Trial Outcomes & Findings for A Phase 1/2A Study to Evaluate the Safety, Immunogenicity, and Shedding of MEDI-560 in Infants 1 to < 12 Months of Age (NCT NCT00508651)
NCT ID: NCT00508651
Last Updated: 2011-12-30
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Results posted on
2011-12-30
Participant Flow
Participants 6 to \< 12 months of age were screened prior to randomization at 8 sites in the USA. The first and last days of informed consent were 07Nov2007 and 30Jun2008, respectively. No participants were screened for Cohort 2 (1 to \< 3 months of age) because the study was closed prior to enrollment into Cohort 2 for reasons other than safety.
Thirty participants were randomized into Cohort 1 between 12Nov2007 and 07Jul2008. Participants were randomized in a 2:1 ratio to receive MEDI-560 or placebo, and randomization into Cohort 1 was not stratified.
Participant milestones
| Measure |
Cohort 1 MEDI-560
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
10
|
|
Overall Study
COMPLETED
|
16
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1 MEDI-560
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Phase 1/2A Study to Evaluate the Safety, Immunogenicity, and Shedding of MEDI-560 in Infants 1 to < 12 Months of Age
Baseline characteristics by cohort
| Measure |
Cohort 1 MEDI-560
n=20 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=10 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
8.94 Months
STANDARD_DEVIATION 1.85 • n=5 Participants
|
8.44 Months
STANDARD_DEVIATION 1.20 • n=7 Participants
|
8.77 Months
STANDARD_DEVIATION 1.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 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
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=20 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=8 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
runny/stuffy nose
|
14 participants
|
6 participants
|
|
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
cough
|
13 participants
|
5 participants
|
|
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
drowsiness
|
8 participants
|
2 participants
|
|
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
irritability/fussiness
|
6 participants
|
2 participants
|
|
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
fever greater than or equal to 100.4° F
|
3 participants
|
1 participants
|
|
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
fever greater than or equal to 101.5° F
|
1 participants
|
0 participants
|
|
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
fever greater than or equal to 103.2° F
|
1 participants
|
0 participants
|
|
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
fever greater than or equal to 104.9° F
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
loss of appetite/decreased urine output
|
3 participants
|
2 participants
|
|
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
oropharygeal inflammation (laryngitis)
|
1 participants
|
0 participants
|
|
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
epistaxis
|
0 participants
|
0 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
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=19 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=6 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants With SEs After Dose 2
runny/stuffy nose
|
12 participants
|
4 participants
|
|
Number of Participants With SEs After Dose 2
cough
|
6 participants
|
2 participants
|
|
Number of Participants With SEs After Dose 2
drowsiness
|
3 participants
|
0 participants
|
|
Number of Participants With SEs After Dose 2
irritability/fussiness
|
8 participants
|
2 participants
|
|
Number of Participants With SEs After Dose 2
fever greater than or equal to 100.4° F
|
5 participants
|
1 participants
|
|
Number of Participants With SEs After Dose 2
fever greater than or equal to 101.5° F
|
2 participants
|
1 participants
|
|
Number of Participants With SEs After Dose 2
fever greater than or equal to 103.2° F
|
1 participants
|
0 participants
|
|
Number of Participants With SEs After Dose 2
fever greater than or equal to 104.9° F
|
0 participants
|
0 participants
|
|
Number of Participants With SEs After Dose 2
loss of appetite/decreased urine output
|
4 participants
|
0 participants
|
|
Number of Participants With SEs After Dose 2
oropharygeal inflammation (laryngitis)
|
2 participants
|
0 participants
|
|
Number of Participants With SEs After Dose 2
epistaxis
|
0 participants
|
0 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.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=16 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=7 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants With SEs After Dose 3
runny/stuffy nose
|
7 participants
|
3 participants
|
|
Number of Participants With SEs After Dose 3
cough
|
5 participants
|
1 participants
|
|
Number of Participants With SEs After Dose 3
drowsiness
|
2 participants
|
0 participants
|
|
Number of Participants With SEs After Dose 3
irritability/fussiness
|
6 participants
|
3 participants
|
|
Number of Participants With SEs After Dose 3
fever greater than or equal to 100.4° F
|
3 participants
|
0 participants
|
|
Number of Participants With SEs After Dose 3
fever greater than or equal to 101.5° F
|
2 participants
|
0 participants
|
|
Number of Participants With SEs After Dose 3
fever greater than or equal to 103.2° F
|
0 participants
|
0 participants
|
|
Number of Participants With SEs After Dose 3
fever greater than or equal to 104.9° F
|
0 participants
|
0 participants
|
|
Number of Participants With SEs After Dose 3
loss of appetite/decreased urine output
|
4 participants
|
1 participants
|
|
Number of Participants With SEs After Dose 3
oropharygeal inflammation (laryngitis)
|
0 participants
|
0 participants
|
|
Number of Participants With SEs After Dose 3
epistaxis
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Days 0-28 after Dose 1 (Dose 1 was on Day 0)Population: Safety population for adverse events included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose).
