Healthy
Conditions
Keywords
parainfluenza virus, children, vaccine
Brief summary
The primary objective of this study is to describe the safety and tolerability of 3 doses of MEDI-560 at 10\^5 TCID50 when administered to children 6 to \< 12 months of age who are HPIV3 (human parainfluenza virus type 3) seronegative at baseline and to infants 1 to \< 3 months of age regardless of baseline serostatus.
Detailed description
This is a randomized, double-blind, placebo-controlled, multidose Phase 1/2a multicenter study designed to evaluate the safety, tolerability, viral shedding, immunogenicity, and genotypic and phenotypic stability of MEDI-560 in infants 1 to \< 12 months of age. Three doses of MEDI-560 at a dosage level of 10\^5 TCID50 were administered 0, 2, and 4 months after enrollment to a 30-participant cohort of 6 to \< 12 month-old HPIV3 seronegative children randomized 2:1 to MEDI-560 vs placebo. A second 160-participant cohort of 1 to \< 3 month-old infants not screened for baseline serostatus was planned but was not opened to enrollment for reasons other than safety. Participants were followed for safety through 180 days post last dose. Nasal wash specimens were collected at screening and Days 7, 12, and 28 following each dose and during unscheduled illness visits to assess vaccine virus shedding and genotypic and phenotypic stability of any shed vaccine virus. Blood was collected at screening to determine eligibility and prior to Dose 1 for baseline serostatus. Blood for assessment of antibodies to HPIV3 was collected approximately 7 to 12 days after Dose 1 and Dose 3 and 1 month after each dose for antibodies to PIV3.
Interventions
BIOLOGICALMEDI-560
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson\^TM luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI-560 in a sucrose phosphate glutamate buffer.
BIOLOGICALPlacebo
Placebo was a frozen preparation filled into Becton Dickinson\^TM luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 11 Months
Healthy volunteers
Yes
Inclusion criteria
1. Male or female whose age on the day of randomization falls within one of the two age cohorts: Cohort 1: 6 to \< 12 months (≥ 6 months of age and not yet reached their 1st year birthday); Cohort 2: 1 to \< 3 months (\> 28 days of age and not yet reached their 3rd month birthday) 2. Cohort 1 only: Participant is seronegative to HPIV3 at screening as determined by ELISA; or the legal representative is willing to provide access to data documenting that the participant was screened for another MedImmune trial after written informed consent was obtained, and that the participant is seronegative to HPIV3 within 21 days prior to randomization into MI-CP150 as determined by ELISA at MedImmune 3. Participant was the product of a normal full term pregnancy, defined as 36-42 weeks gestation 4. Participant is in general good health 5. Participant's legal representative is available by telephone 6. Written informed consent and Health Insurance Portability and Accountability Act authorization (if applicable) obtained from the participant's legal representative 7. Participant's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator 8. Participant is available to complete the follow-up period of 180 days after the final dose of investigational product as required by the protocol 9. Participant's legal representative is willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol
Exclusion criteria
1. Any fever (≥ 100.4°F \[≥ 38.0°C\], regardless of route) or lower respiratory illness within 7 days prior to randomization 2. Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of investigational product 3. Cohort 1 only: weight \< the fifth percentile for age on the day of randomization 4. Cohort 2 only: history of low birth-weight (ie, \< 2,500 grams at birth) or weight \< fifth percentile for age on the day of randomization 5. Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt through the protocol-specified blood collection 28 days after each investigational product dosing, except that infrequent use of over-the-counter medications such as pain relievers are permitted according to the judgment of the investigator 6. Any current or expected receipt of immunosuppressive agents including steroids (≥ 2 mg/kg per day of prednisone or its equivalent, or ≥ 20 mg/day if the participant weighs \>10 kg, given daily or on alternate days for ≥ 14 days); children in this category should not receive investigational product until immunosuppressive agents including corticosteroid therapy have been discontinued for ≥ 30 days; the use of topical steroids is permitted according to the judgment of the investigator 7. History of receipt of blood transfusion or expected receipt through 30 days after final investigational product dosing 8. History of receipt of immunoglobulin products or expected receipt through 30 days after final investigational product dosing 9. Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 30 days after final investigational product dosing 10. Receipt of any live virus vaccine (excluding rotavirus vaccine) within 28 days prior to randomization or expected receipt within a 28-day window around any dose 11. Receipt of any inactivated (eg, non-live) vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any dose 12. Known or suspected immunodeficiency, including human immunodeficiency virus 13. Living in the same home or enrolled in the same classroom at day care with infants \< 24 months of age within 28 days after each dose (only one child per household may be enrolled into the study) 14. Contact with pregnant caregiver within 28 days after each dose 15. Household contact with an immunocompromised person within 28 days after each dose; the participant should also avoid close contact with immunocompromised individuals for at least 28 days after each investigational product dose 16. Household contact within 28 days after each dose with a healthcare worker who has direct patient care responsibilities or household contact within 28 days after each dose with someone who is a day care provider or preschool teacher for children \< 24 months of age 17. History of allergic reaction to any component of the investigational product 18. Previous medical history or evidence of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the participant 19. Known or suspected active or chronic hepatitis infection 20. History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, bronchoconstriction or treatment with a β2 agonist (eg, albuterol), cystic fibrosis, chronic lung disease of prematurity (eg, bronchopulmonary dysplasia), chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation 21. A family member or a household contact who is an employee of the research center or otherwise involved with the conduct of the study 22. Any condition that, in the opinion of the investigator, might interfere with investigational product evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | Days 0-28 after Dose 1 (Dose 1 was on Day 0) | — |
