Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ended
Participants planned
3,300
Countries
7
Sites
45
Prevention of RSV
1. To evaluate the efficacy of MK-1654 compared to placebo as assessed by the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) [outpatient and inpatient] from Days 1 through 150 postdose. 2. To evaluate the safety and tolerability of MK-1654 compared to pl…
Key facts
- Sponsor
- Merck Sharp & Dohme Corp.
- Participant type
- Pediatric, Healthy volunteers
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Immune system processes [G12]
- Trial duration
- 7 Nov 2022 → 9 Jul 2024
- Decision date (initial)
- 2022-11-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Merck Sharp & Dohme Corp
External identifiers
- EU CT number
- 2022-500350-42-01
- WHO UTN
- U1111-1275-5918
- ClinicalTrials.gov
- NCT04767373
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Pharmacodynamic, Efficacy, Prophylaxis, Safety
1. To evaluate the efficacy of MK-1654 compared to placebo as assessed by the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) [outpatient and inpatient] from Days 1 through 150 postdose.
2. To evaluate the safety and tolerability of MK-1654 compared to placebo as assessed by the proportion of participants experiencing adverse events (AEs)
Secondary objectives 2
- To evaluate the efficacy of MK-1654 compared to placebo as assessed by the incidence of RSV-associated hospitalization from Days 1 through 150 postdose
- To estimate the efficacy of MK-1654 compared to placebo as assessed by the incidence of RSV-associated MALRI (outpatient and inpatient) from Days 1 through 180 postdose
Conditions and MedDRA coding
Prevention of RSV
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10066742 | Respiratory syncytial virus infection prophylaxis | 10042613 |
| 21.1 | PT | 10061603 | Respiratory syncytial virus infection | 100000004862 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- EMA paediatric investigation plan (PIP)
- EMEA-002755-PIP01-19
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-500350-42-00 | 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 | Merck Sharp & Dohme Corp. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Is a healthy male or female who 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)
- For the phase 2b cohort only: Has a chronological age >2 weeks of age up to 1 year and is entering their first RSV season at the time of obtaining documented informed consent
- For the phase 3 cohort only: Has a chronological age from birth up to 1 year and is entering their first RSV season at the time of obtaining documented informed consent
- For participants in South Korea only: Weighs ≥2 kg
Exclusion criteria 6
- Is recommended to receive palivizumab per local guidelines or professional society recommendations
- Has known hypersensitivity to any component of MK-1654
- Has a bleeding disorder contraindicating IM 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 received any vaccine or monoclonal antibody for the prevention of RSV
- 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 study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 8
- 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)
Secondary endpoints 2
- Percentage of participants with RSV-associated hospitalization
- Percentage of participants with RSV-associated MALRI
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
—
PRD9355634 · Product
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 2
—
SUB20722 · Substance
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
PRD567881 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- 6697366.00.00 (ENR 0697366)
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme Corp.
- Sponsor organisation
- Merck Sharp & Dohme Corp.
- Address
- 1 Merck Drive, PO Box 100 PO Box 100
- City
- Whitehouse Station
- Postcode
- 08889-3400
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme Corp.
- Contact name
- Anushua Sinha
Public contact point
- Organisation
- Merck Sharp & Dohme Corp.
- Contact name
- Anushua Sinha
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Perceptive Eclinical Limited ORG-100041144
|
Nottingham, United Kingdom | Other |
| Parexel International Corporation ORG-100007310
|
Auburndale, United States | Other |
| Labcorp Drug Development Inc. ORG-100041590
|
Princeton, United States | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100012849
|
Meyrin, Switzerland | Other |
| Eurofins Viracor Biopharma Services Inc. ORG-100041736
|
Lees Summit, United States | Other |
Locations
7 EU/EEA countries · 45 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 60 | 5 |