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=20 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=8 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) After Dose 1
Pharyngeal erythema
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) After Dose 1
Rhinorrhea
|
2 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs) After Dose 1
Dermatitis atopic
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) After Dose 1
Rash
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs) After Dose 1
Tachycardia
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) After Dose 1
Conjunctivitis
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) After Dose 1
Diarrhoea
|
3 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs) After Dose 1
Vomiting
|
2 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs) After Dose 1
Gastroenteritis
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) After Dose 1
Otitis media
|
3 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) After Dose 1
Upper respiratory infection
|
5 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AEs) After Dose 1
Body temperature increased
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)Population: Safety population for adverse events included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=19 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=6 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants With AEs After Dose 2
Conjunctivitis
|
2 participants
|
0 participants
|
|
Number of Participants With AEs After Dose 2
Diarrhoea
|
2 participants
|
0 participants
|
|
Number of Participants With AEs After Dose 2
Vomiting
|
1 participants
|
0 participants
|
|
Number of Participants With AEs After Dose 2
Gastroenteritis
|
1 participants
|
1 participants
|
|
Number of Participants With AEs After Dose 2
Otitis media
|
1 participants
|
0 participants
|
|
Number of Participants With AEs After Dose 2
Upper respiratory infection
|
8 participants
|
2 participants
|
|
Number of Participants With AEs After Dose 2
Body temperature increased
|
2 participants
|
0 participants
|
|
Number of Participants With AEs After Dose 2
Pharyngeal erythema
|
1 participants
|
0 participants
|
|
Number of Participants With AEs After Dose 2
Rhinorrhea
|
0 participants
|
1 participants
|
|
Number of Participants With AEs After Dose 2
Dermatitis atopic
|
0 participants
|
1 participants
|
|
Number of Participants With AEs After Dose 2
Rash
|
1 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)Population: Safety population for adverse events included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=16 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=7 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants With AEs After Dose 3
Conjunctivitis
|
1 participants
|
0 participants
|
|
Number of Participants With AEs After Dose 3
Diarrhoea
|
2 participants
|
2 participants
|
|
Number of Participants With AEs After Dose 3
Vomiting
|
1 participants
|
0 participants
|
|
Number of Participants With AEs After Dose 3
Otitis media
|
1 participants
|
0 participants
|
|
Number of Participants With AEs After Dose 3
Upper respiratory infection
|
2 participants
|
1 participants
|
|
Number of Participants With AEs After Dose 3
Body temperature increased
|
1 participants
|
0 participants
|
|
Number of Participants With AEs After Dose 3
Dermatitis atopic
|
0 participants
|
1 participants
|
|
Number of Participants With AEs After Dose 3
Rash
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Days 0-28 after Dose 1 (Dose 1 was on Day 0)Population: Safety population for MA-LRIs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=20 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=8 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1
Bronchiolitis
|
1 participant
|
0 participant
|
|
Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1
Wheezing
|
1 participant
|
0 participant
|
|
Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1
Pneumonia
|
0 participant
|
0 participant
|
PRIMARY outcome
Timeframe: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)Population: Safety population for MA-LRIs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=19 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=6 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants With MA-LRIs After Dose 2
Bronchiolitis
|
0 participant
|
0 participant
|
|
Number of Participants With MA-LRIs After Dose 2
Wheezing
|
0 participant
|
0 participant
|
|
Number of Participants With MA-LRIs After Dose 2
Pneumonia
|
1 participant
|
0 participant
|
PRIMARY outcome
Timeframe: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)Population: Safety population for MA-LRIs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=16 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=7 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants With MA-LRIs After Dose 3
Bronchiolitis
|
0 participant
|
0 participant
|
|
Number of Participants With MA-LRIs After Dose 3
Wheezing
|
0 participant
|
0 participant
|
|
Number of Participants With MA-LRIs After Dose 3
Pneumonia
|
0 participant
|
0 participant
|
PRIMARY outcome
Timeframe: Days 0-28 after Dose 1 (Dose 1 was on Day 0)Population: Safety population for SAEs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=20 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=8 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) After Dose 1
|
0 participant
|
0 participant
|
PRIMARY outcome
Timeframe: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)Population: Safety population for SAEs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)
One participant had event of pneumonia after Dose 2.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=19 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=6 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants With SAEs After Dose 2
