Trial Outcomes & Findings for Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age (NCT NCT00493285)
NCT ID: NCT00493285
Last Updated: 2012-07-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
49 participants
Primary outcome timeframe
Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Results posted on
2012-07-19
Participant Flow
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.
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).
Participant milestones
| Measure |
10^4 MEDI-534
|
10^4 PLACEBO
|
10^5 MEDI-534
|
10^5 PLACEBO
|
10^6 MEDI-534
|
10^6 PLACEBO
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
6
|
9
|
6
|
10
|
5
|
|
Overall Study
COMPLETED
|
13
|
6
|
9
|
6
|
9
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
10^4 MEDI-534
|
10^4 PLACEBO
|
10^5 MEDI-534
|
10^5 PLACEBO
|
10^6 MEDI-534
|
10^6 PLACEBO
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age
Baseline characteristics by cohort
| Measure |
10^4 MEDI-534
n=13 Participants
|
10^4 PLACEBO
n=6 Participants
|
10^5 MEDI-534
n=9 Participants
|
10^5 PLACEBO
n=6 Participants
|
10^6 MEDI-534
n=10 Participants
|
10^6 PLACEBO
n=5 Participants
|
TOTAL
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age Continuous
|
10.8 Months
STANDARD_DEVIATION 5.0 • n=5 Participants
|
12.2 Months
STANDARD_DEVIATION 7.6 • n=7 Participants
|
8.1 Months
STANDARD_DEVIATION 1.8 • n=5 Participants
|
11.3 Months
STANDARD_DEVIATION 3.7 • n=4 Participants
|
9.3 Months
STANDARD_DEVIATION 2.1 • n=21 Participants
|
9.9 Months
STANDARD_DEVIATION 4.3 • n=10 Participants
|
10.1 Months
STANDARD_DEVIATION 4.3 • n=115 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=13 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
|
12 participants
|
5 participants
|
8 participants
|
6 participants
|
9 participants
|
4 participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=11 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=7 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants With SEs After Dose 2
|
9 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=11 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=5 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants With SEs After Dose 3
|
9 participants
|
5 participants
|
4 participants
|
5 participants
|
8 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 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.
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.
Outcome measures
| Measure |
10^4 MEDI-534
n=13 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) After Dose 1
|
8 participants
|
4 participants
|
8 participants
|
5 participants
|
5 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 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.
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.
Outcome measures
| Measure |
10^4 MEDI-534
n=11 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=7 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants With AEs After Dose 2
|
6 participants
|
4 participants
|
5 participants
|
4 participants
|
3 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 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.
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.
Outcome measures
| Measure |
10^4 MEDI-534
n=11 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=5 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants With AEs After Dose 3
|
7 participants
|
3 participants
|
3 participants
|
3 participants
|
4 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Days 0 to 180 days after final dose or the end of the RSV season, whichever was laterPopulation: The safety population for MA-LRIs included randomized participants who received investigational product and had any safety follow-up.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=13 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs)
|
3 participants
|
2 participants
|
2 participants
|
3 participants
|
2 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Days 0-28 after any dosePopulation: The safety population included all subjects who received investigational product for the specified dose and had any safety follow-up.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=13 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 0 through 180 days after the final dose or through the end of the RSV season, whichever was laterPopulation: 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).
A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.
Outcome measures
| Measure |
10^4 MEDI-534
n=13 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Significant New Medical Conditions (SNMCs)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=13 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=8 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation
|
6 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
5 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
7 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=13 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=7 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1
|
6 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
5 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
6 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=13 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=8 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1
|
1 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
3 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
2 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=13 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=7 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=13 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=8 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1
|
6 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
5 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
7 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=7 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=8 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
1 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=6 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=6 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=11 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=7 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
1 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=5 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
1 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=11 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=5 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
1 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=5 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=8 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=11 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=5 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
0 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
1 participants
|
NA participants
Nasal wash samples from participants receiving placebo were not analyzed for vaccine-type virus shedding.
