Study to Investigate the Safety and Immunogenicity of a T... | NCT01511250 | Trialant
NCT01511250
Sponsor
Takeda
Status
Completed
Last Update Posted
Apr 12, 2023Actual
Enrollment
360Actual
Phase
Phase 2
Conditions
Healthy
Interventions
TDV
Placebo
Countries
Colombia
Puerto Rico
Singapore
Thailand
Protocol Section
Identification Module
NCT ID
NCT01511250
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INV-DEN-203
Secondary IDs
ID
Type
Description
Link
2022-003455-33
EudraCT Number
Brief Title
Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years
Official Title
A Double-Blind, Randomized, Placebo-Controlled, Age Descending and Expansion Phase 2 Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years
Acronym
Not provided
Organization
TakedaINDUSTRY
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
Nov 16, 2011Actual
Primary Completion Date
Apr 1, 2016Actual
Completion Date
Apr 15, 2016Actual
First Submitted Date
Nov 16, 2011
First Submission Date that Met QC Criteria
Jan 17, 2012
First Posted Date
Jan 18, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 20, 2017
Results First Submitted that Met QC Criteria
Feb 27, 2018
Results First Posted Date
Mar 27, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 29, 2016
Certification/Extension First Submitted that Passed QC Review
Nov 29, 2016
Certification/Extension First Posted Date
Nov 30, 2016Estimated
Last Update Submitted Date
Apr 7, 2023
Last Update Posted Date
Apr 12, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
TakedaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the safety of Takeda's tetravalent dengue vaccine (TDV) (previously DENVax) administered subcutaneously in healthy adults and children. In addition the antibody response to the four dengue virus serotypes will be evaluated.
Detailed Description
The vaccine tested in this study was tetravalent dengue vaccine (TDV). TDV was tested to assess safety and immunogenicity in healthy adults and children living in dengue endemic countries.
The study enrolled 360 healthy participants. The study was conducted in 2 parts, Part 1 - age descending and and Part 2 - expansion - ages 1.5-11 years. Participants were allocated to one of the four age cohorts in Part 1 (21 to 45 years, 12 to 20 years, 6 to 11 years, and 1.5 to 5 years) and expansion age cohort 1.5-11 years in Part 2. Participants were randomized in 2:1 ratio and in 3: 1 ratio in Part 1 and 2 respectively to receive:
TDV 0.5 mL SC injection
Placebo (inactive solution) - this is a solution that looks like the study drug but has no active ingredient
This multi-center trial was conducted worldwide. The overall time to participate in this study was up to 37 months (including screening period). Participants made multiple visits to the clinic including a final visit at Day 1080.
Conditions Module
Conditions
Healthy
Keywords
Normal healthy adults and children
Safety and tolerability
Active vaccine
Placebo
Dengue virus vaccine
Immune response
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
360Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part I: TDV 21 to 45 Years (yrs)
Experimental
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: TDV
Part I: Placebo 21 to 45 yrs
Placebo Comparator
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
Biological: Placebo
Part I: TDV 12 to 20 yrs
Experimental
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: TDV
Part I: Placebo 12 to 20 yrs
Placebo Comparator
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
Biological: Placebo
Part I: TDV 6 to 11 yrs
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TDV
Biological
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity
Solicited local injection site reactions were collected by subject diary and graded based on the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 for pain [Grade 0 (no pain), 1 (mild), 2 (moderate) and 3 (severe)] and itching (pruritus) [Grade 0 (no itching), 1 (mild), 2 (moderate) and 3 (Severe]. Severity grade for redness (erythema) and swelling (edema/induration) were derived from recorded length of the longest diameter measurement using the FDA Guidance for Industry: Toxicity Grading Scale of Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial were Grade 0 (<2.5 cm), 1 (mild: 2.5-5 cm), 2 (moderate: 5.1-10 cm) and 3 (severe: >10 cm) and Grade 4 (Potentially Life-threatening: necrosis or exfoliative dermatitis).
Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (In Clinic Assessment) Following Either Vaccination Dose by Severity
Solicited local injection site reactions were collected by subject diary and graded based on the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 for pain [Grade 0 (no pain), 1 (mild), 2 (moderate) and 3 (severe)] and itching (pruritus) [Grade 0 (no itching), 1 (mild), 2 (moderate) and 3 (Severe]. Severity grade for redness (erythema) and swelling (edema/induration) were derived from recorded length of the longest diameter measurement using the FDA Guidance for Industry: Toxicity Grading Scale of Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial were Grade 0 (<2.5 cm), 1 (mild: 2.5-5 cm), 2 (moderate: 5.1-10 cm) and 3 (severe: >10 cm) and Grade 4 (Potentially Life-threatening: necrosis or exfoliative dermatitis).
Within 28 days after either of the vaccination given on Day 0 or 90 (Day 28 for first vaccination, Day 118 for second vaccination)
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity
Solicited systemic AEs (headache, muscle pain [myalgia], joint pain [arthralgia], eye pain, sensitivity to light [photophobia], tiredness [fatigue], body rash, nausea, were recorded in the participant's-diary along with vomiting [number of times]), and body temperature). Diary-recorded severity grades were based on the Common Terminology Criteria for Adverse Events (CTCAE). Severity grades were: Mild (Grade 1): transient symptoms, discomfort noticed but was easily tolerated by the participant with no interference to normal daily activities. Moderate (Grade 2): marked symptoms, moderate interference with participant's daily activities. Severe (Grade 3): Considerable interference with participant's daily activities. The CTCAE severity grades for fever and vomiting were derived from the diary-recorded measurements of temperature level and number of episodes, respectively.
Secondary Outcomes
Measure
Description
Time Frame
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination
Vaccine viremia was assessed for each of the four vaccine strain serotypes: TDV-1, TDV-2, TDV-3 and TDV-4 for Part-1. Vaccine viral ribonucleic acid (RNA) was detected by a quantitative reverse transcription-polymerase chain reaction (qRT-PCR) assay.
Days 0, 7, 14, 90, 97, and 104
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
In good health as determined by medical history, physical examination including height and weight
Normal safety laboratory values at screening
Negative for human immunodeficiency virus-1 (HIV-1) antibodies, Hepatitis C antibodies & Hepatitis B surface antigen
Females negative by urine pregnancy test at screening and immediately prior to injection, and were willing to use reliable means of contraception
Weight: Within 1.3 times of the upper limit of local normal age-adjusted body mass index (BMI)
Exclusion Criteria:
For participants ≥12 years, clinically significant electrocardiogram (ECG) findings
History of significant dermatologic (skin) disease within last 6 months
History of diabetes mellitus
History of thymic pathology, thymectomy, myasthenia or any immunodeficiency
History of recurring headaches or migraines
Hypersensitivity to any vaccine
For participants ≥12 years, positive urine screen for cocaine, amphetamines, opiates, or cannabinoids
History of alcohol abuse
Pregnant or lactating female
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Months
Maximum Age
45 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director Clinical Science
Takeda
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Program For The Study and Control of Tropical Diseases
Rauscher M, Youard Z, Faccin A, Patel SS, Pang H, Zent O. Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine. Expert Rev Vaccines. 2025 Dec;24(1):221-229. doi: 10.1080/14760584.2025.2480297. Epub 2025 Mar 27.
Nascimento EJM, Norwood B, Kpamegan E, Parker A, Fernandes J, Perez-Guzman E, Tricou V, Braun R, Sharma M, Dean HJ. Antibodies Produced in Response to a Live-Attenuated Dengue Vaccine Are Functional in Activating the Complement System. J Infect Dis. 2023 May 29;227(11):1282-1292. doi: 10.1093/infdis/jiac476.
See Also Links
Label
URL
To obtain more information about this study, click this link.
Healthy participants were enrolled in the 2-part study to receive 0.5 mL tetravalent dengue vaccine (TDV) or placebo in 1 of 4 groups for Part I: 21-45 years, 12-20 years, 6-11 years, 1.5-5 years, and in 1 group for Part II: 1.5-11 years. Part II started after all subjects in Part 1 were enrolled.
Recruitment Details
Participants took part in the study at 8 investigative sites in Puerto Rico, Colombia, Singapore and Thailand from 16 November 2011 to 15 April 2016.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part I: TDV 21 to 45 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: TDV
Part I: Placebo 6 to 11 yrs
Placebo Comparator
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
Biological: Placebo
Part I: TDV 1.5 to 5 yrs
Experimental
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: TDV
Part I: Placebo 1.5 to 5 yrs
Placebo Comparator
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
Biological: Placebo
Part II: TDV 1.5 to 11 yrs
Experimental
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: TDV
Part II: Placebo 1.5 to 11 yrs
Placebo Comparator
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
Biological: Placebo
Part I: TDV 1.5 to 5 yrs
Part I: TDV 12 to 20 yrs
Part I: TDV 21 to 45 Years (yrs)
Part I: TDV 6 to 11 yrs
Part II: TDV 1.5 to 11 yrs
Placebo
Biological
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
Part I: Placebo 1.5 to 5 yrs
Part I: Placebo 12 to 20 yrs
Part I: Placebo 21 to 45 yrs
Part I: Placebo 6 to 11 yrs
Part II: Placebo 1.5 to 11 yrs
Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
Number of Participants With Any Solicited AE Following Either Vaccination Dose
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited local injection site reactions included pain, itching, erythema, edema and solicited systemic AEs include myalgia, arthralgia, eye pain, photophobia, fatigue, body rash, nausea, vomiting, and fever.
Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
Number of Participants With at Least One Unsolicited AE Following Either Vaccination Dose by Severity
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The severity of all unsolicited AEs was evaluated by the Investigator (using the Common Terminology Criteria for Adverse Events [CTCAE] v4.03) as follows. Mild (Grade 1): Transient symptoms, discomfort noticed but was easily tolerated by the participant with no interference to normal daily activities. Moderate (Grade 2): Marked symptoms, moderate interference with participant's daily activities. Severe (Grade 3): Considerable interference with participant's daily activities.
Unsolicited AEs were collected within 28 days of all vaccinations. Serious AEs were collected throughout the study up to Day 1080
Seropositivity Rate to Each of the Four Dengue Serotypes at Day 120
Seropositivity rate, defined as the percentage of participants seropositive, was derived from titers of dengue-neutralizing antibodies. Participants were classified by titer after Day 0 as seropositive or seronegative. Seropositive was defined as a MNT50 titre value of ≥10 for any serotype and seronegative was defined as titre value of less than (<) 10 for all 4 serotypes. Seropositivity was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, TDV-4.
30 days after second vaccination (Day 120)
Part I: Duration of Vaccine Viremia
Days 0, 7, 14, 90, 97, and 104
Part I: Titers of Vaccine Viremia
Days 0, 7, 14, 90, 97, and 104
Seropositivity Rate to Each of the Four Dengue Serotypes
Seropositivity rate, defined as the percentage of participants seropositive, was derived from titers of dengue-neutralizing antibodies. Participants were classified by titer after Day 0 as seropositive or seronegative. Seropositive was defined as a MNT50 titre value of ≥10 and seronegative was defined as titre value of less than (<) 10. Seropositivity was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, TDV-4.
Day 28 and Day 90 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1
Seroconversion Rate to Each of the Four Dengue Serotypes
Seroconversion rate was defined as the percentage of participants with microneutralization test 50% (MNT50) titer ≥10 or, if the titer on Day 0 was ≥10, a 4-fold rise in antibody titer.
Day 28, 90 and 120 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes
GMTs were assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, and TDV-4.
Day 28, 90 and 120 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes
Day 28 and Day 90 (Parts 1 and 2) and Days 120, 180, 360, 720 and 1080 in Part 1
Number of Participants With Confirmed Dengue Fever
Dengue fever was assessed in participants who had 3 consecutive days of fever >38°C and tested positive for dengue virus by polymerase chain reaction (PCR) analysis.
Tsuji I, Dominguez D, Egan MA, Dean HJ. Development of a Novel Assay to Assess the Avidity of Dengue Virus-Specific Antibodies Elicited in Response to a Tetravalent Dengue Vaccine. J Infect Dis. 2022 May 4;225(9):1533-1544. doi: 10.1093/infdis/jiab064.
Sirivichayakul C, Barranco-Santana EA, Rivera IE, Kilbury J, Raanan M, Borkowski A, Papadimitriou A, Wallace D. Long-term Safety and Immunogenicity of a Tetravalent Dengue Vaccine Candidate in Children and Adults: A Randomized, Placebo-Controlled, Phase 2 Study. J Infect Dis. 2022 May 4;225(9):1513-1520. doi: 10.1093/infdis/jiaa406.
Sharma M, Glasner DR, Watkins H, Puerta-Guardo H, Kassa Y, Egan MA, Dean H, Harris E. Magnitude and Functionality of the NS1-Specific Antibody Response Elicited by a Live-Attenuated Tetravalent Dengue Vaccine Candidate. J Infect Dis. 2020 Mar 2;221(6):867-877. doi: 10.1093/infdis/jiz081.
Rupp R, Luckasen GJ, Kirstein JL, Osorio JE, Santangelo JD, Raanan M, Smith MK, Wallace D, Gordon GS, Stinchcomb DT. Safety and immunogenicity of different doses and schedules of a live attenuated tetravalent dengue vaccine (TDV) in healthy adults: A Phase 1b randomized study. Vaccine. 2015 Nov 17;33(46):6351-9. doi: 10.1016/j.vaccine.2015.09.008. Epub 2015 Sep 15.
FG001
Part I: Placebo 21 to 45 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
FG002
Part I: TDV 12 to 20 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
FG003
Part I: Placebo 12 to 20 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
FG004
Part I: TDV 6 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
FG005
Part I: Placebo 6 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
FG006
Part I: TDV 1.5 to 5 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
FG007
Part I: Placebo 1.5 to 5 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
FG008
Part II: TDV 1.5 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
FG009
Part II: Placebo 1.5 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
FG00024 subjects
FG00114 subjects
FG00222 subjects
FG00314 subjects
FG00421 subjects
FG00517 subjects
FG00623 subjects
FG00713 subjects
FG008159 subjects
FG00953 subjects
COMPLETED
FG00015 subjects
FG0019 subjects
FG00218 subjects
FG00311 subjects
FG00421 subjects
FG00517 subjects
FG00621 subjects
FG0079 subjects
FG008145 subjects
FG00948 subjects
NOT COMPLETED
FG0009 subjects
FG0015 subjects
FG0024 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0074 subjects
FG00814 subjects
FG0095 subjects
Type
Comment
Reasons
Withdrawal of Consent
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
Sponsor/Investigator Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0007 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG004
Protocol Violation
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
The full analysis set (FAS) included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part I: TDV 21 to 45 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
BG001
Part I: Placebo 21 to 45 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
BG002
Part I: TDV 12 to 20 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
BG003
Part I: Placebo 12 to 20 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
BG004
Part I: TDV 6 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
BG005
Part I: Placebo 6 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
BG006
Part I: TDV 1.5 to 5 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
BG007
Part I: Placebo 1.5 to 5 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
BG008
Part II: TDV 1.5 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
BG009
Part II: Placebo 1.5 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00024
BG00114
BG00222
BG00314
BG00421
BG00517
BG00623
BG00713
BG008159
BG00953
BG010360
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00029.2(21.0 to 45.0)
BG00130.1(21.0 to 40.0)
BG00215.5(12.0 to 19.0)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00010
BG0018
BG002
Race
Number
participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0003
BG0013
BG002
Seropositive to any Serotype at Day 0
Seropositivity is defined as a reciprocal neutralizing titer measured by a microneutralizing test 50% (MNT50) greater or equal to (≥)10.
Number
participants
Title
Denominators
Categories
Seropositive to any Serotype=No
Title
Measurements
BG0005
BG0012
Height
Mean
Full Range
meters (m)
Title
Denominators
Categories
Title
Measurements
BG0001.68(1.57 to 1.82)
BG0011.65(1.53 to 1.87)
BG002
Weight
Mean
Full Range
kilograms (kg)
Title
Denominators
Categories
Title
Measurements
BG00081.6(41.4 to 115.1)
BG00180.2(56.3 to 120.4)
BG002
Body Mass Index (BMI)
Mean
Full Range
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00028.81(14.70 to 41.30)
BG00129.05(21.30 to 38.70)
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
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity
Solicited local injection site reactions were collected by subject diary and graded based on the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 for pain [Grade 0 (no pain), 1 (mild), 2 (moderate) and 3 (severe)] and itching (pruritus) [Grade 0 (no itching), 1 (mild), 2 (moderate) and 3 (Severe]. Severity grade for redness (erythema) and swelling (edema/induration) were derived from recorded length of the longest diameter measurement using the FDA Guidance for Industry: Toxicity Grading Scale of Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial were Grade 0 (<2.5 cm), 1 (mild: 2.5-5 cm), 2 (moderate: 5.1-10 cm) and 3 (severe: >10 cm) and Grade 4 (Potentially Life-threatening: necrosis or exfoliative dermatitis).
The safety set included all randomized participants who received at least one dose of study vaccine (or placebo). Only categories for which there was at least 1 participant are reported.
Posted
Number
participants
Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
ID
Title
Description
OG000
Part I: TDV 21 to 45 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG001
Part I: Placebo 21 to 45 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
OG002
Part I: TDV 12 to 20 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG003
Part I: Placebo 12 to 20 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
OG004
Part I: TDV 6 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG005
Part I: Placebo 6 to 11 Years
Units
Counts
Participants
OG00024
OG00114
OG00222
OG003
Title
Denominators
Categories
Pain, Any Severity
Title
Measurements
OG0007
OG0010
OG00214
OG003
Primary
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (In Clinic Assessment) Following Either Vaccination Dose by Severity
Solicited local injection site reactions were collected by subject diary and graded based on the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 for pain [Grade 0 (no pain), 1 (mild), 2 (moderate) and 3 (severe)] and itching (pruritus) [Grade 0 (no itching), 1 (mild), 2 (moderate) and 3 (Severe]. Severity grade for redness (erythema) and swelling (edema/induration) were derived from recorded length of the longest diameter measurement using the FDA Guidance for Industry: Toxicity Grading Scale of Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial were Grade 0 (<2.5 cm), 1 (mild: 2.5-5 cm), 2 (moderate: 5.1-10 cm) and 3 (severe: >10 cm) and Grade 4 (Potentially Life-threatening: necrosis or exfoliative dermatitis).
The safety set included all randomized participants who received at least one dose of study vaccine (or placebo). Only categories for which there was at least 1 participant are reported.
Posted
Number
participants
Within 28 days after either of the vaccination given on Day 0 or 90 (Day 28 for first vaccination, Day 118 for second vaccination)
ID
Title
Description
OG000
Part I: TDV 21 to 45 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Primary
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity
Solicited systemic AEs (headache, muscle pain [myalgia], joint pain [arthralgia], eye pain, sensitivity to light [photophobia], tiredness [fatigue], body rash, nausea, were recorded in the participant's-diary along with vomiting [number of times]), and body temperature). Diary-recorded severity grades were based on the Common Terminology Criteria for Adverse Events (CTCAE). Severity grades were: Mild (Grade 1): transient symptoms, discomfort noticed but was easily tolerated by the participant with no interference to normal daily activities. Moderate (Grade 2): marked symptoms, moderate interference with participant's daily activities. Severe (Grade 3): Considerable interference with participant's daily activities. The CTCAE severity grades for fever and vomiting were derived from the diary-recorded measurements of temperature level and number of episodes, respectively.
The safety set included all randomized participants who received at least one dose of study vaccine (or placebo). Only categories for which there was at least 1 participant are reported.
Posted
Number
participants
Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
ID
Title
Description
OG000
Part I: TDV 21 to 45 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Primary
Number of Participants With Any Solicited AE Following Either Vaccination Dose
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited local injection site reactions included pain, itching, erythema, edema and solicited systemic AEs include myalgia, arthralgia, eye pain, photophobia, fatigue, body rash, nausea, vomiting, and fever.
The safety set included all randomized participants who received at least one dose of study vaccine (or placebo).
Posted
Number
participants
Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
ID
Title
Description
OG000
Part I: TDV 21 to 45 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG001
Part I: Placebo 21 to 45 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
Primary
Number of Participants With at Least One Unsolicited AE Following Either Vaccination Dose by Severity
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The severity of all unsolicited AEs was evaluated by the Investigator (using the Common Terminology Criteria for Adverse Events [CTCAE] v4.03) as follows. Mild (Grade 1): Transient symptoms, discomfort noticed but was easily tolerated by the participant with no interference to normal daily activities. Moderate (Grade 2): Marked symptoms, moderate interference with participant's daily activities. Severe (Grade 3): Considerable interference with participant's daily activities.
The safety set included all randomized participants who received at least one dose of study vaccine (or placebo).
Posted
Number
participants
Unsolicited AEs were collected within 28 days of all vaccinations. Serious AEs were collected throughout the study up to Day 1080
ID
Title
Description
OG000
Part I: TDV 21 to 45 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG001
Part I: Placebo 21 to 45 Years
Primary
Seropositivity Rate to Each of the Four Dengue Serotypes at Day 120
Seropositivity rate, defined as the percentage of participants seropositive, was derived from titers of dengue-neutralizing antibodies. Participants were classified by titer after Day 0 as seropositive or seronegative. Seropositive was defined as a MNT50 titre value of ≥10 for any serotype and seronegative was defined as titre value of less than (<) 10 for all 4 serotypes. Seropositivity was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, TDV-4.
FAS included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample has been received.
Posted
Number
95% Confidence Interval
percentage of participants
30 days after second vaccination (Day 120)
ID
Title
Description
OG000
Part I: TDV 21 to 45 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG001
Part I: Placebo 21 to 45 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
Secondary
Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination
Vaccine viremia was assessed for each of the four vaccine strain serotypes: TDV-1, TDV-2, TDV-3 and TDV-4 for Part-1. Vaccine viral ribonucleic acid (RNA) was detected by a quantitative reverse transcription-polymerase chain reaction (qRT-PCR) assay.
