| Primary | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | | 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 | Posted | | Number | | participants | | Days 0-28 after Dose 1 (Dose 1 was on Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| | | Title | Denominators | Categories |
|---|
| runny/stuffy nose | | | | cough | | |
| |
| Primary | Number of Participants With SEs After Dose 2 | | 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 | Posted | | Number | | participants | | Days 0-28 after Dose 2 (Dose 2 was on Day 48-64) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| Primary | Number of Participants With SEs After Dose 3 | | 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. | Posted | | Number | | participants | | Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | 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). | Posted | | Number | | participants | | Days 0-28 after Dose 1 (Dose 1 was on Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | 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) | Posted | | Number | | participants | | Days 0-28 after Dose 2 (Dose 2 was on Day 48-64) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | 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) | Posted | | Number | | participants | | Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| Primary | Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1 | | 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) | Posted | | Number | | participant | | Days 0-28 after Dose 1 (Dose 1 was on Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| Primary | Number of Participants With MA-LRIs After Dose 2 | | 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) | Posted | | Number | | participant | | Days 0-28 after Dose 2 (Dose 2 was on Day 48-64) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| Primary | Number of Participants With MA-LRIs After Dose 3 | | 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) | Posted | | Number | | participant | | Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| Primary | Number of Participants With Serious Adverse Events (SAEs) After Dose 1 | | 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) | Posted | | Number | | participant | | Days 0-28 after Dose 1 (Dose 1 was on Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| Primary | Number of Participants With SAEs After Dose 2 | One participant had event of pneumonia after Dose 2. | 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) | Posted | | Number | | participants | | Days 0-28 after Dose 2 (Dose 2 was on Day 48-64) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| Primary | Number of Participants With SAEs After Dose 3 | | 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) | Posted | | Number | | participants | | Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | 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). | Posted | | Number | | participants | | Day 0 through 180 days after final dose | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available. | Posted | | Number | | participants | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available. | Posted | | Number | | participants | | Days 7-10 after Dose 1 (Dose 1 was on Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available. | Posted | | Number | | participants | | Days 12-18 after Dose 1 (Dose 1 was on Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available. | Posted | | Number | | participants | | Days 28-34 after Dose 1 (Dose 1 was on Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| Secondary | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1 | | The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available. | Posted | | Number | | participants | | Days 0-34 after Dose 1 (Dose 1 was on Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available. | Posted | | Number | | participants | | Days 7-10 after Dose 2 (Dose 2 was on Day 48-64) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available. | Posted | | Number | | participants | | Days 12-18 after Dose 2 (Dose 2 was on Day 48-64) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available. | Posted | | Number | | participants | | Days 28-34 after Dose 2 (Dose 2 was on Day 48-64) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available. | Posted | | Number | | participants | | Days 0-34 after Dose 2 (Dose 2 was on Day 48-64) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available. | Posted | | Number | | participants | | Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available. | Posted | | Number | | participants | | Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available. | Posted | | Number | | participants | | Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available. | Posted | | Number | | participants | | Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | 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. | Posted | | Number | | participants | | Days 28-34 after Dose 1 (Dose 1 was on Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | 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. | Posted | | Number | | participants | | Days 28-34 after Dose 2 (Dose 2 was on Day 48-64) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | 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. | Posted | | Number | | participants | | Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | 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 | Posted | | Number | | samples containing vaccine-like virus | | Day 0 after Dose 1 to 180 days after the final dose | nasal wash samples | Participants | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| 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. | 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 | Posted | | Number | | samples containing vaccine-like virus | | Day 0 after Dose 1 to 180 days after the final dose | Samples | Participants | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
| |
| Secondary | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline | Pre-dose GMT of HAI antibody to HPIV3 | 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. | Posted | | Mean | 95% Confidence Interval | GMT | | Baseline (Day 0 prior to Dose 1) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
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| Secondary | Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1 | Post-Dose 1 GMT of HAI antibody to HPIV3 | 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. | Posted | | Mean | 95% Confidence Interval | GMT | | Day 28-34 after Dose 1 (Dose 1 was on Day 0) | | | | ID | Title | Description |
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| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
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| Secondary | Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2 | Post-Dose 2 GMT of HAI antibody to HPIV3 | 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. | Posted | | Mean | 95% Confidence Interval | GMT | | Day 28-34 after Dose 2 (Dose 2 was on Day 48-64) | | | | ID | Title | Description |
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| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
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| Secondary | Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3 | Post-Dose 3 GMT of HAI antibody to HPIV3 | 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. | Posted | | Mean | 95% Confidence Interval | GMT | | Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | | | | ID | Title | Description |
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| OG000 | Cohort 1 MEDI-560 | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinsonâ„¢ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer. | | OG001 | Cohort 1 Placebo | Placebo was a frozen preparation filled into Becton Dickinsonâ„¢ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
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