B974 Respiratory syncytial virus as the cause of diseases classified to other chapters Respiratory syncytial virus as the cause of diseases classified to other chapters
Conditions
Interventions
Season 1: single dose of 105 mg
of MK-1654 (Dose
strength 150 mg/mL), sterile solution
administered
intramuscularly at visit 1
(day 1) + single dose of placebo sterile solution for intramuscular injec
Sponsors
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Recommended to receive palivizumab and meets 1 or more of the following criteria: a) Early or Moderate Pre-term Group: =35 weeks, 0 days gestational age b) CLD/CHD Group: • Participants that have CLD of prematurity (also known as bronchopulmonary Dysplasia) • Participants that have hemodynamically significant CHD. Is available to complete the follow-up period: • Up to 575 days (180 days after RSV Season 2 dose) for participants eligible for RSV Season 2 dose of MK-1654, or • Approximately 365 days after the RSV Season 1 Dose 1 for all other participants. Is male or female and has a chronological age from birth up to 1 year and is entering their first RSV season at the time informed consent is provided. The participant’s legally acceptable representative provides documented informed consent for the study. The participant’s legally acceptable representative may also provide documented consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research. Additional Inclusion criteria for participation in RSV season 2: Participants enrolled in the CLD/CHD group as defined in Inclusion Criteria #1b. Participants with CHD are required to meet the following additional criteria: • Have hemodynamically significant CHD at the beginning of RSV Season 2, or • If the participant has had surgically repaired hemodynamically significant CHD that did not include ECMO or cardiopulmonary bypass: • Continues to require medications to manage CHD, or • Any additional medical intervention related to their CHD Additional Inclusion criteria for participation in RSV season 2: Participants enrolled in the Early or Moderate Pre-term Group as defined in Inclusion Criteria #1a, with the following conditions: • Neuromuscular disease or congenital pulmonary anomaly that impairs the ability to clear secretions from the upper airway because of ineffective cough • Down Syndrome (trisomy of chromosome 21) • Cystic fibrosis with nutritional compromise (eg, weight <10th percentile at time of enrollment) •
Exclusion criteria
Exclusion criteria: Has known hypersensitivity to any component of MK-1654 (refer to the IB for a list of components) or palivizumab (refer to the Synagis® label for a list of components). Has received other investigational agents at any time before study entry. Has a prior surgical correction of CHD or anticipated cardiac surgical procedure within 60 days of randomization resulting in hemodynamically insignificant CHD. Requires ECMO or continuous positive airway pressure at the time of enrollment. Has an anticipated or planned cardiac transplantation to occur during the course of this study. Has a bleeding disorder contraindicating intramuscular administration. Has had a recent illness with rectal temperature =100.5°F (=38.1°C) or axillary temperature =100.0°F (=37.8°C) within 72 hours predose. Has symptoms of LRI (defined in Section 8.2.1) within 7 days predose. Has received any vaccine or mAb for the prevention of RSV, including receipt of maternal RSV vaccination during the mother’s pregnancy. Is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time before first dose administration or while participating in this current study. Participants enrolled in observational studies may be included and will be reviewed on a case-by-case basis for approval by the Sponsor. Has enrolled previously in the current study and been discontinued. Has a parent/legal guardian/legally acceptable representative who is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study. Has any other reason that in the opinion of the investigator may interfere with the evaluation required by the study. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study. Exclusion criteria for participation in RSV season 2: Has a life expectancy <6 months. Exclusion criteria for participation in RSV season 2: Has known hepatic or renal dysfunction, or chronic seizure disorder. Exclusion criteria for participa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weekly follow-up of the participant and information declared in the patient diary from day 1 through 28 after Dose 1 and 14 days after each subsequent dose in RSV Season 1 NAME OF THE RESULT: Safety: • Number of participants with nonserious AEs PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Days 1 through 28 after Dose 1 and 14 days after each subsequent dose in RSV Season 1 ;Weekly follow-up of the participant and information declared in the patient diary from through the duration of study participation in RSV Season 1. NAME OF THE RESULT: Safety: • Number of participants with SAEs PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Through the duration of study participation in RSV Season 1. ;Observation of the participant after the dose application and information declared in the patient diary from days 1 through 5 after each dose in RSV Season 1. NAME OF THE RESULT: Safety: • Number of participants with solicited injection-site AEs • Number of participants with fever as measured by solicited daily body temperatures • Number of participants with solicited systemic AEs PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Days 1 through 5 after each dose in RSV Season 1 ;Observation of the participant after the dose application and information declared in the patient diary from day 1 through 28 after Dose 1 and Days 1 through 14 after Dose 2 in RSV Season 1. NAME OF THE RESULT: Safety: • Number of participants with anaphylaxis/ hypersensitivity AESI • Number of participants with rash AESI PERIOD OF | — |
Secondary
| Measure | Time frame |
|---|---|
| Weekly follow-up of the participant and information declared in the patient diary from day 1 through 28 after Dose 1 and 14 days after each subsequent dose in RSV Season 1 NAME OF THE RESULT: Safety: • Number of participants with nonserious AEs PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Days 1 through 28 after Dose 1 and 14 days after each subsequent dose in RSV Season 1 ;Weekly follow-up of the participant and information declared in the patient diary from through the duration of study participation in RSV Season 1. NAME OF THE RESULT: Safety: • Number of participants with SAEs PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Through the duration of study participation in RSV Season 1. ;Observation of the participant after dose application and information declared in the patient diary from day 1 to 5 postdose in RSV Season 2. NAME OF THE RESULT: Safety: • Number of participants with solicited injection-site AEs • Number of participants with fever as measured by solicited daily body temperatures. • Number of participants with solicited systemic AEs PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Days 1 through 5 postdose in RSV Season 2. ;Observation of the participant after dose application and information declared in the patient diary from day 1 to 42 postdose in RSV Season 2. NAME OF THE RESULT: Safety: • Number of participants with anaphylaxis/hypersensitivity AESI. • Number of participants with rash AESI. • Number of participants with nonserious AEs. PERIOD OF TIME WHERE | — |
Countries
Australia, Canada, Chile, Colombia, Czech Republic, Finland, France, Germany, Hungary, Italy, Japan, Malasya, Mexico, New Zealand, Peru, Puerto Rico, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, United Kindgdom, United States
Contacts
Public ContactNELVA GARCIA
MERCK SHARP & DOHME PERU S.R.L.
Outcome results
None listed