Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children
Official Title
SINGLE-BLIND, RANDOMIZED, PHASE III B STUDY IN CHILDREN AGED 1 - 11 YEARS TO INVESTIGATE THE IMMUNOGENICITY, SAFETY AND INTERCHANGEABILITY OF TWO TICK-BORNE ENCEPHALITIS (TBE) VACCINES ADMINISTERED ACCORDING TO A CONVENTIONAL SCHEDULE
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Apr 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
Feb 6, 2009Actual
Primary Completion Date
May 20, 2010Actual
Completion Date
May 20, 2010Actual
First Submitted Date
Feb 9, 2009
First Submission Date that Met QC Criteria
Feb 9, 2009
First Posted Date
Feb 10, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 6, 2022
Results First Submitted that Met QC Criteria
Apr 19, 2023
Results First Posted Date
Jan 19, 2024Actual
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
Apr 19, 2023
Last Update Posted Date
Jan 19, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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 objective of this study is to assess the immunogenicity, safety and interchangeability of two different TBE vaccines in children aged 1-11 years, the first and second vaccination with either FSME-IMMUN 0.25ml Junior or Encepur 0.25ml Children and the third vaccination with FSME-IMMUN 0.25 ml Junior only, administered according to the conventional schedule (0, 28 and 360 days).
Detailed Description
Not provided
Conditions Module
Conditions
Encephalitis, Tick-Borne
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
302Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.
Subjects receive three vaccinations with FSME-IMMUN 0.25ml Junior on days 0, 28 and 360
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Seropositivity Rate as Determined by Neutralization Test (NT) 28 Days After the Second Vaccination
Percentage of participants achieving NT titer greater than or equal to (>=) 10.
28 days after Vaccination 2
Secondary Outcomes
Measure
Description
Time Frame
Seropositivity Rate Determined by NT 180 Days After the First Vaccination and 28 Days After the Third Vaccination
Percentage of participants with NT titer >=10. Here, "number of participants analyzed" signifies total number of participants included in the modified intent-to-treat (mITT) population and "Number Analyzed" signifies number of participants who were evaluable at specified timeframe.
180 days after the Vaccination 1, 28 days after the Vaccination 3
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male and female children will be eligible for participation in this study if:
they are aged >= 1 years (from the 1st birthday) to 11 years (to the last day before the 12th birthday) at screening;
their parents / legal guardians provide written informed consent;
children provide written assent to the study according to age and capacity of understanding;
their parents/guardians understand the nature of the clinical study and will comply with the requirements of the protocol (e.g., completion of the Subject Diary, return for follow-up visits);
they are generally healthy, (i.e. the physician would have no reservations vaccinating with a TBE vaccine outside the scope of a clinical study);
provide a negative pregnancy test result at the first medical examination (if the subject is a female and capable of bearing children).
Exclusion Criteria:
Subjects will be excluded from participation if:
they have a history of any previous TBE vaccination;
they have a history of TBE infection;
they have a history of infection with other flaviviruses;
they have a history of vaccination against yellow fever and/or Japanese B encephalitis;
they have a history of severe allergic reactions, in particular a known sensitivity or allergy to any components of the vaccines;
they are suffering from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions;
they have received any blood product or immunoglobulins within 90 days prior to study entry;
they are known to be Human Immunodeficiency Virus (HIV) positive (an HIV test is not required specifically for the purpose of this study);
they have a functional or surgical asplenia;
they have a rash or other dermatological condition at the injection site which could interfere with injection site reaction evaluation;
they were administered an investigational product within six weeks prior to study start or are concurrently participating in another clinical study that includes the administration of an investigational product;
they are pregnant or breastfeeding (if a female subject);
they or their parents/legal guardian(s) are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e., children or grandchildren, partner/spouse, siblings) as well as employees of the investigator or site conducting the study.
Subjects who have an acute illness with or without elevated body temperature (>=37.5°C) within 3 days prior to the scheduled first vaccination will not be vaccinated. Subjects may be included at a repeat visit provided that (1) the illness has resolved (body temperature < 37.5 °C), (2) the repeat visit is no more than 14 calendar days after the Screening Visit, and (3) the center is still open for recruitment.
If subjects have received antipyretics within 4 hours prior to the scheduled time of vaccination, the vaccination should be performed at a later date, as long as the center is still open for recruitment.
Subjects who received any live vaccine within 4 weeks or any inactivated vaccine within 2 weeks prior to the scheduled first study vaccination will not be vaccinated until an interval of 4 or 2 weeks, respectively, has passed, provided the center is still open for recruitment.
If a subject was bitten by a tick within 4 weeks prior to the scheduled first or second vaccination, the vaccination must be postponed until an interval of 4 weeks has passed.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
1 Year
Maximum Age
11 Years
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Baxter Bioscience Investigator
Baxter BioScience
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Unterer Graben 2
Eferding
Upper Austria
4070
Austria
Grieskirchnerstr.17
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
The study was conducted from 06 February 2009 to 20 May 2010 in Austria and Czech Republic.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: FSME-IMMUN
Participants received FSME-IMMUN (FSME-IMMUN Junior) at Day 0 and 28 as first and second vaccination according to the conventional immunization schedule.
Subjects receive two vaccinations with Encepur 0.25ml Children on days 0 and 28 and a third vaccination with FSME-IMMUN 0.25ml Junior on day 360.
2
Seropositivity Rate Determined by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
Percentage of participants with IMMUNOZYM ELISA >126 Vienna Units per milliliter (VIEU/mL) or Enzygnost ELISA >10.32 Units per milliliter (U/mL). Here, "Number Analyzed" signifies number of participants who were evaluable at the specified timeframe.
28 days after Vaccination 2, 180 days after the Vaccination 1, 28 days after the Vaccination 3
Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
Geometric mean of antibody response measured by NT. Here, "Number Analyzed" signifies number of participants who were evaluable at the specified timeframe.