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=13 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=8 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline
|
14.52 GMT
Interval 8.1 to 26.1
|
17.82 GMT
Interval 7.9 to 44.9
|
15.42 GMT
Interval 10.0 to 23.8
|
3.79 GMT
Interval 2.9 to 5.0
|
6.60 GMT
Interval 3.8 to 11.5
|
7.58 GMT
Interval 3.8 to 17.4
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=11 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=7 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1
|
12.08 GMT
Interval 6.4 to 24.2
|
10.00 GMT
Interval 5.0 to 17.4
|
80.00 GMT
Interval 22.1 to 320.0
|
8.71 GMT
Interval 2.9 to 40.0
|
29.39 GMT
Interval 7.3 to 127.0
|
7.58 GMT
Interval 3.8 to 13.2
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=5 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2
|
13.20 GMT
Interval 5.4 to 37.6
|
3.79 GMT
Interval 2.9 to 5.0
|
22.97 GMT
Interval 10.0 to 69.6
|
7.07 GMT
Interval 2.8 to 25.2
|
18.52 GMT
Interval 8.6 to 43.2
|
5.00 GMT
Interval 3.3 to 7.6
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=8 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=4 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=5 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=8 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=4 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3
|
30.84 GMT
Interval 5.5 to 174.5
|
10.00 GMT
Interval 2.5 to 160.0
|
22.97 GMT
Interval 6.6 to 91.9
|
6.60 GMT
Interval 2.9 to 23.0
|
15.42 GMT
Interval 7.1 to 33.6
|
3.54 GMT
Interval 2.5 to 5.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=13 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=8 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline
|
3.23 GMT
Interval 2.2 to 5.0
|
2.52 GMT
Interval 2.0 to 4.0
|
2.59 GMT
Interval 2.0 to 4.4
|
4.59 GMT
Interval 2.0 to 10.6
|
2.30 GMT
Interval 2.0 to 3.0
|
2.00 GMT
Interval 2.0 to 2.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=11 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=7 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1
|
13.24 GMT
Interval 6.2 to 28.2
|
2.00 GMT
Interval 2.0 to 2.0
|
19.50 GMT
Interval 7.2 to 52.5
|
3.03 GMT
Interval 2.0 to 7.0
|
14.93 GMT
Interval 6.5 to 34.3
|
2.00 GMT
Interval 2.0 to 2.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=4 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=5 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=6 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2
|
13.93 GMT
Interval 7.4 to 26.0
|
2.00 GMT
Interval 2.0 to 2.0
|
24.25 GMT
Interval 10.6 to 55.7
|
4.00 GMT
Interval 2.0 to 8.0
|
11.76 GMT
Interval 5.9 to 23.5
|
2.00 GMT
Interval 2.0 to 2.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
10^4 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=3 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=5 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=8 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=4 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3
|
18.38 GMT
Interval 10.6 to 32.0
|
2.00 GMT
Interval 2.0 to 2.0
|
16.00 GMT
Interval 7.0 to 36.8
|
3.03 GMT
Interval 2.0 to 7.0
|
38.05 GMT
Interval 17.4 to 107.6
|
2.00 GMT
Interval 2.0 to 2.0
|
SECONDARY outcome
Timeframe: 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.
Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.
Outcome measures
| Measure |
10^4 MEDI-534
n=11 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=7 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=4 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Seroresponse to RSV 28 Days After Dose 1
|
2 participants
|
0 participants
|
3 participants
|
0 participants
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 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.
Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.
Outcome measures
| Measure |
10^4 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=5 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Seroresponse to RSV 28 Days After Dose 2
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
5 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 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.
Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.
Outcome measures
| Measure |
10^4 MEDI-534
n=8 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=4 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=5 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=4 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=8 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=4 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Seroresponse to RSV 28 Days After Dose 3
|
3 participants
|
1 participants
|
1 participants
|
0 participants
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 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.
Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.
Outcome measures
| Measure |
10^4 MEDI-534
n=11 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=7 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=4 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Seroresponse to PIV3 28 Days After Dose 1
|
6 participants
|
0 participants
|
5 participants
|
0 participants
|
8 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 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.
Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.
Outcome measures
| Measure |
10^4 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=4 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=5 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=9 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=5 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Seroresponse to PIV3 28 Days After Dose 2
|
6 participants
|
0 participants
|
4 participants
|
0 participants
|
7 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 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.
Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.
