Safety, Tolerability, and Pharmacokinetics of Clesrovimab... | NCT03524118 | Trialant
NCT03524118
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Jan 14, 2025Actual
Enrollment
183Actual
Phase
Phase 1Phase 2
Conditions
Respiratory Tract Infection
Respiratory Syncytial Virus
Interventions
Clesrovimab
Placebo
Countries
United States
Chile
Colombia
South Africa
South Korea
Spain
Protocol Section
Identification Module
NCT ID
NCT03524118
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1654-002
Secondary IDs
ID
Type
Description
Link
MK-1654-002
Other Identifier
Merck Protocol Number
2017-005062-21
EudraCT Number
Brief Title
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
Official Title
A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1654 in Pre-Term and Full-Term Infants
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jan 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 20, 2018Actual
Primary Completion Date
Sep 14, 2022Actual
Completion Date
Sep 14, 2022Actual
First Submitted Date
May 11, 2018
First Submission Date that Met QC Criteria
May 11, 2018
First Posted Date
May 14, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Aug 29, 2023
Results First Submitted that Met QC Criteria
Nov 10, 2023
Results First Posted Date
Nov 29, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 6, 2025
Last Update Posted Date
Jan 14, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and incidence of anti-drug antibodies (ADAs) of single ascending doses of clesrovimab in healthy pre-term (born at 29 to 35 weeks gestational age) and full-term (born at >35 weeks gestational age) infants. Participants will be randomized into 1 of 4 dose escalation panels (Panels A to D); an additional panel (Panel E) of full-term infants will receive the same dose as Panel D. Key safety and tolerability variables will be reviewed after each dose panel prior to administering the next-highest dose.
Detailed Description
Participants in Dose Panels A, B, C, D1, and E1 will be followed for up to 365 days. After protocol Amendment 4 (AM4), participants in Dose Panels D2 and E2 will be followed for up to 545 days.
Conditions Module
Conditions
Respiratory Tract Infection
Respiratory Syncytial Virus
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
183Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Panel A: Pre-term clesrovimab Dose 1
Experimental
Pre-term infants will receive clesrovimab Dose 1 via intramuscular (IM) injection and will be followed for up to 365 days.
Drug: Clesrovimab
Panel B: Pre-term clesrovimab Dose 2
Experimental
Pre-term infants will receive clesrovimab Dose 2 via IM injection and will be followed for up to 365 days.
Drug: Clesrovimab
Panel C: Pre-term clesrovimab Dose 3
Experimental
Pre-term infants will receive clesrovimab Dose 3 via IM injection and will be followed for up to 365 days.
Drug: Clesrovimab
Panel D1: Pre-term clesrovimab Dose 4
Experimental
Pre-term infants enrolled prior to AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 365 days.
Drug: Clesrovimab
Panel D2: Pre-term clesrovimab Dose 4
Experimental
Pre-term infants enrolled after AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 545 days.
Drug: Clesrovimab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Clesrovimab
Drug
Single ascending doses of clesrovimab will be administered via IM injection.
Panel A: Pre-term clesrovimab Dose 1
Panel B: Pre-term clesrovimab Dose 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Experienced At Least One Solicited Injection Site Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection site AEs were monitored from Day 1 to Day 5.
Up to Day 5
Percentage of Participants Who Experienced At Least One Solicited Systemic Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs were monitored from Day 1 to Day 5.
Up to Day 5
Percentage of Participants Who Experienced At Least One Serious Adverse Event (SAE)
An SAE is any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant injury/incapacity; is a congenital anomaly/birth defect; or is an other important medical event.
Up to Day 545
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Serum-Concentration Time Curve From Zero to Infinity (AUC0-∞)
AUC0-∞ is a measure of the extrapolated mean concentration in serum from dosing to infinity.