28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Antibody Response Measured by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
Geometric mean of antibody response measured by IMMUNOZYM ELISA (VIEU/mL) and Enzygnost ELISA (U/mL). Here, "Number Analyzed" signifies number of participants who were evaluable at specified timeframe for the specified ELISA assay.
28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Fold Increase of Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination as Compared to Baseline
Geometric mean of fold increase of antibody response measured by NT from day 0 to specified timeframe. Here, "Number Analyzed" signifies number of participants who were evaluable at specified timeframe.
28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Fold Increase of Antibody Response Measured by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination as Compared to Baseline
Geometric mean of fold increase of antibody response measured by IMMUNOZYM ELISA (VIEU/ml) and Enzygnost ELISA (U/ml) from day 0 to specified timeframe. Here, "Number Analyzed" signifies number of participants who were evaluable at the specified timeframe for the specified ELISA assay.
28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Frequency and Severity of Systemic Reactions Occurring After First Vaccination
Systemic symptoms included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, loss of appetite and changes in sleeping behavior in all age strata; restlessness in children 1 to 2 years of age; malaise and fatigue in participants 3 to 11 years of age as collected in participant diary. Number of participants with systemic reactions according to severity after first vaccination were reported.
Within 28 days after Vaccination 1
Frequency and Severity of Systemic Reactions Occurring After Second Vaccination
Systemic symptoms included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, loss of appetite and changes in sleeping behavior in all age strata; restlessness in children 1 to 2 years of age; malaise and fatigue in participants 3 to 11 years of age as collected in participant diary. Number of participants with systemic reactions according to severity after second vaccination were reported.
Within 28 days after Vaccination 2
Frequency and Severity of Systemic Reactions Occurring After Third Vaccination
Systemic symptoms included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, loss of appetite and changes in sleeping behavior in all age strata; restlessness in children 1 to 2 years of age; malaise and fatigue in participants 3 to 11 years of age as collected in participant diary. Number of participants with systemic reactions according to severity after third vaccination were reported. Here, "number of participants analyzed" signifies those participants who received FSME-IMMUN or Encepur during the first and second vaccination and received FSME-IMMUN at Day 360 as third vaccination.
Within 28 days after Vaccination 3
Frequency and Severity of Injection Site Reactions Occurring After the First Vaccination
Injection site reactions included swelling, induration, redness, injection site pain and tenderness, ecchymosis and hematoma as collected in participant diary. Number of participants with injection site reactions according to severity after first vaccination were reported.
Within 6 days of Vaccination 1
Frequency and Severity of Injection Site Reactions Occurring After the Second Vaccination
Injection site reactions included swelling, induration, redness, injection site pain and tenderness, ecchymosis and hematoma as collected in participant diary. Number of participants with injection site reactions according to severity after second vaccination were reported.
Within 6 days of Vaccination 2
Frequency and Severity of Injection Site Reactions Occurring After the Third Vaccination
Injection site reactions included swelling, induration, redness, injection site pain and tenderness, ecchymosis and hematoma as collected in participant diary. Number of participants with injection site reactions according to severity after third vaccination were reported. Here, "number of participants analyzed" signifies those participants who received FSME-IMMUN or Encepur during the first and second vaccination and received FSME-IMMUN at Day 360 as third vaccination.
Within 6 days of Vaccination 3
Frequency and Severity of Adverse Events (AE) Observed Before the Third Vaccination
An AE was any untoward medical occurrence in a participants who received study vaccination without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study vaccine and up to one month after last dose that were absent before treatment or that worsened relative to pre-treatment state. Number of participants with serious and non-serious adverse events according to severity before third vaccination were reported.
Part A: Within 28 days after Vaccination 1 and Vaccination 2, Part B: 28 days after Vaccination 2 to before Vaccination 3
Frequency and Severity of Adverse Events (AE) Observed After the Third Vaccination
An AE was any untoward medical occurrence in a participants who received study vaccination without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability / incapacity; congenital anomaly. Treatment-emergent are events between first dose of study vaccine and up to one month after last dose that were absent before treatment or that worsened relative to pre-treatment state. Number of participants with serious and non-serious adverse events according to severity after third vaccination were reported. Here, "number of participants analyzed" signifies those participants who received FSME-IMMUN or Encepur during the first and second vaccination and received FSME-IMMUN at Day 360 as third vaccination.
Within 28 days after Vaccination 3
Wels
Upper Austria
4600
Austria
Private surgery of General Practitioner for children and juveniles
Havlíčkův Brod
580 01
Czechia
University Hospital Hradec Kralove, Vaccinal center, Clinic of infectious diseases, Sokolská 581
Hradec Králové
50005
Czechia
Private surgery of General Practitioner for children and juveniles
Pardubice
530 02
Czechia
Private surgery of General Practitioner for children and juveniles
Pardubice
530 03
Czechia
Private surgery of General Practitioner for children and juveniles
Pardubice
530 09
Czechia
Chemiku 129
Pardubice-Polabiny
530 09
Czechia
Participants received Encepur (Encepur Children) at Day 0 and 28 as first and second vaccination according to the conventional immunization schedule.
FG002
Part B: FSME-IMMUN
Participants received FSME-IMMUN (FSME-IMMUN Junior) at Day 360 as third vaccination in period 2.
FG000150 subjects
FG001152 subjects
FG0020 subjects
COMPLETED
FG000149 subjects
FG001152 subjects
FG0020 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
Type
Comment
Reasons
Screen failure
FG0001 subjects
FG0010 subjects
FG0020 subjects
Part B:Day 28 Postdose2-Day 28 Postdose3
Type
Comment
Milestone Data
STARTED
FG0000 subjectsAll participants received FSME-IMMUN. Thus, the participant flow for this arm has not been reported.
FG0010 subjectsAll participants received FSME-IMMUN. Thus, the participant flow for this arm has not been reported.
FG002301 subjectsParticipants received FSME-IMMUN (encompassing both Part A: FSME-IMMUN and Part A: Encepur arms).
COMPLETED
FG0000 subjectsAll participants received FSME-IMMUN. Thus, the participant flow for this arm has not been reported.
FG0010 subjectsAll participants received FSME-IMMUN. Thus, the participant flow for this arm has not been reported.
FG002297 subjectsParticipants received FSME-IMMUN (encompassing both Part A: FSME-IMMUN and Part A: Encepur arms).
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0024 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
Other
FG000
The safety analysis set included all participants who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur and had documented adverse event information at least immediately afterwards.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: FSME-IMMUN
Participants received FSME-IMMUN (FSME-IMMUN Junior) at Day 0 and 28 as first and second vaccination according to the conventional immunization schedule.
BG001
Part A: Encepur
Participants received Encepur (Encepur Children) at Day 0 and 28 as first and second vaccination according to the conventional immunization schedule.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000150
BG001152
BG002302
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Infants and toddlers (28 days- 23 months)
BG00050
BG00150
BG002100
Children (2-11 years)
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00077
BG00174
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
Seropositivity Rate as Determined by Neutralization Test (NT) 28 Days After the Second Vaccination
Percentage of participants achieving NT titer greater than or equal to (>=) 10.
Per-protocol analysis set included eligible participants who received first and second vaccination; had negative baseline values in NT; had immunogenicity measurements available at baseline; 28 days after second vaccination and no major protocol violations.
Posted
Number
95% Confidence Interval
Percentage of participants
28 days after Vaccination 2
ID
Title
Description
OG000
FSME-IMMUN
It Included participants who received FSME-IMMUN during the first and second vaccination.
OG001
Encepur
It Included participants who received Encepur during the first and second vaccination.
Units
Counts
Participants
OG000127
OG001134
Title
Denominators
Categories
Title
Measurements
OG000100(97.1 to 100)
OG00197.8(93.6 to 99.5)
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
OG001
Non-inferiority Test on Seropositive Response Rate
Stratified score test
<0.001
Non-Inferiority or Equivalence (legacy)
A stratified score test was used to test the non-inferiority with a margin of -10% at 2.5% type I error (one-sided).
Secondary
Seropositivity Rate Determined by NT 180 Days After the First Vaccination and 28 Days After the Third Vaccination
Percentage of participants with NT titer >=10. Here, "number of participants analyzed" signifies total number of participants included in the modified intent-to-treat (mITT) population and "Number Analyzed" signifies number of participants who were evaluable at specified timeframe.
mITT analysis set included eligible participants who fulfilled all inclusion and exclusion criteria, received first and second vaccination, had no positive baseline values in ELISA(IMMUNOZYM FSME ELISA and Enzygnost TBE ELISA)and NT, had immunogenicity measurements available at baseline and 28 days after second vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
180 days after the Vaccination 1, 28 days after the Vaccination 3
ID
Title
Description
OG000
FSME-IMMUN
It Included participants who received FSME-IMMUN during the first and second vaccination, received FSME-IMMUN at Day 360 as third vaccination.
OG001
Encepur
It Included participants who received Encepur during the first and second vaccination, received FSME-IMMUN at Day 360 as third vaccination.
Units
Secondary
Seropositivity Rate Determined by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
Percentage of participants with IMMUNOZYM ELISA >126 Vienna Units per milliliter (VIEU/mL) or Enzygnost ELISA >10.32 Units per milliliter (U/mL). Here, "Number Analyzed" signifies number of participants who were evaluable at the specified timeframe.
mITT analysis set included eligible participants who fulfilled all inclusion and exclusion criteria, received first and second vaccination, had no positive baseline values in ELISA (IMMUNOZYM FSME ELISA and Enzygnost TBE ELISA) and NT, had immunogenicity measurements available at baseline and 28 days after second vaccination.
Posted
Number
95% Confidence Interval
percentage of participants
28 days after Vaccination 2, 180 days after the Vaccination 1, 28 days after the Vaccination 3
ID
Title
Description
OG000
FSME-IMMUN
It Included participants who received FSME-IMMUN during the first and second vaccination, received FSME-IMMUN at Day 360 as third vaccination.
OG001
Encepur
It Included participants who received Encepur during the first and second vaccination, received FSME-IMMUN at Day 360 as third vaccination.
Secondary
Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
Geometric mean of antibody response measured by NT. Here, "Number Analyzed" signifies number of participants who were evaluable at the specified timeframe.
mITT analysis set included eligible participants who fulfilled all inclusion and exclusion criteria, received first and second vaccination, had no positive baseline values in ELISA (IMMUNOZYM FSME ELISA and Enzygnost TBE ELISA) and NT, had immunogenicity measurements available at baseline and 28 days after second vaccination.
Posted
Geometric Mean
95% Confidence Interval
titer
28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
ID
Title
Description
OG000
FSME-IMMUN
It Included participants who received FSME-IMMUN during the first and second vaccination, received FSME-IMMUN at Day 360 as third vaccination.
OG001
Encepur
It Included participants who received Encepur during the first and second vaccination, received FSME-IMMUN at Day 360 as third vaccination.
Units
Counts
Secondary
Antibody Response Measured by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
Geometric mean of antibody response measured by IMMUNOZYM ELISA (VIEU/mL) and Enzygnost ELISA (U/mL). Here, "Number Analyzed" signifies number of participants who were evaluable at specified timeframe for the specified ELISA assay.
mITT analysis set included eligible participants who fulfilled all inclusion and exclusion criteria, received first and second vaccination, had no positive baseline values in ELISA (IMMUNOZYM FSME ELISA and Enzygnost TBE ELISA) and NT, had immunogenicity measurements available at baseline and 28 days after the second vaccination.
Posted
Geometric Mean
95% Confidence Interval
titer
28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
ID
Title
Description
OG000
FSME-IMMUN
It Included participants who received FSME-IMMUN during the first and second vaccination, received FSME-IMMUN at Day 360 as third vaccination.
