Parainfluenza Virus 3, Human, Respiratory Syncytial Virus Infections, Respiratory Viral Infections
Conditions
Keywords
Lower Respiratory Tract Illness, RSV and PIV3 infection
Brief summary
The overall objective of the MEDI-534 clinical development program is to evaluate the safety, efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in young infants.
Detailed description
The primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 at 10\^4, 10\^5, or 10\^6 TCID50 when administered to RSV and PIV3 seronegative children 6 to \<24 months of age.
Interventions
BIOLOGICALMEDI-534
Multiple doses of MEDI-534 or Placebo at 10\^4 TCID50
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 23 Months
Healthy volunteers
Yes
Inclusion criteria
* Male or female whose age on the day of randomization is 6 to \<24 months (reached 6th month birthday and not yet reached 2nd year birthday) * Subject is seronegative to both RSV and PIV3 at screening * Subject was the product of normal full term pregnancy (defined as \>36 weeks gestation) * Subject is in general good health * Subject's legal representative is available by telephone * Written informed consent and HIPAA authorization (if applicable) obtained from the subject's legal representative * Subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator * Subject is available to complete the follow-up period, which will be through the end of RSV season (provisionally defined as 01/Apr for the United States) or 180 days after the final dose of study vaccine, whichever is later * Subject's legal representative must be willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol
Exclusion criteria
* Any fever (equal to or greater than 100.4°F \[equal to or greater than 38.0°C\], regardless of route) or lower respiratory illness (Section 4.1.2) within 7 days prior to randomization * Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of vaccine * Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt through the protocol-specified blood collection 28 days after each study vaccine dosing, except that infrequent use of over-the-counter medications such as pain relievers are permitted according to the judgment of the investigator * Any current or expected receipt of immunosuppressive agents including steroids (2 mg/kg per day of prednisone or its equivalent, or equal to or greater than 20 mg/day if the subject weighs \>10 kg, given daily or on alternate days for equal to or greater than 14 days); children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for equal to or greater than 30 days; the use of topical steroids is permitted according to the judgment of the investigator * History of receipt of blood transfusion or expected receipt through 30 days following final study vaccine dosing * History of receipt of immunoglobulin products or expected receipt through 30 days after study vaccine dosing * Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 30 days after final study vaccine dosing * Receipt of any live virus vaccine (excluding rotavirus vaccine) within 28 days prior to randomization or expected receipt within a 28-day window around any study vaccine dose * Receipt of any inactivated (i.e., non-live) vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any study vaccine dose * Known or suspected immunodeficiency, including HIV * Living in the same home or enrolled in the same classroom at day care with infants \<24 months of age (only one child per household may be enrolled into the study) * Contact with pregnant caregiver * A household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 30 days after any study vaccine dose * A household contact who is a health care provider in contact with immunocompromised patients or who is a day care provider for infants under the age of 6 months * History of allergic reaction to any component of the study vaccine * Previous medical history, or evidence, of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the subject * Known or suspected active or chronic hepatitis infection * History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation * Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study * Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | Days 0-28 after Dose 1 (Dose 1 was on Day 0) | The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis. |
| Number of Participants With SEs After Dose 2 | Days 0-28 after Dose 2 (Dose 2 was on Day 48-64) | The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis. |
| Number of Participants With SEs After Dose 3 | Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis. |
| Number of Participants With Adverse Events (AEs) After Dose 1 | Days 0-28 after Dose 1 (Dose 1 was on Day 0) | Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1. |
| Number of Participants With AEs After Dose 2 | Days 0-28 after Dose 2 (Dose 2 was on Day 48-64) | Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2. |
| Number of Participants With AEs After Dose 3 | Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3. |
| Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs) | Days 0 to 180 days after final dose or the end of the RSV season, whichever was later | An MA-LRI was a healthcare provider-confirmed diagnosis of 1 or more of the following: wheezing, pneumonia, croup, rhonchi (not cleared with cough or suctioning), rales, bronchitis, bronchiolitis, apnea. |
| Number of Participants With Serious Adverse Events (SAEs) | Days 0-28 after any dose | Events resulting in death; were life-threatening; resulted in inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and may have jeopardized the participant and required medical/surgical intervention to prevent one of the above outcomes. |
| Number of Participants With Significant New Medical Conditions (SNMCs) | Day 0 through 180 days after the final dose or through the end of the RSV season, whichever was later | A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3 | Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. |
| Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3 | Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. |
| Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3 | Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. |
| Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3 | Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. |
| Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline | Baseline (Day 0 prior to Dose 1) | Pre-dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as \< 5, a value of 2.5 was imputed. |
| Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1 | Day 28-34 after Dose 1 (Dose 1 was on Day 0) | Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as \< 5, a value of 2.5 was imputed. |
| Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2 | Day 28-34 after Dose 2 (Dose 2 was on Day 48-64) | Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as \< 5, a value of 2.5 was imputed. |
| Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3 | Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as \< 5, a value of 2.5 was imputed. |
| Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline | Baseline (Day 0 prior to Dose 1) | Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as \< 4, a value of 2 was imputed. |
| Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation | Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 28-34 days post each dose. | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. |
| Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2 | Day 28-34 after Dose 2 (Dose 2 was on Day 48-64) | Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as \< 4, a value of 2 was imputed. |
| Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3 | Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as \< 4, a value of 2 was imputed. |
| Number of Participants With Seroresponse to RSV 28 Days After Dose 1 | Days 28-34 after Dose 1 (Dose 1 was on Day 0) | Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay. |
| Number of Participants With Seroresponse to RSV 28 Days After Dose 2 | Days 28-34 after Dose 2 (Dose 2 was on Day 48-64) | Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay. |
| Number of Participants With Seroresponse to RSV 28 Days After Dose 3 | Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay. |
| Number of Participants With Seroresponse to PIV3 28 Days After Dose 1 | Days 28-34 after Dose 1 (Dose 1 was on Day 0) | Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay. |
| Number of Participants With Seroresponse to PIV3 28 Days After Dose 2 | Days 28-34 after Dose 2 (Dose 2 was on Day 48-64) | Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay. |
| Number of Participants With Seroresponse to PIV3 28 Days After Dose 3 | Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay. |
| Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1 | Day 28-34 after Dose 1 (Dose 1 was on Day 0) | Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as \< 4, a value of 2 was imputed. |
| Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1 | Days 7-10 after Dose 1 (Dose 1 was on Day 0) | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. |
| Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1 | Days 12-18 after Dose 1 (Dose 1 was on Day 0) | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. |
| Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1 | Days 28-34 after Dose 1 (Dose 1 was on Day 0) | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. |
| Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1 | Days 0-34 after Dose 1 (Dose 1 was on Day 0) | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. |
| Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2 | Days 7-10 after Dose 2 (Dose 2 was on Day 48-64) | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. |
| Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2 | Days 12-18 after Dose 2 (Dose 2 was on Day 48-64) | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. |
| Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2 | Days 28-34 after Dose 2 (Dose 2 was on Day 48-64) | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. |
| Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2 | Days 0-34 after Dose 2 (Dose 2 was on Day 48-64) | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. |
Countries
United States
Participant flow
Recruitment details
Participants 6 to \< 24 months of age were screened prior to randomization at 13 sites in the USA. The first subject entered the study on 02Jul2007 and the last subject completed the study on 20Apr2010.
Pre-assignment details
A total of 49 participants were entered into the study between 02Jul2007 and 25Jun2009. Participants were RSV and PIV3 seronegative at screening, and randomized in a 2:1 ratio to receive MEDI-534 or placebo, and randomization was stratified by age (≤ 12 months vs \> 12 months).
Participants by arm
| Arm | Count |
|---|---|
| 10^4 MEDI-534 | 13 |
| 10^4 PLACEBO | 6 |
| 10^5 MEDI-534 | 9 |
| 10^5 PLACEBO | 6 |
| 10^6 MEDI-534 | 10 |
| 10^6 PLACEBO | 5 |
| TOTAL Total of all reporting groups | 49 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | 10^4 MEDI-534 | 10^4 PLACEBO | 10^5 MEDI-534 | 10^5 PLACEBO | 10^6 MEDI-534 | 10^6 PLACEBO | TOTAL |
|---|---|---|---|---|---|---|---|
| Age Continuous | 10.8 Months STANDARD_DEVIATION 5 | 12.2 Months STANDARD_DEVIATION 7.6 | 8.1 Months STANDARD_DEVIATION 1.8 | 11.3 Months STANDARD_DEVIATION 3.7 | 9.3 Months STANDARD_DEVIATION 2.1 | 9.9 Months STANDARD_DEVIATION 4.3 | 10.1 Months STANDARD_DEVIATION 4.3 |
| Sex: Female, Male Female | 8 Participants | 2 Participants | 5 Participants | 4 Participants | 6 Participants | 3 Participants | 28 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 4 Participants | 2 Participants | 4 Participants | 2 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 13 | 5 / 6 | 8 / 9 | 5 / 6 | 9 / 10 | 3 / 5 |
| serious Total, serious adverse events | 1 / 13 | 0 / 6 | 0 / 9 | 1 / 6 | 0 / 10 | 0 / 5 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) After Dose 1
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.
Time frame: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Population: The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants With Adverse Events (AEs) After Dose 1 | 8 participants |
| 10^4 Placebo | Number of Participants With Adverse Events (AEs) After Dose 1 | 4 participants |
| 10^5 MEDI-534 | Number of Participants With Adverse Events (AEs) After Dose 1 | 8 participants |
| 10^5 Placebo | Number of Participants With Adverse Events (AEs) After Dose 1 | 5 participants |
| 10^6 MEDI-534 | Number of Participants With Adverse Events (AEs) After Dose 1 | 5 participants |
| 10^6 Placebo | Number of Participants With Adverse Events (AEs) After Dose 1 | 3 participants |
Primary
Number of Participants With AEs After Dose 2
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.
Time frame: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Population: The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants With AEs After Dose 2 | 6 participants |
| 10^4 Placebo | Number of Participants With AEs After Dose 2 | 4 participants |
| 10^5 MEDI-534 | Number of Participants With AEs After Dose 2 | 5 participants |
| 10^5 Placebo | Number of Participants With AEs After Dose 2 | 4 participants |
| 10^6 MEDI-534 | Number of Participants With AEs After Dose 2 | 3 participants |
| 10^6 Placebo | Number of Participants With AEs After Dose 2 | 2 participants |
Primary
Number of Participants With AEs After Dose 3
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.
Time frame: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Population: The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants With AEs After Dose 3 | 7 participants |
| 10^4 Placebo | Number of Participants With AEs After Dose 3 | 3 participants |
| 10^5 MEDI-534 | Number of Participants With AEs After Dose 3 | 3 participants |
| 10^5 Placebo | Number of Participants With AEs After Dose 3 | 3 participants |
| 10^6 MEDI-534 | Number of Participants With AEs After Dose 3 | 4 participants |
| 10^6 Placebo | Number of Participants With AEs After Dose 3 | 2 participants |
Primary
Number of Participants With Serious Adverse Events (SAEs)
Events resulting in death; were life-threatening; resulted in inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and may have jeopardized the participant and required medical/surgical intervention to prevent one of the above outcomes.
Time frame: Days 0-28 after any dose
Population: The safety population included all subjects who received investigational product for the specified dose and had any safety follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants With Serious Adverse Events (SAEs) | 0 participants |
| 10^4 Placebo | Number of Participants With Serious Adverse Events (SAEs) | 0 participants |
| 10^5 MEDI-534 | Number of Participants With Serious Adverse Events (SAEs) | 0 participants |
| 10^5 Placebo | Number of Participants With Serious Adverse Events (SAEs) | 0 participants |
| 10^6 MEDI-534 | Number of Participants With Serious Adverse Events (SAEs) | 0 participants |
| 10^6 Placebo | Number of Participants With Serious Adverse Events (SAEs) | 0 participants |
Primary
Number of Participants With SEs After Dose 2
The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.
Time frame: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Population: Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants With SEs After Dose 2 | 9 participants |
| 10^4 Placebo | Number of Participants With SEs After Dose 2 | 5 participants |
| 10^5 MEDI-534 | Number of Participants With SEs After Dose 2 | 6 participants |
| 10^5 Placebo | Number of Participants With SEs After Dose 2 | 6 participants |
| 10^6 MEDI-534 | Number of Participants With SEs After Dose 2 | 6 participants |
| 10^6 Placebo | Number of Participants With SEs After Dose 2 | 3 participants |
Primary
Number of Participants With SEs After Dose 3
The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.
Time frame: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Population: Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants With SEs After Dose 3 | 9 participants |
| 10^4 Placebo | Number of Participants With SEs After Dose 3 | 5 participants |
| 10^5 MEDI-534 | Number of Participants With SEs After Dose 3 | 4 participants |
| 10^5 Placebo | Number of Participants With SEs After Dose 3 | 5 participants |
| 10^6 MEDI-534 | Number of Participants With SEs After Dose 3 | 8 participants |
| 10^6 Placebo | Number of Participants With SEs After Dose 3 | 2 participants |
Primary
Number of Participants With Significant New Medical Conditions (SNMCs)
A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.
Time frame: Day 0 through 180 days after the final dose or through the end of the RSV season, whichever was later
Population: Safety population was participants who received investigational product and had any safety follow-up for ≥ 1 day after dosing (ie, did not discontinue on Day 0 after receiving Dose 1).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants With Significant New Medical Conditions (SNMCs) | 0 participants |
| 10^4 Placebo | Number of Participants With Significant New Medical Conditions (SNMCs) | 0 participants |
| 10^5 MEDI-534 | Number of Participants With Significant New Medical Conditions (SNMCs) | 0 participants |
| 10^5 Placebo | Number of Participants With Significant New Medical Conditions (SNMCs) | 0 participants |
| 10^6 MEDI-534 | Number of Participants With Significant New Medical Conditions (SNMCs) | 0 participants |
| 10^6 Placebo | Number of Participants With Significant New Medical Conditions (SNMCs) | 0 participants |
Primary
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.
Time frame: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Population: Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | 12 participants |
| 10^4 Placebo | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | 5 participants |
| 10^5 MEDI-534 | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | 8 participants |
| 10^5 Placebo | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | 6 participants |
| 10^6 MEDI-534 | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | 9 participants |
| 10^6 Placebo | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | 4 participants |
Primary
Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs)
An MA-LRI was a healthcare provider-confirmed diagnosis of 1 or more of the following: wheezing, pneumonia, croup, rhonchi (not cleared with cough or suctioning), rales, bronchitis, bronchiolitis, apnea.
Time frame: Days 0 to 180 days after final dose or the end of the RSV season, whichever was later
Population: The safety population for MA-LRIs included randomized participants who received investigational product and had any safety follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs) | 3 participants |
| 10^4 Placebo | Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs) | 2 participants |
| 10^5 MEDI-534 | Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs) | 2 participants |
| 10^5 Placebo | Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs) | 3 participants |
| 10^6 MEDI-534 | Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs) | 2 participants |
| 10^6 Placebo | Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs) | 1 participants |
Secondary
Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline
Pre-dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as \< 5, a value of 2.5 was imputed.
Time frame: Baseline (Day 0 prior to Dose 1)
Population: The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 10^4 MEDI-534 | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline | 14.52 GMT |
| 10^4 Placebo | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline | 17.82 GMT |
| 10^5 MEDI-534 | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline | 15.42 GMT |
| 10^5 Placebo | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline | 3.79 GMT |
| 10^6 MEDI-534 | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline | 6.60 GMT |
| 10^6 Placebo | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline | 7.58 GMT |
Secondary
Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1
Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as \< 5, a value of 2.5 was imputed.
Time frame: Day 28-34 after Dose 1 (Dose 1 was on Day 0)
Population: The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 10^4 MEDI-534 | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1 | 12.08 GMT |
| 10^4 Placebo | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1 | 10.00 GMT |
| 10^5 MEDI-534 | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1 | 80.00 GMT |
| 10^5 Placebo | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1 | 8.71 GMT |
| 10^6 MEDI-534 | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1 | 29.39 GMT |
| 10^6 Placebo | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1 | 7.58 GMT |
Secondary
Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2
Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as \< 5, a value of 2.5 was imputed.
Time frame: Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Population: The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 10^4 MEDI-534 | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2 | 13.20 GMT |
| 10^4 Placebo | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2 | 3.79 GMT |
| 10^5 MEDI-534 | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2 | 22.97 GMT |
| 10^5 Placebo | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2 | 7.07 GMT |
| 10^6 MEDI-534 | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2 | 18.52 GMT |
| 10^6 Placebo | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2 | 5.00 GMT |
Secondary
Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3
Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as \< 5, a value of 2.5 was imputed.
