Safety Study of a Vaccine to Help Protect Against Lyme Di... | NCT05634811 | Trialant
NCT05634811
Sponsor
Pfizer
Status
Completed
Last Update Posted
May 7, 2026Actual
Enrollment
3,547Actual
Phase
Phase 3
Conditions
Lyme Disease
Interventions
VLA15
Normal Saline
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT05634811
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C4601012
Secondary IDs
ID
Type
Description
Link
NCT05634811
Registry Identifier
ClinicalTrials.gov
2025-000441-15
EudraCT Number
Brief Title
Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children
Official Title
A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY OF A 6-VALENT OspA-BASED LYME DISEASE VACCINE (VLA15) IN HEALTHY CHILDREN 5 THROUGH 17 YEARS OF AGE
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Apr 2026
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
Dec 12, 2022Actual
Primary Completion Date
Jul 21, 2025Actual
Completion Date
Jul 21, 2025Actual
First Submitted Date
Nov 22, 2022
First Submission Date that Met QC Criteria
Nov 22, 2022
First Posted Date
Dec 2, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Apr 14, 2026
Results First Submitted that Met QC Criteria
Apr 14, 2026
Results First Posted Date
May 7, 2026Actual
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 14, 2026
Last Update Posted Date
May 7, 2026Actual
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
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is to understand if the study vaccine (called VLA15) is safe in healthy children.
We are looking for children who:
are healthy
are age 5 through 17
have not been diagnosed with any form of Lyme disease in the past
have not received any vaccines for Lyme disease in the past
Lyme disease happens most often in children of this age. The study vaccine may be used potentially to help prevent Lyme disease. The goal of this study is to get more information about the safety of the study vaccine in this age group.
Participants will be in this study for about 2 years. During that time, they will receive VLA15 or placebo (sterile saltwater solution) by a "shot" in the arm. We will compare experience of children receiving VLA15 to those receiving the placebo. Participants will not know whether they get VLA15 or placebo.
Everyone participating in this study will:
get the shots in a clinic or in a hospital office
receive a total of 4 shots
receive the first 3 shots within 6 months
receive the last shot about 1 year afterwards
need to come to the trial site for 6 planned visits; 4 of these are vaccination visits and 2 are follow-up visits. We will contact you by phone 1 time every year during the study to monitor your experience. You may have extra visits if you experience a severe reaction after a vaccine dose.
Detailed Description
Not provided
Conditions Module
Conditions
Lyme Disease
Keywords
Borreliosis
Borrelia burgdorferi
Spirochetes
Vector-Borne Disease
Lyme Disease Vaccine
VLA15
Outer Surface Protein A (OspA)
Ticks
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
3,547Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
VLA15
Experimental
Participants will receive 6-valent OspA-based Lyme disease vaccine (VLA15).
Biological: VLA15
Normal Saline (Placebo)
Placebo Comparator
Participants will receive 0.9% sodium chloride solution for injection
Other: Normal Saline
Interventions
Name
Type
Description
Arm Group Labels
Other Names
VLA15
Biological
6-valent OspA-based Lyme disease vaccine
VLA15
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 1
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 1 (Vaccination on Day 1, Month 0)
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 2
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 2 (Vaccination on Day 1, Month 2)
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 3
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 3 (Vaccination on Day 1, Month 6)
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 4 (Booster Dose)
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy participants at enrollment who are determined to be eligible for inclusion in the study. Participants with preexisting chronic medical conditions determined to be stable may be included.
Participants and/or participants' parent(s)/guardian who are willing and able to comply with all scheduled visits, study procedures and lifestyle considerations for the duration of the study.
Exclusion Criteria:
Female participants that are pregnant, breastfeeding, or have a positive urine pregnancy test at Visit 1. Sexually active females and fertile males unwilling to use contraception as per protocol.
Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
Any diagnosis of Lyme disease within the past 3 months.
Any history of Lyme arthritis, carditis, neuroborreliosis, or other disseminated Lyme Disease (LD), regardless of when diagnosed.
Known tick bite within the past 4 weeks.
Congenital or acquired immunodeficiency or other conditions or treatments associated with immunosuppression that would inhibit the ability to mount an immune response to a vaccine.