| Denmark | Ended | 48 | 4 |
| Finland | Ended | 140 | 10 |
| France | Ended | 20 | 3 |
| Italy | Ended | 70 | 5 |
| Poland | Ended | 224 | 14 |
| Romania | Ended | 28 | 4 |
| Rest of world
Argentina, Japan, Korea, Democratic People's Republic of, China, South Africa, Israel, Colombia, Chile, United Kingdom, Malaysia, Turkey, Peru, Philippines, Thailand, United States, Canada, Mexico
|
— | 2,710 | — |
Investigational sites
Antwerp University Hospital
Department of Pediatrics, Drie Eikenstraat 655, 2650, Edegem
Cliniques Universitaires Saint-Luc
UC Louvain Brussels / Department of Pediatrics, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Az Delta
Department of Pediatrics, Deltalaan 1, 8800, Roeselare
Medif
Cabinet Médical De Meulemeester Gozée / Cabinet Médical Pédiatrie, Rue De Marchienne 113, 6534, Thuin
CHU Saint Pierre
Department of Pediatrics, Hoogstraat 322, 1000, Brussels
Regionshospital Nordjylland
Borne- og ungeafdelingen, Bispensgade 37, 9800, Hjoerring
Regionshospitalet Godstrup
Børn og Unge Klinik, Gl. Landevej 61, 7400, Herning
Odense University Hospital
Department of Gynaecology and Obstetrics, J B Winsloews Vej 4, 5000, Odense C
Aalborg University Hospital
Department of Pediatrics, Hobrovej 18/22, 9000, Aalborg
FVR Suomen rokotetutkimus Oy
Espoon rokotetutkimusklinikka, Piispansilta 11, 02230, Espoo
FVR Suomen rokotetutkimus Oy
Kokkolan rokotetutkimusklinikka, Rantakatu 16, 67100, Kokkola
FVR Suomen rokotetutkimus Oy
Turun Rokotetutkimusklinikka, Lemminkaisenkatu 14-18 B, 20520, Turku
FVR Suomen rokotetutkimus Oy
Järvenpään rokotetutkimusklinikka, Mannilantie 44, 04400, Jarvenpaa
FVR Suomen rokotetutkimus Oy
Itä-Helsingin rokotetutkimusklinikka, Turunlinnantie 8 3 Krs, 00930, Helsinki
FVR Suomen rokotetutkimus Oy
Seinäjoki Vaccine Research Center, Kauppatori 1-3, 60100, Seinajoki
FVR Suomen rokotetutkimus Oy
Porin rokotetutkimusklinikka, Yrjonkatu 23, 28100, Pori
FVR Suomen rokotetutkimus Oy
Etelä-Helsingin rokotetutkimusklinikka, Vuorikatu 18 B 3 Krs, 00100, Helsinki
FVR Suomen rokotetutkimus Oy
Oulun rokotetutkimusklinikka, Kiviharjunlenkki 6, 90220, Oulu
FVR Suomen rokotetutkimus Oy
Tampereen rokotetutkimusklinikka, Tullikatu 6, 33100, Tampere
Centre Hospitalier Universitaire De Caen Normandie
Pole Femme Enfant, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire De Bordeaux
Groupe Hospitalier Pellegrin/Unite Neonatalogie Reanimation Soins Intensifs-Pediatrie de Maternite, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier De Versailles
Service pediatrie, 177 Rue De Versailles, 78150, Le Chesnay-Rocquencourt
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
U.O.S di Malattie Infettive Pediatriche, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Di Padova
UOC Terapia Intensiva e Patologia Neonatale, Assistenza Neonatale, Via Nicolo' Giustiniani 2, 35128, Padova
University Hospital Consorziale Policlinico
Palazzo Istituti Biologici Sezione di Igiene, Piazzale Giulio Cesare 11, 70124, Bari
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
U.O di Neonatologia e Terapia Intensiva Neonatale, Via Della Commenda 12, 20122, Milan
Azienda Ospedaliero Universitaria Meyer
U.O. di Immunologia Pediatrica, Viale Gaetano Pieraccini 24, 50139, Florence
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Klinika Pediatrii i Chorob lnfekcyjnych, Ul Tytusa Chalubinskiego 2-2a, 50-368, Wroclaw
In Vivo Sp. z o.o.
In Vivo Sp. z o.o., Ul. Kaszubska 17h, 85-048, Bydgoszcz
Gravita Diagnostyka I Leczenie Nieplodnosci
Gravita , Diagnostyka I Leczenie Niepłodności, Ul. Gen. Karola Kniaziewicza 20a, 91-347, Lodz
Niepubliczny Zaklad Opieki Zdrowotnej Salmed
Niepubliczny Zaklad Opieki Zdrowotnej Salmed, Ul. Waclawa Jawoszka 3, 21-010, Leczna
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o., Pck 26 Street, 33-100, Tarnow
Szpital Im. Sw. Jadwigi Slaskiej W Trzebnicy Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Oddział Pediatryczny z Pododdziałem Niemowlęcym, Ul. Prusicka 53/55, 55-100, Trzebnica
WIP Warsaw Ibd Point Profesor Kierkus
N/A, Ul. Bobrowiecka 9b, 00-728, Warsaw
Uniwersytecki Szpital Dzieciecy W Lublinie
Oddział Patologii Noworodków, Oddział Patologii Niemowląt, Ul. Prof. Antoniego Gebali Nr 6, 20-093, Lublin
Mtl Centrum Medyczne Pulawska Sp. z o.o. S.K.
MTL Centrum Medyczne Puławska Spółka z Ograniczoną Odpowiedzialnością Spółka Komandytowa, Aleja Rzeczypospolitej 1, 02-972, Warsaw
Szpital Bielanski Im.Ks.Jerzego Popieluszki samodzielny publiczny zakład opieki zdrowotnej
Oddział Pediatryczny, Ul. Ceglowska 80, 01-809, Warsaw
Szpital Miejski W Tychach Sp. z o.o.