| Number of Participants With SEs After Dose 2 | Days 0-28 after Dose 2 (Dose 2 was on Day 48-64) | — |
| Number of Participants With SEs After Dose 3 | Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | — |
| Number of Participants With Adverse Events (AEs) After Dose 1 | Days 0-28 after Dose 1 (Dose 1 was on Day 0) | Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1. |
| Number of Participants With AEs After Dose 2 | Days 0-28 after Dose 2 (Dose 2 was on Day 48-64) | Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2. |
| Number of Participants With AEs After Dose 3 | Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3. |
| Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1 | Days 0-28 after Dose 1 (Dose 1 was on Day 0) | — |
| Number of Participants With MA-LRIs After Dose 2 | Days 0-28 after Dose 2 (Dose 2 was on Day 48-64) | — |
| Number of Participants With MA-LRIs After Dose 3 | Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | — |
| Number of Participants With Serious Adverse Events (SAEs) After Dose 1 | Days 0-28 after Dose 1 (Dose 1 was on Day 0) | — |
| Number of Participants With SAEs After Dose 2 | Days 0-28 after Dose 2 (Dose 2 was on Day 48-64) | One participant had event of pneumonia after Dose 2. |
| Number of Participants With SAEs After Dose 3 | Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | — |
| Number of Participants With Significant New Medical Conditions (SNMCs) | Day 0 through 180 days after final dose | A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hemagglutination Inhibition (HAI) Seroconversion/Seroresponse to HPIV3 28 Days After Dose 1 | Days 28-34 after Dose 1 (Dose 1 was on Day 0) | 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. |
| Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 2 | Days 28-34 after Dose 2 (Dose 2 was on Day 48-64) | 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. |
| Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 3 | Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | 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. |
| 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 | Day 0 after Dose 1 to 180 days after the final dose | 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. |
| Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3. | Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified. |
| Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline | Baseline (Day 0 prior to Dose 1) | Pre-dose GMT of HAI antibody to HPIV3 |
| Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1 | Day 28-34 after Dose 1 (Dose 1 was on Day 0) | Post-Dose 1 GMT of HAI antibody to HPIV3 |
| Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2 | Day 28-34 after Dose 2 (Dose 2 was on Day 48-64) | Post-Dose 2 GMT of HAI antibody to HPIV3 |
| Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3 | Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | Post-Dose 3 GMT of HAI antibody to HPIV3 |
| 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 | Day 0 after Dose 1 to 180 days after the final dose | 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. |
| Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation | Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose. | Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified. |
| Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1 | Days 7-10 after Dose 1 (Dose 1 was on Day 0) | Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified. |
| Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1 | Days 12-18 after Dose 1 (Dose 1 was on Day 0) | Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified. |
| Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1 | Days 28-34 after Dose 1 (Dose 1 was on Day 0) | Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified. |
| Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1 | Days 0-34 after Dose 1 (Dose 1 was on Day 0) | — |
| Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2 | Days 7-10 after Dose 2 (Dose 2 was on Day 48-64) | Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified. |
| Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2 | Days 12-18 after Dose 2 (Dose 2 was on Day 48-64) | Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified. |
| Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2 | Days 28-34 after Dose 2 (Dose 2 was on Day 48-64) | Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified. |
| Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2 | Days 0-34 after Dose 2 (Dose 2 was on Day 48-64) | Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified. |
| Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3 | Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified. |
| Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3 | Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified. |
| Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3 | Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 10 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Cohort 1 MEDI-560 | Cohort 1 Placebo | Total |
|---|---|---|---|
| Age Continuous | 8.94 Months STANDARD_DEVIATION 1.85 | 8.44 Months STANDARD_DEVIATION 1.2 | 8.77 Months STANDARD_DEVIATION 1.66 |
| Sex: Female, Male Female | 12 Participants | 4 Participants | 16 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 20 | 8 / 8 |
| serious Total, serious adverse events | 1 / 20 | 0 / 8 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) After Dose 1
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.