Outcome measures
| Measure |
10^4 MEDI-534
n=10 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^4 Placebo
n=3 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^5 MEDI-534
n=5 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^5 Placebo
n=4 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
10^6 MEDI-534
n=8 Participants
MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
|
10^6 Placebo
n=4 Participants
Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Seroresponse to PIV3 28 Days After Dose 3
|
8 participants
|
0 participants
|
3 participants
|
0 participants
|
8 participants
|
0 participants
|
Adverse Events
10^4 MEDI-534
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
10^4 PLACEBO
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
10^5 MEDI-534
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
10^5 PLACEBO
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
10^6 MEDI-534
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
10^6 PLACEBO
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
10^4 MEDI-534
n=13 participants at risk
|
10^4 PLACEBO
n=6 participants at risk
|
10^5 MEDI-534
n=9 participants at risk
|
10^5 PLACEBO
n=6 participants at risk
|
10^6 MEDI-534
n=10 participants at risk
|
10^6 PLACEBO
n=5 participants at risk
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Pharyngitis streptococcal
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
Other adverse events
| Measure |
10^4 MEDI-534
n=13 participants at risk
|
10^4 PLACEBO
n=6 participants at risk
|
10^5 MEDI-534
n=9 participants at risk
|
10^5 PLACEBO
n=6 participants at risk
|
10^6 MEDI-534
n=10 participants at risk
|
10^6 PLACEBO
n=5 participants at risk
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
1/5 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Ear and labyrinth disorders
Middle ear effusion
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
11.1%
1/9 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
1/5 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Ear and labyrinth disorders
Tympanic membrane hyperaemia
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
33.3%
3/9 • Number of events 3 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
1/5 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Eye disorders
Eye discharge
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Eye disorders
Eye disorder
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Eye disorders
Eye swelling
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Eye disorders
Eyelid margin crusting
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
50.0%
3/6 • Number of events 3 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
1/5 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Gastrointestinal disorders
Diarrhoea
|
38.5%
5/13 • Number of events 8 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
50.0%
3/6 • Number of events 4 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
33.3%
3/9 • Number of events 6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
33.3%
2/6 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
2/10 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
1/5 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Gastrointestinal disorders
Eructation
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Gastrointestinal disorders
Faeces discoloured
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Gastrointestinal disorders
Frequent bowel movements
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Gastrointestinal disorders
Infantile spitting up
|
7.7%
1/13 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Gastrointestinal disorders
Teething
|
46.2%
6/13 • Number of events 13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
33.3%
3/9 • Number of events 5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
33.3%
2/6 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
2/10 • Number of events 4 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
1/5 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Gastrointestinal disorders
Vomiting
|
30.8%
4/13 • Number of events 4 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
33.3%
2/6 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
33.3%
3/9 • Number of events 5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
66.7%
4/6 • Number of events 6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
1/5 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
General disorders
Pain
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Acute sinusitis
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Body tinea
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Bronchiolitis
|
7.7%
1/13 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Candidiasis
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Croup infectious
|
7.7%
1/13 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
33.3%
2/6 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Gastroenteritis viral
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Otitis media
|
15.4%
2/13 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
22.2%
2/9 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
2/10 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
1/5 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Otitis media acute
|
15.4%
2/13 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
1/5 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Pharyngotonsillitis
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Pneumonia
|
15.4%
2/13 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Rhinitis
|
7.7%
1/13 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Roseola
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Skin candida
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Tonsillitis streptococcal
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
1/5 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Infections and infestations
Viral rhinitis
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
11.1%
1/9 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Investigations
Body temperature increased
|
7.7%
1/13 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
33.3%
3/9 • Number of events 4 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
2/10 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
1/5 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
1/5 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Psychiatric disorders
Decreased activity
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
1/5 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
1/5 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
22.2%
2/9 • Number of events 5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
33.3%
2/6 • Number of events 4 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
22.2%
2/9 • Number of events 3 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
11.1%
1/9 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
1/5 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
7.7%
1/13 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
11.1%
1/9 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
20.0%
2/10 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
7.7%
1/13 • Number of events 2 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
7.7%
1/13 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
16.7%
1/6 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/10 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
|
Vascular disorders
Pallor
|
0.00%
0/13 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/9 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/6 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
10.0%
1/10 • Number of events 1 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
0.00%
0/5 • AEs:0-28 Days Postdose1, Postdose2, or postdose3 SAEs:0-180 Days Post Final Dose or Through 01 April Following Dosing for Sites in the USA, Whichever was Later
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it is understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER