A Study to Evaluate the Safety, Tolerability, and Immunog... | NCT03565900 | Trialant
NCT03565900
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Jul 28, 2023Actual
Enrollment
277Actual
Phase
Phase 3
Conditions
Pneumococcal Infections
Interventions
V114
Prevnar 13â„¢
PNEUMOVAXâ„¢23
Countries
United States
Australia
Belgium
Brazil
Canada
Colombia
France
Germany
Mexico
Sweden
Protocol Section
Identification Module
NCT ID
NCT03565900
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V114-022
Secondary IDs
ID
Type
Description
Link
V114-022
Other Identifier
Merck Protocol Number
2018-000066-11
EudraCT Number
Brief Title
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)
Official Title
A Phase 3, Randomized, Double-blind, Active Comparator-controlled, Multicenter Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Recipients of Allogeneic Hematopoietic Stem Cell Transplant (PNEU-STEM)
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jul 2023
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 12, 2018Actual
Primary Completion Date
Nov 4, 2021Actual
Completion Date
Nov 4, 2021Actual
First Submitted Date
Jun 12, 2018
First Submission Date that Met QC Criteria
Jun 12, 2018
First Posted Date
Jun 21, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Aug 9, 2022
Results First Submitted that Met QC Criteria
Sep 23, 2022
Results First Posted Date
Oct 20, 2022Actual
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
Jul 20, 2023
Last Update Posted Date
Jul 28, 2023Actual
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)
Yes
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 1) evaluate the safety and tolerability, and immunogenicity of blinded V114 and Prevnar 13â„¢ within each vaccination group, and 2) evaluate the safety and tolerability, and immunogenicity of PNEUMOVAXâ„¢23 (administered as open label, 12 months after allogeneic hematopoietic stem cell transplant [allo-HSCT] in participants who do not develop chronic graft-versus-host disease [GVHD]).
Detailed Description
Not provided
Conditions Module
Conditions
Pneumococcal Infections
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
277Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
V114
Experimental
Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who develop chronic graft-versus-host-disease (GVHD) during the first year after HSCT will receive V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
Biological: V114
Biological: PNEUMOVAXâ„¢23
Prevnar 13â„¢
Active Comparator
Participants will receive a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who develop chronic GVHD during the first year after HSCT will receive Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Biological: Prevnar 13â„¢
Biological: PNEUMOVAXâ„¢23
Interventions
Name
Type
Description
Arm Group Labels
Other Names
V114
Biological
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13â„¢
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the first 3 doses of V114 or Prevnar 13â„¢, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling.
Up to 5 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13â„¢)
Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13â„¢
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the first 3 doses of V114 or Prevnar 13â„¢, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling.
Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13â„¢)
Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13â„¢
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the first 3 doses of V114 or Prevnar 13â„¢, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were arthralgia, fatigue, headache, and myalgia.
Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13â„¢)
Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13â„¢
Secondary Outcomes
Measure
Description
Time Frame
Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAXâ„¢23
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following a single dose vaccination with PNEUMOVAXâ„¢23, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Received a human leukocyte antigen (HLA) compatible donor including haploidentical and mismatched (related or unrelated) first allogeneic HSCT (i.e., bone marrow or peripheral blood stem cell) 90 to 180 days prior to randomization.
Received the allogeneic HSCT for acute lymphoblastic leukemia (ALL) in first or second remission, acute myeloid leukemia (AML) in first or second remission, chronic myeloid leukemia (CML) in first chronic or accelerated phase, Hodgkin's lymphoma, non-Hodgkin's lymphoma, myelodysplastic syndrome (MDS), myelofibrosis and myeloproliferative diseases, and non-malignant disease such as aplastic anemia or sickle cell disease in participants ≥18 years of age and any non-malignant disease for participants 3 to <18 years of age.
Life expectancy >12 months after allogeneic HSCT, according to investigator judgement.
Clinically stable engraftment according to investigator judgment.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: a) not a woman of childbearing potential (WOCBP) OR b) a WOCBP who agrees to use acceptable contraceptive methods during the treatment period and for at least 6 weeks after the last dose of study intervention.
Exclusion Criteria:
Receipt of a previous allogeneic HSCT.
Received allogeneic HSCT with ex-vivo graft manipulation, in vivo T cell depletion with alemtuzumab, or haploidentical allogeneic HSCT with high dose anti-thymocyte globulin.
Received allogeneic HSCT for multiple myeloma or, for participants ≥18 years of age only, for any nonmalignant diseases except sickle cell disease and aplastic anemia.
Persistent or relapsed primary disease after allogeneic HSCT.
History of severe GVHD (Grade 3 or 4 GVHD) after allogeneic HSCT.
Planned organ transplantation after allogeneic HSCT.
History of culture-positive pneumococcal disease occurring after allogeneic HSCT.
Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine.
History of acquired immunodeficiency such as documented HIV infection, or anatomic asplenia.
Severe hepatic impairment (defined as Child-Pugh Class C) at Screening.
Serum aspartate transaminase (AST) or alanine transaminase (ALT) >6 × upper limit of normal (ULN) or serum total bilirubin >2.5 × ULN at Screening.
A WOCBP who has a positive urine or serum pregnancy test before the 1st vaccination.
Received chimeric antigen receptor T-cell (CAR-T) therapy or checkpoint inhibitor directed therapy (i.e., anti-Programmed Cell Death (PD)-1) after allogeneic HSCT.
Received or planned to receive anti-Cluster of Differentiation (CD) 20 B-cell targeted therapy (e.g., rituximab) after allogeneic HSCT.
Non-study pneumococcal vaccine administered after allogeneic HSCT, or is expected to receive non-study pneumococcal vaccine during participation in the study.
Is currently participating or has participated in an interventional clinical study with an investigational compound/agent or device within 2 weeks of participating in this current study, or plans to receive any investigational compound/agent or device (in addition to existing therapy) within 2 weeks of any vaccination, that in the opinion of the investigator would interfere with the evaluation of the study objectives.
Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence as assessed by the study investigator.
Has history or current evidence of any condition, therapy, laboratory test result abnormality, or other circumstance that might expose the participant to 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.
Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study.
263 adult participants and 14 pediatric participants (3 to 18 years of age) were randomized in a 1:1 ratio to receive either V114 or Prevnar 13â„¢ on Day 1.
Recruitment Details
This study recruited male and female participants at least 3 years of age who have received allogeneic hematopoietic stem cell transplant (allo-HSCT) 90 to 180 days prior to randomization.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
V114
Participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
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
Apr 2, 2019
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
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
V114
VAXNEUVANCEâ„¢
Pneumococcal 15-Valent Conjugate Vaccine
Prevnar 13â„¢
Biological
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg), and aluminum phosphate adjuvant (125 mcg aluminum) in each 0.5 ml dose
Prevnar 13â„¢
PNEUMOVAXâ„¢23
Biological
23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
Prevnar 13â„¢
V114
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the first 3 doses of V114 or Prevnar 13â„¢, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were arthralgia, fatigue, headache, myalgia, and hives or welts.
Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13â„¢)
Percentage of Participants With a Vaccine-related Serious Adverse Event Up to Month 12 After Allogeneic HSCT
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or Prevnar 13â„¢) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 up to 12 months post-HSCT, which could be up to 9 months post-vaccine dose 1.
Up to 9 months
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13â„¢ (Day 90)
The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13â„¢)
Up to 5 days after the PNEUMOVAXâ„¢23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAXâ„¢23
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following single dose vaccination with PNEUMOVAXâ„¢23, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were induration, pain, swelling, and erythema.
Up to 14 days after the PNEUMOVAXâ„¢23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAXâ„¢23
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following a single dose vaccination with PNEUMOVAXâ„¢23, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs were arthralgia, fatigue, headache, and myalgia.
Up to 14 days after the PNEUMOVAXâ„¢23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAXâ„¢23
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following a single dose vaccination with PNEUMOVAXâ„¢23, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, hives or welts, and arthralgia.
Up to 14 days after the PNEUMOVAXâ„¢23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With PNEUMOVAXâ„¢23
A SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following a single dose vaccination with PNEUMOVAXâ„¢23 was reported.
Up to 1 month after PNEUMOVAXâ„¢23 vaccination (12 months after HSCT and approximately 6 to 10 months after Day 1)
Adult Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13â„¢
This end point applies to adult participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13â„¢ as the fourth vaccination. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following dose 4 with V114 or Prevnar 13â„¢, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling.
Up to 5 days after the fourth V114 or Prevnar 13â„¢ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13â„¢
This end point applies to pediatric participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13â„¢ as the fourth vaccination dose. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following dose 4 with V114 or Prevnar 13â„¢, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AE assessed were pain, erythema, swelling, and induration.
Up to 14 days after the fourth V114 or Prevnar 13â„¢ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13â„¢
This end point applies to adult participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13â„¢ as the fourth vaccination dose. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following dose 4 with V114 or Prevnar 13â„¢, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs were arthralgia, fatigue, headache, and myalgia.
Up to 14 days after the fourth V114 or Prevnar 13â„¢ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13â„¢
This end point applies to pediatric participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13â„¢ as the fourth vaccination. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following dose 4 with V114 or Prevnar 13â„¢, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed myalgia, arthralgia, headache, fatigue, and hives or welts.
Up to 14 days after the fourth V114 or Prevnar 13â„¢ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
Participants With GVHD: Percentage of Participants With a Vaccine-related Serious Adverse Event Following Dose 4 With V114 or Prevnar 13â„¢
This end point applies to participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13â„¢ as vaccine dose 4. An SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following dose 4 with V114 or Prevnar 13â„¢ through completion of study was reported.
Up to 6 months after the fourth V114 or Prevnar 13â„¢ vaccination (12 months after HSCT and approximately 6 to 15 months after Day 1)
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13â„¢ (Day 90)
The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay.
Up to Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13â„¢)
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
The GMFR of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
Day 1 (Baseline) and Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13â„¢)
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Activity for the 15 serotypes contained in V114 vaccine were determined using a Multiplex Opsonophagocytic Assay. The GMFR of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using multiplexed opsonophagocytic assay.
Time Frame: Day 1 (Baseline) and Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13â„¢)
Aurora
Colorado
80045
United States
University of Florida ( Site 0011)
Gainesville
Florida
32610
United States
University of Chicago ( Site 0016)
Chicago
Illinois
60637
United States
Indiana Blood and Marrow Transplantation ( Site 0001)
Indianapolis
Indiana
46237
United States
University of Kansas Medical Center ( Site 0007)
Kansas City
Kansas
66160
United States
Johns Hopkins - University ( Site 0023)
Baltimore
Maryland
21287
United States
Children's Mercy Hospital ( Site 0167)
Kansas City
Missouri
64108
United States
Montefiore Einstein Center ( Site 0164)
The Bronx
New York
10467
United States
Cincinnati Children's Hospital Medical Center ( Site 0010)
Cincinnati
Ohio
45229
United States
Cleveland Clinic Foundation ( Site 0168)
Cleveland
Ohio
44106
United States
Oregon Health & Science University ( Site 0018)
Portland
Oregon
97239
United States
Baylor College of Medicine - Texas Children's Hospital ( Site 0165)
Houston
Texas
77030
United States
St. Vincent's Hospital ( Site 0041)
Sydney
New South Wales
2010
Australia
The Children s Hospital at Westmead ( Site 0191)
Westmead
New South Wales
2145
Australia
Royal Adelaide Hospital ( Site 0040)
Adelaide
South Australia
5000
Australia
Austin Health-Austin Hospital ( Site 0038)
Heidelberg
Victoria
3084
Australia
The Alfred Hospital ( Site 0037)
Melbourne
Victoria
3004
Australia
Royal Melbourne Hospital ( Site 0039)
Parkville
Victoria
3050
Australia
Cliniques Universitaires Saint-Luc ( Site 0122)
Brussels
Bruxelles-Capitale, Region de
1200
Belgium
UZ Leuven ( Site 0119)
Leuven
Vlaams-Brabant
3000
Belgium
AZ Sint Jan Brugge-Oostende ( Site 0118)
Bruges
West-Vlaanderen
8000
Belgium
AZ Delta ( Site 0120)
Roeselare
West-Vlaanderen
8800
Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0121)
Liège
4000
Belgium
Hospital Sao Rafael ( Site 0049)
Salvador
Estado de Bahia
41253-190
Brazil
Santa Casa de Misericordia de Belo Horizonte ( Site 0050)
Belo Horizonte
Minas Gerais
30150-221
Brazil
Instituto de Cancer e Transplante de Curitiba ICTR ( Site 0051)
Curitiba
Paraná
80510-130
Brazil
Nova Scotia Health Authority QEII-HSC ( Site 0033)
Halifax
Nova Scotia
B3H 1V7
Canada
Juravinski Cancer Centre ( Site 0032)
Hamilton
Ontario
L8V 1C3
Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0031)
Montreal
Quebec
H1T 2M4
Canada
Hospital Pablo Tobon Uribe ( Site 0077)
MedellÃn
Antioquia
050034
Colombia
Fundacion Valle del Lili ( Site 0073)
Cali
Valle del Cauca Department
760032
Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0075)
Cali
Valle del Cauca Department
760042
Colombia
CHU de Nice ( Site 0084)
Nice
Alpes-Maritimes
06002
France
Hopital Jean Minjoz Besancon ( Site 0085)
Besançon
Doubs
25030
France
CHU de Grenoble Hopital Nord ( Site 0083)
La Tronche
Isere
38700
France
CHRU de Lille - Hopital Claude Huriez ( Site 0090)
Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
FG000139 subjects
FG001138 subjects
Vaccination 1 With V114 or Prevnar 13â„¢ (PCV) (Day 1)
FG000139 subjects
FG001135 subjects
Vaccination 2 With PCV (Day 30)
FG000135 subjects
FG001128 subjects
Vaccination 3 With PCV (Day 60)
FG000130 subjects
FG001124 subjects
Vaccination 4 With PNEUMOVAXâ„¢23 (PPV23) (12 Months After Allo-HSCT, Without Chronic GVHD)
FG00089 subjects
FG00175 subjects
Vaccination 4 With PCV (12 Months After Allo-HSCT, With Chronic GVHD)
FG00029 subjects
FG00137 subjects
COMPLETED
FG000115 subjects
FG001111 subjects
NOT COMPLETED
FG00024 subjects
FG00127 subjects
Type
Comment
Reasons
Disposition Unknown
FG0004 subjects
FG0011 subjects
Withdrawal By Parent/Guardian
FG0000 subjects
FG0011 subjects
Withdrawal by Subject
FG0004 subjects
FG0015 subjects
Randomized By Mistake
FG0000 subjects
FG0012 subjects
Physician Decision
FG0007 subjects
FG00111 subjects
Death
FG0009 subjects
FG0017 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
V114
Participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
BG001
Prevnar 13â„¢
Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000139
BG001138
BG002277
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00047.9± 16.0
BG00146.3± 18.3
BG00247.1± 17.1
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
In utero
BG0000
BG0010
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00057
BG00162
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00030
BG00129
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0004
BG0013
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
Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13â„¢
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the first 3 doses of V114 or Prevnar 13â„¢, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling.
All randomized participants who received at least 1 dose of study vaccination were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 5 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13â„¢)
ID
Title
Description
OG000
V114 (Adult)
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢ (Adult)
Adult participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Units
Counts
Participants
OG000131
OG001129
Title
Denominators
Categories
Injection site erythema
Title
Measurements
OG00020.6(14.0 to 28.6)
OG00114.0(8.5 to 21.2)
Injection site pain
Title
Measurements
OG000
Primary
Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13â„¢
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the first 3 doses of V114 or Prevnar 13â„¢, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling.
All randomized participants who received at least 1 dose of study vaccination were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13â„¢)
ID
Title
Description
OG000
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Primary
Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13â„¢
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the first 3 doses of V114 or Prevnar 13â„¢, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were arthralgia, fatigue, headache, and myalgia.
All randomized participants who received at least 1 dose of study vaccination were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13â„¢)
ID
Title
Description
OG000
V114 (Adult)
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢ (Adult)
Adult participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Primary
Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13â„¢
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the first 3 doses of V114 or Prevnar 13â„¢, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were arthralgia, fatigue, headache, myalgia, and hives or welts.
All randomized participants who received at least 1 dose of study vaccination were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13â„¢)
ID
Title
Description
OG000
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Primary
Percentage of Participants With a Vaccine-related Serious Adverse Event Up to Month 12 After Allogeneic HSCT
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or Prevnar 13â„¢) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 up to 12 months post-HSCT, which could be up to 9 months post-vaccine dose 1.
All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 9 months
ID
Title
Description
OG000
V114 (Adult)
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢ (Adult)
Adult participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Primary
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13â„¢ (Day 90)
The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
Posted
Geometric Mean
95% Confidence Interval
µg/mL
Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13â„¢)
ID
Title
Description
OG000
V114
Participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢
Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Secondary
Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAXâ„¢23
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following a single dose vaccination with PNEUMOVAXâ„¢23, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling.
All randomized participants who received at least 1 dose of study vaccination were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 5 days after the PNEUMOVAXâ„¢23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
ID
Title
Description
OG000
V114 (Adult)
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢ (Adult)
Adult participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Secondary
Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAXâ„¢23
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following single dose vaccination with PNEUMOVAXâ„¢23, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were induration, pain, swelling, and erythema.
All randomized participants who received at least 1 dose of study vaccination were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 14 days after the PNEUMOVAXâ„¢23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
ID
Title
Description
OG000
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Secondary
Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAXâ„¢23
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following a single dose vaccination with PNEUMOVAXâ„¢23, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs were arthralgia, fatigue, headache, and myalgia.
All randomized participants who received at least 1 dose of study vaccination were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 14 days after the PNEUMOVAXâ„¢23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
ID
Title
Description
OG000
V114 (Adult)
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢ (Adult)
Adult participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Secondary
Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAXâ„¢23
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following a single dose vaccination with PNEUMOVAXâ„¢23, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, hives or welts, and arthralgia.
All randomized participants who received at least 1 dose of study vaccination were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 14 days after the PNEUMOVAXâ„¢23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
ID
Title
Description
OG000
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Secondary
Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With PNEUMOVAXâ„¢23
A SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following a single dose vaccination with PNEUMOVAXâ„¢23 was reported.
All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 1 month after PNEUMOVAXâ„¢23 vaccination (12 months after HSCT and approximately 6 to 10 months after Day 1)
ID
Title
Description
OG000
V114 (Adult)
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢ (Adult)
Adult participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Secondary
Adult Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13â„¢
This end point applies to adult participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13â„¢ as the fourth vaccination. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following dose 4 with V114 or Prevnar 13â„¢, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling.
All randomized participants who received at least 1 dose of study vaccination were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 5 days after the fourth V114 or Prevnar 13â„¢ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
ID
Title
Description
OG000
V114 (Adult)
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢ (Adult)
Adult participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Secondary
Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13â„¢
This end point applies to pediatric participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13â„¢ as the fourth vaccination dose. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following dose 4 with V114 or Prevnar 13â„¢, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AE assessed were pain, erythema, swelling, and induration.
All randomized participants who received at least 1 dose of study vaccination were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 14 days after the fourth V114 or Prevnar 13â„¢ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
ID
Title
Description
OG000
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢ (Pediatric)
Secondary
Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13â„¢
This end point applies to adult participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13â„¢ as the fourth vaccination dose. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following dose 4 with V114 or Prevnar 13â„¢, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs were arthralgia, fatigue, headache, and myalgia.
All randomized participants who received at least 1 dose of study vaccination were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 14 days after the fourth V114 or Prevnar 13â„¢ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
ID
Title
Description
OG000
V114 (Adult)
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢ (Adult)
Adult participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Secondary
Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13â„¢
This end point applies to pediatric participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13â„¢ as the fourth vaccination. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following dose 4 with V114 or Prevnar 13â„¢, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed myalgia, arthralgia, headache, fatigue, and hives or welts.
All randomized participants who received at least 1 dose of study vaccination were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 14 days after the fourth V114 or Prevnar 13â„¢ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
ID
Title
Description
OG000
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢ (Pediatric)
Secondary
Participants With GVHD: Percentage of Participants With a Vaccine-related Serious Adverse Event Following Dose 4 With V114 or Prevnar 13â„¢
This end point applies to participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13â„¢ as vaccine dose 4. An SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following dose 4 with V114 or Prevnar 13â„¢ through completion of study was reported.
All randomized participants who received at least 1 dose of relevant study vaccination for the timepoint of interest were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 6 months after the fourth V114 or Prevnar 13â„¢ vaccination (12 months after HSCT and approximately 6 to 15 months after Day 1)
ID
Title
Description
OG000
V114 (Adult)
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢ (Adult)
Secondary
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13â„¢ (Day 90)
The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay.
All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
Posted
Geometric Mean
95% Confidence Interval
Titers
Up to Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13â„¢)
ID
Title
Description
OG000
V114
Participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢
Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Secondary
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
The GMFR of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
Posted
Geometric Mean
95% Confidence Interval
Percentage of Participants
Day 1 (Baseline) and Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13â„¢)
ID
Title
Description
OG000
V114
Participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢
Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Secondary
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Activity for the 15 serotypes contained in V114 vaccine were determined using a Multiplex Opsonophagocytic Assay. The GMFR of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using multiplexed opsonophagocytic assay.
All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
Posted
Number
95% Confidence Interval
Percentage of Participants
Time Frame: Day 1 (Baseline) and Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13â„¢)
ID
Title
Description
OG000
V114
Participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG001
Prevnar 13â„¢
Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Time Frame
Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13â„¢ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAXâ„¢23 (up to 10 months total).
Description
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
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
V114 (Following Any of the First 3 Doses of PCV) Adults
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
6
131
38
131
125
131
EG001
Prevnar 13â„¢ (Following Any of the First 3 Doses of PCV) Adults
Adult participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
9
129
48
129
108
129
EG002
V114 (Following PPV23) Adults
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
1
84
2
84
65
84
EG003
Prevnar 13â„¢ (Following PPV23) Adults
Adult participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
0
71
4
71
53
71
EG004
V114 (Following Dose 4 of PCV) Adults
Adult participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
2
27
6
27
22
27
EG005
Prevnar 13â„¢ (Following Dose 4 of PCV) Adults
Adult participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
1
36
7
36
26
36
EG006
V114 (Following Any of the First 3 Doses of PCV) Pediatric
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
1
8
2
8
7
8
EG007
Prevnar 13â„¢ (Following Any of the First 3 Doses of PCV) Pediatric
Pediatric participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
0
6
1
6
6
6
EG008
V114 (Following PPV23) Pediatric
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
0
5
0
5
3
5
EG009
Prevnar 13â„¢ (Following PPV23) Pediatric
Pediatric participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
0
4
0
4
3
4
EG010
V114 (Following Dose 4 of PCV) Pediatric
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
0
2
0
2
1
2
EG011
Prevnar 13â„¢ (Following Dose 4 of PCV) Pediatric
Pediatric participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
0
1
0
1
0
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Agranulocytosis
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG0030 events0 affected71 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected36 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected2 at risk
EG0110 events0 affected1 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0012 events2 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Immune thrombocytopenia
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Methaemoglobinaemia
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0012 events2 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected131 at risk
EG0012 events2 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0021 events1 affected84 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Disease progression
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Malaise
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Polyserositis
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Pyrexia
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0013 events3 affected129 at risk
EG0021 events1 affected84 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Gallbladder obstruction
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Acute graft versus host disease
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0012 events2 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Chronic graft versus host disease
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0012 events2 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Graft versus host disease
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected131 at risk
EG0015 events5 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Graft versus host disease in gastrointestinal tract
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Graft versus host disease in liver
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Graft versus host disease in lung
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
COVID-19
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Clostridium colitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Cytomegalovirus colitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Cytomegalovirus infection reactivation
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Enterobacter bacteraemia
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0012 events2 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Infected skin ulcer
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Influenza
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Nocardia sepsis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected131 at risk
EG0019 events6 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Pneumonia parainfluenzae viral
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Respiratory syncytial virus bronchiolitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Sepsis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0012 events2 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Septic shock
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Sinusitis fungal
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Transfusion microchimerism
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Hyperammonaemia
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Acute leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Acute lymphocytic leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0017 events7 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Acute myeloid leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected131 at risk
EG0013 events3 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Central nervous system leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Chronic lymphocytic leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Chronic myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Post transplant lymphoproliferative disorder
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Depression
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Cystitis haemorrhagic
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Epiglottic cyst
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0012 events2 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Hypotension
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Adrenal insufficiency
Endocrine disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG0030 events0 affected71 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected36 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected2 at risk
EG0110 events0 affected1 at risk
Conjunctival hyperaemia
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0003 events2 affected131 at risk
EG0016 events6 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG00015 events12 affected131 at risk
EG0016 events5 affected129 at risk
EG0022 events2 affected84 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected131 at risk
EG0013 events3 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Fatigue
General disorders
MedDRA 24.1
Systematic Assessment
EG000105 events59 affected131 at risk
EG001111 events52 affected129 at risk
EG00221 events19 affected84 at risk
EG003
Injection site erythema
General disorders
MedDRA 24.1
Systematic Assessment
EG00037 events27 affected131 at risk
EG00122 events18 affected129 at risk
EG00215 events15 affected84 at risk
EG003
Injection site hypersensitivity
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Injection site induration
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Injection site pain
General disorders
MedDRA 24.1
Systematic Assessment
EG000284 events116 affected131 at risk
EG001237 events97 affected129 at risk
EG00257 events57 affected84 at risk
EG003
Injection site swelling
General disorders
MedDRA 24.1
Systematic Assessment
EG00064 events42 affected131 at risk
EG00135 events23 affected129 at risk
EG00218 events18 affected84 at risk
EG003
Pyrexia
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0012 events2 affected129 at risk
EG0025 events5 affected84 at risk
EG003
Chronic graft versus host disease in skin
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Graft versus host disease in eye
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Graft versus host disease in gastrointestinal tract
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0014 events4 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Graft versus host disease in skin
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0013 events3 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0012 events2 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0015 events2 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG00033 events21 affected131 at risk
EG00138 events24 affected129 at risk
EG0026 events6 affected84 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG000111 events64 affected131 at risk
EG00177 events45 affected129 at risk
EG00230 events27 affected84 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG00073 events38 affected131 at risk
EG00167 events40 affected129 at risk
EG00220 events18 affected84 at risk
EG003
Depression
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected131 at risk
EG0011 events1 affected129 at risk
EG0020 events0 affected84 at risk
EG003
Prurigo
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected131 at risk
EG0010 events0 affected129 at risk
EG0020 events0 affected84 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
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Preterm newborn infants (gestational age < 37 wks)
BG0000
BG0010
BG0020
Newborns (0-27 days)
BG0000
BG0010
BG0020
Infants and toddlers (28 days-23 months)
BG0000
BG0010
BG0020
Children (2-11 years)
BG0005
BG0014
BG0029
Adolescents (12-17 years)
BG0003
BG0012
BG0025
Adults (18-64 years)
BG000108
BG001107
BG002215
From 65-84 years
BG00023
BG00125
BG00248
85 years and over
BG0000
BG0010
BG0020
119
Male
BG00082
BG00176
BG002158
59
Not Hispanic or Latino
BG000104
BG001104
BG002208
Unknown or Not Reported
BG0005
BG0015
BG00210
7
Asian
BG0002
BG0014
BG0026
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
Black or African American
BG0006
BG0011
BG0027
White
BG000122
BG001115
BG002237
More than one race
BG0005
BG00115
BG00220
Unknown or Not Reported
BG0000
BG0010
BG0020
88.5
(81.8 to 93.4)
OG00174.4(66.0 to 81.7)
Injection site swelling
Title
Measurements
OG00032.1(24.2 to 40.8)
OG00117.8(11.7 to 25.5)
Units
Counts
Participants
OG0008
OG0016
Title
Denominators
Categories
Injection site erythema
Title
Measurements
OG0000.0(0.0 to 36.9)
OG00133.3(4.3 to 77.7)
Injection site induration
Title
Measurements
OG00012.5(0.0 to 52.7)
OG00133.3(4.3 to 77.0)
Injection site pain
Title
Measurements
OG00075.0(34.9 to 96.8)
OG00183.3(35.9 to 99.6)
Injection site swelling
Title
Measurements
OG00025.0(3.2 to 65.1)
OG00150.0(11.8 to 88.2)
Units
Counts
Participants
OG000131
OG001129
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG00016.0(10.2 to 23.5)
OG00118.6(12.3 to 26.4)
Fatigue
Title
Measurements
OG00045.0(36.3 to 54.0)
OG00140.3(31.8 to 49.3)
Headache
Title
Measurements
OG00029.0(21.4 to 37.6)
OG00131.0(23.2 to 39.7)
Myalgia
Title
Measurements
OG00048.9(40.0 to 57.7)
OG00134.9(26.7 to 43.8)
Units
Counts
Participants
OG0008
OG0016
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG00012.5(0.3 to 52.7)
OG0010.0(0.0 to 45.9)
Fatigue
Title
Measurements
OG00025.0(3.2 to 65.1)
OG00116.7(0.4 to 64.1)
Headache
Title
Measurements
OG00012.5(0.3 to 52.7)
OG00116.7(0.4 to 64.1)
Myalgia
Title
Measurements
OG00050.0(15.7 to 84.3)
OG00116.7(0.4 to 64.1)
Hives or welts
Title
Measurements
OG0000.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
OG0010.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
OG002
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG003
Prevnar 13â„¢ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Units
Counts
Participants
OG000131
OG001129
OG0028
OG0036
Title
Denominators
Categories
Title
Measurements
OG0000.8(0.0 to 4.2)
OG0010.0(0.0 to 2.8)
OG0020.0(0.0 to 36.9)
OG0030.0(0.0 to 45.9)
Units
Counts
Participants
OG000105
OG00188
Title
Denominators
Categories
Serotype 1 (Shared)
ParticipantsOG000105
ParticipantsOG00188
Title
Measurements
OG0002.97(2.22 to 3.99)
OG0011.90(1.34 to 2.69)
Serotype 3 (Shared)
ParticipantsOG000105
ParticipantsOG00188
Title
Measurements
OG0000.80(0.63 to 1.02)
OG001
Serotype 4 (Shared)
ParticipantsOG000105
ParticipantsOG00188
Title
Measurements
OG0001.61(1.23 to 2.11)
OG001
Serotype 5 (Shared)
ParticipantsOG000105
ParticipantsOG00188
Title
Measurements
OG0002.85(2.13 to 3.81)
OG001
Serotype 6A (Shared)
ParticipantsOG000105
ParticipantsOG00188
Title
Measurements
OG0003.40(2.42 to 4.76)
OG001
Serotype 6B (Shared)
ParticipantsOG000105
ParticipantsOG00188
Title
Measurements
OG0003.49(2.45 to 4.98)
OG001
Serotype 7F (Shared)
ParticipantsOG000105
ParticipantsOG00188
Title
Measurements
OG0003.20(2.38 to 4.30)
OG001
Serotype 9V (Shared)
ParticipantsOG000105
ParticipantsOG00188
Title
Measurements
OG0002.56(1.94 to 3.38)
OG001
Serotype 14 (Shared)
ParticipantsOG000105
ParticipantsOG00187
Title
Measurements
OG0006.50(4.94 to 8.57)
OG001
Serotype 18C (Shared)
ParticipantsOG000105
ParticipantsOG00188
Title
Measurements
OG0003.84(2.83 to 5.22)
OG001
Serotype 19A (Shared)
ParticipantsOG000105
ParticipantsOG00188
Title
Measurements
OG0005.03(3.88 to 6.53)
OG001
Serotype 19F (Shared)
ParticipantsOG000105
ParticipantsOG00188
Title
Measurements
OG0005.03(3.72 to 6.79)
OG001
Serotype 23F (Shared)
ParticipantsOG000105
ParticipantsOG00188
Title
Measurements
OG0003.59(2.64 to 4.88)
OG001
Serotype 22F (Unique to V114)
ParticipantsOG000105
ParticipantsOG00186
Title
Measurements
OG0004.09(3.02 to 5.54)
OG001
Serotype 33F (Unique to V114)
ParticipantsOG000105
ParticipantsOG00188
Title
Measurements
OG0003.40(2.58 to 4.48)
OG001
Units
Counts
Participants
OG00084
OG00171
Title
Denominators
Categories
Injection site erythema
Title
Measurements
OG00017.9(10.4 to 27.7)
OG00122.5(13.5 to 34.0)
Injection site pain
Title
Measurements
OG00067.9(56.8 to 77.6)
OG00157.7(45.4 to 69.4)
Injection site swelling
Title
Measurements
OG00021.4(13.2 to 31.7)
OG00123.9(14.6 to 35.5)
Units
Counts
Participants
OG0005
OG0014
Title
Denominators
Categories
Injection site induration
Title
Measurements
OG0000.0(0.0 to 52.2)
OG00125.0(0.6 to 80.6)
Injection site pain
Title
Measurements
OG00060.0(14.7 to 94.7)
OG00150.0(6.8 to 93.2)
Injection site swelling
Title
Measurements
OG00020.0(0.5 to 71.6)
OG00125.0(0.6 to 80.6)
Injection site erythema
Title
Measurements
OG0000.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
OG0010.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
Units
Counts
Participants
OG00084
OG00171
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG0007.1(2.7 to 14.9)
OG0018.5(3.2 to 17.5)
Fatigue
Title
Measurements
OG00022.6(14.2 to 33.0)
OG00116.9(9.0 to 27.7)
Headache
Title
Measurements
OG00021.4(13.2 to 31.7)
OG00119.7(11.2 to 30.9)
Myalgia
Title
Measurements
OG00032.1(22.4 to 43.2)
OG00126.8(16.9 to 38.6)
Units
Counts
Participants
OG0005
OG0014
Title
Denominators
Categories
Fatigue
Title
Measurements
OG00020.0(0.5 to 71.6)
OG0010.0(0.0 to 60.2)
Headache
Title
Measurements
OG00020.0(0.5 to 71.6)
OG0010.0(0.0 to 60.2)
Myalgia
Title
Measurements
OG00040.0(5.3 to 85.3)
OG0010.0(0.0 to 60.2)
Hives or welts
Title
Measurements
OG0000.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
OG0010.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
Arthralgia
Title
Measurements
OG0000.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
OG0010.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
OG002
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG003
Prevnar 13â„¢ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Units
Counts
Participants
OG00084
OG00171
OG0025
OG0034
Title
Denominators
Categories
Title
Measurements
OG0001.2(0.0 to 6.5)
OG0010.0(0.0 to 5.1)
OG0020.0(0.0 to 52.2)
OG0030.0(0.0 to 60.2)
Units
Counts
Participants
OG00027
OG00136
Title
Denominators
Categories
Injection site erythema
Title
Measurements
OG0003.7(0.1 to 19.0)
OG0018.3(1.8 to 22.5)
Injection site pain
Title
Measurements
OG00077.8(57.7 to 91.4)
OG00161.1(43.5 to 76.9)
Injection site swelling
Title
Measurements
OG00022.2(8.6 to 42.3)
OG00113.9(4.7 to 29.5)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Units
Counts
Participants
OG0002
OG0011
Title
Denominators
Categories
Injection site pain
Title
Measurements
OG00050.0(1.3 to 98.7)
OG0010.0(0.0 to 97.5)
Injection site erythema
Title
Measurements
OG0000.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
OG0010.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
Injection site swelling
Title
Measurements
OG0000.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
OG0010.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
Injection site induration
Title
Measurements
OG0000.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
OG0010.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
Units
Counts
Participants
OG00027
OG00136
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG00011.1(2.4 to 29.2)
OG0018.3(1.8 to 22.5)
Fatigue
Title
Measurements
OG00029.6(13.8 to 50.2)
OG00116.7(6.4 to 32.8)
Headache
Title
Measurements
OG00022.2(8.6 to 42.3)
OG00111.1(3.1 to 26.1)
Myalgia
Title
Measurements
OG00029.6(13.8 to 50.2)
OG00122.2(10.1 to 39.2)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
Units
Counts
Participants
OG0002
OG0011
Title
Denominators
Categories
Myalgia
Title
Measurements
OG0000.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
OG0010.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
Arthralgia
Title
Measurements
OG0000.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
OG0010.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
Headache
Title
Measurements
OG0000.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
OG0010.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
Fatigue
Title
Measurements
OG0000.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
OG0010.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
Hives or welts
Title
Measurements
OG0000.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
OG0010.0(NA to NA)95% Confidence Interval could not be calculated, because 0 events were observed.
Adult participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG002
V114 (Pediatric)
Pediatric participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAXâ„¢23 as their fourth dose.
OG003
Prevnar 13â„¢ (Pediatric)
Pediatric participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13â„¢ instead of PNEUMOVAXâ„¢23 as their fourth dose.