The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.
Posted
Number
participants
Days 0, 7, 14, 90, 97, and 104
ID
Title
Description
OG000
Part I: TDV 21 to 45 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG001
Part I: Placebo 21 to 45 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
OG002
Part I: TDV 12 to 20 Years
Secondary
Part I: Duration of Vaccine Viremia
Due to the very low prevalence of vaccine viremia, there was insufficient data for the estimation of average titer duration of viral RNA within study groups.
Posted
Days 0, 7, 14, 90, 97, and 104
ID
Title
Description
OG000
Part I: TDV 21 to 45 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG001
Part I: Placebo 21 to 45 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
OG002
Part I: TDV 12 to 20 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Secondary
Part I: Titers of Vaccine Viremia
Due to the very low prevalence of vaccine viremia, there was insufficient data for the estimation of average titer duration of viral RNA within study groups.
Posted
Days 0, 7, 14, 90, 97, and 104
ID
Title
Description
OG000
Part I: TDV 21 to 45 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG001
Part I: Placebo 21 to 45 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
OG002
Part I: TDV 12 to 20 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Secondary
Seropositivity Rate to Each of the Four Dengue Serotypes
Seropositivity rate, defined as the percentage of participants seropositive, was derived from titers of dengue-neutralizing antibodies. Participants were classified by titer after Day 0 as seropositive or seronegative. Seropositive was defined as a MNT50 titre value of ≥10 and seronegative was defined as titre value of less than (<) 10. Seropositivity was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, TDV-4.
FAS included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.
Posted
Number
95% Confidence Interval
percentage of participants
Day 28 and Day 90 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1
ID
Title
Description
OG000
Part I: TDV 21 to 45 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG001
Part I: Placebo 21 to 45 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
Secondary
Seroconversion Rate to Each of the Four Dengue Serotypes
Seroconversion rate was defined as the percentage of participants with microneutralization test 50% (MNT50) titer ≥10 or, if the titer on Day 0 was ≥10, a 4-fold rise in antibody titer.
FAS included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.
Posted
Number
95% Confidence Interval
percentage of participants
Day 28, 90 and 120 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1
ID
Title
Description
OG000
Part I: TDV 21 to 45 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG001
Part I: Placebo 21 to 45 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
OG002
Part I: TDV 12 to 20 Years
Secondary
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes
GMTs were assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, and TDV-4.
The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received. Here "n" is the number of participants with microneutralizing (MN) assay samples.
Posted
Mean
95% Confidence Interval
titer
Day 28, 90 and 120 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1
ID
Title
Description
OG000
Part I: TDV 21 to 45 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG001
Part I: Placebo 21 to 45 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
OG002
Part I: TDV 12 to 20 Years
Secondary
Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes
FAS included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.
Posted
Geometric Mean
95% Confidence Interval
fold rise
Day 28 and Day 90 (Parts 1 and 2) and Days 120, 180, 360, 720 and 1080 in Part 1
ID
Title
Description
OG000
Part I: TDV 21 to 45 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG001
Part I: Placebo 21 to 45 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
OG002
Part I: TDV 12 to 20 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Secondary
Number of Participants With Confirmed Dengue Fever
Dengue fever was assessed in participants who had 3 consecutive days of fever >38°C and tested positive for dengue virus by polymerase chain reaction (PCR) analysis.
The safety set included all randomized participants who received at least one dose of study vaccine (or placebo).
Posted
Number
participants
Day 1 to Day 1080
ID
Title
Description
OG000
Part I: TDV 21 to 45 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG001
Part I: Placebo 21 to 45 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
OG002
Part I: TDV 12 to 20 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Time Frame
Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118).
Description
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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 I: TDV 21 to 45 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
4
24
11
24
EG001
Part I: Placebo 21 to 45 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
0
14
7
14
EG002
Part I: TDV 12 to 20 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
1
22
13
22
EG003
Part I: Placebo 12 to 20 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
0
14
8
14
EG004
Part I: TDV 6 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
4
21
9
21
EG005
Part I: Placebo 6 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
1
17
11
17
EG006
Part I: TDV 1.5 to 5 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
1
23
14
23
EG007
Part I: Placebo 1.5 to 5 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
2
13
12
13
EG008
Part II: TDV 1.5 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
14
159
87
159
EG009
Part II: Placebo 1.5 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
2
53
30
53
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cholecystitis
Hepatobiliary disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG0030 affected14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
Cholecystitis acute
Hepatobiliary disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Incision site haematoma
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Incision site haemorrhage
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Brain contusion
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Child maltreatment syndrome
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Skull fractured base
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA (14.0)
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Abscess limb
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Dengue fever
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Gastritis viral
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0021 affected22 at risk
EG003
Influenza
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Viral infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Headache
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0004 affected24 at risk
EG0013 affected14 at risk
EG0027 affected22 at risk
EG0031 affected14 at risk
EG0044 affected21 at risk
EG0053 affected17 at risk
EG0061 affected23 at risk
EG0070 affected13 at risk
EG00813 affected159 at risk
EG0093 affected53 at risk
Laryngitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0002 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0002 affected24 at risk
EG0011 affected14 at risk
EG0021 affected22 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Hordeolum
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0023 affected22 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0020 affected22 at risk
EG003
Viral infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Viral rash
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0002 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected24 at risk
EG0011 affected14 at risk
EG0021 affected22 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0022 affected22 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0022 affected22 at risk
EG003
Injection site pain
General disorders
MedDRA (14.0)
Systematic Assessment
EG0002 affected24 at risk
EG0010 affected14 at risk
EG0022 affected22 at risk
EG003
Injection site erythema
General disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected14 at risk
EG0022 affected22 at risk
EG003
Fatigue
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0012 affected14 at risk
EG0022 affected22 at risk
EG003
Influenza like illness
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0020 affected22 at risk
EG003
Pyrexia
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0022 affected22 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected24 at risk
EG0011 affected14 at risk
EG0020 affected22 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected24 at risk
EG0011 affected14 at risk
EG0020 affected22 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0021 affected22 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0021 affected22 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0020 affected22 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0021 affected22 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0020 affected22 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0020 affected22 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Eye pain
Eye disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0020 affected22 at risk
EG003
Photophobia
Eye disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0020 affected22 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0020 affected22 at risk
EG003
Blood pressure increased
Investigations
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0020 affected22 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0020 affected22 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0020 affected22 at risk
EG003
Depression
Psychiatric disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0020 affected22 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0020 affected22 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0020 affected22 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected14 at risk
EG0020 affected22 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0021 affected22 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Urticaria papular
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected14 at risk
EG0020 affected22 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Director
Takeda
+1-877-825-3327
trialdisclosures@takeda.com
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0062 subjects
FG0073 subjects
FG00813 subjects
FG0095 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
16.8
(12.0 to 20.0)
BG0048.4(6.0 to 11.0)
BG0057.8(6.0 to 11.0)
BG0063.3(1.5 to 5.0)
BG0073.5(2.3 to 5.0)
BG0086.6(1.6 to 11.0)
BG0096.8(2.1 to 11.0)
BG0109.8(1.5 to 45.0)
12
BG0037
BG0046
BG0058
BG0067
BG0077
BG00888
BG00919
BG010172
Male
BG00014
BG0016
BG00210
BG0037
BG00415
BG0059
BG00616
BG0076
BG00871
BG00934
BG010188
16
BG0038
BG00416
BG00512
BG00612
BG0076
BG00877
BG00924
BG010177
Hispanic or Latino
Title
Measurements
BG00020
BG00110
BG0026
BG0036
BG0044
BG0055
BG00611
BG0077
BG00879
BG00927
BG010175
White
Title
Measurements
BG0001
BG0011
BG0020
BG0030
BG0041
BG0050
BG0060
BG0070
BG0080
BG0090
BG0103
Black or African American
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0083
BG0092
BG0105
BG0027
BG0031
BG00412
BG00514
BG00616
BG00712
BG00893
BG00924
BG010186
Seropositive to any Serotype=Yes
Title
Measurements
BG00019
BG00112
BG00215
BG00313
BG0049
BG0053
BG0067
BG0071
BG00866
BG00929
BG010174
1.58
(1.38 to 1.72)
BG0031.60(1.41 to 1.73)
BG0041.29(1.08 to 1.52)
BG0051.27(1.13 to 1.42)
BG0060.98(0.83 to 1.13)
BG0070.99(0.90 to 1.06)
BG0081.20(0.77 to 1.62)
BG0091.22(0.83 to 1.63)
BG0101.28(0.77 to 1.87)
57.0
(28.6 to 93.4)
BG00359.5(48.6 to 89.9)
BG00431.2(18.5 to 51.2)
BG00527.0(20.3 to 37.5)
BG00615.1(10.3 to 22.2)
BG00716.5(13.3 to 20.8)
BG00825.7(10.4 to 61.0)
BG00926.7(10.6 to 53.2)
BG01034.3(10.3 to 120.4)
22.60
(15.00 to 33.60)
BG00323.09(18.60 to 31.50)
BG00418.38(12.90 to 28.80)
BG00516.56(14.20 to 20.60)
BG00615.63(12.50 to 19.00)
BG00716.95(13.20 to 20.40)
BG00817.02(12.10 to 30.10)
BG00917.08(13.20 to 24.30)
BG01018.83(12.10 to 41.30)
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
OG006
Part I: TDV 1.5 to 5 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG007
Part I: Placebo 1.5 to 5 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
OG008
Part II: TDV 1.5 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG009
Part II: Placebo 1.5 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
14
OG00421
OG00517
OG00623
OG00713
OG008159
OG00953
3
OG0049
OG0050
OG0067
OG0072
OG00856
OG0096
Pain, Grade 1
Title
Measurements
OG0007
OG0010
OG00211
OG0032
OG0044
OG0050
OG0067
OG0072
OG00841
OG0093
Pain, Grade 2
Title
Measurements
OG0000
OG0010
OG0023
OG0031
OG0044
OG0050
OG0060
OG0070
OG00811
OG0093
Pain, Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