Time frame: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With Adverse Events (AEs) After Dose 1 | Dermatitis atopic | 1 participants |
| Cohort 1 MEDI-560 | Number of Participants With Adverse Events (AEs) After Dose 1 | Pharyngeal erythema | 1 participants |
| Cohort 1 MEDI-560 | Number of Participants With Adverse Events (AEs) After Dose 1 | Rhinorrhea | 2 participants |
| Cohort 1 MEDI-560 | Number of Participants With Adverse Events (AEs) After Dose 1 | Rash | 0 participants |
| Cohort 1 MEDI-560 | Number of Participants With Adverse Events (AEs) After Dose 1 | Tachycardia | 2 participants |
| Cohort 1 MEDI-560 | Number of Participants With Adverse Events (AEs) After Dose 1 | Conjunctivitis | 1 participants |
| Cohort 1 MEDI-560 | Number of Participants With Adverse Events (AEs) After Dose 1 | Diarrhoea | 3 participants |
| Cohort 1 MEDI-560 | Number of Participants With Adverse Events (AEs) After Dose 1 | Vomiting | 2 participants |
| Cohort 1 MEDI-560 | Number of Participants With Adverse Events (AEs) After Dose 1 | Gastroenteritis | 1 participants |
| Cohort 1 MEDI-560 | Number of Participants With Adverse Events (AEs) After Dose 1 | Otitis media | 3 participants |
| Cohort 1 MEDI-560 | Number of Participants With Adverse Events (AEs) After Dose 1 | Upper respiratory infection | 5 participants |
| Cohort 1 MEDI-560 | Number of Participants With Adverse Events (AEs) After Dose 1 | Body temperature increased | 1 participants |
| Cohort 1 Placebo | Number of Participants With Adverse Events (AEs) After Dose 1 | Upper respiratory infection | 2 participants |
| Cohort 1 Placebo | Number of Participants With Adverse Events (AEs) After Dose 1 | Diarrhoea | 1 participants |
| Cohort 1 Placebo | Number of Participants With Adverse Events (AEs) After Dose 1 | Pharyngeal erythema | 0 participants |
| Cohort 1 Placebo | Number of Participants With Adverse Events (AEs) After Dose 1 | Otitis media | 0 participants |
| Cohort 1 Placebo | Number of Participants With Adverse Events (AEs) After Dose 1 | Rhinorrhea | 1 participants |
| Cohort 1 Placebo | Number of Participants With Adverse Events (AEs) After Dose 1 | Dermatitis atopic | 0 participants |
| Cohort 1 Placebo | Number of Participants With Adverse Events (AEs) After Dose 1 | Vomiting | 1 participants |
| Cohort 1 Placebo | Number of Participants With Adverse Events (AEs) After Dose 1 | Rash | 1 participants |
| Cohort 1 Placebo | Number of Participants With Adverse Events (AEs) After Dose 1 | Body temperature increased | 0 participants |
| Cohort 1 Placebo | Number of Participants With Adverse Events (AEs) After Dose 1 | Tachycardia | 0 participants |
| Cohort 1 Placebo | Number of Participants With Adverse Events (AEs) After Dose 1 | Gastroenteritis | 0 participants |
| Cohort 1 Placebo | Number of Participants With Adverse Events (AEs) After Dose 1 | Conjunctivitis | 0 participants |
Primary
Number of Participants With AEs After Dose 2
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.
