A Study Evaluating Safety And Immunogenicity Of Meningoco... | NCT00808028 | Trialant
NCT00808028
Sponsor
Pfizer
Status
Completed
Last Update Posted
Apr 14, 2015Estimated
Enrollment
538Actual
Phase
Phase 2
Conditions
Meningitis, Meningococcal
Interventions
meningococcal B rLP2086 vaccine.
meningococcal B rLP2086 vaccine.
meningococcal B rLP2086 vaccine.
normal saline (placebo)
Countries
Australia
Poland
Spain
Protocol Section
Identification Module
NCT ID
NCT00808028
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
6108A1-2001
Secondary IDs
ID
Type
Description
Link
B1971005
Other Identifier
Alias Study Number
2008-007789-51
EudraCT Number
Brief Title
A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents
Official Title
A Randomized, Single-blind, Placebo-controlled, Phase 2 Trial Of The Safety, Immunogenicity, And Tolerability Of Meningococcal Serogroup B (Mnb) Rlp2086 Vaccine At Doses Of 60 Mug, 120 Mug, And 200 Mug In Healthy Adolescents Aged 11 To 18 Years
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Mar 2015
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
Feb 2009
Primary Completion Date
Mar 2014Actual
Completion Date
Mar 2014Actual
First Submitted Date
Dec 12, 2008
First Submission Date that Met QC Criteria
Dec 12, 2008
First Posted Date
Dec 15, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 27, 2015
Results First Submitted that Met QC Criteria
Mar 27, 2015
Results First Posted Date
Apr 14, 2015Estimated
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
Mar 27, 2015
Last Update Posted Date
Apr 14, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.
Detailed Description
Not provided
Conditions Module
Conditions
Meningitis, Meningococcal
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
538Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
dose level 1 rLP2086 vaccine
Biological: meningococcal B rLP2086 vaccine.
2
Experimental
dose level 2 rLP2086 vaccine
Biological: meningococcal B rLP2086 vaccine.
3
Experimental
dose level 3 rLP2086 vaccine
Biological: meningococcal B rLP2086 vaccine.
4
Placebo Comparator
normal saline (placebo)
Other: normal saline (placebo)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
meningococcal B rLP2086 vaccine.
Biological
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2
Before vaccination 1 up to 1 month after vaccination 2
Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3
Before vaccination 1 up to 1 month after vaccination 3
Percentage of Participants With Atleast One Adverse Event (AE): Stage 1
Vaccination 1 upto 1 Month after vaccination 3
Percentage of Participants With Atleast One Adverse Event (AE): Stage 2
6 month after vaccination 3 up to 48 months
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level
1 month before vaccination 1, 1 month after vaccination 2, 3
Other Outcomes
Measure
Description
Time Frame
Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B
Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy male or female subjects between the ages of >=11 and <=18 years at the time of enrollment.
Negative urine pregnancy test for all female subjects.
Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.
Exclusion Criteria:
History of any invasive meningococcal disease.
A previous anaphylactic or severe vaccine-associated adverse reaction.
Any clinically significant chronic disease.
A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.
Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.
Richmond PC, Marshall HS, Nissen MD, Jiang Q, Jansen KU, Garces-Sanchez M, Martinon-Torres F, Beeslaar J, Szenborn L, Wysocki J, Eiden J, Harris SL, Jones TR, Perez JL; 2001 Study Investigators. Safety, immunogenicity, and tolerability of meningococcal serogroup B bivalent recombinant lipoprotein 2086 vaccine in healthy adolescents: a randomised, single-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2012 Aug;12(8):597-607. doi: 10.1016/S1473-3099(12)70087-7. Epub 2012 May 7.