Other medical, psychiatric condition, active suicidal ideation/behavior or lab abnormality which increases risk of study participation or, in investigator's judgment is inappropriate for the study.
Receipt of a previous vaccination for LD.
Treatment for LD in the 3 months prior to study intervention administration.
Receipt of blood/plasma products or immunoglobulins within 6 months before study intervention administration through conclusion of the study.
Receipt of systemic corticosteroids for ≥14 days within 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical corticosteroids are permitted.
Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months before study intervention administration.
Current use of any prohibited concomitant medication(s) or participants unwilling/unable to use a permitted concomitant medication(s).
Participation in other studies involving investigational drugs/vaccines/devices within 28 days prior to study entry and/or during study participation (observational studies are acceptable).
Investigator site staff, sponsor/sponsor delegates directly involved in the conduct of the study and their family members; site staff supervised by the investigator and their family members.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
5 Years
Maximum Age
17 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
Locations
Facility
Status
City
State
ZIP
Country
Contacts
UAB Child Health Research Unit (CHRU)
Birmingham
Alabama
35233
United States
University of Alabama at Birmingham - School of Medicine
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.
This study was conducted across 57 sites across the United States of America (USA).
Recruitment Details
A total of 3646 participants were enrolled, of which 3547 participants were randomized.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years were randomized to receive Lyme borreliosis 6-valent vaccine (VLA15 [PF-07307405]), 180 micrograms (ug), 0.5 milliliter (mL) intramuscular (IM) injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Randomized participants as per the interventions assigned.
From Day 1 through Day 7 after Study Vaccination 4 (Vaccination on Day 1, Month 18)
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days After Any Study Vaccination
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
From Day 1 through Day 7 after any study vaccination
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 1
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 1 (Vaccination on Day 1, Month 0)
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 2
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 2 (Vaccination on Day 1, Month 2)
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 3
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 3 (Vaccination on Day 1, Month 6)
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 4 (Booster Dose)
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
From Day 1 through Day 7 after Study Vaccination 4 (Vaccination on Day 1, Month 18)
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days After Any Study Vaccination
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
From Day 1 through Day 7 after any study vaccination
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 1
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 1 were included in this outcome measure. AEs included both serious AEs (SAEs) and non-SAEs.
From Day 1 through 1 Month after Study Vaccination 1 (Vaccination on Day 1, Month 0)
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 2
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 2 were included in this outcome measure. AEs included both SAEs and non-SAEs.
From Day 1 through 1 Month after Study Vaccination 2 (Vaccination on Day 1, Month 2)
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 3
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 3 were included in this outcome measure. AEs included both SAEs and non-SAEs.
From Day 1 through 1 Month after Study Vaccination 3 (Vaccination on Day 1, Month 6)
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 4 (Booster Dose)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 4 were included in this outcome measure. AEs included both SAEs and non-SAEs.
From Day 1 through 1 Month after Study Vaccination 4 (Vaccination on Day 1, Month 18)
Percentage of Participants With AEs Through 1 Month Following Any Study Vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after any dose were included in this outcome measure.
From Day 1 through 1 Month after any study vaccination
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMCs) Throughout the Study
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. NDCMCs included conditions that were undiagnosed prior to study entry (diagnosed while in the study and confirmed not to be a preexisting condition) and that were not considered temporary conditions based upon the expected natural history of the condition. An NDCMC was not reported on AE CRF.
Throughout the study (from study vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months)
Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other important medical event.
Throughout the study (from study vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months)
Birmingham
Alabama
35233
United States
Lakeview Clinical Research
Guntersville
Alabama
35976
United States
Coast Clinical Research, LLC
Bellflower
California
90706
United States
Apex Research Group LLC
Fair Oaks
California
95628
United States
New England Research Associates
Bridgeport
Connecticut
06606
United States
Stamford Therapeutics Consortium
Stamford
Connecticut
06905
United States
Children's National Medical Center
Washington D.C.
District of Columbia
20010
United States
Bio-Medical Research LLC
Miami
Florida
33144
United States
GCP Research, Global Clinical professionals
St. Petersburg
Florida
33705
United States
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
Tampa
Florida
33609
United States
ForCare Clinical Research
Tampa
Florida
33613
United States
Tekton Research, LLC.
