicited Symptoms After Dose 3Epistaxis2 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Fever: >104.9 degrees F0 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Fever: 103.2 to 104.9 degrees F0 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Loss of appetite/decreased urine output8 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Runny/stuffy nose24 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Epistaxis0 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Drowsiness4 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Any solicited symptom36 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Fever: 100.4 to 101.4 degrees F7 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Oropharyngeal inflammation2 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Fever: 101.5 to 103.1 degrees F2 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Irritability/fussiness11 participants
MEDI-534, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Cough14 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Drowsiness4 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Runny/stuffy nose21 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Fever: >104.9 degrees F0 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Loss of appetite/decreased urine output10 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Fever: 103.2 to 104.9 degrees F0 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Epistaxis0 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Irritability/fussiness11 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Fever: 101.5 to 103.1 degrees F1 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Fever: 100.4 to 101.4 degrees F8 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Oropharyngeal inflammation4 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Any solicited symptom33 participants
Placebo, Cohort 4Number of Participants With Solicited Symptoms After Dose 3Cough15 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Fever: >104.9 degrees F0 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Irritability/fussiness20 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Fever: 100.4 to 101.4 degrees F10 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Runny/stuffy nose32 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Epistaxis0 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Cough25 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Oropharyngeal inflammation8 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Drowsiness7 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Loss of appetite/decreased urine output11 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Fever: 103.2 to 104.9 degrees F1 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Any solicited symptom48 participants
MEDI-534, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Fever: 101.5 to 103.1 degrees F4 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Fever: 101.5 to 103.1 degrees F4 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Runny/stuffy nose31 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Oropharyngeal inflammation6 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Irritability/fussiness14 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Epistaxis0 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Fever: >104.9 degrees F0 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Fever: 100.4 to 101.4 degrees F10 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Cough23 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Any solicited symptom41 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Fever: 103.2 to 104.9 degrees F0 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Drowsiness9 participants
Placebo, Cohort 5Number of Participants With Solicited Symptoms After Dose 3Loss of appetite/decreased urine output11 participants
Primary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) for Dose 1 are events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 1 were reported.

Time frame: Within 28 days after Dose 1

Population: Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.

ArmMeasureValue (NUMBER)
MEDI-534, Cohort 1Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 151 participants
Placebo, Cohort 1Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 151 participants
MEDI-534, Cohort 2Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 147 participants
Placebo, Cohort 2Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 135 participants
MEDI-534, Cohort 3Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 115 participants
Placebo, Cohort 3Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 115 participants
MEDI-534, Cohort 4Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 120 participants
Placebo, Cohort 4Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 126 participants
MEDI-534, Cohort 5Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 129 participants
Placebo, Cohort 5Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 121 participants
Primary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 2

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 2 are events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 2 were reported.

Time frame: Within 28 days after Dose 2

Population: Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.

ArmMeasureValue (NUMBER)
MEDI-534, Cohort 1Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 231 participants
Placebo, Cohort 1Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 241 participants
MEDI-534, Cohort 2Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 231 participants
Placebo, Cohort 2Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 227 participants
MEDI-534, Cohort 3Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 29 participants
Placebo, Cohort 3Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 210 participants
MEDI-534, Cohort 4Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 221 participants
Placebo, Cohort 4Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 221 participants
MEDI-534, Cohort 5Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 225 participants
Placebo, Cohort 5Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 224 participants
Primary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 3

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 3 are events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 3 were reported.

Time frame: Within 28 days after Dose 3

Population: Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.

ArmMeasureValue (NUMBER)
MEDI-534, Cohort 1Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 334 participants
Placebo, Cohort 1Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 335 participants
MEDI-534, Cohort 2Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 333 participants
Placebo, Cohort 2Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 325 participants
MEDI-534, Cohort 3Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 311 participants
Placebo, Cohort 3Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 310 participants
MEDI-534, Cohort 4Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 325 participants
Placebo, Cohort 4Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 322 participants
MEDI-534, Cohort 5Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 329 participants
Placebo, Cohort 5Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 327 participants
Primary

Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 1

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 1 were reported.

Time frame: Within 28 days after Dose 1

Population: Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.