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)Population: Safety population for SAEs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=16 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=7 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants With SAEs After Dose 3
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 0 through 180 days after final dosePopulation: Safety population was randomized participants who received investigational product and had any safety follow-up, including a temperature measurement, SE, AE, concomitant medication use, or 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 |
Cohort 1 MEDI-560
n=20 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=8 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants With Significant New Medical Conditions (SNMCs)
|
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 180 days post final dose.Population: The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=20 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=8 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation
|
17 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 7-10 after Dose 1 (Dose 1 was on Day 0)Population: The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=20 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=8 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1
|
16 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 12-18 after Dose 1 (Dose 1 was on Day 0)Population: The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=19 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=8 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1
|
13 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 28-34 after Dose 1 (Dose 1 was on Day 0)Population: The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=20 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=7 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip 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
|
0 participants
|
SECONDARY outcome
Timeframe: Days 0-34 after Dose 1 (Dose 1 was on Day 0)Population: The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=20 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=8 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip 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
|
17 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)Population: The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=19 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=5 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)Population: The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=18 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=6 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip 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
|
0 participants
|
SECONDARY outcome
Timeframe: Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)Population: The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=16 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=6 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip 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
|
0 participants
|
SECONDARY outcome
Timeframe: Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)Population: The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=19 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=6 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip 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
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)Population: The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=16 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=6 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip 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
|
0 participants
|
SECONDARY outcome
Timeframe: Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)Population: The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=15 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=7 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip 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
|
0 participants
|
SECONDARY outcome
Timeframe: Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)Population: The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=15 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=7 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip 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
|
0 participants
|
SECONDARY outcome
Timeframe: Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)Population: The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=16 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=7 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip 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
|
0 participants
|
SECONDARY outcome
Timeframe: Days 28-34 after Dose 1 (Dose 1 was on Day 0)Population: The immunogenicity population included all randomized participants who received investigational product and who did not have a major protocol violation that would affect interpretation of immune response assay results and who had valid HAI results.
Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=18 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=7 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants With Hemagglutination Inhibition (HAI) Seroconversion/Seroresponse to HPIV3 28 Days After Dose 1
|
11 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 randomized participants who received investigational product and who did not have a major protocol violation that would affect interpretation of immune response assay results and who had valid HAI results.
Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=15 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=6 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 2
|
11 participants
|
1 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 randomized participants who received investigational product and who did not have a major protocol violation that would affect interpretation of immune response assay results and who had valid HAI results.
Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=13 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=6 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 3
|
10 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Day 0 after Dose 1 to 180 days after the final dosePopulation: All nasal wash samples in which MEDI-560 was identified in the absence of wild-type HPIV3 and for which valid genotype data are available
A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication. Genotypic stability of recovered vaccine-type virus at the 15 mutations of phenotypic importance was assessed.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=29 nasal wash samples
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Genotypically Stable
|
28 samples containing vaccine-like virus
|
—
|
SECONDARY outcome
Timeframe: Day 0 after Dose 1 to 180 days after the final dosePopulation: All nasal wash samples in which MEDI-560 was identified in the absence of wild-type HPIV3 and for which valid phenotype data are available
A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication. Determination of the temperature sensitivity of recovered vaccine-type virus.
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=28 Samples
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Phenotypically Stable
|
28 samples containing vaccine-like virus
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0 prior to Dose 1)Population: Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers \< 4.
Pre-dose GMT of HAI antibody to HPIV3
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=18 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=6 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline
|
3.05 GMT
Interval 2.2 to 4.8
|
NA GMT
Results were less than the assay's limit of quantification, therefore were all imputed to be 2.0.
|
SECONDARY outcome
Timeframe: Day 28-34 after Dose 1 (Dose 1 was on Day 0)Population: Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers \< 4.
Post-Dose 1 GMT of HAI antibody to HPIV3
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=18 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=7 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1
|
17.28 GMT
Interval 9.3 to 33.3
|
NA GMT
Results were less than the assay's limit of quantification, therefore were all imputed to be 2.0.
|
SECONDARY outcome
Timeframe: Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)Population: Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers \< 4.
Post-Dose 2 GMT of HAI antibody to HPIV3
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=15 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=6 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2
|
25.40 GMT
Interval 11.1 to 55.7
|
3.17 GMT
Interval 2.0 to 8.0
|
SECONDARY outcome
Timeframe: Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)Population: Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers \< 4.
Post-Dose 3 GMT of HAI antibody to HPIV3
Outcome measures
| Measure |
Cohort 1 MEDI-560
n=13 Participants
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=6 Participants
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3
|
42.91 GMT
Interval 13.3 to 142.4
|
6.35 GMT
Interval 2.0 to 26.9
|
Adverse Events
Cohort 1 MEDI-560
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Cohort 1 Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 MEDI-560
n=20 participants at risk
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=8 participants at risk
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
Other adverse events
| Measure |
Cohort 1 MEDI-560
n=20 participants at risk
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
|
Cohort 1 Placebo
n=8 participants at risk
Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
10.0%
2/20 • Number of events 2 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Eye disorders
Conjunctivitis
|
20.0%
4/20 • Number of events 4 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
35.0%
7/20 • Number of events 7 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
25.0%
2/8 • Number of events 4 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • Number of events 4 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Infections and infestations
Gastroenteritis
|
10.0%
2/20 • Number of events 2 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Infections and infestations
Otitis media
|
20.0%
4/20 • Number of events 5 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
45.0%
9/20 • Number of events 15 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
50.0%
4/8 • Number of events 6 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Investigations
Body temperature increased
|
15.0%
3/20 • Number of events 4 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
10.0%
2/20 • Number of events 2 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
2/20 • Number of events 2 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
25.0%
2/8 • Number of events 2 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
25.0%
2/8 • Number of events 2 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
50.0%
4/8 • Number of events 4 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Gastrointestinal disorders
Teething
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/20 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Infections and infestations
Candida nappy rash
|
0.00%
0/20 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/20 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Eye disorders
Lacrimation increased
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.0%
1/20 • Number of events 2 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Gastrointestinal disorders
Stomach discomfort
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Infections and infestations
Bronchiolitis
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Infections and infestations
Oral herpes
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Infections and infestations
Otitis externa
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Infections and infestations
Rhinitis
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Infections and infestations
Skin candida
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Psychiatric disorders
Listless
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
0.00%
0/8 • Adverse events were collected during the 28-day period following each dose of investigational product. Serious adverse events were collected from Day 0 through 180 days after the final dose of investigational product.
Other adverse events include events that occurred in at least 1 subject within 28 days after any dose.
|
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