Time frame: Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Population: The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 10^4 MEDI-534 | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3 | 30.84 GMT |
| 10^4 Placebo | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3 | 10.00 GMT |
| 10^5 MEDI-534 | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3 | 22.97 GMT |
| 10^5 Placebo | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3 | 6.60 GMT |
| 10^6 MEDI-534 | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3 | 15.42 GMT |
| 10^6 Placebo | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3 | 3.54 GMT |
Secondary
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1
Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as \< 4, a value of 2 was imputed.
Time frame: Day 28-34 after Dose 1 (Dose 1 was on Day 0)
Population: The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 10^4 MEDI-534 | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1 | 13.24 GMT |
| 10^4 Placebo | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1 | 2.00 GMT |
| 10^5 MEDI-534 | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1 | 19.50 GMT |
| 10^5 Placebo | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1 | 3.03 GMT |
| 10^6 MEDI-534 | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1 | 14.93 GMT |
| 10^6 Placebo | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1 | 2.00 GMT |
Secondary
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2
Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as \< 4, a value of 2 was imputed.
Time frame: Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Population: The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 10^4 MEDI-534 | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2 | 13.93 GMT |
| 10^4 Placebo | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2 | 2.00 GMT |
| 10^5 MEDI-534 | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2 | 24.25 GMT |
| 10^5 Placebo | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2 | 4.00 GMT |
| 10^6 MEDI-534 | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2 | 11.76 GMT |
| 10^6 Placebo | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2 | 2.00 GMT |
Secondary
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3
Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as \< 4, a value of 2 was imputed.
Time frame: Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Population: The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 10^4 MEDI-534 | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3 | 18.38 GMT |
| 10^4 Placebo | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3 | 2.00 GMT |
| 10^5 MEDI-534 | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3 | 16.00 GMT |
| 10^5 Placebo | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3 | 3.03 GMT |
| 10^6 MEDI-534 | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3 | 38.05 GMT |
| 10^6 Placebo | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3 | 2.00 GMT |
Secondary
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline
Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as \< 4, a value of 2 was imputed.
Time frame: Baseline (Day 0 prior to Dose 1)
Population: The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 10^4 MEDI-534 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline | 3.23 GMT |
| 10^4 Placebo | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline | 2.52 GMT |
| 10^5 MEDI-534 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline | 2.59 GMT |
| 10^5 Placebo | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline | 4.59 GMT |
| 10^6 MEDI-534 | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline | 2.30 GMT |
| 10^6 Placebo | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline | 2.00 GMT |
Secondary
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Time frame: Days 12-18 after Dose 1 (Dose 1 was on Day 0)
Population: The shedding population included all subjects who received investigational product and had any valid shedding data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1 | 1 participants |
| 10^4 Placebo | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1 | NA participants |
| 10^5 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1 | 3 participants |
| 10^5 Placebo | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1 | NA participants |
| 10^6 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1 | 2 participants |
| 10^6 Placebo | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1 | NA participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Time frame: Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)
Population: The shedding population included all subjects who received investigational product and had any valid shedding data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2 | 0 participants |
| 10^4 Placebo | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2 | NA participants |
| 10^5 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2 | 0 participants |
| 10^5 Placebo | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2 | NA participants |
| 10^6 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2 | 0 participants |
| 10^6 Placebo | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2 | NA participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Time frame: Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Population: The shedding population included all subjects who received investigational product and had any valid shedding data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3 | 0 participants |
| 10^4 Placebo | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3 | NA participants |
| 10^5 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3 | 0 participants |
| 10^5 Placebo | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3 | NA participants |
| 10^6 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3 | 1 participants |
| 10^6 Placebo | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3 | NA participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Time frame: Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Population: The shedding population included all subjects who received investigational product and had any valid shedding data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1 | 0 participants |
| 10^4 Placebo | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1 | NA participants |
| 10^5 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1 | 0 participants |
| 10^5 Placebo | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1 | NA participants |