At designated time points (up to 1 year post-dose)
Maximum Serum Concentration (Cmax) of Clesrovimab
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
is healthy, based on screening safety laboratory, medical history, and physical examination results
is a pre-term infant (born at 29 weeks to 35 weeks gestational age [inclusive]) or a full-term infant (born at over 35 weeks gestational age), as confirmed in medical records
weighs ≥2 kg at screening
Exclusion Criteria:
has been recommended to receive palivizumab per local standard of care
has ≥1 documented out-of-range safety laboratory results (adjusted for age) at the time of screening
has a known hypersensitivity to any component of the respiratory syncytial virus (RSV) monoclonal antibody
has a history of congenital or acquired immunodeficiency (e.g., splenomegaly)
has documented human immunodeficiency virus (HIV) infection, hepatitis B (HBsAg positive), or hepatitis C (HCV ribonucleic acid [RNA] positive)
has known history of functional or anatomic asplenia
has a diagnosis of failure to thrive within 14 days of screening
has known or history of a coagulation disorder contraindicating intramuscular injection
has received or is expected to receive blood products (except irradiated platelets) within 3 months prior to enrollment
has prior known documented RSV infection
has hemodynamically significant congenital heart disease
has chronic lung disease of prematurity requiring ongoing medical therapy
has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that, in the opinion of the investigator, might expose the participant to undue risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study
has any history of malignancy prior to randomization
if any of the following apply, the Day 1 visit may be rescheduled for a time when these criteria are not met:
has had a recent febrile illness (rectal temperature 38.1°C [100.5°F] or higher or axillary temperature 37.8°C [100.0°F] or higher) within 72 hours pre-dose
is not up-to-date on required vaccinations per local pediatric vaccine schedule at time of screening
has received inactivated or component vaccines (eg, influenza, hepatitis B) less than 14 days pre-dose
has received live, attenuated, non-study licensed pediatric vaccines (e.g., Bacillus Calmette-Guerin vaccine) less than 30 days pre-dose
has received any prior vaccine or monoclonal antibody (mAb) 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 prior to 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 this study and been discontinued
participant's mother participated in a RSV vaccine clinical study while pregnant and participant is ≤3 months of chronological age
is unable to provide blood sample at screening
cannot be adequately followed for safety according to the protocol plan
has a parent/legally acceptable representative who is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study
is, or has, an immediate family member (eg, spouse, parent/guardian, sibling, or child) who is directly involved with the study at the site or with the Sponsor
Madhi SA, Simoes EAF, Acevedo A, Novoa Pizarro JM, Shepard JS, Railkar RA, Cao X, Maas BM, Zang X, Krick A, Roadcap B, Vora KA, Aliprantis AO, Lee AW, Sinha A. A Phase 1b/2a Trial of a Half-life Extended Respiratory Syncytial Virus Neutralizing Antibody, Clesrovimab, in Healthy Preterm and Full-term Infants. J Infect Dis. 2025 Mar 17;231(3):e478-e487. doi: 10.1093/infdis/jiae581.
Participants enrolled in panels D and E prior to protocol amendment 04 who chose not to participate in the modified schedule followed the D1 and E1 schedule of activities. Participants enrolled in panels D and E prior to protocol amendment 04 who chose to participate in the modified schedule followed the D2 and E2 schedule of activities.
Recruitment Details
183 participants were randomized and 181 were dosed and included in the All Participants as Treated (APaT) population. Two participants who were randomized to the MK-1654 20 mg dose group actually received MK-1654 50 mg and were included in the MK-1654 50 mg group for safety, pharmacokinetic (PK) and immunogenicity analyses.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Panel A: Preterm Clesrovimab 20mg
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
FG001
Panel B: Pre-term Clesrovimab 50mg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jul 30, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Single ascending dose
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Panel E1: Full-term clesrovimab Dose 4
Experimental
Full-term infants enrolled prior to AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 365 days.
Drug: Clesrovimab
Panel E2: Full-term clesrovimab Dose 4
Experimental
Full-term infants enrolled after AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 545 days.
Drug: Clesrovimab
Placebo
Placebo Comparator
Pre-term infants will receive placebo via IM injection.
Drug: Placebo
Panel C: Pre-term clesrovimab Dose 3
Panel D1: Pre-term clesrovimab Dose 4
Panel D2: Pre-term clesrovimab Dose 4
Panel E1: Full-term clesrovimab Dose 4
Panel E2: Full-term clesrovimab Dose 4
MK-1654
Placebo
Drug
Placebo (0.9% sodium chloride [NaCl]) will be administered via IM injection.
Placebo
Cmax is the highest observed serum drug concentration.