Chamblee
Georgia
30341
United States
ASR, LLC
Boise
Idaho
83702
United States
Clinical Research Prime
Idaho Falls
Idaho
83404
United States
Clinical Research Prime Rexburg
Rexburg
Idaho
83440
United States
University of Chicago Medical Center
Chicago
Illinois
60637
United States
AMR Clinical
El Dorado
Kansas
67042
United States
AMR Clinical
Wichita
Kansas
67207
United States
Kentucky Pediatric/ Adult Research
Bardstown
Kentucky
40004
United States
All Children Pediatrics
Louisville
Kentucky
40243
United States
MD Medical Research
Oxon Hill
Maryland
20745
United States
White Oak Pediatrics
Silver Spring
Maryland
20904
United States
Sisu BHR
Springfield
Massachusetts
01103
United States
Michigan Center of Medical Research (MICHMER)
Bingham Farms
Michigan
48025
United States
Vida Clinical Studies, LLC
Dearborn Heights
Michigan
48127
United States
Great Lakes Research Institute
Southfield
Michigan
48075
United States
Clinical Research Institute
Minneapolis
Minnesota
55402
United States
Velocity Clinical Research, Omaha
Omaha
Nebraska
68134
United States
Hassman Research Institute
Marlton
New Jersey
08053
United States
Rutgers University
New Brunswick
New Jersey
08901
United States
IMA Clinical Research Warren
Warren Township
New Jersey
07059
United States
Velocity Clinical Research, Binghamton
Binghamton
New York
13905
United States
Buffalo Clinical and Translational Research Center
Buffalo
New York
14203
United States
Advanced Specialty Care
Commack
New York
11725
United States
Smith Allergy and Asthma Specialists
Cortland
New York
13045
United States
Stony Brook Medicine Clinical Research Center
East Setauket
New York
11733
United States
Upstate Global Health Institute
East Syracuse
New York
13057
United States
Southampton Hospital
Hampton Bays
New York
11946
United States
Smith Allergy & Asthma Specialists
Horseheads
New York
14845
United States
NYU Langone Hospital - Long Island
Mineola
New York
11501
United States
DiGiovanna Institute for Medical Education & Research
North Massapequa
New York
11758
United States
Rochester Clinical Research, LLC
Rochester
New York
14609
United States
Stony Brook University
Stony Brook
New York
11794
United States
Prime Global Research
The Bronx
New York
10456
United States
Advantage Clinical Trials
The Bronx
New York
10467
United States
Velocity Clinical Research, Vestal
Vestal
New York
13850
United States
Centricity Research Columbus Ohio Multispecialty
Columbus
Ohio
43213
United States
Allegheny Health and Wellness Pavilion
Erie
Pennsylvania
16506
United States
Central Erie Primary Care
Erie
Pennsylvania
16508
United States
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
Pittsburgh
Pennsylvania
15236
United States
Northeast Clinical Trials Group
Scranton
Pennsylvania
18510
United States
Coastal Carolina Research Center
North Charleston
South Carolina
29405
United States
Benchmark Research
Austin
Texas
78705
United States
Benchmark Research
Fort Worth
Texas
76135
United States
Texas Health Resources
Fort Worth
Texas
76135
United States
C & R Research Services USA
Houston
Texas
77022
United States
DM Clinical Research - Kool Kids Pediatrics
Houston
Texas
77065
United States
Research Your Health
Plano
Texas
75093
United States
Sun Research Institute
San Antonio
Texas
78215
United States
Velocity Clinical Research, Salt Lake City
West Jordan
Utah
84088
United States
Pediatric Research of Charlottesville, LLC
Charlottesville
Virginia
22902
United States
Clinical Research Partners, LLC
Richmond
Virginia
23226
United States
Frontier Clinical research
Kingwood
West Virginia
26537
United States
Preston Healthcare Services
Kingwood
West Virginia
26537
United States
Placebo: 5 to 11 Years
Participants aged 5 to 11 years were randomized to receive placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
FG002
VLA15: 12 to 17 Years
Participants aged 12 to 17 years were randomized to receive VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
FG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years were randomized to receive placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
FG0001432 subjects
FG001475 subjects
FG0021221 subjects
FG003419 subjects
Vaccinated
Participants as per the interventions received.