OG001
Encepur
It Included participants who received Encepur during the first and second vaccination, received FSME-IMMUN at Day 360 as third vaccination.
Units
Secondary
Fold Increase of Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination as Compared to Baseline
Geometric mean of fold increase of antibody response measured by NT from day 0 to specified timeframe. Here, "Number Analyzed" signifies number of participants who were evaluable at specified timeframe.
mITT analysis set included eligible participants who fulfilled all inclusion and exclusion criteria, received first and second vaccination, had no positive baseline values in ELISA (IMMUNOZYM FSME ELISA and Enzygnost TBE ELISA) and NT, had immunogenicity measurements available at baseline and 28 days after second vaccination.
Posted
Geometric Mean
95% Confidence Interval
fold rise
28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
ID
Title
Description
OG000
FSME-IMMUN
It Included participants who received FSME-IMMUN during the first and second vaccination, received FSME-IMMUN at Day 360 as third vaccination.
OG001
Encepur
It Included participants who received Encepur during the first and second vaccination, received FSME-IMMUN at Day 360 as third vaccination.
Secondary
Fold Increase of Antibody Response Measured by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination as Compared to Baseline
Geometric mean of fold increase of antibody response measured by IMMUNOZYM ELISA (VIEU/ml) and Enzygnost ELISA (U/ml) from day 0 to specified timeframe. Here, "Number Analyzed" signifies number of participants who were evaluable at the specified timeframe for the specified ELISA assay.
mITT population included eligible participants who fulfilled all inclusion and exclusion criteria, received first and second vaccination, had no positive baseline values in ELISA (IMMUNOZYM FSME ELISA and Enzygnost TBE ELISA) and NT, had immunogenicity measurements available at baseline and 28 days after the second vaccination.
Posted
Geometric Mean
95% Confidence Interval
fold rise
28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
ID
Title
Description
OG000
FSME-IMMUN
It Included participants who received FSME-IMMUN during the first and second vaccination, received FSME-IMMUN at Day 360 as third vaccination.
OG001
Encepur
It Included participants who received Encepur during the first and second vaccination, received FSME-IMMUN at Day 360 as third vaccination.
Secondary
Frequency and Severity of Systemic Reactions Occurring After First Vaccination
Systemic symptoms included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, loss of appetite and changes in sleeping behavior in all age strata; restlessness in children 1 to 2 years of age; malaise and fatigue in participants 3 to 11 years of age as collected in participant diary. Number of participants with systemic reactions according to severity after first vaccination were reported.
The safety analysis set included all participants who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur and had documented adverse event information at least immediately afterwards.
Posted
Number
participants
Within 28 days after Vaccination 1
ID
Title
Description
OG000
FSME-IMMUN
It Included participants who received FSME-IMMUN during the first and second vaccination.
OG001
Encepur
It Included participants who received Encepur during the first and second vaccination.
Units
Counts
Participants
Secondary
Frequency and Severity of Systemic Reactions Occurring After Second Vaccination
Systemic symptoms included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, loss of appetite and changes in sleeping behavior in all age strata; restlessness in children 1 to 2 years of age; malaise and fatigue in participants 3 to 11 years of age as collected in participant diary. Number of participants with systemic reactions according to severity after second vaccination were reported.
The safety analysis set included all participants who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur and had documented adverse event information at least immediately afterwards.
Posted
Number
participants
Within 28 days after Vaccination 2
ID
Title
Description
OG000
FSME-IMMUN
It Included participants who received FSME-IMMUN during the first and second vaccination.
OG001
Encepur
It Included participants who received Encepur during the first and second vaccination.
Units
Counts
Participants
Secondary
Frequency and Severity of Systemic Reactions Occurring After Third Vaccination
Systemic symptoms included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, loss of appetite and changes in sleeping behavior in all age strata; restlessness in children 1 to 2 years of age; malaise and fatigue in participants 3 to 11 years of age as collected in participant diary. Number of participants with systemic reactions according to severity after third vaccination were reported. Here, "number of participants analyzed" signifies those participants who received FSME-IMMUN or Encepur during the first and second vaccination and received FSME-IMMUN at Day 360 as third vaccination.
The safety analysis set included all participants who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur and had documented adverse event information at least immediately afterwards.
Posted
Number
participants
Within 28 days after Vaccination 3
ID
Title
Description
OG000
FSME-IMMUN
It Included participants who received FSME-IMMUN or Encepur during the first and second vaccination and received FSME-IMMUN at Day 360 as third vaccination.
Units
Counts
Participants
Secondary
Frequency and Severity of Injection Site Reactions Occurring After the First Vaccination
Injection site reactions included swelling, induration, redness, injection site pain and tenderness, ecchymosis and hematoma as collected in participant diary. Number of participants with injection site reactions according to severity after first vaccination were reported.
The safety analysis set included all participants who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur and had documented adverse event information at least immediately afterwards.
Posted
Number
participants
Within 6 days of Vaccination 1
ID
Title
Description
OG000
FSME-IMMUN
It Included participants who received FSME-IMMUN during the first and second vaccination.
OG001
Encepur
It Included participants who received Encepur during the first and second vaccination.
Units
Counts
Participants
OG000
Secondary
Frequency and Severity of Injection Site Reactions Occurring After the Second Vaccination
Injection site reactions included swelling, induration, redness, injection site pain and tenderness, ecchymosis and hematoma as collected in participant diary. Number of participants with injection site reactions according to severity after second vaccination were reported.
The safety analysis set included all participants who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur and had documented adverse event information at least immediately afterwards.
Posted
Number
participants
Within 6 days of Vaccination 2
ID
Title
Description
OG000
FSME-IMMUN
It Included participants who received FSME-IMMUN during the first and second vaccination.
OG001
Encepur
It Included participants who received Encepur during the first and second vaccination.