OG0084
OG0090
Itching, Any Severity
Title
Measurements
OG0003
OG0011
OG0027
OG0031
OG0042
OG0051
OG0062
OG0070
OG00826
OG0094
Itching, Grade 1
Title
Measurements
OG0003
OG0011
OG0027
OG0031
OG0041
OG0051
OG0062
OG0070
OG00819
OG0093
Itching, Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
OG0086
OG0091
Itching, Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0081
OG0090
Erythema, Any Severity
Title
Measurements
OG0006
OG0010
OG0024
OG0030
OG0042
OG0050
OG0063
OG0070
OG00824
OG0091
Erythema, Grade 1
Title
Measurements
OG0005
OG0010
OG0024
OG0030
OG0041
OG0050
OG0063
OG0070
OG00821
OG0090
Erythema, Grade 2
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0082
OG0090
Erythema, Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
OG0081
OG0091
Edema, Any Severity
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0043
OG0050
OG0061
OG0070
OG00813
OG0090
Edema, Grade 1
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0043
OG0050
OG0061
OG0070
OG0089
OG0090
Edema, Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0083
OG0090
Edema, Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0081
OG0090
OG001
Part I: Placebo 21 to 45 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
OG002
Part I: TDV 12 to 20 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG003
Part I: Placebo 12 to 20 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
OG004
Part I: TDV 6 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG005
Part I: Placebo 6 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
OG006
Part I: TDV 1.5 to 5 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG007
Part I: Placebo 1.5 to 5 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
OG008
Part II: TDV 1.5 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG009
Part II: Placebo 1.5 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Units
Counts
Participants
OG00024
OG00114
OG00222
OG00314
OG00421
OG00517
OG00623
OG00713
OG008159
OG00953
Title
Denominators
Categories
Pain, Any Severity
Title
Measurements
OG0002
OG0010
OG0024
OG0032
OG0049
OG0055
OG0065
OG0071
OG00833
OG00914
Pain, Grade 1
Title
Measurements
OG0002
OG0010
OG0023
OG003
Pain, Grade 2
Title
Measurements
OG0000
OG0010
OG0021
OG003
Itching, Any Severity
Title
Measurements
OG0002
OG0012
OG0022
OG003
Itching, Grade 1
Title
Measurements
OG0002
OG0012
OG0022
OG003
Erythema, Any Severity
Title
Measurements
OG0000
OG0010
OG0020
OG003
Edema, Any Severity
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
Part I: Placebo 21 to 45 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
OG002
Part I: TDV 12 to 20 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG003
Part I: Placebo 12 to 20 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
OG004
Part I: TDV 6 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG005
Part I: Placebo 6 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
OG006
Part I: TDV 1.5 to 5 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG007
Part I: Placebo 1.5 to 5 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
OG008
Part II: TDV 1.5 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG009
Part II: Placebo 1.5 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Units
Counts
Participants
OG00024
OG00114
OG00222
OG00314
OG00421
OG00517
OG00623
OG00713
OG008159
OG00953
Title
Denominators
Categories
Fever, Any Severity
Title
Measurements
OG0001
OG0013
OG0024
OG0031
OG0041
OG0051
OG0064
OG0074
OG00833
OG0099
Fever, Grade 1
Title
Measurements
OG0000
OG0011
OG0024
OG003
Fever, Grade 2
Title
Measurements
OG0001
OG0012
OG0020
OG003
Fever, Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Headache, Any Grade
Title
Measurements
OG0006
OG0014
OG0029
OG003
Headache, Grade 1
Title
Measurements
OG0003
OG0011
OG0024
OG003
Headache, Grade 2
Title
Measurements
OG0002
OG0012
OG0025
OG003
Headache, Grade 3
Title
Measurements
OG0001
OG0011
OG0020
OG003
Myalgia, Any Severity
Title
Measurements
OG0004
OG0013
OG0024
OG003
Myalgia, Grade 1
Title
Measurements
OG0003
OG0011
OG0022
OG003
Myalgia, Grade 2
Title
Measurements
OG0000
OG0011
OG0022
OG003
Myalgia, Grade 3
Title
Measurements
OG0001
OG0011
OG0020
OG003
Arthralgia, Any Severity
Title
Measurements
OG0001
OG0013
OG0022
OG003
Arthralgia, Grade 1
Title
Measurements
OG0001
OG0011
OG0021
OG003
Arthralgia, Grade 2
Title
Measurements
OG0000
OG0011
OG0021
OG003
Arthralgia, Grade 3
Title
Measurements
OG0000
OG0011
OG0020
OG003
Eye Pain, Any Severity
Title
Measurements
OG0003
OG0013
OG0021
OG003
Eye Pain, Grade 1
Title
Measurements
OG0001
OG0012
OG0020
OG003
Eye Pain, Grade 2
Title
Measurements
OG0001
OG0010
OG0021
OG003
Eye Pain, Grade 3
Title
Measurements
OG0001
OG0011
OG0020
OG003
Photophobia, Any Severity
Title
Measurements
OG0003
OG0011
OG0020
OG003
Photophobia, Grade 1
Title
Measurements
OG0001
OG0011
OG0020
OG003
Photophobia, Grade 2
Title
Measurements
OG0001
OG0010
OG0020
OG003
Photophobia, Grade 3
Title
Measurements
OG0001
OG0010
OG0020
OG003
Fatigue, Any Severity
Title
Measurements
OG0004
OG0014
OG0029
OG003
Fatigue, Grade 1
Title
Measurements
OG0002
OG0012
OG0027
OG003
Fatigue, Grade 2
Title
Measurements
OG0000
OG0010
OG0022
OG003
Fatigue, Grade 3
Title
Measurements
OG0002
OG0012
OG0020
OG003
Body rash, Any Severity
Title
Measurements
OG0001
OG0010
OG0022
OG003
Body rash, Grade 1
Title
Measurements
OG0001
OG0010
OG0021
OG003
Body rash, Grade 2
Title
Measurements
OG0000
OG0010
OG0021
OG003
Body rash, Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Nausea, Any Severity
Title
Measurements
OG0004
OG0011
OG0023
OG003
Nausea, Grade 1
Title
Measurements
OG0002
OG0011
OG0023
OG003
Nausea, Grade 2
Title
Measurements
OG0001
OG0010
OG0020
OG003
Nausea, Grade 3
Title
Measurements
OG0001
OG0010
OG0020
OG003
Vomiting, Any Severity
Title
Measurements
OG0002
OG0011
OG0020
OG003
Vomiting, Grade 1
Title
Measurements
OG0000
OG0011
OG0020
OG003
Vomiting, Grade 2
Title
Measurements
OG0001
OG0010
OG0020
OG003
Vomiting, Grade 3
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG002
Part I: TDV 12 to 20 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG003
Part I: Placebo 12 to 20 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
OG004
Part I: TDV 6 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG005
Part I: Placebo 6 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
OG006
Part I: TDV 1.5 to 5 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG007
Part I: Placebo 1.5 to 5 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
OG008
Part II: TDV 1.5 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG009
Part II: Placebo 1.5 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Units
Counts
Participants
OG00024
OG00114
OG00222
OG00314
OG00421
OG00517
OG00623
OG00713
OG008159
OG00953
Title
Denominators
Categories
Title
Measurements
OG00013
OG0019
OG00217
OG00312
OG00412
OG0058
OG00617
OG00710
OG008110
OG00928
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.
OG002
Part I: TDV 12 to 20 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG003
Part I: Placebo 12 to 20 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
OG004
Part I: TDV 6 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG005
Part I: Placebo 6 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
OG006
Part I: TDV 1.5 to 5 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG007
Part I: Placebo 1.5 to 5 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
OG008
Part II: TDV 1.5 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG009
Part II: Placebo 1.5 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Units
Counts
Participants
OG00024
OG00114
OG00222
OG00314
OG00421
OG00517
OG00623
OG00713
OG008159
OG00953
Title
Denominators
Categories
At least one unsolicited AE
Title
Measurements
OG00013
OG0017
OG00214
OG0038
OG00412
OG00511
OG00617
OG00712
OG008101
OG00937
Unsolicited AEs by worst severity, Mild
Title
Measurements
OG0006
OG0012
OG0027
OG003
Unsolicited AEs by worst severity, Moderate
Title
Measurements
OG0005
OG0015
OG0026
OG003
Unsolicited AEs by worst severity, Severe
Title
Measurements
OG0002
OG0010
OG0021
OG003
OG002
Part I: TDV 12 to 20 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG003
Part I: Placebo 12 to 20 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
OG004
Part I: TDV 6 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG005
Part I: Placebo 6 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
OG006
Part I: TDV 1.5 to 5 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG007
Part I: Placebo 1.5 to 5 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
OG008
Part II: TDV 1.5 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG009
Part II: Placebo 1.5 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Units
Counts
Participants
OG00022
OG00113
OG00222
OG00314
OG00421
OG00517
OG00622
OG00711
OG008156
OG00953
Title
Denominators
Categories
TDV-1
Title
Measurements
OG000100.0(84.6 to 100.0)
OG00192.3(64 to 99.8)
OG002100.0(84.6 to 100.0)
OG00385.7(57.2 to 98.2)
OG004100.0(83.9 to 100.0)
OG00523.5(6.8 to 49.9)
OG006100.0(84.6 to 100.0)
OG0070.0(0.0 to 28.5)
OG008100.0(97.7 to 100.0)
OG00943.4(29.8 to 57.7)
TDV-2
Title
Measurements
OG000100.0(84.6 to 100.0)
OG00184.6(54.6 to 98.1)
OG00295.5(77.2 to 99.9)
OG003
TDV-3
Title
Measurements
OG000100.0(84.6 to 100.0)
OG001100.0(75.3 to 100.0)
OG002100.0(84.6 to 100.0)
OG003
TDV-4
Title
Measurements
OG00090.9(70.8 to 98.9)
OG00161.5(31.6 to 86.1)
OG00272.7(49.8 to 89.3)
OG003
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG003
Part I: Placebo 12 to 20 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
OG004
Part I: TDV 6 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG005
Part I: Placebo 6 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
OG006
Part I: TDV 1.5 to 5 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG007
Part I: Placebo 1.5 to 5 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Units
Counts
Participants
OG00024
OG00114
OG00222
OG00314
OG00421
OG00517
OG00623
OG00713
Title
Denominators
Categories
Day 0, TDV-1
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Day 0, TDV-2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 0, TDV-3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 0, TDV-4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 7, TDV-1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 7, TDV-2
Title
Measurements
OG0002
OG0010
OG0024
OG003
Day 7, TDV-3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 7, TDV-4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 14, TDV-1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 14, TDV-2
Title
Measurements
OG0000
OG0010
OG0023
OG003
Day 14, TDV-3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 14, TDV-4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 90, TDV-1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 90, TDV-2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 90, TDV-3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 90, TDV-4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 97, TDV-1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 97, TDV-2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 97, TDV-3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 97, TDV-4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 104, TDV-1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 104, TDV-2
Title
Measurements
OG0001
OG0010
OG0020
OG003
Day 104, TDV-3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 104, TDV-4
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Part I: Placebo 12 to 20 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
OG004
Part I: TDV 6 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG005
Part I: Placebo 6 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
OG006
Part I: TDV 1.5 to 5 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG007
Part I: Placebo 1.5 to 5 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG003
Part I: Placebo 12 to 20 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
OG004
Part I: TDV 6 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG005
Part I: Placebo 6 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
OG006
Part I: TDV 1.5 to 5 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG007
Part I: Placebo 1.5 to 5 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
Part I: TDV 12 to 20 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG003
Part I: Placebo 12 to 20 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
OG004
Part I: TDV 6 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG005
Part I: Placebo 6 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
OG006
Part I: TDV 1.5 to 5 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG007
Part I: Placebo 1.5 to 5 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
OG008
Part II: TDV 1.5 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG009
Part II: Placebo 1.5 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Units
Counts
Participants
OG00024
OG00114
OG00222
OG00314
OG00421
OG00517
OG00623
OG00713
OG008159
OG00953
Title
Denominators
Categories
Day 28, TDV-1
ParticipantsOG00024
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00623
ParticipantsOG00713
ParticipantsOG008158
ParticipantsOG00953
Title
Measurements
OG000100.0(85.8 to 100.0)
OG00192.3(64.0 to 99.8)
OG00286.4(65.1 to 97.1)
OG003
Day 28, TDV-2
ParticipantsOG00024
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 28, TDV-3
ParticipantsOG00024
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 28, TDV-4
ParticipantsOG00024
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 90, TDV-1
ParticipantsOG00023
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 90, TDV-2
ParticipantsOG00023
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 90, TDV-3
ParticipantsOG00023
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 90, TDV-4
ParticipantsOG00023
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 180, TDV-1
ParticipantsOG00020
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00314
Day 180, TDV-2
ParticipantsOG00020
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00314
Day 180, TDV-3
ParticipantsOG00020
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00314
Day 180, TDV-4
ParticipantsOG00020
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00314
Day 360, TDV-1
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00313
Day 360, TDV-2
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00313
Day 360, TDV-3
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00313
Day 360, TDV-4
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00313
Day 720, TDV-1
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00219
ParticipantsOG00313
Day 720, TDV-2
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00219
ParticipantsOG00313
Day 720, TDV-3
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00219
ParticipantsOG00313
Day 720, TDV-4
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00219
ParticipantsOG00313
Day 1080, TDV-1
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00218
ParticipantsOG00311
Day 1080, TDV-2
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00218
ParticipantsOG00311
Day 1080, TDV-3
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00218
ParticipantsOG00311
Day 1080, TDV-4
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00218
ParticipantsOG00311
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG003
Part I: Placebo 12 to 20 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
OG004
Part I: TDV 6 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG005
Part I: Placebo 6 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
OG006
Part I: TDV 1.5 to 5 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG007
Part I: Placebo 1.5 to 5 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
OG008
Part II: TDV 1.5 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG009
Part II: Placebo 1.5 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Units
Counts
Participants
OG00024
OG00114
OG00222
OG00314
OG00421
OG00517
OG00623
OG00713
OG008159
OG00953
Title
Denominators
Categories
Day 28, TDV-1
ParticipantsOG00024
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00623
ParticipantsOG00713
ParticipantsOG008158
ParticipantsOG00953
Title
Measurements
OG00045.8(25.6 to 67.2)
OG0017.7(0.2 to 36.0)
OG00263.6(40.7 to 82.8)
OG003
Day 28, TDV-2
ParticipantsOG00024
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 28, TDV-3
ParticipantsOG00024
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 28, TDV-4
ParticipantsOG00024
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 90, TDV-1
ParticipantsOG00023
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 90, TDV-2
ParticipantsOG00023
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 90, TDV-3
ParticipantsOG00023
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 90, TDV-4
ParticipantsOG00023
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 120, TDV-1
ParticipantsOG00022
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 120, TDV-2
ParticipantsOG00022
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 120, TDV-3
ParticipantsOG00022
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 120, TDV-4
ParticipantsOG00022
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 180, TDV-1
ParticipantsOG00020
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00314
Day 180, TDV-2
ParticipantsOG00020
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00314
Day 180, TDV-3
ParticipantsOG00020
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00314
Day 180, TDV-4
ParticipantsOG00020
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00314
Day 360, TDV-1
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00313
Day 360, TDV-2
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00313
Day 360, TDV-3
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00313
Day 360, TDV-4
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00313
Day 720, TDV-1
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00219
ParticipantsOG00313
Day 720, TDV-2
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00219
ParticipantsOG00313
Day 720, TDV-3
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00219
ParticipantsOG00313
Day 720, TDV-4
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00219
ParticipantsOG00313
Day 1080, TDV-1
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00218
ParticipantsOG00311
Day 1080, TDV-2
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00218
ParticipantsOG00311
Day 1080, TDV-3
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00218
ParticipantsOG00311
Day 1080, TDV-4
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00218
ParticipantsOG00311
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG003
Part I: Placebo 12 to 20 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
OG004
Part I: TDV 6 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG005
Part I: Placebo 6 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
OG006
Part I: TDV 1.5 to 5 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG007
Part I: Placebo 1.5 to 5 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
OG008
Part II: TDV 1.5 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG009
Part II: Placebo 1.5 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Units
Counts
Participants
OG00024
OG00114
OG00222
OG00314
OG00421
OG00517
OG00623
OG00713
OG008159
OG00953
Title
Denominators
Categories
Day 28, TDV-1
ParticipantsOG00024
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00623
ParticipantsOG00713
ParticipantsOG008158
ParticipantsOG00953
Title
Measurements
OG0001156.9(582.0 to 2299.9)
OG001396.1(120.6 to 1301.2)
OG002919.5(273.1 to 3096.1)
OG003
Day 28, TDV-2
ParticipantsOG00024
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 28, TDV-3
ParticipantsOG00024
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 28, TDV-4
ParticipantsOG00024
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 90, TDV-1
ParticipantsOG00023
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 90, TDV-2
ParticipantsOG00023
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 90, TDV-3
ParticipantsOG00023
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 90, TDV-4
ParticipantsOG00023
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 120, TDV-1
ParticipantsOG00022
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 120, TDV-2
ParticipantsOG00022
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 120, TDV-3
ParticipantsOG00022
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 120, TDV-4
ParticipantsOG00022
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 180, TDV-1
ParticipantsOG00020
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00314
Day 180, TDV-2
ParticipantsOG00020
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00314
Day 180, TDV-3
ParticipantsOG00020
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00314
Day 180, TDV-4
ParticipantsOG00020
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00314
Day 360, TDV-1
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00313
Day 360, TDV-2
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00313
Day 360, TDV-3
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00313
Day 360, TDV-4
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00313
Day 720, TDV-1
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00219
ParticipantsOG00313
Day 720, TDV-2
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00219
ParticipantsOG00313
Day 720, TDV-3
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00219
ParticipantsOG00313
Day 720, TDV-4
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00219
ParticipantsOG00313
Day 1080, TDV-1
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00218
ParticipantsOG00311
Day 1080, TDV-2
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00218
ParticipantsOG00311
Day 1080, TDV-3
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00218
ParticipantsOG00311
Day 1080, TDV-4
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00218
ParticipantsOG00311
OG003
Part I: Placebo 12 to 20 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
OG004
Part I: TDV 6 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG005
Part I: Placebo 6 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
OG006
Part I: TDV 1.5 to 5 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG007
Part I: Placebo 1.5 to 5 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
OG008
Part II: TDV 1.5 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG009
Part II: Placebo 1.5 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Units
Counts
Participants
OG00024
OG00114
OG00222
OG00314
OG00421
OG00517
OG00623
OG00713
OG008159
OG00953
Title
Denominators
Categories
Day 28, TDV-1
ParticipantsOG00024
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00623
ParticipantsOG00713
ParticipantsOG008158
ParticipantsOG00953
Title
Measurements
OG0003.41(1.61 to 7.24)
OG0010.90(0.57 to 1.41)
OG0028.93(3.61 to 22.09)
OG003
Day 28, TDV-2
ParticipantsOG00024
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 28, TDV-3
ParticipantsOG00024
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 28, TDV-4
ParticipantsOG00024
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 90, TDV-1
ParticipantsOG00023
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 90, TDV-2
ParticipantsOG00023
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 90, TDV-3
ParticipantsOG00023
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 90, TDV-4
ParticipantsOG00023
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 120, TDV-1
ParticipantsOG00022
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 120, TDV-2
ParticipantsOG00022
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 120, TDV-3
ParticipantsOG00022
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 120, TDV-4
ParticipantsOG00022
ParticipantsOG00113
ParticipantsOG00222
ParticipantsOG00314
Day 180, TDV-1
ParticipantsOG00020
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00314
Day 180, TDV-2
ParticipantsOG00020
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00314
Day 180, TDV-3
ParticipantsOG00020
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00314
Day 180, TDV-4
ParticipantsOG00020
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00314
Day 360, TDV-1
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00313
Day 360, TDV-2
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00313
Day 360, TDV-3
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00313
Day 360, TDV-4
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00221
ParticipantsOG00313
Day 720, TDV-1
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00219
ParticipantsOG00313
Day 720, TDV-2
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00219
ParticipantsOG00313
Day 720, TDV-3
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00219
ParticipantsOG00313
Day 720, TDV-4
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00219
ParticipantsOG00313
Day 1080, TDV-1
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00218
ParticipantsOG00311
Day 1080, TDV-2
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00218
ParticipantsOG00311
Day 1080, TDV-3
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00218
ParticipantsOG00311
Day 1080, TDV-4
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00218
ParticipantsOG00311
OG003
Part I: Placebo 12 to 20 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.
OG004
Part I: TDV 6 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG005
Part I: Placebo 6 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.
OG006
Part I: TDV 1.5 to 5 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG007
Part I: Placebo 1.5 to 5 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
OG008
Part II: TDV 1.5 to 11 Years
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
OG009
Part II: Placebo 1.5 to 11 Years
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.
