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
Single dose of 0 mg of Placebo administrated intramuscularly at visit 1 (day 1) -
Single dose of 105 mg of MK-1654 (Dose strength 150 mg/mL) administrated intramuscularly at vis
Sponsors
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The participant’s legally acceptable representative provides written informed consent for the study. The participant’s legally acceptable representative may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research. Has a chronological age from birth up to 1 year and is entering the first RSV season at the time of signing the informed consent (for the Phase 3 cohort only). Has a chronological age >2 weeks of age up to 1 year and is entering the first RSV season at the time of signing the informed consent (for the Phase 2b cohort only). Is male or female and is an early or moderate pre-term infant (=29 to 34 weeks and 6 days gestational age) or a late pre-term or full-term infant (=35 weeks gestational age). Is healthy (based on medical history and physical examination results).
Exclusion criteria
Exclusion criteria: Has enrolled previously in the current study and been discontinued. 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 received any vaccine or mAb for the prevention of RSV, including receipt of maternal RSV vaccination during the mother’s pregnancy. 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 a bleeding disorder contraindicating intramuscular administration. Has known hypersensitivity to any component of MK-1654. Is recommended to receive palivizumab per local guidelines or professional society recommendations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Miettinen and Nurminen method NAME OF THE RESULT: Safety: Number of participants experiencing solicited injection-site AEs from Days 1 through 5 postdose, solicited daily body temperature to identify fever from Days 1 through 5 postdose, solicited systemic AEs from Days 1 through 5 postdose, anaphylaxis/hypersensitivity AESI from Days 1 through 42 postdose, rash AESI from Days 1 through 42 postdose, nonserious AEs from Days 1 through 42 postdose, and SAEs through the duration of study participation. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From Days 1 through 5 or 42 ;Modified Poisson regression with robust variance proposed by Zou (estimate, 95% CI, P-value) NAME OF THE RESULT: Efficacy: Number of participants with RSV-MALRI in the MK- 1654 and placebo groups from Days 1 through 150 postdose. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From Days 1 through 150 | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Poisson regression (estimate, 95% CI, P-value) NAME OF THE RESULT: Safety: Number of participants with RSV-MALRI in the MK-1654 and placebo groups from Days 1 through 180 postdose. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From Days 1 through 150 ;Modified Poisson regression (estimate, 95% CI, P-value) NAME OF THE RESULT: Efficacy: Number of participants with RSV hospitalization in the MK-1654 and placebo groups from Days 1 through 150 postdose. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From Days 1 through 150 ;Miettinen and Nurminen method NAME OF THE RESULT: Safety: Number of participants experiencing solicited injection-site AEs from Days 1 through 5 postdose, solicited daily body temperature to identify fever from Days 1 through 5 postdose, solicited systemic AEs from Days 1 through 5 postdose, anaphylaxis/hypersensitivity AESI from Days 1 through 42 postdose, rash AESI from Days 1 through 42 postdose, nonserious AEs from Days 1 through 42 postdose, and SAEs through the duration of study participation. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From Days 1 through 5 or 42 ;Modified Poisson regression with robust variance proposed by Zou (estimate, 95% CI, P-value) NAME OF THE RESULT: Efficacy: Number of participants with RSV-MALRI in the MK- 1654 and placebo groups from Days 1 through 150 postdose. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From Days 1 through 150 | — |
Countries
Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Korea South, Malasya, Mexico, Philippines, Poland, Romania, South Africa, Thailand, Turkey, United Kindgdom, United States
Contacts
Public ContactNELVA GARCIA
MERCK SHARP & DOHME PERU S.R.L.
Outcome results
None listed