Units
Counts
Participants
OG000
Secondary
Frequency and Severity of Injection Site Reactions Occurring After the Third Vaccination
Injection site reactions included swelling, induration, redness, injection site pain and tenderness, ecchymosis and hematoma as collected in participant diary. Number of participants with injection site reactions according to severity after third vaccination were reported. Here, "number of participants analyzed" signifies those participants who received FSME-IMMUN or Encepur during the first and second vaccination and received FSME-IMMUN at Day 360 as third vaccination.
The safety analysis set included all participants who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur and had documented adverse event information at least immediately afterwards.
Posted
Number
participants
Within 6 days of Vaccination 3
ID
Title
Description
OG000
FSME-IMMUN
It Included participants who received FSME-IMMUN or Encepur during the first and second vaccination and received FSME-IMMUN at Day 360 as third vaccination.
Units
Counts
Participants
OG000
Secondary
Frequency and Severity of Adverse Events (AE) Observed Before the Third Vaccination
An AE was any untoward medical occurrence in a participants who received study vaccination without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study vaccine and up to one month after last dose that were absent before treatment or that worsened relative to pre-treatment state. Number of participants with serious and non-serious adverse events according to severity before third vaccination were reported.
The safety analysis set included all participants who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur and had documented adverse event information at least immediately afterwards.
Posted
Number
participants
Part A: Within 28 days after Vaccination 1 and Vaccination 2, Part B: 28 days after Vaccination 2 to before Vaccination 3
ID
Title
Description
OG000
FSME-IMMUN
It Included participants who received FSME-IMMUN during the first and second vaccination, received FSME-IMMUN at Day 360 as third vaccination.
OG001
Encepur
It Included participants who received Encepur during the first and second vaccination, received FSME-IMMUN at Day 360 as third vaccination.
Secondary
Frequency and Severity of Adverse Events (AE) Observed After the Third Vaccination
An AE was any untoward medical occurrence in a participants who received study vaccination without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability / incapacity; congenital anomaly. Treatment-emergent are events between first dose of study vaccine and up to one month after last dose that were absent before treatment or that worsened relative to pre-treatment state. Number of participants with serious and non-serious adverse events according to severity after third vaccination were reported. Here, "number of participants analyzed" signifies those participants who received FSME-IMMUN or Encepur during the first and second vaccination and received FSME-IMMUN at Day 360 as third vaccination.
The safety analysis set included all participants who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur and had documented adverse event information at least immediately afterwards.
Posted
Number
participants
Within 28 days after Vaccination 3
ID
Title
Description
OG000
FSME-IMMUN
It Included participants who received FSME-IMMUN during the first and second vaccination, received FSME-IMMUN at Day 360 as third vaccination.
Time Frame
Part A: Within 28 days after Vaccination 1 and Vaccination 2, Part B: 28 days after Vaccination 2 to before the Vaccination 3, within 28 days after Vaccination 3
Description
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in participant diary (local and systemic reactions for FSME-IMMUN) and AEs were documented in participant diary (non-systematic assessment).
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
Part A (1-2 Years of Age) FSME-IMMUN: After Vaccination 1
Participants aged 1 - 2 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 0, assessed after first vaccination.
1
50
17
50
EG001
Part A (1-2 Years of Age) FSME-IMMUN: After Vaccination 2
Participants aged 1 - 2 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 28, assessed after second vaccination.
0
50
13
50
EG002
Part B (1-2 Years of Age) FSME-IMMUN: Before Vaccination 3
Participants aged 1 - 2 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 0 and 28, assessed 28 Days after the second vaccination to prior to third vaccination.
1
50
37
50
EG003
Part A (3-6 Years of Age) FSME-IMMUN: After Vaccination 1
Participants aged 3 - 6 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 0, assessed after first vaccination.
0
51
15
51
EG004
Part A (3-6 Years of Age) FSME-IMMUN: After Vaccination 2
Participants aged 3 - 6 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 28, assessed after second vaccination.
0
51
11
51
EG005
Part B (3-6 Years of Age) FSME-IMMUN: Before Vaccination 3
Participants aged 3 - 6 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 0 and 28, assessed 28 Days after the second vaccination to prior to third vaccination.
3
51
30
51
EG006
Part A (7-11 Years of Age) FSME-IMMUN: After Vaccination 1
Participants aged 7 - 11 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 0, assessed after first vaccination.
0
49
14
49
EG007
Part A (7-11 Years of Age) FSME-IMMUN: After Vaccination 2
Participants aged 7 - 11 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 28, assessed after second vaccination.
0
49
10
49
EG008
Part B (7-11 Years of Age) FSME-IMMUN: Before Vaccination 3
Participants aged 7 - 11 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 0 and 28, assessed 28 Days after the second vaccination to prior to third vaccination.
2
48
30
48
EG009
Part A (1-2 Years of Age) Encepur: After Vaccination 1
Participants aged 1 - 2 years who received single dose of Encepur Children (Encepur) suspension at Day 0, assessed after first vaccination.
0
50
25
50
EG010
Part A (1-2 Years of Age) Encepur: After Vaccination 2
Participants aged 1 - 2 years who received single dose of Encepur Children (Encepur) suspension at Day 28, assessed after second vaccination.
0
50
13
50
EG011
Part B (1-2 Years of Age) Encepur: Before Vaccination 3
Participants aged 1 - 2 years who received single dose of Encepur Children (Encepur) suspension at Day 0 and 28, assessed 28 Days after the second vaccination to prior to third vaccination.
4
50
39
50
EG012
Part A (3-6 Years of Age) Encepur: After Vaccination 1
Participants aged 3 - 6 years who received single dose of Encepur Children (Encepur) suspension at Day 0, assessed after first vaccination.
0
51
33
51
EG013
Part A (3-6 Years of Age) Encepur: After Vaccination 2
Participants aged 3 - 6 years who received single dose of Encepur Children (Encepur) suspension at Day 28, assessed after second vaccination.
0
51
19
51
EG014
Part B (3-6 Years of Age) Encepur: Before Vaccination 3
Participants aged 3 - 6 years who received single dose of Encepur Children (Encepur) suspension at Day 0 and 28, assessed 28 Days after the second vaccination to prior to third vaccination.
3
51
33
51
EG015
Part A (7-11 Years of Age) Encepur: After Vaccination 1
Participants aged 7 - 11 years who received single dose of Encepur Children (Encepur) suspension at Day 0, assessed after first vaccination.
0
51
30
51
EG016
Part A (7-11 Years of Age) Encepur: After Vaccination 2
Participants aged 7 - 11 years who received single dose of Encepur Children (Encepur) suspension at Day 28, assessed after second vaccination.
0
51
26
51
EG017
Part B (7-11 Years of Age) Encepur: Before Vaccination 3
Participants aged 7 - 11 years who received single dose of Encepur Children (Encepur) suspension at Day 0 and 28, assessed 28 Days after the second vaccination to prior to third vaccination.
3
51
30
51
EG018
Part B (1-2 Years of Age) FSME-IMMUN: After Vaccination 3
Participants aged 1 - 2 years who received either FSME-IMMUN or Encepur during the first and second vaccination, received FSME-IMMUN Junior (FSME-IMMUN) at Day 360 as third vaccination. Assessment of AEs was done after the third vaccination.
0
99
23
99
EG019
Part B (3-6 Years of Age) FSME-IMMUN: After Vaccination 3
Participants aged 3 - 6 years who received either FSME-IMMUN or Encepur during the first and second vaccination, received FSME-IMMUN Junior (FSME-IMMUN) at Day 360 as third vaccination. Assessment of AEs was done after the third vaccination.
0
100
29
100
EG020
Part B (7-11 Years of Age) FSME-IMMUN: After Vaccination 3
Participants aged 7 - 11 years who received either FSME-IMMUN or Encepur during the first and second vaccination, received FSME-IMMUN Junior (FSME-IMMUN) at Day 360 as third vaccination. Assessment of AEs was done after the third vaccination.
0
99
30
99
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
HYPOSPADIAS
Congenital, familial and genetic disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG0030 affected51 at risk
EG004
CRYPTORCHISM
Congenital, familial and genetic disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
EUSTACHIAN TUBE DISORDER
Ear and labyrinth disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
HERPANGINA
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
OTITIS MEDIA CHRONIC
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ACUTE TONSILLITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 events0 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
LARYNGITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
FOREIGN BODY
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
TRAUMATIC LIVER INJURY
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
CONCUSSION
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ACQUIRED PHIMOSIS
Reproductive system and breast disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
TONSILLAR HYPERTROPHY
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ADENOIDAL DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ADENOIDAL HYPERTROPHY
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ORCHIDOPEXY
Surgical and medical procedures
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG0030 affected51 at risk
EG0040 affected51 at risk
EG0050 affected51 at risk
EG0060 affected49 at risk
EG0070 affected49 at risk
EG0080 affected48 at risk
EG0090 affected50 at risk
EG0100 affected50 at risk
EG0110 affected50 at risk
EG0120 affected51 at risk
EG0131 affected51 at risk
EG0140 affected51 at risk
EG0150 affected51 at risk
EG0160 affected51 at risk
EG0170 affected51 at risk
EG0180 affected99 at risk
EG0190 affected100 at risk
EG0200 affected99 at risk
LYMPHADENITIS
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG003
LYMPHADENOPATHY
Blood and lymphatic system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
CRYPTORCHISM
Congenital, familial and genetic disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
EAR PAIN
Ear and labyrinth disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
MIDDLE EAR INFLAMMATION
Ear and labyrinth disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
THYROIDITIS
Endocrine disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
CONJUNCTIVITIS
Eye disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
CONJUNCTIVITIS ALLERGIC
Eye disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ANAL FISSURE
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
APHTHOUS STOMATITIS
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0022 affected50 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0023 affected50 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ENTERITIS
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0024 affected50 at risk
EG003
ENTEROCOLITIS
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
GASTRITIS
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
FATIGUE
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
INJECTION SITE ERYTHEMA
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
INJECTION SITE HAEMATOMA
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
INJECTION SITE HAEMORRHAGE
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0002 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
INJECTION SITE INDURATION
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected50 at risk
EG0020 affected50 at risk
EG003
INJECTION SITE PAIN
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0012 affected50 at risk
EG0020 affected50 at risk
EG003
INJECTION SITE PRURITUS
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
INJECTION SITE SWELLING
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
MALAISE
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
PYREXIA
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0009 affected50 at risk
EG0012 affected50 at risk
EG0020 affected50 at risk
EG003
TENDERNESS
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
HEPATIC STEATOSIS
Hepatobiliary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ALLERGIC OEDEMA
Immune system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
HYPERSENSITIVITY
Immune system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
MULTIPLE ALLERGIES
Immune system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
SEASONAL ALLERGY
Immune system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ACUTE SINUSITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ACUTE TONSILLITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0025 affected50 at risk
EG003
BACTERIAL INFECTION
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected50 at risk
EG0024 affected50 at risk
EG003
BRONCHITIS BACTERIAL
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG003
BRONCHOPNEUMONIA
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
CONJUNCTIVITIS INFECTIVE
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG003
ENTEROBIASIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG003
ERYTHEMA INFECTIOSUM
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0012 affected50 at risk
EG0020 affected50 at risk
EG003
EXANTHEMA SUBITUM
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
FUNGAL SKIN INFECTION
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected50 at risk
EG0023 affected50 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
GENITAL CANDIDIASIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
HERPANGINA
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
HERPES SIMPLEX
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
IMPETIGO
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
LARYNGITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected50 at risk
EG0023 affected50 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0022 affected50 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
OTITIS EXTERNA
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
OTITIS MEDIA
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0013 affected50 at risk
EG0028 affected50 at risk
EG003
OTITIS MEDIA ACUTE
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
PARONYCHIA
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
PAROTITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
PHARYNGOTONSILLITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG003
PSEUDOCROUP
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0022 affected50 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG003
RESPIRATORY TRACT INFECTION VIRAL
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0022 affected50 at risk
EG003
RHINITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
SCARLET FEVER
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
TONSILLITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0012 affected50 at risk
EG00210 affected50 at risk
EG003
TOOTH INFECTION
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
TRACHEITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0012 affected50 at risk
EG00217 affected50 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0011 affected50 at risk
EG0020 affected50 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
VARICELLA
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0002 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG003
VIRAL INFECTION
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0024 affected50 at risk
EG003
VIRAL RASH
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0022 affected50 at risk
EG003
VIRAL TONSILLITIS
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ANKLE FRACTURE
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ARTHROPOD BITE
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG003
BURNS SECOND DEGREE
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
CLAVICLE FRACTURE
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG003
FOREARM FRACTURE
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
HEAD INJURY
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
HEAT STROKE
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
JOINT DISLOCATION
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG003
JOINT INJURY
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
JOINT SPRAIN
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
LIMB INJURY
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
MOUTH INJURY
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG003
MUSCLE STRAIN
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
OPEN WOUND
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
SKIN LACERATION
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
THERMAL BURN
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
TRAUMATIC LIVER INJURY
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
WRIST FRACTURE
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
BLOOD THYROID STIMULATING HORMONE INCREASED
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
BODY TEMPERATURE INCREASED
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
HEART RATE INCREASED
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
OBESITY
Metabolism and nutrition disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
UNDERWEIGHT
Metabolism and nutrition disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
FOOT DEFORMITY
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
MELANOCYTIC NAEVUS
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
RESTLESSNESS
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG0002 affected50 at risk
EG0012 affected50 at risk
EG0020 affected50 at risk
EG003
SLEEP DISORDER
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG0002 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
TIC
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG003
MICTURITION DISORDER
Renal and urinary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ACQUIRED PHIMOSIS
Reproductive system and breast disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
BALANITIS
Reproductive system and breast disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ADENOIDAL DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ADENOIDAL HYPERTROPHY
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG003
RHINITIS ALLERGIC
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
TONSILLAR HYPERTROPHY
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0021 affected50 at risk
EG003
TRACHEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
DERMATITIS ALLERGIC
Skin and subcutaneous tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
DERMATITIS ATOPIC
Skin and subcutaneous tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
DERMATITIS DIAPER
Skin and subcutaneous tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0022 affected50 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 at risk
EG003
TOOTH EXTRACTION
Surgical and medical procedures
MedDRA 13.0
Non-systematic Assessment
EG0000 affected50 at risk
EG0010 affected50 at risk
EG0020 affected50 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
D004675
Encephalitis, Tick-Borne
Ancestor Terms
ID
Term
D004671
Encephalitis, Arbovirus
D018792
Encephalitis, Viral
D020805
Central Nervous System Viral Diseases
D002494
Central Nervous System Infections
D007239
Infections
D000069544
Infectious Encephalitis
D001102
Arbovirus Infections
D000079426
Vector Borne Diseases
D017282