ArmMeasureValue (NUMBER)
MEDI-534, Cohort 1Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 10 participants
Placebo, Cohort 1Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 10 participants
MEDI-534, Cohort 2Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 10 participants
Placebo, Cohort 2Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 10 participants
MEDI-534, Cohort 3Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 10 participants
Placebo, Cohort 3Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 10 participants
MEDI-534, Cohort 4Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 10 participants
Placebo, Cohort 4Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 10 participants
MEDI-534, Cohort 5Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 12 participants
Placebo, Cohort 5Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 11 participants
Primary

Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 2

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 2 were reported.

Time frame: Within 28 days after Dose 2

Population: Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.

ArmMeasureValue (NUMBER)
MEDI-534, Cohort 1Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 21 participants
Placebo, Cohort 1Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 20 participants
MEDI-534, Cohort 2Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 20 participants
Placebo, Cohort 2Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 20 participants
MEDI-534, Cohort 3Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 20 participants
Placebo, Cohort 3Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 21 participants
MEDI-534, Cohort 4Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 20 participants
Placebo, Cohort 4Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 21 participants
MEDI-534, Cohort 5Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 20 participants
Placebo, Cohort 5Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 20 participants
Primary

Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 3

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 3 were reported.

Time frame: Within 28 days after Dose 3

Population: Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.

ArmMeasureValue (NUMBER)
MEDI-534, Cohort 1Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 30 participants
Placebo, Cohort 1Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 31 participants
MEDI-534, Cohort 2Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 30 participants
Placebo, Cohort 2Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 30 participants
MEDI-534, Cohort 3Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 31 participants
Placebo, Cohort 3Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 30 participants
MEDI-534, Cohort 4Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 30 participants
Placebo, Cohort 4Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 30 participants
MEDI-534, Cohort 5Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 31 participants
Placebo, Cohort 5Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 30 participants
Secondary

Genotypic Stability of Recovered Vaccine-Type Virus

Nasal wash samples with vaccine-type virus were evaluated for genotypic stability, defined as the presence of the entire RSV-Fusion (RSV F) insert based on the RSV F sequence results. If the insert was absent or truncated, the recovered virus was counted as genotypically unstable. Nasal wash samples were categorized as genotypically stable, genotypically unstable or undetermined genotypic stability.

Time frame: Within 28 days after any dose

Population: Shedding population included all randomized participants who received study vaccine and had valid shedding data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

ArmMeasureGroupValue (NUMBER)
MEDI-534, Cohort 1Genotypic Stability of Recovered Vaccine-Type VirusUndetermined genotypic stability4 nasal wash samples
MEDI-534, Cohort 1Genotypic Stability of Recovered Vaccine-Type VirusGenotypically unstable0 nasal wash samples
MEDI-534, Cohort 1Genotypic Stability of Recovered Vaccine-Type VirusGenotypically stable77 nasal wash samples
MEDI-534, Cohort 2Genotypic Stability of Recovered Vaccine-Type VirusGenotypically stable67 nasal wash samples
MEDI-534, Cohort 2Genotypic Stability of Recovered Vaccine-Type VirusGenotypically unstable0 nasal wash samples
MEDI-534, Cohort 2Genotypic Stability of Recovered Vaccine-Type VirusUndetermined genotypic stability0 nasal wash samples
MEDI-534, Cohort 3Genotypic Stability of Recovered Vaccine-Type VirusUndetermined genotypic stability5 nasal wash samples
MEDI-534, Cohort 3Genotypic Stability of Recovered Vaccine-Type VirusGenotypically stable54 nasal wash samples
MEDI-534, Cohort 3Genotypic Stability of Recovered Vaccine-Type VirusGenotypically unstable0 nasal wash samples
Placebo, Cohort 3Genotypic Stability of Recovered Vaccine-Type VirusGenotypically unstable0 nasal wash samples
Placebo, Cohort 3Genotypic Stability of Recovered Vaccine-Type VirusGenotypically stable1 nasal wash samples
Placebo, Cohort 3Genotypic Stability of Recovered Vaccine-Type VirusUndetermined genotypic stability0 nasal wash samples
MEDI-534, Cohort 4Genotypic Stability of Recovered Vaccine-Type VirusGenotypically stable135 nasal wash samples
MEDI-534, Cohort 4Genotypic Stability of Recovered Vaccine-Type VirusGenotypically unstable0 nasal wash samples
MEDI-534, Cohort 4Genotypic Stability of Recovered Vaccine-Type VirusUndetermined genotypic stability6 nasal wash samples
MEDI-534, Cohort 5Genotypic Stability of Recovered Vaccine-Type VirusGenotypically stable110 nasal wash samples
MEDI-534, Cohort 5Genotypic Stability of Recovered Vaccine-Type VirusUndetermined genotypic stability7 nasal wash samples
MEDI-534, Cohort 5Genotypic Stability of Recovered Vaccine-Type VirusGenotypically unstable0 nasal wash samples
Secondary

Number of Participants Who Shed Vaccine-Type Virus

Nasal wash specimens were collected to assess vaccine virus recovery in the upper respiratory tract on 7, 12 and 28 days after each dosing.

Time frame: 7, 12 and 28 days after Dose 1, 2 and 3

Population: Shedding population included all randomized participants who received study vaccine and had valid shedding data after the specified dose. 'N' (number of participants analyzed) = participants who were evaluable for this measure; and 'n' = participants who were evaluable for this measure at given time points for each group, respectively.

ArmMeasureGroupValue (NUMBER)
MEDI-534, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 12 (n=59,60,61,61,28,29,76,70,70,68)1 participants
MEDI-534, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 7 (n=76,76,78,79,40,39,82,77,78,75)33 participants
MEDI-534, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 7 (n=62,65,65,63,25,26,75,70,72,68)9 participants
MEDI-534, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 12 (n=75,78,78,78,40,40,81,76,78,76)21 participants
MEDI-534, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 28 (n=76,77,77,78,39,40,82,76,77,76)2 participants
MEDI-534, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 28 (n=63,65,65,65,25,26,76,71,73,68)0 participants
MEDI-534, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 28 (n=60,60,63,61,28,30,76,70,71,68)0 participants
MEDI-534, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 7 (n=58,59,62,59,28,30,75,70,69,68)6 participants
MEDI-534, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 12 (n=63,65,65,64,25,25,76,71,72,68)2 participants
Placebo, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 12 (n=63,65,65,64,25,25,76,71,72,68)0 participants
Placebo, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 7 (n=62,65,65,63,25,26,75,70,72,68)0 participants
Placebo, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 12 (n=59,60,61,61,28,29,76,70,70,68)0 participants
Placebo, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 7 (n=58,59,62,59,28,30,75,70,69,68)0 participants
Placebo, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 12 (n=75,78,78,78,40,40,81,76,78,76)0 participants
Placebo, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 28 (n=63,65,65,65,25,26,76,71,73,68)0 participants
Placebo, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 28 (n=60,60,63,61,28,30,76,70,71,68)0 participants
Placebo, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 28 (n=76,77,77,78,39,40,82,76,77,76)0 participants
Placebo, Cohort 1Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 7 (n=76,76,78,79,40,39,82,77,78,75)0 participants
MEDI-534, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 7 (n=62,65,65,63,25,26,75,70,72,68)6 participants
MEDI-534, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 28 (n=60,60,63,61,28,30,76,70,71,68)0 participants
MEDI-534, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 28 (n=76,77,77,78,39,40,82,76,77,76)1 participants
MEDI-534, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 12 (n=63,65,65,64,25,25,76,71,72,68)1 participants
MEDI-534, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 7 (n=76,76,78,79,40,39,82,77,78,75)41 participants
MEDI-534, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 12 (n=75,78,78,78,40,40,81,76,78,76)14 participants
MEDI-534, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 7 (n=58,59,62,59,28,30,75,70,69,68)1 participants
MEDI-534, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 12 (n=59,60,61,61,28,29,76,70,70,68)0 participants
MEDI-534, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 28 (n=63,65,65,65,25,26,76,71,73,68)0 participants
Placebo, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 12 (n=63,65,65,64,25,25,76,71,72,68)0 participants
Placebo, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 7 (n=76,76,78,79,40,39,82,77,78,75)0 participants
Placebo, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 12 (n=75,78,78,78,40,40,81,76,78,76)0 participants
Placebo, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 28 (n=76,77,77,78,39,40,82,76,77,76)0 participants
Placebo, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 7 (n=62,65,65,63,25,26,75,70,72,68)0 participants
Placebo, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 28 (n=63,65,65,65,25,26,76,71,73,68)0 participants
Placebo, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 7 (n=58,59,62,59,28,30,75,70,69,68)0 participants
Placebo, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 12 (n=59,60,61,61,28,29,76,70,70,68)0 participants
Placebo, Cohort 2Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 28 (n=60,60,63,61,28,30,76,70,71,68)0 participants
MEDI-534, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 28 (n=63,65,65,65,25,26,76,71,73,68)0 participants
MEDI-534, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 12 (n=63,65,65,64,25,25,76,71,72,68)3 participants
MEDI-534, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 28 (n=60,60,63,61,28,30,76,70,71,68)0 participants
MEDI-534, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 7 (n=76,76,78,79,40,39,82,77,78,75)22 participants
MEDI-534, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 12 (n=59,60,61,61,28,29,76,70,70,68)0 participants
MEDI-534, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 7 (n=58,59,62,59,28,30,75,70,69,68)4 participants
MEDI-534, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 7 (n=62,65,65,63,25,26,75,70,72,68)5 participants
MEDI-534, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 28 (n=76,77,77,78,39,40,82,76,77,76)3 participants
MEDI-534, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 12 (n=75,78,78,78,40,40,81,76,78,76)16 participants
Placebo, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 28 (n=76,77,77,78,39,40,82,76,77,76)0 participants
Placebo, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 7 (n=62,65,65,63,25,26,75,70,72,68)0 participants
Placebo, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 12 (n=63,65,65,64,25,25,76,71,72,68)0 participants
Placebo, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 12 (n=75,78,78,78,40,40,81,76,78,76)0 participants
Placebo, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 28 (n=63,65,65,65,25,26,76,71,73,68)0 participants
Placebo, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 7 (n=58,59,62,59,28,30,75,70,69,68)1 participants
Placebo, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 7 (n=76,76,78,79,40,39,82,77,78,75)0 participants
Placebo, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 12 (n=59,60,61,61,28,29,76,70,70,68)0 participants
Placebo, Cohort 3Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 28 (n=60,60,63,61,28,30,76,70,71,68)0 participants
MEDI-534, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 7 (n=62,65,65,63,25,26,75,70,72,68)20 participants
MEDI-534, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 28 (n=60,60,63,61,28,30,76,70,71,68)1 participants
MEDI-534, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 28 (n=63,65,65,65,25,26,76,71,73,68)0 participants
MEDI-534, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 7 (n=58,59,62,59,28,30,75,70,69,68)18 participants
MEDI-534, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 7 (n=76,76,78,79,40,39,82,77,78,75)50 participants
MEDI-534, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 28 (n=76,77,77,78,39,40,82,76,77,76)4 participants
MEDI-534, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 12 (n=59,60,61,61,28,29,76,70,70,68)5 participants
MEDI-534, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 12 (n=63,65,65,64,25,25,76,71,72,68)7 participants
MEDI-534, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 12 (n=75,78,78,78,40,40,81,76,78,76)29 participants
Placebo, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 7 (n=76,76,78,79,40,39,82,77,78,75)0 participants
Placebo, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 12 (n=63,65,65,64,25,25,76,71,72,68)0 participants
Placebo, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 28 (n=76,77,77,78,39,40,82,76,77,76)0 participants
Placebo, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 7 (n=58,59,62,59,28,30,75,70,69,68)0 participants
Placebo, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 28 (n=63,65,65,65,25,26,76,71,73,68)0 participants
Placebo, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 7 (n=62,65,65,63,25,26,75,70,72,68)0 participants
Placebo, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 12 (n=75,78,78,78,40,40,81,76,78,76)0 participants
Placebo, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 12 (n=59,60,61,61,28,29,76,70,70,68)0 participants
Placebo, Cohort 4Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 28 (n=60,60,63,61,28,30,76,70,71,68)0 participants
MEDI-534, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 12 (n=59,60,61,61,28,29,76,70,70,68)4 participants
MEDI-534, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 12 (n=75,78,78,78,40,40,81,76,78,76)22 participants
MEDI-534, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 28 (n=63,65,65,65,25,26,76,71,73,68)0 participants
MEDI-534, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 7 (n=58,59,62,59,28,30,75,70,69,68)11 participants
MEDI-534, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 28 (n=60,60,63,61,28,30,76,70,71,68)0 participants
MEDI-534, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 7 (n=62,65,65,63,25,26,75,70,72,68)13 participants
MEDI-534, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 12 (n=63,65,65,64,25,25,76,71,72,68)4 participants
MEDI-534, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 7 (n=76,76,78,79,40,39,82,77,78,75)52 participants
MEDI-534, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 28 (n=76,77,77,78,39,40,82,76,77,76)5 participants
Placebo, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 12 (n=75,78,78,78,40,40,81,76,78,76)0 participants
Placebo, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 7 (n=62,65,65,63,25,26,75,70,72,68)0 participants
Placebo, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 7 (n=58,59,62,59,28,30,75,70,69,68)0 participants
Placebo, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 12 (n=63,65,65,64,25,25,76,71,72,68)0 participants
Placebo, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 12 (n=59,60,61,61,28,29,76,70,70,68)0 participants
Placebo, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 28 (n=76,77,77,78,39,40,82,76,77,76)0 participants
Placebo, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 3: Day 28 (n=60,60,63,61,28,30,76,70,71,68)0 participants
Placebo, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 2: Day 28 (n=63,65,65,65,25,26,76,71,73,68)0 participants
Placebo, Cohort 5Number of Participants Who Shed Vaccine-Type VirusDose 1: Day 7 (n=76,76,78,79,40,39,82,77,78,75)0 participants
Secondary

Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After Randomization

An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea. MA-LRIs occurring within 28 days post any dose and after 28 days post any dose were summarized separately.

Time frame: Day 0 to Day 365

Population: Safety population included all randomized participants who received study vaccine and had any safety follow-up data.

ArmMeasureGroupValue (NUMBER)
MEDI-534, Cohort 1Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationWithin 28 days post any dose8 participants
MEDI-534, Cohort 1Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationAfter 28 days post any dose16 participants
Placebo, Cohort 1Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationWithin 28 days post any dose5 participants
Placebo, Cohort 1Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationAfter 28 days post any dose16 participants
MEDI-534, Cohort 2Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationWithin 28 days post any dose12 participants
MEDI-534, Cohort 2Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationAfter 28 days post any dose18 participants
Placebo, Cohort 2Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationWithin 28 days post any dose10 participants
Placebo, Cohort 2Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationAfter 28 days post any dose10 participants
MEDI-534, Cohort 3Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationAfter 28 days post any dose6 participants
MEDI-534, Cohort 3Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationWithin 28 days post any dose3 participants
Placebo, Cohort 3Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationAfter 28 days post any dose7 participants
Placebo, Cohort 3Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationWithin 28 days post any dose4 participants
MEDI-534, Cohort 4Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationAfter 28 days post any dose13 participants
MEDI-534, Cohort 4Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationWithin 28 days post any dose2 participants
Placebo, Cohort 4Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationWithin 28 days post any dose3 participants
Placebo, Cohort 4Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationAfter 28 days post any dose20 participants
MEDI-534, Cohort 5Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationWithin 28 days post any dose10 participants
MEDI-534, Cohort 5Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationAfter 28 days post any dose23 participants
Placebo, Cohort 5Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationWithin 28 days post any dose7 participants
Placebo, Cohort 5Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After RandomizationAfter 28 days post any dose15 participants
Secondary

Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization

An SNMC was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of SNMCs include diabetes, asthma, autoimmune disease (for example, lupus, rheumatoid arthritis), and neurological disease (for example, epilepsy, autism).

Time frame: Day 0 to Day 365

Population: Safety population included all randomized participants who received study vaccine and had any safety follow-up data.

ArmMeasureValue (NUMBER)
MEDI-534, Cohort 1Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization0 participants
Placebo, Cohort 1Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization0 participants
MEDI-534, Cohort 2Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization1 participants
Placebo, Cohort 2Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization1 participants
MEDI-534, Cohort 3Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization0 participants
Placebo, Cohort 3Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization0 participants
MEDI-534, Cohort 4Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization3 participants
Placebo, Cohort 4Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization1 participants
MEDI-534, Cohort 5Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization1 participants
Placebo, Cohort 5Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization1 participants
Secondary

Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events after administration of drug which were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) within 365 days after randomization were reported.

Time frame: Day 0 to Day 365

Population: Safety population included all randomized participants who received study vaccine and had any safety follow-up data.