| 10^6 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1 | 0 participants |
| 10^6 Placebo | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1 | NA participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Time frame: Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Population: The shedding population included all subjects who received investigational product and had any valid shedding data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2 | 0 participants |
| 10^4 Placebo | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2 | NA participants |
| 10^5 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2 | 0 participants |
| 10^5 Placebo | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2 | NA participants |
| 10^6 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2 | 0 participants |
| 10^6 Placebo | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2 | NA participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Time frame: Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Population: The shedding population included all subjects who received investigational product and had any valid shedding data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3 | 0 participants |
| 10^4 Placebo | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3 | NA participants |
| 10^5 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3 | 0 participants |
| 10^5 Placebo | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3 | NA participants |
| 10^6 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3 | 0 participants |
| 10^6 Placebo | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3 | NA participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Time frame: Days 7-10 after Dose 1 (Dose 1 was on Day 0)
Population: The shedding population included all subjects who received investigational product and had any valid shedding data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1 | 6 participants |
| 10^4 Placebo | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1 | NA participants |
| 10^5 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1 | 5 participants |
| 10^5 Placebo | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1 | NA participants |
| 10^6 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1 | 6 participants |
| 10^6 Placebo | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1 | NA participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Time frame: Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)
Population: The shedding population included all subjects who received investigational product and had any valid shedding data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2 | 0 participants |
| 10^4 Placebo | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2 | NA participants |
| 10^5 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2 | 1 participants |
| 10^5 Placebo | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2 | NA participants |
| 10^6 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2 | 0 participants |
| 10^6 Placebo | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2 | NA participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Time frame: Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Population: The shedding population included all subjects who received investigational product and had any valid shedding data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3 | 0 participants |
| 10^4 Placebo | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3 | NA participants |
| 10^5 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3 | 0 participants |
| 10^5 Placebo | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3 | NA participants |
| 10^6 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3 | 1 participants |
| 10^6 Placebo | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3 | NA participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Time frame: Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 28-34 days post each dose.
Population: The shedding population included all subjects who received investigational product and had any valid shedding data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation | 6 participants |
| 10^4 Placebo | Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation | NA participants |
| 10^5 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation | 5 participants |
| 10^5 Placebo | Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation | NA participants |
| 10^6 MEDI-534 | Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation | 7 participants |
| 10^6 Placebo | Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation | NA participants |
Secondary
Number of Participants With Seroresponse to PIV3 28 Days After Dose 1
Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.
Time frame: Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Population: The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants With Seroresponse to PIV3 28 Days After Dose 1 | 6 participants |
| 10^4 Placebo | Number of Participants With Seroresponse to PIV3 28 Days After Dose 1 | 0 participants |
| 10^5 MEDI-534 | Number of Participants With Seroresponse to PIV3 28 Days After Dose 1 | 5 participants |
| 10^5 Placebo | Number of Participants With Seroresponse to PIV3 28 Days After Dose 1 | 0 participants |
| 10^6 MEDI-534 | Number of Participants With Seroresponse to PIV3 28 Days After Dose 1 | 8 participants |
| 10^6 Placebo | Number of Participants With Seroresponse to PIV3 28 Days After Dose 1 | 0 participants |
Secondary
Number of Participants With Seroresponse to PIV3 28 Days After Dose 2
Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.
Time frame: Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Population: The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants With Seroresponse to PIV3 28 Days After Dose 2 | 6 participants |
| 10^4 Placebo | Number of Participants With Seroresponse to PIV3 28 Days After Dose 2 | 0 participants |
| 10^5 MEDI-534 | Number of Participants With Seroresponse to PIV3 28 Days After Dose 2 | 4 participants |
| 10^5 Placebo | Number of Participants With Seroresponse to PIV3 28 Days After Dose 2 | 0 participants |
| 10^6 MEDI-534 | Number of Participants With Seroresponse to PIV3 28 Days After Dose 2 | 7 participants |
| 10^6 Placebo | Number of Participants With Seroresponse to PIV3 28 Days After Dose 2 | 0 participants |
Secondary
Number of Participants With Seroresponse to PIV3 28 Days After Dose 3
Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.