Time frame: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Population: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 2 | Gastroenteritis | 1 participants |
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 2 | Body temperature increased | 2 participants |
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 2 | Vomiting | 1 participants |
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 2 | Pharyngeal erythema | 1 participants |
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 2 | Otitis media | 1 participants |
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 2 | Rhinorrhea | 0 participants |
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 2 | Diarrhoea | 2 participants |
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 2 | Dermatitis atopic | 0 participants |
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 2 | Upper respiratory infection | 8 participants |
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 2 | Rash | 1 participants |
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 2 | Conjunctivitis | 2 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 2 | Rash | 2 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 2 | Conjunctivitis | 0 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 2 | Diarrhoea | 0 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 2 | Vomiting | 0 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 2 | Gastroenteritis | 1 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 2 | Otitis media | 0 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 2 | Upper respiratory infection | 2 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 2 | Body temperature increased | 0 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 2 | Pharyngeal erythema | 0 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 2 | Rhinorrhea | 1 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 2 | Dermatitis atopic | 1 participants |
Primary
Number of Participants With AEs After Dose 3
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.
Time frame: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Population: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 3 | Conjunctivitis | 1 participants |
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 3 | Upper respiratory infection | 2 participants |
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 3 | Body temperature increased | 1 participants |
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 3 | Vomiting | 1 participants |
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 3 | Dermatitis atopic | 0 participants |
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 3 | Diarrhoea | 2 participants |
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 3 | Rash | 0 participants |
| Cohort 1 MEDI-560 | Number of Participants With AEs After Dose 3 | Otitis media | 1 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 3 | Rash | 1 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 3 | Conjunctivitis | 0 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 3 | Diarrhoea | 2 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 3 | Vomiting | 0 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 3 | Otitis media | 0 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 3 | Body temperature increased | 0 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 3 | Dermatitis atopic | 1 participants |
| Cohort 1 Placebo | Number of Participants With AEs After Dose 3 | Upper respiratory infection | 1 participants |
Primary
Number of Participants With MA-LRIs After Dose 2
Time frame: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With MA-LRIs After Dose 2 | Bronchiolitis | 0 participant |
| Cohort 1 MEDI-560 | Number of Participants With MA-LRIs After Dose 2 | Wheezing | 0 participant |
| Cohort 1 MEDI-560 | Number of Participants With MA-LRIs After Dose 2 | Pneumonia | 1 participant |
| Cohort 1 Placebo | Number of Participants With MA-LRIs After Dose 2 | Bronchiolitis | 0 participant |
| Cohort 1 Placebo | Number of Participants With MA-LRIs After Dose 2 | Wheezing | 0 participant |
| Cohort 1 Placebo | Number of Participants With MA-LRIs After Dose 2 | Pneumonia | 0 participant |
Primary
Number of Participants With MA-LRIs After Dose 3
Time frame: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With MA-LRIs After Dose 3 | Wheezing | 0 participant |
| Cohort 1 MEDI-560 | Number of Participants With MA-LRIs After Dose 3 | Pneumonia | 0 participant |
| Cohort 1 MEDI-560 | Number of Participants With MA-LRIs After Dose 3 | Bronchiolitis | 0 participant |
| Cohort 1 Placebo | Number of Participants With MA-LRIs After Dose 3 | Bronchiolitis | 0 participant |
| Cohort 1 Placebo | Number of Participants With MA-LRIs After Dose 3 | Wheezing | 0 participant |
| Cohort 1 Placebo | Number of Participants With MA-LRIs After Dose 3 | Pneumonia | 0 participant |
Primary
Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1
Time frame: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1 | Bronchiolitis | 1 participant |
| Cohort 1 MEDI-560 | Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1 | Wheezing | 1 participant |
| Cohort 1 MEDI-560 | Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1 | Pneumonia | 0 participant |
| Cohort 1 Placebo | Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1 | Pneumonia | 0 participant |
| Cohort 1 Placebo | Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1 | Bronchiolitis | 0 participant |
| Cohort 1 Placebo | Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1 | Wheezing | 0 participant |
Primary
Number of Participants With SAEs After Dose 2
One participant had event of pneumonia after Dose 2.