At designated time points (up to 1 year post-dose)
Time to Maximum Serum Concentration (Tmax) of Clesrovimab
Tmax is the time taken to reach the maximum observed plasma (Cmax) concentration of Clesrovimab.
At designated time points (up to 1 year post-dose)
Apparent Terminal Half-life (t1/2) of Clesrovimab
t1/2 is the time required for 50% of drug to be cleared from serum.
At designated time points (up to 1 year post-dose)
Serum Concentration of Clesrovimab on Day 7 (C7days)
Serum concentration of clesrovimab was measured on Day 7.
Day 7
Serum Concentration of Clesrovimab on Day 14 (C14days)
Serum concentration of clesrovimab was measured on Day 14.
Day 14
Serum Concentration of Clesrovimab on Day 90 (C90days)
Serum concentration of clesrovimab was measured on Day 90.
Day 90
Serum Concentration of Clesrovimab on Day 150 (C150days)
Serum concentration of clesrovimab was measured on Day 150.
Day 150
Serum Concentration of Clesrovimab on Day 365 (C365days)
Serum concentration of clesrovimab was measured on Day 365.
Day 365
Number of Participants With Positive Titer of Anti-Drug Antibodies (ADAs) for Clesrovimab: Panels A, B, C, D1, D2, E1, and E2
ADA was assessed at 2 or 3 of the following timepoints for each participant: Days 14, 90, 150, 365 and 545. ADA status for each participant was determined across the timepoints assessed. The definitions of the categories are as follows: (1) ADA Negative: participants whose ADA results were negative at all timepoints measured; (2) Non-treatment emergent positive: participants whose ADA result was positive only at baseline or if postdose titer increased by less than 2-fold relative to the baseline titer; (3) Positive response to MK-1654: participants whose ADA result was negative at baseline and positive at one or more postdose timepoints or participants whose ADA result was positive at baseline and postdose titer increased by greater than or equal to 2-fold relative to the baseline titer.
Days 14, 90, 150, 365 and 545
Homestead
Florida
33030
United States
Acevedo Clinical Research Associates ( Site 0025)
Miami
Florida
33142
United States
Kapiolani Medical Center for Women and Children ( Site 0027)
Honolulu
Hawaii
96826
United States
Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0081)
Topeka
Kansas
66604
United States
Children's Mercy Hospital ( Site 0037)
Kansas City
Missouri
64108
United States
Dartmouth-Hitchcock Medical Center ( Site 0032)
Lebanon
New Hampshire
03766
United States
SUNY Upstate Medical University Hospital ( Site 0029)
Syracuse
New York
13210
United States
WakeMed Health and Hospitals ( Site 0033)
Raleigh
North Carolina
27610
United States
Cincinnati Children's Hospital Medical Center ( Site 0031)
Cincinnati
Ohio
45229
United States
Ohio Pediatric Research Association ( Site 0066)
Dayton
Ohio
45414
United States
Coastal Pediatric Research ( Site 0028)
Charleston
South Carolina
29414
United States
Tribe Clinical Research, LLC ( Site 0082)
Greenville
South Carolina
29607
United States
University of Texas Medical Branch at Galveston ( Site 0039)
Galveston
Texas
77555
United States
Tekton Research, Inc. ( Site 0026)
San Antonio
Texas
78240
United States
Multicare Institute For Research And Innovation ( Site 0035)
Tacoma
Washington
98405
United States
University of Wisconsin American Family Children's Hospital ( Site 0068)
Madison
Wisconsin
53792
United States
Centro de Investigacion Clinica Bradford Hill ( Site 0103)
Santiago
Region M. de Santiago
7650698
Chile
Hospital La Florida ( Site 0050)
Santiago
Region M. de Santiago
8242238
Chile
Facultad Medicina Universidad de Chile ( Site 0104)
Santiago
Region M. de Santiago
8380453
Chile
Hospital Padre Hurtado ( Site 0102)
Santiago
Region M. de Santiago
8880465
Chile
Fundacion Hospital San Vicente de Paul ( Site 0097)
MedellÃn
Antioquia
050010
Colombia
Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0098)
MedellÃn
Antioquia
050036
Colombia
MedPlus Medicina Prepagada S.A. ( Site 0095)
Bogotá
Bogota D.C.