Tick-Borne Diseases
D014777
Virus Diseases
D012327
RNA Virus Infections
D018177
Flavivirus Infections
D018178
Flaviviridae Infections
D004660
Encephalitis
D001927
Brain Diseases
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
D000090862
Neuroinflammatory Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D014612
Vaccines
Ancestor Terms
ID
Term
D001688
Biological Products
D045424
Complex Mixtures
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0010 subjects
FG0021 subjects
Refused blood draw
FG0000 subjects
FG0010 subjects
FG0022 subjects
BG000100
BG001102
BG002202
151
Male
BG00073
BG00178
BG002151
Counts
Participants
OG000149
OG001152
Title
Denominators
Categories
180 Days after Vaccination 1
ParticipantsOG000129
ParticipantsOG001133
Title
Measurements
OG00095.3(90.2 to 98.3)
OG00191(84.8 to 95.3)
28 Days after Vaccination 3
ParticipantsOG000128
ParticipantsOG001132
Title
Measurements
OG000100(97.2 to 100)
OG001
Units
Counts
Participants
OG000149
OG001152
Title
Denominators
Categories
180 Days after Vaccination 1
ParticipantsOG000142
ParticipantsOG001146
Title
Measurements
OG00095.1(90.1 to 98)
OG00181.5(74.2 to 87.4)
28 Days after Vaccination 2
ParticipantsOG000143
ParticipantsOG001148
Title
Measurements
OG000100(97.5 to 100)
OG001
28 Days after Vaccination 3
ParticipantsOG000141
ParticipantsOG001145
Title
Measurements
OG000100(97.4 to 100)
OG001
Participants
OG000149
OG001152
Title
Denominators
Categories
180 Days after Vaccination 1
ParticipantsOG000129
ParticipantsOG001133
Title
Measurements
OG00039.7(34.4 to 45.8)
OG00125(21.3 to 29.4)
28 Days after Vaccination 2
ParticipantsOG000129
ParticipantsOG001135
Title
Measurements
OG000236.8(199.6 to 281)
OG001
28 Days after Vaccination 3
ParticipantsOG000128
ParticipantsOG001132
Title
Measurements
OG000538.2(499.2 to 580.2)
OG001
Counts
Participants
OG000149
OG001152
Title
Denominators
Categories
IMMUNOZYM: 180 Days after Vaccination 1
ParticipantsOG000142
ParticipantsOG001147
Title
Measurements
OG000493.7(436.5 to 558.5)
OG001161.2(140.5 to 184.9)
IMMUNOZYM: 28 Days after Vaccination 2
ParticipantsOG000143
ParticipantsOG001149
Title
Measurements
OG0003026.3(2652.2 to 3453.2)
OG001
IMMUNOZYM: 28 Days after Vaccination 3
ParticipantsOG000141
ParticipantsOG001146
Title
Measurements
OG00011292.9(9693.5 to 13156.3)
OG001
Enzygnost: 180 Days after Vaccination 1
ParticipantsOG000148
ParticipantsOG001149
Title
Measurements
OG00047.9(41.4 to 55.4)
OG001
Enzygnost: 28 Days after Vaccination 2
ParticipantsOG000149
ParticipantsOG001151
Title
Measurements
OG000163.3(152.8 to 174.5)
OG001
Enzygnost: 28 Days after Vaccination 3
ParticipantsOG000147
ParticipantsOG001148
Title
Measurements
OG000682.2(579.6 to 802.9)
OG001
Units
Counts
Participants
OG000149
OG001152
Title
Denominators
Categories
180 Days after Vaccination 1
ParticipantsOG000129
ParticipantsOG001133
Title
Measurements
OG0007.9(6.8 to 9.1)
OG0015(4.2 to 5.8)
28 Days after Vaccination 2
ParticipantsOG000129
ParticipantsOG001135
Title
Measurements
OG00046.9(39.5 to 55.8)
OG001
28 Days after Vaccination 3
ParticipantsOG000128
ParticipantsOG001132
Title
Measurements
OG000106.7(98.5 to 115.5)
OG001
Units
Counts
Participants
OG000149
OG001152
Title
Denominators
Categories
IMMUNOZYM: 180 Days after Vaccination 1
ParticipantsOG000142
ParticipantsOG001147
Title
Measurements
OG00031.6(26.8 to 37.2)
OG0019.5(8.1 to 11)
IMMUNOZYM: 28 Days after Vaccination 2
ParticipantsOG000143
ParticipantsOG001149
Title
Measurements
OG000193.7(163 to 230.1)
OG001
IMMUNOZYM: 28 Days after Vaccination 3
ParticipantsOG000141
ParticipantsOG001146
Title
Measurements
OG000719.9(591.5 to 876.3)
OG001
Enzygnost: 180 Days after Vaccination 1
ParticipantsOG000148
ParticipantsOG001149
Title
Measurements
OG0009.5(8.2 to 11)
OG001
Enzygnost: 28 Days after Vaccination 2
ParticipantsOG000149
ParticipantsOG001151
Title
Measurements
OG00032.5(30.4 to 34.8)
OG001
Enzygnost: 28 Days after Vaccination 3
ParticipantsOG000147
ParticipantsOG001148
Title
Measurements
OG000135.8(115.3 to 160)
OG001
OG000150
OG001152
Title
Denominators
Categories
Systemic reactions: None
Title
Measurements
OG000136(6.8 to 9.1)
OG001134(4.2 to 5.8)
Systemic reactions: Mild
Title
Measurements
OG00013(39.5 to 55.8)
OG00115(19.4 to 28.8)
Systemic reactions: Moderate
Title
Measurements
OG0001(98.5 to 115.5)
OG0013(94.6 to 113.2)
Systemic reactions: Severe
Title
Measurements
OG0000
OG0010
OG000150
OG001152
Title
Denominators
Categories
Systemic reactions: None
Title
Measurements
OG000143(6.8 to 9.1)
OG001144(4.2 to 5.8)
Systemic reactions: Mild
Title
Measurements
OG0007(39.5 to 55.8)
OG0018(19.4 to 28.8)
Systemic reactions: Moderate
Title
Measurements
OG0000(98.5 to 115.5)
OG0010(94.6 to 113.2)
Systemic reactions: Severe
Title
Measurements
OG0000
OG0010
OG000298
Title
Denominators
Categories
Systemic reactions: None
Title
Measurements
OG000282(6.8 to 9.1)
Systemic reactions: Mild
Title
Measurements
OG00015(39.5 to 55.8)
Systemic reactions: Moderate
Title
Measurements
OG0001(98.5 to 115.5)
Systemic reactions: Severe
Title
Measurements
OG0000
150
OG001152
Title
Denominators
Categories
None
Title
Measurements
OG000131(6.8 to 9.1)
OG001108(4.2 to 5.8)
Unknown
Title
Measurements
OG0001(39.5 to 55.8)
OG0010(19.4 to 28.8)
Mild
Title
Measurements
OG00018(98.5 to 115.5)
OG00141(94.6 to 113.2)
Moderate
Title
Measurements
OG0000
OG0013
Severe
Title
Measurements
OG0000
OG0010
150
OG001152
Title
Denominators
Categories
None
Title
Measurements
OG000137(6.8 to 9.1)
OG001118(4.2 to 5.8)
Mild
Title
Measurements
OG00012(98.5 to 115.5)
OG00127(94.6 to 113.2)
Moderate
Title
Measurements
OG0001
OG0017
Severe
Title
Measurements
OG0000
OG0010
298
Title
Denominators
Categories
None
Title
Measurements
OG000249(6.8 to 9.1)
Mild
Title
Measurements
OG00043(39.5 to 55.8)
Moderate
Title
Measurements
OG0004(98.5 to 115.5)
Severe
Title
Measurements
OG0002
Units
Counts
Participants
OG000150
OG001152
Title
Denominators
Categories
Non-Serious AE: within 28 days after Vaccination 1
Title
Measurements
OG00057(6.8 to 9.1)
OG00180(4.2 to 5.8)
Serious AE: within 28 days after Vaccination 1
Title
Measurements
OG0001(39.5 to 55.8)
OG0010(19.4 to 28.8)
Non-Serious AE: within 28 days after Vaccination 2
Title
Measurements
OG00042(98.5 to 115.5)
OG00166(94.6 to 113.2)
Serious AE: within 28 days after Vaccination 2
Title
Measurements
OG0000
OG0010
Non-Serious AE:after Part A to before Vaccination3
Title
Measurements
OG00097
OG001102
Serious AE: after Part A to before Vaccination 3
Title
Measurements
OG0006
OG00110
Units
Counts
Participants
OG000298
Title
Denominators
Categories
Non-Serious AE: within 28 days after Vaccination 3