Time frame: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With SAEs After Dose 2 | 1 participants |
| Cohort 1 Placebo | Number of Participants With SAEs After Dose 2 | 0 participants |
Primary
Number of Participants With SAEs After Dose 3
Time frame: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With SAEs After Dose 3 | 0 participants |
| Cohort 1 Placebo | Number of Participants With SAEs After Dose 3 | 0 participants |
Primary
Number of Participants With Serious Adverse Events (SAEs) After Dose 1
Time frame: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With Serious Adverse Events (SAEs) After Dose 1 | 0 participant |
| Cohort 1 Placebo | Number of Participants With Serious Adverse Events (SAEs) After Dose 1 | 0 participant |
Primary
Number of Participants With SEs After Dose 2
Time frame: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Population: Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 2 | irritability/fussiness | 8 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 2 | fever greater than or equal to 103.2° F | 1 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 2 | drowsiness | 3 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 2 | fever greater than or equal to 104.9° F | 0 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 2 | fever greater than or equal to 100.4° F | 5 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 2 | loss of appetite/decreased urine output | 4 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 2 | cough | 6 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 2 | oropharygeal inflammation (laryngitis) | 2 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 2 | fever greater than or equal to 101.5° F | 2 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 2 | epistaxis | 0 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 2 | runny/stuffy nose | 12 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 2 | epistaxis | 0 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 2 | runny/stuffy nose | 4 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 2 | cough | 2 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 2 | drowsiness | 0 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 2 | irritability/fussiness | 2 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 2 | fever greater than or equal to 100.4° F | 1 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 2 | fever greater than or equal to 101.5° F | 1 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 2 | fever greater than or equal to 103.2° F | 0 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 2 | fever greater than or equal to 104.9° F | 0 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 2 | loss of appetite/decreased urine output | 0 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 2 | oropharygeal inflammation (laryngitis) | 0 participants |
Primary
Number of Participants With SEs After Dose 3
Time frame: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Population: Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 3 | drowsiness | 2 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 3 | fever greater than or equal to 103.2° F | 0 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 3 | irritability/fussiness | 6 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 3 | fever greater than or equal to 104.9° F | 0 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 3 | cough | 5 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 3 | loss of appetite/decreased urine output | 4 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 3 | fever greater than or equal to 100.4° F | 3 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 3 | oropharygeal inflammation (laryngitis) | 0 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 3 | runny/stuffy nose | 7 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 3 | epistaxis | 0 participants |
| Cohort 1 MEDI-560 | Number of Participants With SEs After Dose 3 | fever greater than or equal to 101.5° F | 2 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 3 | epistaxis | 0 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 3 | runny/stuffy nose | 3 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 3 | cough | 1 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 3 | irritability/fussiness | 3 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 3 | fever greater than or equal to 100.4° F | 0 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 3 | fever greater than or equal to 101.5° F | 0 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 3 | fever greater than or equal to 103.2° F | 0 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 3 | fever greater than or equal to 104.9° F | 0 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 3 | loss of appetite/decreased urine output | 1 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 3 | oropharygeal inflammation (laryngitis) | 0 participants |
| Cohort 1 Placebo | Number of Participants With SEs After Dose 3 | drowsiness | 0 participants |
Primary
Number of Participants With Significant New Medical Conditions (SNMCs)
A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.