ArmMeasureValue (NUMBER)
MEDI-534, Cohort 1Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization6 participants
Placebo, Cohort 1Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization5 participants
MEDI-534, Cohort 2Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization5 participants
Placebo, Cohort 2Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization1 participants
MEDI-534, Cohort 3Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization1 participants
Placebo, Cohort 3Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization2 participants
MEDI-534, Cohort 4Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization3 participants
Placebo, Cohort 4Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization4 participants
MEDI-534, Cohort 5Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization9 participants
Placebo, Cohort 5Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization3 participants
Secondary

Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3

Seroresponse was defined as a \>=4-fold rise from Baseline in neutralizing antibody titer, regardless of Baseline serostatus. Respiratory Syncytial Virus (RSV) and hPIV3 antibody titers were determined by using microneutralization assay and hemagglutination inhibition assay, respectively. Clopper-pearson exact confidence interval was reported.

Time frame: Day 28 after Dose 3

Population: Immunogenicity population included all randomized participants who received study vaccine for the specified dose and had valid immunogenicity data. 'N' (number of participants analyzed) = participants evaluable for this measure; and 'n' = participants evaluable for specified virus type, for each group, respectively.

ArmMeasureGroupValue (NUMBER)
MEDI-534, Cohort 1Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3RSV (n=44, 51, 50, 51, 19, 19, 68, 59, 63, 61)29.5 percentage of participants
MEDI-534, Cohort 1Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3hPIV3 (n=55, 53, 51, 53, 20, 22, 65, 59, 57, 52)67.3 percentage of participants
Placebo, Cohort 1Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3RSV (n=44, 51, 50, 51, 19, 19, 68, 59, 63, 61)17.6 percentage of participants
Placebo, Cohort 1Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3hPIV3 (n=55, 53, 51, 53, 20, 22, 65, 59, 57, 52)7.5 percentage of participants
MEDI-534, Cohort 2Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3RSV (n=44, 51, 50, 51, 19, 19, 68, 59, 63, 61)36.0 percentage of participants
MEDI-534, Cohort 2Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3hPIV3 (n=55, 53, 51, 53, 20, 22, 65, 59, 57, 52)86.3 percentage of participants
Placebo, Cohort 2Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3RSV (n=44, 51, 50, 51, 19, 19, 68, 59, 63, 61)25.5 percentage of participants
Placebo, Cohort 2Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3hPIV3 (n=55, 53, 51, 53, 20, 22, 65, 59, 57, 52)11.3 percentage of participants
MEDI-534, Cohort 3Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3hPIV3 (n=55, 53, 51, 53, 20, 22, 65, 59, 57, 52)35.0 percentage of participants
MEDI-534, Cohort 3Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3RSV (n=44, 51, 50, 51, 19, 19, 68, 59, 63, 61)15.8 percentage of participants
Placebo, Cohort 3Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3hPIV3 (n=55, 53, 51, 53, 20, 22, 65, 59, 57, 52)4.5 percentage of participants
Placebo, Cohort 3Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3RSV (n=44, 51, 50, 51, 19, 19, 68, 59, 63, 61)5.3 percentage of participants
MEDI-534, Cohort 4Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3hPIV3 (n=55, 53, 51, 53, 20, 22, 65, 59, 57, 52)16.9 percentage of participants
MEDI-534, Cohort 4Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3RSV (n=44, 51, 50, 51, 19, 19, 68, 59, 63, 61)7.4 percentage of participants
Placebo, Cohort 4Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3RSV (n=44, 51, 50, 51, 19, 19, 68, 59, 63, 61)3.4 percentage of participants
Placebo, Cohort 4Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3hPIV3 (n=55, 53, 51, 53, 20, 22, 65, 59, 57, 52)5.1 percentage of participants
MEDI-534, Cohort 5Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3RSV (n=44, 51, 50, 51, 19, 19, 68, 59, 63, 61)0.0 percentage of participants
MEDI-534, Cohort 5Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3hPIV3 (n=55, 53, 51, 53, 20, 22, 65, 59, 57, 52)19.3 percentage of participants
Placebo, Cohort 5Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3RSV (n=44, 51, 50, 51, 19, 19, 68, 59, 63, 61)0.0 percentage of participants
Placebo, Cohort 5Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3hPIV3 (n=55, 53, 51, 53, 20, 22, 65, 59, 57, 52)5.8 percentage of participants

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026