臨床研究等提出・公開システム

A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease

Palivizumab-Controlled Evaluation of Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease

Kobayashi Masayuki

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@merck.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@merck.com

Not Recruiting

June. 01, 2022

Interventional

randomized controlled trial

double blind

active control

parallel assignment

prevention purpose

- Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations.
- Is available to complete the follow-up period.

- Requires mechanical ventilation at time of enrollment.
- Has a life expectancy <6 months.
- Has known hepatic or renal dysfunction, or chronic seizure disorder.
- Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
- Has severe immunodeficiency or is severely immunocompromised.
- Has known hypersensitivity to any component of MK-1654 or palivizumab.

Both

Respiratory syncytial virus infection

'- Drug: MK-1654
MK-1654 administered via IM injection.
- Drug: Palivizumab
Palivizumab administered via IM injection.

- Solicited injection-site AEs from Days 1 through 5 after each dose in RSV Season 1
- Solicited daily body temperature with fever from Days 1 through 5 after each dose in RSV Season 1
- Solicited systemic AEs from Days 1 through 5 after each dose in RSV Season 1
- Anaphylaxis/hypersensitivity adverse events of special interest (AESI) from Days 1 through 42 post Dose 1 in RSV Season 1
- Rash AESI from Days 1 through 42 post Dose 1 in RSV Season 1
- Nonserious AEs from Days 1 through 42 post Dose 1 and 14 days after each subsequent dose in RSV Season 1
- SAEs through the duration of participation in RSV Season 1

- RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1
- RSV-associated hospitalization in RSV Season 1
- Solicited injection-site AEs from Days 1 through 5 postdose in RSV Season 2
- Solicited daily body temperature with fever from Days 1 through 5 postdose in RSV Season 2
- Solicited systemic AEs from Days 1 through 5 postdose in RSV Season 2
- Anaphylaxis/hypersensitivity AESI from Days 1 through 42 postdose in RSV Season 2
- Rash AESI from Days 1 through 42 postdose in RSV Season 2
- Nonserious AEs from Days 1 through 42 postdose in RSV Season 2
- SAEs from Days 1 through 180 postdose in RSV Season 2
- MK-1654 PK concentration in RSV Season 1
- MK-1654 PK concentration in RSV Season 2

+81-3-3454-3311

Feb. 03, 2022

Yes

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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