FG002
rLP2086 120 mcg
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
FG003
rLP2086 200 mcg
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
FG000121 subjects
FG00122 subjectsParticipants in rLP2086 60 mcg group participated only in Stage 1 and were not eligible for Stage 2
FG002198 subjects
FG003198 subjects
COMPLETED
FG000116 subjects
FG00121 subjectsParticipants in rLP2086 60 mcg group participated only in Stage 1 and were not eligible for Stage 2
FG002191 subjects
FG003183 subjects
NOT COMPLETED
FG0005 subjects
FG0011 subjects
FG0027 subjects
FG00315 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0003 subjects
FG0010 subjects
FG0022 subjects
FG0035 subjects
Other
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0034 subjects
Parent/legal guardian request
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0033 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Stage 2 (Followed up to 48 Months )
Type
Comment
Milestone Data
STARTED
FG00080 subjectsOut of 511 completed participants in Stage 1, 89 did not enter Stage 2
FG0010 subjects
FG002170 subjects
FG003151 subjects
COMPLETED
FG00069 subjectsOut of 511 completed participants in Stage 1, 89 did not enter Stage 2
FG0010 subjects
FG002141 subjects
FG003128 subjects
NOT COMPLETED
FG00011 subjects
FG0010 subjects
FG00229 subjects
FG00323 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0006 subjects
FG0010 subjects
FG0029 subjects
FG003
The stage 1 intent-to-treat (ITT) population included all randomized participants who received at least 1 vaccination and have at least 1 valid and determinate assay result from blood samples drawn during stage 1.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Control
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
BG001
rLP2086 60 mcg
Given on a 0, 2-, 6-month schedule in Stage 1.
BG002
rLP2086 120 mcg
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
BG003
rLP2086 200 mcg
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000121
BG00122
BG002198
BG003198
BG004539
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
BG00013.8± 2.05
BG00113.3± 1.84
BG00214.3± 2.11
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00061
BG00111
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2
mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Posted
Number
Percentage of participants
Before vaccination 1 up to 1 month after vaccination 2
ID
Title
Description
OG000
Control-Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
OG001
rLP2086 60 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1
OG002
rLP2086 120 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
OG003
rLP2086 200 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Units
Counts
Participants
OG000119
OG00122
OG002195
OG003
Title
Denominators
Categories
Subfamily A Strain A05 (N= 80, 18, 115, 106)
Title
Measurements
OG0001.3
OG00188.9
OG00283.5
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Binomial Distribution
>0.9999
No
Superiority or Other
OG001
Primary
Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3
mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Posted
Number
Percentage of participants
Before vaccination 1 up to 1 month after vaccination 3
ID
Title
Description
OG000
Control-Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
OG001
rLP2086 60 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1
OG002
rLP2086 120 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
OG003
rLP2086 200 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Primary
Percentage of Participants With Atleast One Adverse Event (AE): Stage 1
Safety population included participants who received at least 1 dose of study vaccine.
Posted
Number
Percentage of participants
Vaccination 1 upto 1 Month after vaccination 3
ID
Title
Description
OG000
Control-Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
OG001
rLP2086 60 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1
OG002
rLP2086 120 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
OG003
rLP2086 200 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Units
Counts
Primary
Percentage of Participants With Atleast One Adverse Event (AE): Stage 2
Safety population included participants who received at least 1 dose of study vaccine.
Posted
Number
Percentage of participants
6 month after vaccination 3 up to 48 months
ID
Title
Description
OG000
Control- Stage 2
Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
OG001
rLP2086 120 mcg- Stage 2
Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
OG002
rLP2086 200 mcg- Stage 2
Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level
mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Posted
Number
Percentage of participants
1 month before vaccination 1, 1 month after vaccination 2, 3
ID
Title
Description
OG000
Control-Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
OG001
rLP2086 60 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1
OG002
rLP2086 120 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
OG003
rLP2086 200 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Other Pre-specified
Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B
mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Posted
Geometric Mean
95% Confidence Interval
Titer
Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3
ID
Title
Description
OG000
Control-Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
OG001
rLP2086 60 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1
OG002
rLP2086 120 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
OG003
rLP2086 200 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Time Frame
AE reported from Vaccination 1 upto 48 months after vaccincation 3 and SAE reported from Vaccination 1 upto 48 months after vaccincation 3
Description
Not provided
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
Control- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1
3
121
54
121
EG001
rLP2086 60 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1
1
22
18
22
EG002
rLP2086 120 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1
3
198
75
198
EG003
rLP2086 200 mcg- Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1
8
195
91
195
EG004
Control-Stage 1 Follow-up
Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
0
121
5
121
EG005
rLP2086 60 mcg- Stage 1 Follow up
Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
1
22
3
22
EG006
rLP2086 120 mcg- Stage 1 Follow up
Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
1
198
2
198
EG007
rLP2086 200 mcg- Stage 1 Follow up
Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
2
195
4
195
EG008
Control-Stage 2
Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
1
80
1
80
EG009
rLP2086 120 mcg- Stage 2
Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
6
170
1
170
EG010
rLP2086 200 mcg- Stage 2
Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
3
151
0
151
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Eczema impetiginous
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG0030 affected195 at risk
EG0040 affected121 at risk
EG0050 affected22 at risk
EG0060 affected198 at risk
EG0070 affected195 at risk
EG0080 affected80 at risk
EG0091 affected170 at risk
EG0100 affected151 at risk
Perirectal abscess
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Pilonidal cyst
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Tonsillitis streptococcal
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
CNS germinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Depression
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Cerebellar tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0020 affected198 at risk
EG003
Mononucleosis syndrome
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Abdominal injury
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Headache
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0020 affected198 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Hypertension
Vascular disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Gastroenteritis viral
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG0030 affected195 at risk
EG0040 affected121 at risk
EG0050 affected22 at risk
EG0061 affected198 at risk
EG0070 affected195 at risk
EG0080 affected80 at risk
EG0090 affected170 at risk
EG0100 affected151 at risk
Otitis media
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG00020 affected121 at risk
EG00113 affected22 at risk
EG00228 affected198 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0011 affected22 at risk
EG0021 affected198 at risk
EG003
Blood iron decreased
Investigations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0022 affected198 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Factor V Leiden mutation
Congenital, familial and genetic disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0023 affected198 at risk
EG003
Eye inflammation
Eye disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Eyelid cyst
Eye disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Photophobia
Eye disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0002 affected121 at risk
EG0010 affected22 at risk
EG0022 affected198 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0021 affected198 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Gingivitis
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0020 affected198 at risk
EG003
Tooth impacted
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Influenza like illness
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0004 affected121 at risk
EG0011 affected22 at risk
EG0022 affected198 at risk
EG003
Injection site pain
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Pyrexia
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Injection site swelling
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Chest pain
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Hypothermia
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Injection site dermatitis
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0020 affected198 at risk
EG003
Injection site erythema
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Injection site haematoma
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Injection site pallor
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Injection site paraesthesia
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0020 affected198 at risk
EG003
Injection site pruritus
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0020 affected198 at risk
EG003
Vaccination site pallor
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Vessel puncture site haematoma
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0020 affected198 at risk
EG003
Allergy to animal
Immune system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Allergy to chemicals
Immune system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0020 affected198 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0005 affected121 at risk
EG0010 affected22 at risk
EG0024 affected198 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0003 affected121 at risk
EG0010 affected22 at risk
EG0025 affected198 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0028 affected198 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0023 affected198 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0004 affected121 at risk
EG0010 affected22 at risk
EG0022 affected198 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0024 affected198 at risk
EG003
Viral infection
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0002 affected121 at risk
EG0014 affected22 at risk
EG0021 affected198 at risk
EG003
Ear infection
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Influenza
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0021 affected198 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0003 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Acute tonsillitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
H1N1 influenza
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Mumps
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0022 affected198 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0011 affected22 at risk
EG0025 affected198 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0020 affected198 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Gastritis viral
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Impetigo
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Pertussis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0002 affected121 at risk
EG0011 affected22 at risk
EG0021 affected198 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0020 affected198 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0011 affected22 at risk
EG0020 affected198 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0002 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0011 affected22 at risk
EG0020 affected198 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0011 affected22 at risk
EG0020 affected198 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0022 affected198 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0020 affected198 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Whiplash injury
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Back injury
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Chemical burn of skin
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Foreign body
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Ligament injury
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Post concussion syndrome
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Skeletal injury
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0021 affected198 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Muscle contracture
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Torticollis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Scar
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0021 affected198 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Hangnail
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Fibroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0020 affected198 at risk
EG003
Headache
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0008 affected121 at risk
EG0012 affected22 at risk
EG0023 affected198 at risk
EG003
Syncope
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Migraine
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Burning sensation mucosal
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0020 affected198 at risk
EG003
Tremor
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Abnormal behaviour
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0021 affected198 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 17.0
Non-systematic Assessment
EG0002 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Penile discharge
Reproductive system and breast disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0004 affected121 at risk
EG0012 affected22 at risk
EG0022 affected198 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0006 affected121 at risk
EG0010 affected22 at risk
EG0023 affected198 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0022 affected198 at risk
EG003
Asthma exercise induced
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0011 affected22 at risk
EG0021 affected198 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0003 affected121 at risk
EG0011 affected22 at risk
EG0022 affected198 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 17.0
Non-systematic Assessment
EG0000 affected121 at risk
EG0010 affected22 at risk
EG0020 affected198 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
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D008585
Meningitis, Meningococcal
Ancestor Terms
ID
Term
D016920
Meningitis, Bacterial
D020806
Central Nervous System Bacterial Infections
D001424
Bacterial Infections
D001423
Bacterial Infections and Mycoses
D007239
Infections
D008589
Meningococcal Infections
D016870
Neisseriaceae Infections
D016905
Gram-Negative Bacterial Infections
D002494
Central Nervous System Infections
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
D008581
Meningitis
D000090862
Neuroinflammatory Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000077330
Saline Solution
Ancestor Terms
ID
Term
D000077324
Crystalloid Solutions
D007552
Isotonic Solutions
D012996
Solutions
D004364
Pharmaceutical Preparations
Browse Leaves
Not provided
Browse Branches
Not provided
11 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0028 subjects
FG0037 subjects
Failed to return
FG0002 subjects
FG0010 subjects
FG0025 subjects
FG0034 subjects
Adverse Event
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
Parent's or guardian request
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Non-compliance
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
14.0
± 2.01
BG00414.0± 2.05
113
BG003103
BG004288
Male
BG00060
BG00111
BG00285
BG00395
BG004251
192
87.7
Subfamily B Strain B02 (N= 84, 21, 121, 114)
Title
Measurements
OG0000.0
OG00171.4
OG00259.5
OG00359.6
Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Binomial Distribution
0.0007
No
Superiority or Other
OG002
Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Binomial Distribution
<0.0001
No
Superiority or Other
OG003
Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Binomial Distribution
<0.0001
No
Superiority or Other
OG000
Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Binomial Distribution
>0.9999
No
Superiority or Other
OG001
Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Binomial Distribution
0.0392
No
Superiority or Other
OG002
Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Binomial Distribution
0.0225
No
Superiority or Other
OG003
Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Binomial Distribution
0.0244
No
Superiority or Other
Units
Counts
Participants
OG000119
OG00122
OG002195
OG003192
Title
Denominators
Categories
Subfamily A Strain A05 (N= 73, 19, 111,100)
Title
Measurements
OG0005.5
OG00189.5
OG00292.8
OG00394.0
Subfamily B Strain B02 (N= 79, 21, 112,105)
Title
Measurements
OG0001.3
OG00181.0
OG00286.6
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Binomial Distribution
>0.9999
No
Superiority or Other
OG001
Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Binomial Distribution
0.0004
No
Superiority or Other
OG002
Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Binomial Distribution
<0.0001
No
Superiority or Other
OG003
Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Binomial Distribution
<0.0001
No
Superiority or Other
OG000
Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Binomial Distribution
>0.9999
No
Superiority or Other
OG001
Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Binomial Distribution
0.0036
No
Superiority or Other
OG002
Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Binomial Distribution
<0.0001
No
Superiority or Other
OG003
Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.