110221
Colombia
Fundacion Universitaria de Ciencias de la Salud - Sociedad de Cirugia ( Site 0099)
Chris Hani Baragwanath Academic Hospital ( Site 0262)
Johannesburg
Gauteng
2013
South Africa
Tygerberg Hospital ( Site 0261)
Cape Town
Western Cape
7505
South Africa
Seoul National University Hospital ( Site 0071)
Seoul
03080
South Korea
Severance Hospital Yonsei University Health System ( Site 0073)
Seoul
03722
South Korea
Samsung Medical Center ( Site 0072)
Seoul
06351
South Korea
Hospital Clinico Universitario de Santiago ( Site 0241)
Santiago de Compostela
La Coruna
15706
Spain
Hospital Universitario La Paz ( Site 0242)
Madrid
28046
Spain
Result
Thambi N, Phuah JY, Staupe RP, Tobias LM, Cao Y, McKelvey T, Railkar RA, Aliprantis AO, Arriola CS, Maas BM, Vora KA. Development of High-Titer Antidrug Antibodies in a Phase 1b/2a Infant Clesrovimab Trial Are Associated With RSV Exposure Beyond Day 150. J Infect Dis. 2025 Mar 17;231(3):e488-e496. doi: 10.1093/infdis/jiae582.
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
FG002
Panel C: Pre-term Clesrovimab 75mg
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
FG003
Panel D1 and D2: Pre-term Clesrovimab 100mg
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
FG004
Panel E1 and E2: Full-term Clesrovimab 100mg
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
FG005
Placebo
Pre-term and Full-term infants received placebo via IM injection.
FG0008 subjects
FG00131 subjects
FG00241 subjects
FG00332 subjects
FG00433 subjects
FG00538 subjects
Treated
FG0008 subjects
FG00131 subjects
FG00240 subjects
FG00332 subjects
FG00432 subjects
FG00538 subjects
Safety Analysis Population
Two participants who were randomized to the MK-1654 20 mg dose group actually received MK-1654 50 mg
FG0006 subjects
FG00133 subjects
FG00240 subjects
FG00332 subjects
FG00432 subjects
FG00538 subjects
COMPLETED
FG0008 subjects
FG00129 subjects
FG00240 subjects
FG00331 subjects
FG00426 subjects
FG00537 subjects
NOT COMPLETED
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG0047 subjects
FG0051 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
Other
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Parent/Guardian
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Panel A: Preterm Clesrovimab 20mg
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
BG001
Panel B: Pre-term Clesrovimab 50mg
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
BG002
Panel C: Pre-term Clesrovimab 75mg
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
BG003
Panel D1 and D2: Pre-term Clesrovimab 100mg
Pre-term infants received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days.
BG004
Panel E1 and E2: Full-term Clesrovimab 100mg
Full-term infants received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days.
BG005
Placebo
Pre-term and Full-term infants received placebo via IM injection.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG00131
BG00241
BG00332
BG00433
BG00538
BG006183
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
days
Title
Denominators
Categories
Title
Measurements
BG00068.0(31 to 257)
BG001109.0(23 to 255)
BG00294.0(24 to 245)
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
In utero
Title
Measurements
BG0000
BG0010
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG00115
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG00112
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Who Experienced At Least One Solicited Injection Site Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection site AEs were monitored from Day 1 to Day 5.
Safety analysis population consisted of all participants who received at least one dose of study treatment. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
Posted
Count of Participants
Participants
Up to Day 5
ID
Title
Description
OG000
Panel A: Preterm Clesrovimab 20mg
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
OG001
Panel B: Pre-term Clesrovimab 50mg
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
OG002
Panel C: Pre-term Clesrovimab 75mg
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
OG003
Panel D1 and D2: Pre-term Clesrovimab 100mg
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
OG004
Panel E1 and E2: Full-term Clesrovimab 100mg
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
OG005
Placebo
Pre-term and Full-term infants received placebo via IM injection.
Units
Counts
Participants
OG0006
OG00133
OG00240
OG003
Title
Denominators
Categories
with solicited injection site adverse events
Title
Measurements
OG0003
OG0013
OG0023
OG003
Primary
Percentage of Participants Who Experienced At Least One Solicited Systemic Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs were monitored from Day 1 to Day 5.