Units
Counts
Participants
OG00024
OG00114
OG00222
OG00314
OG00421
OG00517
OG00623
OG00713
OG008159
OG00953
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0050
OG0060
OG0071
OG0082
OG0091
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0081 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0081 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0081 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0081 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0051 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0081 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0083 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0051 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0041 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0071 affected13 at risk
EG0082 affected159 at risk
EG0091 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0081 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0085 affected159 at risk
EG0091 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0061 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0071 affected13 at risk
EG0082 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0041 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0041 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0091 affected53 at risk
0 affected
14 at risk
EG0041 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
1 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0061 affected23 at risk
EG0070 affected13 at risk
EG0083 affected159 at risk
EG0092 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0071 affected13 at risk
EG0088 affected159 at risk
EG0090 affected53 at risk
1 affected
14 at risk
EG0040 affected21 at risk
EG0051 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0086 affected159 at risk
EG0092 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0071 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0041 affected21 at risk
EG0050 affected17 at risk
EG0062 affected23 at risk
EG0071 affected13 at risk
EG00816 affected159 at risk
EG0093 affected53 at risk
1 affected
14 at risk
EG0043 affected21 at risk
EG0052 affected17 at risk
EG0068 affected23 at risk
EG0077 affected13 at risk
EG00832 affected159 at risk
EG00914 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0051 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0081 affected159 at risk
EG0091 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0051 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
1 affected
14 at risk
EG0041 affected21 at risk
EG0050 affected17 at risk
EG0061 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
4 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0061 affected23 at risk
EG0070 affected13 at risk
EG0082 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0082 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
2 affected
14 at risk
EG0040 affected21 at risk
EG0051 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0086 affected159 at risk
EG0091 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0071 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
1 affected
14 at risk
EG0041 affected21 at risk
EG0050 affected17 at risk
EG0062 affected23 at risk
EG0071 affected13 at risk
EG00811 affected159 at risk
EG0096 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0082 affected159 at risk
EG0093 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0052 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0082 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0041 affected21 at risk
EG0050 affected17 at risk
EG0061 affected23 at risk
EG0071 affected13 at risk
EG0084 affected159 at risk
EG0090 affected53 at risk
1 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0081 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0071 affected13 at risk
EG0085 affected159 at risk
EG0091 affected53 at risk
2 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0062 affected23 at risk
EG0071 affected13 at risk
EG0081 affected159 at risk
EG0090 affected53 at risk
1 affected
14 at risk
EG0041 affected21 at risk
EG0050 affected17 at risk
EG0063 affected23 at risk
EG0071 affected13 at risk
EG0081 affected159 at risk
EG0090 affected53 at risk
1 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0082 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0051 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
1 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
1 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0081 affected159 at risk
EG0091 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0073 affected13 at risk
EG0084 affected159 at risk
EG0091 affected53 at risk
1 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0051 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0071 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0071 affected13 at risk
EG0081 affected159 at risk
EG0091 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0071 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
1 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0061 affected23 at risk
EG0070 affected13 at risk
EG0081 affected159 at risk
EG0091 affected53 at risk
1 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0081 affected159 at risk
EG0091 affected53 at risk
1 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0091 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
1 affected
14 at risk
EG0040 affected21 at risk
EG0050 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0081 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0041 affected21 at risk
EG0051 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0082 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0051 affected17 at risk
EG0061 affected23 at risk
EG0071 affected13 at risk
EG0082 affected159 at risk
EG0092 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0051 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
0 affected
14 at risk
EG0040 affected21 at risk
EG0051 affected17 at risk
EG0060 affected23 at risk
EG0070 affected13 at risk
EG0080 affected159 at risk
EG0090 affected53 at risk
2
OG0049
OG0055
OG0065
OG0071
OG00828
OG00913
0
OG0040
OG0050
OG0060
OG0070
OG0083
OG0091
1
OG0041
OG0051
OG0061
OG0070
OG0084
OG0095
1
OG0041
OG0051
OG0061
OG0070
OG0084
OG0095
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
1
OG0041
OG0051
OG0064
OG0072
OG00827
OG0096
0
OG0040
OG0050
OG0060
OG0071
OG0085
OG0092
0
OG0040
OG0050
OG0060
OG0071
OG0081
OG0091
8
OG0044
OG0055
OG0063
OG0074
OG00846
OG00912
5
OG0043
OG0053
OG0063
OG0073
OG00830
OG0096
3
OG0041
OG0052
OG0060
OG0071
OG00812
OG0094
0
OG0040
OG0050
OG0060
OG0070
OG0084
OG0092
5
OG0041
OG0053
OG0065
OG0072
OG00830
OG0096
2
OG0041
OG0053
OG0063
OG0070
OG00821
OG0094
2
OG0040
OG0050
OG0062
OG0071
OG0086
OG0091
1
OG0040
OG0050
OG0060
OG0071
OG0083
OG0091
2
OG0040
OG0050
OG0061
OG0071
OG00810
OG0092
0
OG0040
OG0050
OG0061
OG0070
OG0087
OG0091
2
OG0040
OG0050
OG0060
OG0070
OG0083
OG0091
0
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
3
OG0040
OG0050
OG0062
OG0071
OG00814
OG0093
2
OG0040
OG0050
OG0062
OG0071
OG00811
OG0093
1
OG0040
OG0050
OG0060
OG0070
OG0083
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
4
OG0041
OG0050
OG0060
OG0070
OG00811
OG0093
4
OG0040
OG0050
OG0060
OG0070
OG0089
OG0093
0
OG0041
OG0050
OG0060
OG0070
OG0082
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
6
OG0042
OG0055
OG0063
OG0073
OG00829
OG00910
2
OG0041
OG0052
OG0061
OG0072
OG00819
OG0096
4
OG0040
OG0053
OG0062
OG0070
OG0087
OG0093
0
OG0041
OG0050
OG0060
OG0071
OG0083
OG0091
2
OG0042
OG0051
OG0062
OG0072
OG00814
OG0092
1
OG0042
OG0051
OG0062
OG0072
OG00812
OG0092
0
OG0040
OG0050
OG0060
OG0070
OG0081
OG0090
1
OG0040
OG0050
OG0060
OG0070
OG0081
OG0090
4
OG0041
OG0050
OG0063
OG0073
OG00822
OG0094
2
OG0040
OG0050
OG0062
OG0073
OG00814
OG0094
2
OG0041
OG0050
OG0061
OG0070
OG0084
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0084
OG0090
2
OG0041
OG0051
OG0064
OG0075
OG00818
OG0093
2
OG0040
OG0051
OG0061
OG0072
OG0085
OG0092
0
OG0041
OG0050
OG0063
OG0073
OG00811
OG0091
0
OG0040
OG0050
OG0060
OG0070
OG0082
OG0090
2
OG00410
OG0058
OG00613
OG00710
OG00872
OG00931
5
OG0041
OG0053
OG0064
OG0072
OG00825
OG0096
1
OG0041
OG0050
OG0060
OG0070
OG0084
OG0090
85.7
(57.2 to 98.2)
OG004100.0(83.9 to 100.0)
OG00523.5(6.8 to 49.9)
OG006100.0(84.6 to 100.0)
OG0070.0(0.0 to 28.5)
OG008100.0(97.7 to 100.0)
OG00935.8(23.1 to 50.2)
85.7
(57.2 to 98.2)
OG004100.0(83.9 to 100.0)
OG00529.4(10.3 to 56)
OG006100.0(84.6 to 100.0)
OG0070.0(0.0 to 28.5)
OG00899.4(96.5 to 100.0)
OG00935.8(23.1 to 50.2)
71.4
(41.9 to 91.6)
OG00485.7(63.7 to 97.0)
OG00529.4(10.3 to 56.0)
OG006100.0(84.6 to 100.0)
OG0070.0(0.0 to 28.5)
OG00894.9(90.1 to 97.8)
OG00935.8(23.1 to 50.2)
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0044
OG0050
OG0069
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0046
OG0050
OG0064
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0041
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0061
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
85.7
(57.2 to 98.2)
OG004100.0(83.9 to 100.0)
OG00523.5(6.8 to 49.9)
OG006100.0(85.2 to 100.0)
OG0077.7(0.2 to 36.0)
OG008100.0(97.7 to 100.0)
OG00941.5(28.1 to 55.9)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00623
ParticipantsOG00713
ParticipantsOG008158
ParticipantsOG00953
Title
Measurements
OG000100.0(85.8 to 100.0)
OG00192.3(64.0 to 99.8)
OG00286.4(65.1 to 97.1)
OG00385.7(57.2 to 98.2)
OG004100.0(83.9 to 100.0)
OG00523.5(6.8 to 49.9)
OG00695.7(78.1 to 99.9)
OG0070.0(0.0 to 24.7)
OG00896.8(92.8 to 99.0)
OG00934.0(21.5 to 48.3)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00623
ParticipantsOG00713
ParticipantsOG008158
ParticipantsOG00953
Title
Measurements
OG00095.8(78.9 to 99.9)
OG00184.6(54.6 to 98.1)
OG00290.9(70.8 to 98.9)
OG00392.9(66.1 to 99.8)
OG004100.0(83.9 to 100.0)
OG00517.6(3.8 to 43.4)
OG00691.3(72.0 to 98.9)
OG0070.0(0.0 to 24.7)
OG00895.6(91.1 to 98.2)
OG00939.6(26.5 to 54.0)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00623
ParticipantsOG00713
ParticipantsOG008158
ParticipantsOG00953
Title
Measurements
OG00079.2(57.8 to 92.9)
OG00176.9(46.2 to 95.0)
OG00259.1(36.4 to 79.2)
OG00378.6(49.2 to 95.3)
OG00485.7(63.7 to 97.0)
OG00511.8(1.5 to 36.4)
OG00669.6(47.1 to 86.8)
OG0070.0(0.0 to 24.7)
OG00874.1(66.5 to 80.7)
OG00935.8(23.1 to 50.2)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008159
ParticipantsOG00953
Title
Measurements
OG000100.0(85.2 to 100.0)
OG00192.3(64.0 to 99.8)
OG00290.9(70.8 to 98.9)
OG00385.7(57.2 to 98.2)
OG00495.2(76.2 to 99.9)
OG00517.6(3.8 to 43.4)
OG00695.5(77.2 to 99.9)
OG0070.0(0.0 to 28.5)
OG00899.4(96.5 to 100.0)
OG00941.5(28.1 to 55.9)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008159
ParticipantsOG00953
Title
Measurements
OG000100.0(85.2 to 100.0)
OG00184.6(54.6 to 98.1)
OG00290.9(70.8 to 98.9)
OG00385.7(57.2 to 98.2)
OG004100.0(83.9 to 100.0)
OG00517.6(3.8 to 43.4)
OG006100.0(84.6 to 100.0)
OG0070.0(0.0 to 28.5)
OG00898.7(95.5 to 99.8)
OG00934.0(21.5 to 48.3)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00621
ParticipantsOG00711
ParticipantsOG008159
ParticipantsOG00953
Title
Measurements
OG00095.7(78.1 to 99.9)
OG001100.0(75.3 to 100.0)
OG00290.9(70.8 to 98.9)
OG00385.7(57.2 to 98.2)
OG004100(83.9 to 100)
OG00517.6(3.8 to 43.4)
OG00681.8(59.7 to 94.8)
OG0079.1(0.2 to 41.3)
OG00889.9(84.2 to 94.1)
OG00934.0(21.5 to 48.3)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008159
ParticipantsOG00953
Title
Measurements
OG00082.6(61.2 to 95.0)
OG00169.2(38.6 to 90.9)
OG00277.3(54.6 to 92.2)
OG00378.6(49.2 to 95.3)
OG00466.7(43.0 to 85.4)
OG00511.8(1.5 to 36.4)
OG00663.6(40.7 to 82.8)
OG0079.1(0.2 to 41.3)
OG00869.8(62.0 to 76.8)
OG00935.8(23.1 to 50.2)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000100.0(83.2 to 100.0)
OG00191.7(61.5 to 99.8)
OG00295.2(76.2 to 99.9)
OG00385.7(57.2 to 98.2)
OG004100.0(83.9 to 100.0)
OG00523.5(6.8 to 49.9)
OG006100.0(84.6 to 100.0)
OG0070.0(0.0 to 28.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000100.0(83.2 to 100.0)
OG00183.3(51.6 to 97.9)
OG00295.2(76.2 to 99.9)
OG00385.7(57.2 to 98.2)
OG004100.0(83.9 to 100.0)
OG00523.5(6.8 to 49.9)
OG006100.0(84.6 to 100.0)
OG0070.0(0.0 to 28.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000100.0(83.2 to 100.0)
OG00191.7(61.5 to 99.8)
OG00295.2(76.2 to 99.9)
OG00385.7(57.2 to 98.2)
OG004100.0(83.9 to 100.0)
OG00535.3(14.2 to 61.7)
OG00695.5(77.2 to 99.9)
OG0079.1(0.2 to 41.3)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00090.0(68.3 to 98.8)
OG00166.7(34.9 to 90.1)
OG00276.2(52.8 to 91.8)
OG00378.6(49.2 to 95.3)
OG00481.0(58.1 to 94.6)
OG00517.6(3.8 to 43.4)
OG00677.3(54.6 to 92.2)
OG0070.0(0.0 to 28.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000100.0(82.4 to 100.0)
OG00191.7(61.5 to 99.8)
OG00290.5(69.6 to 98.8)
OG00384.6(54.6 to 98.1)
OG00495.2(76.2 to 99.9)
OG00529.4(10.3 to 56.0)
OG006100.0(84.6 to 100.0)
OG0079.1(0.2 to 41.3)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000100.0(82.4 to 100.0)
OG00183.3(51.6 to 97.9)
OG00295.2(76.2 to 99.9)
OG00384.6(54.6 to 98.1)
OG00495.2(76.2 to 99.9)
OG00529.4(10.3 to 56.0)
OG006100.0(84.6 to 100.0)
OG0070.0(0.0 to 28.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00089.5(66.9 to 98.7)
OG00183.3(51.6 to 97.9)
OG00281.0(58.1 to 94.6)
OG00384.6(54.6 to 98.1)
OG00495.2(76.2 to 99.9)
OG00529.4(10.3 to 56.0)
OG00695.5(77.2 to 99.9)
OG0070.0(0.0 to 28.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00084.2(60.4 to 96.6)
OG00175.0(42.8 to 94.5)
OG00266.7(43.0 to 85.4)
OG00384.6(54.6 to 98.1)
OG00461.9(38.4 to 81.9)
OG00517.6(3.8 to 43.4)
OG00663.6(40.7 to 82.8)
OG0070.0(0.0 to 28.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000100.0(79.4 to 100.0)
OG001100.0(66.4 to 100.0)
OG00289.5(66.9 to 98.7)
OG00384.6(54.6 to 98.1)
OG004100.0(83.9 to 100.0)
OG00523.5(6.8 to 49.9)
OG006100.0(84.6 to 100.0)
OG00710.0(0.3 to 44.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000100.0(79.4 to 100.0)
OG00188.9(51.8 to 99.7)
OG00294.7(74.0 to 99.9)
OG00384.6(54.6 to 98.1)
OG004100.0(83.9 to 100.0)
OG00523.5(6.8 to 49.9)
OG006100.0(84.6 to 100.0)
OG00710.0(0.3 to 44.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00087.5(61.7 to 98.4)
OG00188.9(51.8 to 99.7)
OG00268.4(43.4 to 87.4)
OG00384.6(54.6 to 98.1)
OG00471.4(47.8 to 88.7)
OG00517.6(3.8 to 43.4)
OG00690.9(70.8 to 98.9)
OG00710.0(0.3 to 44.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00081.3(54.4 to 96.0)
OG00177.8(40.0 to 97.2)
OG00263.2(38.4 to 83.7)
OG00384.6(54.6 to 98.1)
OG00457.1(34.0 to 78.2)
OG00523.5(6.8 to 49.9)
OG00672.7(49.8 to 89.3)
OG00710.0(0.3 to 44.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00621
ParticipantsOG0079
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000100.0(78.2 to 100.0)
OG001100.0(63.1 to 100.0)
OG00294.4(72.7 to 99.9)
OG00381.8(48.2 to 97.7)
OG00495.2(76.2 to 99.9)
OG00523.5(6.8 to 49.9)
OG006100.0(83.9 to 100.0)
OG00711.1(0.3 to 48.2)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00621
ParticipantsOG0079
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000100.0(78.2 to 100.0)
OG00187.5(47.3 to 99.7)
OG002100.0(81.5 to 100.0)
OG00381.8(48.2 to 97.7)
OG004100.0(83.9 to 100.0)
OG00523.5(6.8 to 49.9)
OG00695.2(76.2 to 99.9)
OG0070.0(0.0 to 33.6)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00621
ParticipantsOG0079
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00093.3(68.1 to 99.8)
OG00187.5(47.3 to 99.7)
OG00277.8(52.4 to 93.6)
OG00381.8(48.2 to 97.7)
OG00485.7(63.7 to 97.0)
OG00523.5(6.8 to 49.9)
OG00695.2(76.2 to 99.9)
OG00711.1(0.3 to 48.2)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00621
ParticipantsOG0079
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00080.0(51.9 to 95.7)
OG00187.5(47.3 to 99.7)
OG00261.1(35.7 to 82.7)
OG00372.7(39.0 to 94.0)
OG00442.9(21.8 to 66.0)
OG00517.6(3.8 to 43.4)
OG00647.6(25.7 to 70.2)
OG00711.1(0.3 to 48.2)
0.0
(0.0 to 23.2)
OG00490.5(69.6 to 98.8)
OG0055.9(0.1 to 28.7)
OG00687.0(66.4 to 97.2)
OG0077.7(0.2 to 36.0)
OG00886.1(79.7 to 91.1)
OG0091.9(0.0 to 10.1)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00623
ParticipantsOG00713
ParticipantsOG008158
ParticipantsOG00953
Title
Measurements
OG00033.3(15.6 to 55.3)
OG00115.4(1.9 to 45.4)
OG00259.1(36.4 to 79.3)
OG0030.0(0.0 to 23.2)
OG00485.7(63.7 to 97.0)
OG00511.8(1.5 to 36.4)
OG00687.0(66.4 to 97.2)
OG0070.0(0.0 to 24.7)
OG00886.7(80.4 to 91.6)
OG0090.0(0.0 to 6.7)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00623
ParticipantsOG00713
ParticipantsOG008158
ParticipantsOG00953
Title
Measurements
OG00033.3(15.6 to 55.3)
OG0010.0(0.0 to 24.7)
OG00263.6(40.7 to 82.8)
OG0037.1(0.2 to 33.9)
OG00490.5(69.6 to 98.8)
OG0050.0(0.0 to 19.5)
OG00678.3(56.3 to 92.5)
OG0070.0(0.0 to 24.7)
OG00882.3(75.4 to 87.9)
OG0091.9(0.0 to 10.1)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00623
ParticipantsOG00713
ParticipantsOG008158
ParticipantsOG00953
Title
Measurements
OG00020.8(7.1 to 42.2)
OG00115.4(1.9 to 45.4)
OG00231.8(13.9 to 54.9)
OG0030.0(0.0 to 23.2)
OG00471.4(47.8 to 88.7)
OG0055.9(0.1 to 28.7)
OG00660.9(38.5 to 80.3)
OG0070.0(0.0 to 24.7)
OG00862.7(54.6 to 70.2)
OG0095.7(1.2 to 15.7)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008159
ParticipantsOG00953
Title
Measurements
OG00039.1(19.7 to 61.5)
OG00115.4(1.9 to 45.4)
OG00254.5(32.2 to 75.6)
OG0037.1(0.2 to 33.9)
OG00481.0(58.1 to 94.6)
OG0050.0(0.0 to 19.5)
OG00681.8(59.7 to 94.8)
OG0070.0(0.0 to 28.5)
OG00882.4(75.6 to 88.0)
OG0093.8(0.5 to 13.0)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008159
ParticipantsOG00953
Title
Measurements
OG00030.4(13.2 to 52.9)
OG00115.4(1.9 to 45.4)
OG00259.1(36.4 to 79.3)
OG0037.1(0.2 to 33.9)
OG00485.7(63.7 to 97.0)
OG0050.0(0.0 to 19.5)
OG00690.9(70.8 to 98.9)
OG0070.0(0.0 to 28.5)
OG00886.2(79.8 to 91.1)
OG0091.9(0.0 to 10.1)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008159
ParticipantsOG00953
Title
Measurements
OG00030.4(13.2 to 52.9)
OG00123.1(5.0 to 53.8)
OG00259.1(36.4 to 79.3)
OG00314.3(1.8 to 42.8)
OG00481.0(58.1 to 94.6)
OG0050.0(0.0 to 19.5)
OG00663.6(40.7 to 82.8)
OG0079.1(0.2 to 41.3)
OG00876.1(68.7 to 82.5)
OG0090.0(0.0 to 6.7)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008159
ParticipantsOG00953
Title
Measurements
OG00021.7(7.5 to 43.7)
OG0010.0(0.0 to 24.7)
OG00250.0(28.2 to 71.8)
OG00321.4(4.7 to 50.8)
OG00461.9(38.4 to 81.9)
OG0055.9(0.1 to 28.7)
OG00654.5(32.2 to 75.6)
OG0079.1(0.2 to 41.3)
OG00857.9(49.8 to 65.6)
OG0095.7(1.2 to 15.7)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008156
ParticipantsOG00953
Title
Measurements
OG00045.5(24.4 to 67.8)
OG0010.0(0.0 to 24.7)
OG00268.2(45.1 to 86.1)
OG00314.3(1.8 to 42.8)
OG00490.5(69.6 to 98.8)
OG0055.9(0.1 to 28.7)
OG00695.5(77.2 to 99.9)
OG0070.0(0.0 to 28.5)
OG00888.5(82.4 to 93.0)
OG0093.8(0.5 to 13.0)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008156