Time frame: Day 0 through 180 days after final dose
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With Significant New Medical Conditions (SNMCs) | 0 participants |
| Cohort 1 Placebo | Number of Participants With Significant New Medical Conditions (SNMCs) | 0 participants |
Primary
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
Time frame: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Population: Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | cough | 13 participants |
| Cohort 1 MEDI-560 | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | drowsiness | 8 participants |
| Cohort 1 MEDI-560 | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | irritability/fussiness | 6 participants |
| Cohort 1 MEDI-560 | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | fever greater than or equal to 100.4° F | 3 participants |
| Cohort 1 MEDI-560 | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | loss of appetite/decreased urine output | 3 participants |
| Cohort 1 MEDI-560 | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | oropharygeal inflammation (laryngitis) | 1 participants |
| Cohort 1 MEDI-560 | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | epistaxis | 0 participants |
| Cohort 1 MEDI-560 | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | runny/stuffy nose | 14 participants |
| Cohort 1 MEDI-560 | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | fever greater than or equal to 101.5° F | 1 participants |
| Cohort 1 MEDI-560 | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | fever greater than or equal to 103.2° F | 1 participants |
| Cohort 1 MEDI-560 | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | fever greater than or equal to 104.9° F | 0 participants |
| Cohort 1 Placebo | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | oropharygeal inflammation (laryngitis) | 0 participants |
| Cohort 1 Placebo | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | cough | 5 participants |
| Cohort 1 Placebo | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | fever greater than or equal to 103.2° F | 0 participants |
| Cohort 1 Placebo | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | drowsiness | 2 participants |
| Cohort 1 Placebo | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | epistaxis | 0 participants |
| Cohort 1 Placebo | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | irritability/fussiness | 2 participants |
| Cohort 1 Placebo | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | fever greater than or equal to 101.5° F | 0 participants |
| Cohort 1 Placebo | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | fever greater than or equal to 104.9° F | 0 participants |
| Cohort 1 Placebo | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | runny/stuffy nose | 6 participants |
| Cohort 1 Placebo | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | loss of appetite/decreased urine output | 2 participants |
| Cohort 1 Placebo | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | fever greater than or equal to 100.4° F | 1 participants |
Secondary
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline
Pre-dose GMT of HAI antibody to HPIV3
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort 1 MEDI-560 | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline | 3.05 GMT |
| Cohort 1 Placebo | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline | NA GMT |
Secondary
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1
Post-Dose 1 GMT of HAI antibody to HPIV3
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort 1 MEDI-560 | Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1 | 17.28 GMT |
| Cohort 1 Placebo | Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1 | NA GMT |
Secondary
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2
Post-Dose 2 GMT of HAI antibody to HPIV3
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort 1 MEDI-560 | Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2 | 25.40 GMT |
| Cohort 1 Placebo | Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2 | 3.17 GMT |
Secondary
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3
Post-Dose 3 GMT of HAI antibody to HPIV3
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort 1 MEDI-560 | Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3 | 42.91 GMT |
| Cohort 1 Placebo | Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3 | 6.35 GMT |
Secondary
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
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.
Time frame: Day 0 after Dose 1 to 180 days after the final dose
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | 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
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
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.
Time frame: Day 0 after Dose 1 to 180 days after the final dose
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | 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
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1 | 13 participants |
| Cohort 1 Placebo | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1 | 0 participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2 | 0 participants |
| Cohort 1 Placebo | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2 | 0 participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3 | 0 participants |
| Cohort 1 Placebo | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3 | 0 participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1 | 0 participants |
| Cohort 1 Placebo | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1 | 0 participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2 | 0 participants |
| Cohort 1 Placebo | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2 | 0 participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3 | 0 participants |
| Cohort 1 Placebo | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3 | 0 participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1 | 16 participants |
| Cohort 1 Placebo | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1 | 0 participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2 | 1 participants |
| Cohort 1 Placebo | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2 | 0 participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3 | 0 participants |
| Cohort 1 Placebo | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3 | 0 participants |
Secondary
Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation | 17 participants |
| Cohort 1 Placebo | Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation | 0 participants |
Secondary
Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 2
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 2 | 11 participants |
| Cohort 1 Placebo | Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 2 | 1 participants |
Secondary
Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 3
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 3 | 10 participants |
| Cohort 1 Placebo | Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 3 | 2 participants |
Secondary
Number of Participants With Hemagglutination Inhibition (HAI) Seroconversion/Seroresponse to HPIV3 28 Days After Dose 1
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With Hemagglutination Inhibition (HAI) Seroconversion/Seroresponse to HPIV3 28 Days After Dose 1 | 11 participants |
| Cohort 1 Placebo | Number of Participants With Hemagglutination Inhibition (HAI) Seroconversion/Seroresponse to HPIV3 28 Days After Dose 1 | 0 participants |
Secondary
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1 | 17 participants |
| Cohort 1 Placebo | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1 | 0 participants |
Secondary
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2 | 1 participants |
| Cohort 1 Placebo | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2 | 0 participants |
Secondary
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3.
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 MEDI-560 | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3. | 0 participants |
| Cohort 1 Placebo | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3. | 0 participants |