Safety analysis population consisted of all participants who received at least one dose of study treatment. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
Posted
Count of Participants
Participants
Up to Day 5
ID
Title
Description
OG000
Panel A: Preterm Clesrovimab 20mg
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
OG001
Panel B: Pre-term Clesrovimab 50mg
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
OG002
Panel C: Pre-term Clesrovimab 75mg
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
Primary
Percentage of Participants Who Experienced At Least One Serious Adverse Event (SAE)
An SAE is any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant injury/incapacity; is a congenital anomaly/birth defect; or is an other important medical event.
Safety analysis population consisted of all participants who received at least one dose of study treatment. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
Posted
Count of Participants
Participants
Up to Day 545
ID
Title
Description
OG000
Panel A: Preterm Clesrovimab 20mg
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
OG001
Panel B: Pre-term Clesrovimab 50mg
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
OG002
Panel C: Pre-term Clesrovimab 75mg
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
Secondary
Area Under the Serum-Concentration Time Curve From Zero to Infinity (AUC0-∞)
AUC0-∞ is a measure of the extrapolated mean concentration in serum from dosing to infinity.
All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*μg/mL
At designated time points (up to 1 year post-dose)
ID
Title
Description
OG000
Panel A: Preterm Clesrovimab 20mg
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
OG001
Panel B: Pre-term Clesrovimab 50mg
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
OG002
Panel C: Pre-term Clesrovimab 75mg
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
Secondary
Maximum Serum Concentration (Cmax) of Clesrovimab
Cmax is the highest observed serum drug concentration.
All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
At designated time points (up to 1 year post-dose)
ID
Title
Description
OG000
Panel A: Preterm Clesrovimab 20mg
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
OG001
Panel B: Pre-term Clesrovimab 50mg
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
OG002
Panel C: Pre-term Clesrovimab 75mg
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
Secondary
Time to Maximum Serum Concentration (Tmax) of Clesrovimab
Tmax is the time taken to reach the maximum observed plasma (Cmax) concentration of Clesrovimab.
All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
Posted
Median
Full Range
day
At designated time points (up to 1 year post-dose)
ID
Title
Description
OG000
Panel A: Preterm Clesrovimab 20mg
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
OG001
Panel B: Pre-term Clesrovimab 50mg
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
OG002
Panel C: Pre-term Clesrovimab 75mg
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
Secondary
Apparent Terminal Half-life (t1/2) of Clesrovimab
t1/2 is the time required for 50% of drug to be cleared from serum.
All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
Posted
Geometric Mean
Geometric Coefficient of Variation
day
At designated time points (up to 1 year post-dose)
ID
Title
Description
OG000
Panel A: Preterm Clesrovimab 20mg
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
OG001
Panel B: Pre-term Clesrovimab 50mg
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
OG002
Panel C: Pre-term Clesrovimab 75mg
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
Secondary
Serum Concentration of Clesrovimab on Day 7 (C7days)
Serum concentration of clesrovimab was measured on Day 7.
All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Day 7
ID
Title
Description
OG000
Panel A: Preterm Clesrovimab 20mg
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
OG001
Panel B: Pre-term Clesrovimab 50mg
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
OG002
Panel C: Pre-term Clesrovimab 75mg
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
OG003
Secondary
Serum Concentration of Clesrovimab on Day 14 (C14days)
Serum concentration of clesrovimab was measured on Day 14.
All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Day 14
ID
Title
Description
OG000
Panel A: Preterm Clesrovimab 20mg
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
OG001
Panel B: Pre-term Clesrovimab 50mg
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
OG002
Panel C: Pre-term Clesrovimab 75mg
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
OG003
Secondary
Serum Concentration of Clesrovimab on Day 90 (C90days)
Serum concentration of clesrovimab was measured on Day 90.
All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Day 90
ID
Title
Description
OG000
Panel A: Preterm Clesrovimab 20mg
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
OG001
Panel B: Pre-term Clesrovimab 50mg
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
OG002
Panel C: Pre-term Clesrovimab 75mg
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
OG003
Secondary
Serum Concentration of Clesrovimab on Day 150 (C150days)
Serum concentration of clesrovimab was measured on Day 150.