Time frame: Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Population: The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants With Seroresponse to PIV3 28 Days After Dose 3 | 8 participants |
| 10^4 Placebo | Number of Participants With Seroresponse to PIV3 28 Days After Dose 3 | 0 participants |
| 10^5 MEDI-534 | Number of Participants With Seroresponse to PIV3 28 Days After Dose 3 | 3 participants |
| 10^5 Placebo | Number of Participants With Seroresponse to PIV3 28 Days After Dose 3 | 0 participants |
| 10^6 MEDI-534 | Number of Participants With Seroresponse to PIV3 28 Days After Dose 3 | 8 participants |
| 10^6 Placebo | Number of Participants With Seroresponse to PIV3 28 Days After Dose 3 | 0 participants |
Secondary
Number of Participants With Seroresponse to RSV 28 Days After Dose 1
Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.
Time frame: Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Population: The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants With Seroresponse to RSV 28 Days After Dose 1 | 2 participants |
| 10^4 Placebo | Number of Participants With Seroresponse to RSV 28 Days After Dose 1 | 0 participants |
| 10^5 MEDI-534 | Number of Participants With Seroresponse to RSV 28 Days After Dose 1 | 3 participants |
| 10^5 Placebo | Number of Participants With Seroresponse to RSV 28 Days After Dose 1 | 0 participants |
| 10^6 MEDI-534 | Number of Participants With Seroresponse to RSV 28 Days After Dose 1 | 4 participants |
| 10^6 Placebo | Number of Participants With Seroresponse to RSV 28 Days After Dose 1 | 0 participants |
Secondary
Number of Participants With Seroresponse to RSV 28 Days After Dose 2
Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.
Time frame: Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Population: The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants With Seroresponse to RSV 28 Days After Dose 2 | 1 participants |
| 10^4 Placebo | Number of Participants With Seroresponse to RSV 28 Days After Dose 2 | 0 participants |
| 10^5 MEDI-534 | Number of Participants With Seroresponse to RSV 28 Days After Dose 2 | 1 participants |
| 10^5 Placebo | Number of Participants With Seroresponse to RSV 28 Days After Dose 2 | 0 participants |
| 10^6 MEDI-534 | Number of Participants With Seroresponse to RSV 28 Days After Dose 2 | 5 participants |
| 10^6 Placebo | Number of Participants With Seroresponse to RSV 28 Days After Dose 2 | 0 participants |
Secondary
Number of Participants With Seroresponse to RSV 28 Days After Dose 3
Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.
Time frame: Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Population: The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants With Seroresponse to RSV 28 Days After Dose 3 | 3 participants |
| 10^4 Placebo | Number of Participants With Seroresponse to RSV 28 Days After Dose 3 | 1 participants |
| 10^5 MEDI-534 | Number of Participants With Seroresponse to RSV 28 Days After Dose 3 | 1 participants |
| 10^5 Placebo | Number of Participants With Seroresponse to RSV 28 Days After Dose 3 | 0 participants |
| 10^6 MEDI-534 | Number of Participants With Seroresponse to RSV 28 Days After Dose 3 | 4 participants |
| 10^6 Placebo | Number of Participants With Seroresponse to RSV 28 Days After Dose 3 | 0 participants |
Secondary
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Time frame: Days 0-34 after Dose 1 (Dose 1 was on Day 0)
Population: The shedding population included all subjects who received investigational product and had any valid shedding data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1 | 6 participants |
| 10^4 Placebo | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1 | NA participants |
| 10^5 MEDI-534 | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1 | 5 participants |
| 10^5 Placebo | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1 | NA participants |
| 10^6 MEDI-534 | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1 | 7 participants |
| 10^6 Placebo | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1 | NA participants |
Secondary
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Time frame: Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)
Population: The shedding population included all subjects who received investigational product and had any valid shedding data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2 | 0 participants |
| 10^4 Placebo | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2 | NA participants |
| 10^5 MEDI-534 | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2 | 1 participants |
| 10^5 Placebo | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2 | NA participants |
| 10^6 MEDI-534 | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2 | 0 participants |
| 10^6 Placebo | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2 | NA participants |
Secondary
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Time frame: Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Population: The shedding population included all subjects who received investigational product and had any valid shedding data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10^4 MEDI-534 | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3 | 0 participants |
| 10^4 Placebo | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3 | NA participants |
| 10^5 MEDI-534 | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3 | 0 participants |
| 10^5 Placebo | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3 | NA participants |
| 10^6 MEDI-534 | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3 | 1 participants |
| 10^6 Placebo | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3 | NA participants |