A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500350-42-01

Acronym

MK-1654-004

Enrollment

590

Registered

2022-11-07

Start date

2022-11-07

Completion date

2024-02-12

Last updated

2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of RSV

Brief summary

Percentage of participants with RSV-associated MALRI, Percentage of participants with solicited injection-site AEs, Percentage of participants with fever, Percentage of participants with solicited systemic AEs, Percentage of participants with anaphylaxis/hypersensitivity AE of special interest (AESI), Percentage of participants with rash AESI, Percentage of participants with ≥1 nonserious AE, Percentage of participants with serious adverse events (SAEs)

Detailed description

Percentage of participants with RSV-associated hospitalization, Percentage of participants with RSV-associated MALRI

Interventions

None listed

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Percentage of participants with RSV-associated MALRI, Percentage of participants with solicited injection-site AEs, Percentage of participants with fever, Percentage of participants with solicited systemic AEs, Percentage of participants with anaphylaxis/hypersensitivity AE of special interest (AESI), Percentage of participants with rash AESI, Percentage of participants with ≥1 nonserious AE, Percentage of participants with serious adverse events (SAEs)	—

Measure

Time frame

—

Secondary

Measure	Time frame
Percentage of participants with RSV-associated hospitalization, Percentage of participants with RSV-associated MALRI	—

Countries

Belgium, Denmark, Finland, France, Italy, Poland, Romania

Outcome results