All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Day 150
ID
Title
Description
OG000
Panel A: Preterm Clesrovimab 20mg
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
OG001
Panel B: Pre-term Clesrovimab 50mg
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
OG002
Panel C: Pre-term Clesrovimab 75mg
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
OG003
Secondary
Serum Concentration of Clesrovimab on Day 365 (C365days)
Serum concentration of clesrovimab was measured on Day 365.
All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Day 365
ID
Title
Description
OG000
Panel A: Preterm Clesrovimab 20mg
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
OG001
Panel B: Pre-term Clesrovimab 50mg
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
OG002
Panel C: Pre-term Clesrovimab 75mg
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
OG003
Secondary
Number of Participants With Positive Titer of Anti-Drug Antibodies (ADAs) for Clesrovimab: Panels A, B, C, D1, D2, E1, and E2
ADA was assessed at 2 or 3 of the following timepoints for each participant: Days 14, 90, 150, 365 and 545. ADA status for each participant was determined across the timepoints assessed. The definitions of the categories are as follows: (1) ADA Negative: participants whose ADA results were negative at all timepoints measured; (2) Non-treatment emergent positive: participants whose ADA result was positive only at baseline or if postdose titer increased by less than 2-fold relative to the baseline titer; (3) Positive response to MK-1654: participants whose ADA result was negative at baseline and positive at one or more postdose timepoints or participants whose ADA result was positive at baseline and postdose titer increased by greater than or equal to 2-fold relative to the baseline titer.
All randomized participants who received at least one dose of study treatment and were evaluable with at least one ADA result after treatment with MK-1654. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50 mg and were included in the MK-1654 50 mg group for the protocol specified immunogenicity analysis population.
Posted
Count of Participants
Participants
Days 14, 90, 150, 365 and 545
ID
Title
Description
OG000
Panel A: Preterm Clesrovimab 20mg
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
OG001
Time Frame
Up to Day 545
Description
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
MK-1654 20 mg in Pre-term Infants
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
0
8
1
6
6
6
EG001
MK-1654 50 mg in Pre-term Infants
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
0
31
4
33
29
33
EG002
MK-1654 75 mg in Pre-term Infants
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
0
41
1
40
29
40
EG003
MK-1654 100 mg Pre-Term Infants
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
0
32
3
32
26
32
EG004
MK-1654 100 mg Full-Term Infants
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
0
33
6
32
29
32
EG005
Placebo
Pre-term and Full-term infants received placebo via IM injection.
0
38
6
38
33
38
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG0030 events0 affected32 at risk
EG004
Biliary cyst
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Croup infectious
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Respiratory syncytial virus bronchiolitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected40 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Irregular breathing
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Constipation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG0030 events0 affected32 at risk
EG0042 events2 affected32 at risk
EG0050 events0 affected38 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0015 events5 affected33 at risk
EG0022 events2 affected40 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0023 events3 affected40 at risk
EG003
Teething
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Injection site erythema
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected33 at risk
EG0021 events1 affected40 at risk
EG003
Injection site pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected33 at risk
EG0023 events2 affected40 at risk
EG003
Injection site swelling
General disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected6 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0003 events2 affected6 at risk
EG0013 events2 affected33 at risk
EG0026 events4 affected40 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0017 events3 affected33 at risk
EG0024 events3 affected40 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0022 events2 affected40 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Croup infectious
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected40 at risk
EG003
Ear infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0017 events2 affected33 at risk
EG00219 events11 affected40 at risk
EG003
Otitis media
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0021 events1 affected40 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected6 at risk
EG00122 events17 affected33 at risk
EG0028 events7 affected40 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected33 at risk
EG0025 events5 affected40 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected6 at risk
EG0017 events7 affected33 at risk
EG0026 events5 affected40 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0013 events3 affected33 at risk
EG0021 events1 affected40 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected6 at risk
EG0016 events5 affected33 at risk
EG0022 events2 affected40 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected33 at risk
EG0021 events1 affected40 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected33 at risk
EG0021 events1 affected40 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected33 at risk
EG0020 events0 affected40 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.