FG0001429 subjects
FG001467 subjects
FG0021219 subjects
FG003418 subjects
COMPLETED
FG0001209 subjects
FG001389 subjects
FG002997 subjects
FG003350 subjects
NOT COMPLETED
FG000223 subjects
FG00186 subjects
FG002224 subjects
FG00369 subjects
Type
Comment
Reasons
Physician Decision
FG0009 subjects
FG0013 subjects
FG0025 subjects
FG0032 subjects
Withdrawal by Subject
FG00045 subjects
FG00112 subjects
FG00249 subjects
FG00316 subjects
No longer met eligibility criteria
FG0003 subjects
FG0010 subjects
FG0027 subjects
FG0031 subjects
Withdrawal by parent or guardian
FG00050 subjects
FG00118 subjects
FG00242 subjects
FG00311 subjects
Lost to Follow-up
FG00096 subjects
FG00143 subjects
FG002106 subjects
FG00334 subjects
Medication error without associated adverse event
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Other
FG0005 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
Randomized but not treated
FG0003 subjects
FG0018 subjects
FG0022 subjects
FG0031 subjects
Adverse Event
FG00010 subjects
FG0011 subjects
FG00210 subjects
FG0034 subjects
Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
BG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
BG002
VLA15: 12 to 17 Years
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
BG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001429
BG001467
BG0021219
BG003418
BG0043533
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
BG0008.2± 2.0
BG0018.2± 2.0
BG00214.3± 1.7
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000653
BG001214
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG000240
BG00175
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0002
BG0012
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 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 1
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after Study Vaccination 1 (Vaccination on Day 1, Month 0)
ID
Title
Description
OG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
OG002
VLA15: 12 to 17 Years
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Units
Counts
Participants
OG0001408
OG001457
OG0021206
OG003
Title
Denominators
Categories
Title
Measurements
OG00080.8(78.6 to 82.8)
OG00134.8(30.4 to 39.4)
OG00280.6(78.3 to 82.8)
OG003
Primary
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 2
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after Study Vaccination 2 (Vaccination on Day 1, Month 2)
ID
Title
Description
OG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
OG002
Primary
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 3
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after Study Vaccination 3 (Vaccination on Day 1, Month 6)
ID
Title
Description
OG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
OG002
Primary
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 4 (Booster Dose)
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after Study Vaccination 4 (Vaccination on Day 1, Month 18)
ID
Title
Description
OG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
OG002
Primary
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days After Any Study Vaccination
Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.
Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after any study vaccination
ID
Title
Description
OG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
OG002
VLA15: 12 to 17 Years
Primary
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 1
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after Study Vaccination 1 (Vaccination on Day 1, Month 0)
ID
Title
Description
OG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
OG002
Primary
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 2
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after Study Vaccination 2 (Vaccination on Day 1, Month 2)
ID
Title
Description
OG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
OG002
Primary
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 3
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after Study Vaccination 3 (Vaccination on Day 1, Month 6)
ID
Title
Description
OG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
OG002
Primary
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 4 (Booster Dose)
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after Study Vaccination 4 (Vaccination on Day 1, Month 18)
ID
Title
Description
OG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
OG002
Primary
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days After Any Study Vaccination
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.
Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after any study vaccination
ID
Title
Description
OG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
OG002
VLA15: 12 to 17 Years
Primary
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 1
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 1 were included in this outcome measure. AEs included both serious AEs (SAEs) and non-SAEs.
Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through 1 Month after Study Vaccination 1 (Vaccination on Day 1, Month 0)
ID
Title
Description
OG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
OG002
VLA15: 12 to 17 Years
Primary
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 2
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 2 were included in this outcome measure. AEs included both SAEs and non-SAEs.
Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through 1 Month after Study Vaccination 2 (Vaccination on Day 1, Month 2)
ID
Title
Description
OG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
OG002
VLA15: 12 to 17 Years
Primary
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 3
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 3 were included in this outcome measure. AEs included both SAEs and non-SAEs.
Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through 1 Month after Study Vaccination 3 (Vaccination on Day 1, Month 6)
ID
Title
Description
OG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
OG002
VLA15: 12 to 17 Years
Primary
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 4 (Booster Dose)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 4 were included in this outcome measure. AEs included both SAEs and non-SAEs.
Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through 1 Month after Study Vaccination 4 (Vaccination on Day 1, Month 18)
ID
Title
Description
OG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
OG002
VLA15: 12 to 17 Years
Primary
Percentage of Participants With AEs Through 1 Month Following Any Study Vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after any dose were included in this outcome measure.
Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through 1 Month after any study vaccination
ID
Title
Description
OG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
OG002
VLA15: 12 to 17 Years
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Primary
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMCs) Throughout the Study
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. NDCMCs included conditions that were undiagnosed prior to study entry (diagnosed while in the study and confirmed not to be a preexisting condition) and that were not considered temporary conditions based upon the expected natural history of the condition. An NDCMC was not reported on AE CRF.
Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Throughout the study (from study vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months)
ID
Title
Description
OG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
OG002
VLA15: 12 to 17 Years
Primary
Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other important medical event.
Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Throughout the study (from study vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months)
ID
Title
Description
OG000
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
OG002
VLA15: 12 to 17 Years
Time Frame
Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination
Description
Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
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
VLA15: 5 to 11 Years
Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
0
1,429
15
1,429
1,290
1,429
EG001
Placebo: 5 to 11 Years
Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
0
467
4
467
341
467
EG002
VLA15: 12 to 17 Years
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
0
1,219
27
1,219
1,121
1,219
EG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
1
418
10
418
295
418
EG004
VLA15: Overall
Participants aged 5 to 17 years received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
0
2,648
42
2,648
2,411
2,648
EG005
Placebo: Overall
Participants aged 5 to 17 years received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
1
885
14
885
636
885
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arnold-Chiari malformation
Congenital, familial and genetic disorders
MedDRAv28.0
Non-systematic Assessment
EG0001 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG0030 affected418 at risk
EG004
Anal fistula
Gastrointestinal disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Appendicitis
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG0001 affected1,429 at risk
EG0011 affected467 at risk
EG0022 affected1,219 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0022 affected1,219 at risk
EG003
Cellulitis orbital
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG0001 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Food allergy
Immune system disorders
MedDRAv28.0
Non-systematic Assessment
EG0001 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Influenza myocarditis
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Mastoiditis
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Mycoplasma infection
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Periorbital abscess
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0011 affected467 at risk
EG0020 affected1,219 at risk
EG003
Periorbital cellulitis
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG0001 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Pharyngitis
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Pneumonia
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG0001 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG0001 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Subperiosteal abscess
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG0001 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Tonsillitis
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRAv28.0
Non-systematic Assessment
EG0001 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Vulvovaginal injury
Injury, poisoning and procedural complications
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRAv28.0
Non-systematic Assessment
EG0002 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Chronic recurrent multifocal osteomyelitis
Musculoskeletal and connective tissue disorders
MedDRAv28.0
Non-systematic Assessment
EG0001 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Hodgkin's disease nodular sclerosis stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Central nervous system lesion
Nervous system disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Epilepsy
Nervous system disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Tethered cord syndrome
Nervous system disorders
MedDRAv28.0
Non-systematic Assessment
EG0001 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Depression
Psychiatric disorders
MedDRAv28.0
Non-systematic Assessment
EG0001 affected1,429 at risk
EG0010 affected467 at risk
EG0022 affected1,219 at risk
EG003
Disruptive mood dysregulation disorder
Psychiatric disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Drug abuse
Psychiatric disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Oppositional defiant disorder
Psychiatric disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0011 affected467 at risk
EG0023 affected1,219 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0022 affected1,219 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRAv28.0
Non-systematic Assessment
EG0001 affected1,429 at risk
EG0011 affected467 at risk
EG0020 affected1,219 at risk
EG003
Asthmatic crisis
Respiratory, thoracic and mediastinal disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRAv28.0
Non-systematic Assessment
EG0001 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Pharyngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Tracheal stenosis
Respiratory, thoracic and mediastinal disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0020 affected1,219 at risk
EG003
Substance-induced psychotic disorder
Psychiatric disorders
MedDRAv28.0
Non-systematic Assessment
EG0000 affected1,429 at risk
EG0010 affected467 at risk
EG0021 affected1,219 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fatigue (FATIGUE)
General disorders
MedDRAv28.0
Systematic Assessment
EG000875 affected1,429 at risk
EG001219 affected467 at risk
EG002769 affected1,219 at risk
EG003193 affected418 at risk
EG0041,644 affected2,648 at risk
EG005412 affected885 at risk
Injection site erythema
General disorders
MedDRAv28.0
Non-systematic Assessment
EG00020 affected1,429 at risk
EG0010 affected467 at risk
EG00212 affected1,219 at risk
EG003
Injection site pain
General disorders
MedDRAv28.0
Non-systematic Assessment
EG00040 affected1,429 at risk
EG0014 affected467 at risk
EG00229 affected1,219 at risk
EG003
Injection site pain (PAIN AT INJECTION SITE)
General disorders
MedDRAv28.0
Systematic Assessment
EG0001,245 affected1,429 at risk
EG001250 affected467 at risk
EG0021,084 affected1,219 at risk
EG003
Injection site swelling
General disorders
MedDRAv28.0
Non-systematic Assessment
EG00020 affected1,429 at risk
EG0010 affected467 at risk
EG0027 affected1,219 at risk
EG003
Pyrexia (FEVER)
General disorders
MedDRAv28.0
Systematic Assessment
EG000193 affected1,429 at risk
EG00129 affected467 at risk
EG00289 affected1,219 at risk
EG003
Swelling (SWELLING)
General disorders
MedDRAv28.0
Systematic Assessment
EG000752 affected1,429 at risk
EG00145 affected467 at risk
EG002277 affected1,219 at risk
EG003
COVID-19
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG00018 affected1,429 at risk
EG0012 affected467 at risk
EG00210 affected1,219 at risk
EG003
Influenza
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG00012 affected1,429 at risk
EG0016 affected467 at risk
EG0025 affected1,219 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG00047 affected1,429 at risk
EG00114 affected467 at risk
EG00212 affected1,219 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRAv28.0
Non-systematic Assessment
EG00031 affected1,429 at risk
EG00113 affected467 at risk
EG00224 affected1,219 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRAv28.0
Non-systematic Assessment
EG0002 affected1,429 at risk
EG0015 affected467 at risk
EG0025 affected1,219 at risk
EG003
Arthralgia (JOINT PAIN)
Musculoskeletal and connective tissue disorders
MedDRAv28.0
Systematic Assessment
EG000375 affected1,429 at risk
EG00164 affected467 at risk
EG002353 affected1,219 at risk
EG003
Myalgia (MUSCLE PAIN)
Musculoskeletal and connective tissue disorders
MedDRAv28.0
Systematic Assessment
EG000717 affected1,429 at risk
EG001112 affected467 at risk
EG002637 affected1,219 at risk
EG003
Headache (HEADACHE)
Nervous system disorders
MedDRAv28.0
Systematic Assessment
EG000750 affected1,429 at risk
EG001192 affected467 at risk
EG002734 affected1,219 at risk
EG003
Attention deficit hyperactivity disorder
Psychiatric disorders
MedDRAv28.0
Non-systematic Assessment
EG00027 affected1,429 at risk
EG0018 affected467 at risk
EG0027 affected1,219 at risk
EG003
Depression
Psychiatric disorders
MedDRAv28.0
Non-systematic Assessment
EG0002 affected1,429 at risk
EG0011 affected467 at risk
EG0029 affected1,219 at risk
EG003
Erythema (REDNESS)
Skin and subcutaneous tissue disorders
MedDRAv28.0
Systematic Assessment
EG000891 affected1,429 at risk
EG00176 affected467 at risk
EG002305 affected1,219 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.