Oddział kliniczny pediatrii, otyłości dziecięcej i chorób metabolicznych kości, Ul. Cicha 27, 43-100, Tychy
Instytut Mikroekologii Sp. z o.o. & Co. S.K.
Instytut Mikroekologii Sp. Z o.o. & CO. Spółka Komandytowa, Ul. Sielska 6, 60-129, Poznan
Uniwersyteckie Centrum Kliniczne
Klinika Neonatologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Promed P.Lach R.Glowacki Sp. j.
Promed P.Łach R.Głowacki Sp. j., Ul. Nad Struga 7, 31-411, Cracow
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Pediatrie, Bulevardul Tomis Nr 145, 900591, Constanta
Spitalul Clinic Filantropia
Neonatologie, Bulevardul Mihalache Ion 11-13, 011171, Bucharest
Spitalul Clinic De Urgenta Pentru Copii Brasov
Pediatrie, Strada Nicopole Nr 45, 500063, Brasov
Spitalul Clinic De Obstetrica Ginecologie Cuza Voda Iasi
Neonatologie, Strada Cuza Voda Nr.34, 700038, Jassi
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2022-11-21 | 2024-02-12 | 2022-11-21 | 2023-01-19 | |
| Denmark | 2022-11-08 | 2023-12-20 | 2022-11-08 | 2022-12-14 | |
| Finland | 2022-11-10 | 2024-02-13 | 2022-11-10 | 2023-01-30 | |
| France | 2022-11-07 | 2023-12-01 | 2022-11-07 | 2022-11-22 | |
| Italy | 2022-11-16 | 2024-01-23 | 2022-11-16 | 2023-01-26 | |
| Poland | 2022-11-21 | 2024-04-17 | 2022-11-21 | 2023-02-06 | |
| Romania | 2022-11-11 | 2023-02-12 | 2022-11-11 | 2023-02-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of results_2022-500350-42-01 SUM-64285
|
2024-12-19T16:52:52 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Results Plain Language Summary | 2024-12-12T13:51:37 | Submitted | Laypersons Summary of Results |
| Results Plain Language Summary translations | 2024-12-19T16:57:54 | Submitted | Laypersons Summary of Results |
Documents 20 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | m5351-p004mk1654-p-app1611-protocol | Final |
| Clinical study report (for publication) | m5351-p004mk1654-p-app1612-crf | Final |
| Clinical study report (for publication) | m5351-p004mk1654-p-app1619-sap | Final |
| Clinical study report (for publication) | m5351-p004mk1654-p-csr-body | Final |
| Clinical study report (for publication) | m5351-p004v01mk1654-p-app1611-protocol | 01 |
| Clinical study report (for publication) | m5351-p004v01mk1654-p-app1612-crf | 01 |
| Clinical study report (for publication) | m5351-p004v01mk1654-p-app1619-sap | 01 |
| Clinical study report (for publication) | m5351-p004v01mk1654-p-csr-body | 01 |
| Laypersons summary of results (for publication) | Results Plain Language Summary_for pub | 2-0 |
| Laypersons summary of results (for publication) | RPLS_BEL_DE_for pub | 2-0 |
| Laypersons summary of results (for publication) | RPLS_BEL_FR_for pub | 2-0 |
| Laypersons summary of results (for publication) | RPLS_BEL_NL_for pub | 2-0 |
| Laypersons summary of results (for publication) | RPLS_DNK_DA_for pub | 2 |
| Laypersons summary of results (for publication) | RPLS_FIN_FI_for pub | 2-0 |
| Laypersons summary of results (for publication) | RPLS_FIN_SV_for pub | 2-0 |
| Laypersons summary of results (for publication) | RPLS_FRA_FR_for pub | 2-0 |
| Laypersons summary of results (for publication) | RPLS_ITA_IT_for pub | 2 |
| Laypersons summary of results (for publication) | RPLS_POL_PL_for pub | 2-0 |
| Laypersons summary of results (for publication) | RPLS_ROU_RO_for pub | 2-0 |
| Summary of results (for publication) | Summary of results_2022-500350-42-01_for pub | 19MAR2026 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-08-29 | Finland | Acceptable 2022-11-07
|
2022-11-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2022-12-16 | Finland | Acceptable 2022-11-07
|
2022-12-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-01-17 | Finland | Acceptable with conditions 2023-04-14
|
2023-04-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-04-26 | Finland | Acceptable 2023-06-26
|
2023-06-26 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-08-24 | Finland | Acceptable 2023-11-23
|
2023-11-23 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-01-17 | Finland | Acceptable | 2024-02-20 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-02-20 | Acceptable | 2024-02-20 |