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Units
Counts
Participants
OG0001297
OG001431
OG0021112
OG003386
Title
Denominators
Categories
Title
Measurements
OG00072.6(70.0 to 75.0)
OG00129.0(24.8 to 33.5)
OG00271.4(68.6 to 74.0)
OG00311.7(8.6 to 15.3)
VLA15: 12 to 17 Years
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Units
Counts
Participants
OG0001225
OG001391
OG0021054
OG003372
Title
Denominators
Categories
Title
Measurements
OG00073.5(70.9 to 75.9)
OG00125.1(20.8 to 29.7)
OG00269.6(66.8 to 72.4)
OG0039.7(6.9 to 13.1)
VLA15: 12 to 17 Years
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Units
Counts
Participants
OG0001169
OG001384
OG002979
OG003349
Title
Denominators
Categories
Title
Measurements
OG00077.0(74.5 to 79.4)
OG00124.7(20.5 to 29.4)
OG00271.6(68.7 to 74.4)
OG00311.7(8.6 to 15.6)
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Units
Counts
Participants
OG0001428
OG001466
OG0021212
OG003415
Title
Denominators
Categories
Title
Measurements
OG00088.3(86.5 to 89.9)
OG00156.0(51.4 to 60.6)
OG00290.0(88.2 to 91.6)
OG00331.6(27.1 to 36.3)
VLA15: 12 to 17 Years
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Units
Counts
Participants
OG0001406
OG001456
OG0021205
OG003410
Title
Denominators
Categories
Title
Measurements
OG00056.0(53.3 to 58.6)
OG00141.0(36.5 to 45.7)
OG00262.2(59.4 to 64.9)
OG00348.8(43.8 to 53.7)
VLA15: 12 to 17 Years
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Units
Counts
Participants
OG0001296
OG001430
OG0021111
OG003386
Title
Denominators
Categories
Title
Measurements
OG00048.1(45.3 to 50.8)
OG00130.2(25.9 to 34.8)
OG00255.3(52.3 to 58.2)
OG00331.6(27.0 to 36.5)
VLA15: 12 to 17 Years
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Units
Counts
Participants
OG0001224
OG001391
OG0021055
OG003371
Title
Denominators
Categories
Title
Measurements
OG00047.5(44.6 to 50.3)
OG00127.6(23.2 to 32.3)
OG00251.6(48.5 to 54.6)
OG00326.1(21.7 to 30.9)
VLA15: 12 to 17 Years
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Units
Counts
Participants
OG0001169
OG001384
OG002977
OG003349
Title
Denominators
Categories
Title
Measurements
OG00053.5(50.6 to 56.4)
OG00128.1(23.7 to 32.9)
OG00254.8(51.6 to 57.9)
OG00328.4(23.7 to 33.4)
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Units
Counts
Participants
OG0001427
OG001466
OG0021212
OG003415
Title
Denominators
Categories
Title
Measurements
OG00077.8(75.5 to 79.9)
OG00160.1(55.5 to 64.6)
OG00282.1(79.8 to 84.2)
OG00363.1(58.3 to 67.8)
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Units
Counts
Participants
OG0001426
OG001467
OG0021219
OG003418
Title
Denominators
Categories
Title
Measurements
OG0003.4(2.6 to 4.5)
OG0013.0(1.6 to 5.0)
OG0023.1(2.2 to 4.3)
OG0034.5(2.8 to 7.0)
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Units
Counts
Participants
OG0001371
OG001452
OG0021173
OG003406
Title
Denominators
Categories
Title
Measurements
OG0002.4(1.7 to 3.4)
OG0012.2(1.1 to 4.0)
OG0021.5(0.9 to 2.4)
OG0032.2(1.0 to 4.2)
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Units
Counts
Participants
OG0001313
OG001428
OG0021126
OG003397
Title
Denominators
Categories
Title
Measurements
OG0004.6(3.5 to 5.8)
OG0013.5(2.0 to 5.7)
OG0024.6(3.5 to 6.0)
OG0034.3(2.5 to 6.8)
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Units
Counts
Participants
OG0001226
OG001396
OG0021019
OG003360
Title
Denominators
Categories
Title
Measurements
OG0004.1(3.0 to 5.3)
OG0012.5(1.2 to 4.6)
OG0024.1(3.0 to 5.5)
OG0034.7(2.8 to 7.5)
OG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Units
Counts
Participants
OG0001429
OG001467
OG0021219
OG003418
Title
Denominators
Categories
Title
Measurements
OG00011.7(10.1 to 13.5)
OG0018.6(6.2 to 11.5)
OG00211.2(9.5 to 13.1)
OG00312.2(9.2 to 15.7)
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Units
Counts
Participants
OG0001429
OG001467
OG0021219
OG003418
Title
Denominators
Categories
Title
Measurements
OG0002.7(1.9 to 3.7)
OG0011.9(0.9 to 3.6)
OG0022.1(1.4 to 3.1)
OG0033.3(1.8 to 5.6)
Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
OG003
Placebo: 12 to 17 Years
Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.