ParticipantsOG00953
Title
Measurements
OG00045.5(24.4 to 67.8)
OG0010.0(0.0 to 24.7)
OG00263.6(40.7 to 82.8)
OG0030.0(0.0 to 23.2)
OG00495.2(76.2 to 99.9)
OG0055.9(0.1 to 28.7)
OG00695.5(77.2 to 99.9)
OG0070.0(0.0 to 28.5)
OG00890.4(84.6 to 94.5)
OG0093.8(0.5 to 13.0)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008156
ParticipantsOG00953
Title
Measurements
OG00045.5(24.4 to 67.8)
OG00130.8(9.1 to 61.4)
OG00268.2(45.1 to 86.1)
OG00314.3(1.8 to 42.8)
OG00490.5(69.6 to 98.8)
OG00517.6(3.8 to 43.4)
OG00695.5(77.2 to 99.9)
OG0070.0(0.0 to 28.5)
OG00886.5(80.2 to 91.5)
OG0091.9(0.0 to 10.1)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008156
ParticipantsOG00953
Title
Measurements
OG00040.9(20.7 to 63.6)
OG0017.7(0.2 to 36.0)
OG00245.5(24.4 to 67.8)
OG00314.3(1.8 to 42.8)
OG00485.7(63.7 to 97.0)
OG00523.5(6.8 to 49.9)
OG00695.5(77.2 to 99.9)
OG0070.0(0.0 to 28.5)
OG00884.0(77.3 to 89.4)
OG0093.8(0.5 to 13.0)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00050.0(27.2 to 72.8)
OG0018.3(0.2 to 38.5)
OG00261.9(38.4 to 81.9)
OG0030.0(0.0 to 23.2)
OG00495.2(76.2 to 99.9)
OG0055.9(0.1 to 28.7)
OG00690.9(70.8 to 99.9)
OG0070.0(0.0 to 28.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00060.0(36.1 to 80.9)
OG0018.3(0.2 to 38.5)
OG00261.9(38.4 to 81.9)
OG0037.1(0.2 to 33.9)
OG00495.2(76.2 to 99.9)
OG0055.9(0.1 to 28.7)
OG00695.5(77.2 to 99.9)
OG0070.0(0.0 to 28.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00040.0(19.1 to 63.9)
OG0018.3(0.2 to 38.5)
OG00261.9(38.4 to 81.9)
OG0037.1(0.2 to 33.9)
OG00490.5(69.5 to 98.8)
OG00517.6(3.8 to 43.4)
OG00686.4(65.1 to 97.1)
OG0079.1(0.2 to 41.3)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00045.0(23.1 to 68.5)
OG0018.3(0.2 to 38.5)
OG00247.6(25.7 to 70.2)
OG0037.1(0.2 to 33.9)
OG00481.0(58.1 to 94.6)
OG00511.8(1.5 to 36.4)
OG00672.7(49.8 to 98.3)
OG0070.0(0.0 to 28.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00052.6(28.9 to 75.6)
OG0010.0(0.0 to 26.5)
OG00257.1(34.0 to 78.2)
OG00315.4(1.9 to 45.4)
OG00485.7(63.7 to 97.0)
OG00511.8(1.5 to 36.4)
OG00690.9(70.8 to 98.9)
OG0079.1(0.2 to 41.3)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00047.4(24.4 to 71.1)
OG0010.0(0.0 to 26.5)
OG00261.9(38.4 to 81.9)
OG00315.4(1.9 to 45.4)
OG00476.2(52.8 to 91.8)
OG00517.6(3.8 to 43.4)
OG00695.5(77.2 to 99.9)
OG0070.0(0.0 to 28.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00036.8(16.3 to 61.6)
OG0010.0(0.0 to 26.5)
OG00257.1(34.0 to 78.2)
OG00315.4(1.9 to 45.4)
OG00476.2(52.8 to 91.8)
OG00511.8(1.5 to 36.4)
OG00681.8(59.7 to 94.8)
OG0070.0(0.0 to 28.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00042.1(20.3 to 66.5)
OG0010.0(0.0 to 26.5)
OG00238.1(18.1 to 61.6)
OG0037.7(0.2 to 36.0)
OG00457.1(34.0 to 78.2)
OG00511.8(1.5 to 36.4)
OG00659.1(36.4 to 79.3)
OG0070.0(0.0 to 28.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00050.0(24.7 to 75.3)
OG0010.0(0.0 to 33.6)
OG00247.4(24.4 to 71.1)
OG00315.4(1.9 to 45.4)
OG00495.2(76.2 to 99.9)
OG0055.9(0.1 to 28.7)
OG00686.4(65.1 to 97.1)
OG00710.0(0.3 to 44.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00050.0(24.7 to 75.3)
OG0010.0(0.0 to 33.6)
OG00257.9(33.5 to 79.7)
OG0037.7(0.2 to 36.0)
OG00485.7(63.7 to 97.0)
OG0055.9(0.1 to 28.7)
OG00695.5(77.2 to 99.9)
OG00710.0(0.3 to 44.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00043.8(19.8 to 70.1)
OG0010.0(0.0 to 33.6)
OG00231.6(12.6 to 56.6)
OG00315.4(1.9 to 45.4)
OG00466.7(43.0 to 85.4)
OG0055.9(0.1 to 28.7)
OG00686.4(65.1 to 97.1)
OG00710.0(0.3 to 44.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00018.8(4.0 to 45.6)
OG0010.0(0.0 to 36.9)
OG00236.8(16.3 to 61.6)
OG00315.4(1.9 to 45.4)
OG00447.6(25.7 to 70.2)
OG00517.6(3.8 to 43.4)
OG00663.6(40.7 to 82.8)
OG00710.0(0.3 to 44.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00621
ParticipantsOG0079
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00046.7(21.3 to 73.4)
OG0010.0(0.0 to 36.9)
OG00255.6(30.8 to 78.5)
OG00318.2(2.3 to 51.8)
OG00490.5(69.6 to 98.8)
OG0055.9(0.1 to 28.7)
OG00685.7(63.7 to 97.0)
OG00711.1(0.3 to 48.2)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00621
ParticipantsOG0079
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00046.7(21.3 to 73.4)
OG0010.0(0.0 to 36.9)
OG00261.1(35.7 to 82.7)
OG0039.1(0.2 to 41.3)
OG00481.0(58.1 to 94.6)
OG0055.9(0.1 to 28.7)
OG00685.7(63.7 to 97.0)
OG0070.0(0.0 to 33.6)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00621
ParticipantsOG0079
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00033.3(11.8 to 61.6)
OG0010.0(0.0 to 36.9)
OG00244.4(21.5 to 69.2)
OG00318.2(2.3 to 51.8)
OG00481.0(58.1 to 94.6)
OG0055.9(0.1 to 28.7)
OG00690.5(69.6 to 98.8)
OG00711.1(0.3 to 48.2)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00621
ParticipantsOG0079
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00013.3(1.7 to 40.5)
OG00112.5(0.3 to 52.7)
OG00227.8(9.7 to 53.5)
OG00318.2(2.3 to 51.8)
OG00433.3(14.6 to 57.0)
OG00511.8(1.5 to 36.4)
OG00638.1(18.1 to 61.6)
OG00711.1(0.3 to 48.2)
204.9
(59.8 to 702.6)
OG004383.7(178.1 to 826.5)
OG00511.3(4.4 to 29.3)
OG006395.2(190.0 to 822.0)
OG0075.3(4.7 to 5.9)
OG008522.2(396.5 to 687.7)
OG00928.7(14.8 to 55.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00623
ParticipantsOG00713
ParticipantsOG008158
ParticipantsOG00953
Title
Measurements
OG0002313.9(1328.1 to 4031.2)
OG001178.0(44.4 to 712.9)
OG0021726.6(539.2 to 5528.8)
OG003420.2(116.5 to 1515.6)
OG0042357.2(1218.6 to 4559.7)
OG00513.9(5.0 to 38.6)
OG0061134.6(479.9 to 2682.6)
OG0075.0(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the lower limit of detection (LLOD).
OG0081496.5(1129.1 to 1983.4)
OG00916.4(9.7 to 27.9)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00623
ParticipantsOG00713
ParticipantsOG008158
ParticipantsOG00953
Title
Measurements
OG000538.2(218.3 to 1326.5)
OG001226.3(70.1 to 730.7)
OG002330.2(94.4 to 1155.9)
OG003304.5(83.9 to 1105.6)
OG004314.8(135.3 to 732.3)
OG0058.5(4.1 to 17.4)
OG006129.6(52.9 to 317.6)
OG0075.0(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
OG008206.9(149.9 to 285.7)
OG00919.4(11.5 to 32.6)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00623
ParticipantsOG00713
ParticipantsOG008158
ParticipantsOG00953
Title
Measurements
OG000130.7(54.3 to 314.5)
OG00155.1(15.6 to 194.9)
OG00256.6(19.1 to 167.3)
OG00346.4(17.6 to 122.4)
OG00461.4(27.1 to 139.4)
OG0057.2(3.9 to 13.4)
OG00627.0(12.5 to 58.5)
OG0075.0(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
OG00845.4(33.2 to 62.0)
OG00911.0(7.8 to 15.6)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008159
ParticipantsOG00953
Title
Measurements
OG000961.3(413.5 to 2235.2)
OG001751.0(227.1 to 2483.1)
OG002555.4(156.9 to 1966.2)
OG003215.3(55.4 to 836.4)
OG004245.7(82.2 to 734.7)
OG00510.8(4.2 to 28.3)
OG006165.1(69.4 to 392.8)
OG0075.0(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
OG008324.2(239.1 to 439.6)
OG00927.9(14.6 to 53.4)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008159
ParticipantsOG00953
Title
Measurements
OG0002073.1(1267.0 to 3392.1)
OG001320.0(74.2 to 1379.3)
OG0021146.4(416.7 to 3153.6)
OG003463.9(120.1 to 1792.0)
OG004966.9(451.8 to 2069.2)
OG00510.0(4.3 to 23.1)
OG006467.0(205.7 to 1060.3)
OG0075.0(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
OG008463.5(364.0 to 590.2)
OG00915.2(8.9 to 25.9)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008159
ParticipantsOG00953
Title
Measurements
OG000510.5(218.3 to 1194.1)
OG001272.7(86.4 to 860.4)
OG002193.3(54.9 to 680.7)
OG003336.2(95.3 to 1185.8)
OG004195.0(73.3 to 518.8)
OG0058.5(4.4 to 16.5)
OG00666.2(28.3 to 154.8)
OG0075.3(4.6 to 6.1)
OG008139.5(99.7 to 195.1)
OG00917.1(10.2 to 28.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008159
ParticipantsOG00953
Title
Measurements
OG000125.7(57.7 to 274.1)
OG00136.0(13.3 to 97.2)
OG00276.3(29.3 to 198.9)
OG00369.0(23.7 to 200.4)
OG00431.2(12.3 to 79.3)
OG0057.5(4.0 to 14.3)
OG00616.8(9.3 to 30.5)
OG0075.3(4.6 to 6.1)
OG00833.7(25.4 to 44.7)
OG00911.8(8.2 to 16.9)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008156
ParticipantsOG00953
Title
Measurements
OG0001240.3(585.2 to 2628.8)
OG001356.0(117.8 to 1076.1)
OG0021300.3(528.5 to 3199.4)
OG003164.0(52.8 to 509.4)
OG004551.7(231.6 to 1313.8)
OG00513.9(4.9 to 39.2)
OG006582.3(275.9 to 1229.1)
OG0075.0(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
OG008710.4(547.5 to 921.9)
OG00929.6(15.6 to 56.1)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008156
ParticipantsOG00953
Title
Measurements
OG0002403.7(1443.5 to 4002.6)
OG001272.7(60.9 to 1221.6)
OG0021754.0(744.2 to 4134.4)
OG003399.9(109.7 to 1457.7)
OG004983.0(423.5 to 2281.6)
OG00517.3(4.6 to 65.9)
OG006459.7(232.6 to 908.7)
OG0075.0(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
OG008605.4(490.6 to 747.1)
OG00916.2(9.5 to 27.8)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008156
ParticipantsOG00953
Title
Measurements
OG000650.2(288.1 to 1467.0)
OG001287.6(116.7 to 709.1)
OG002340.8(121.3 to 957.6)
OG003289.8(82.7 to 1016.1)
OG004377.4(170.3 to 836.6)
OG00514.4(5.0 to 41.8)
OG006196.4(115.2 to 334.8)
OG0075.0(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
OG008332.3(263.1 to 419.7)
OG00919.0(11.3 to 32.0)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008156
ParticipantsOG00953
Title
Measurements
OG000193.3(84.7 to 441.1)
OG00136.0(10.5 to 123.2)
OG00282.6(31.8 to 214.1)
OG00369.0(23.5 to 202.7)
OG00464.6(27.6 to 151.1)
OG00513.9(5.4 to 35.3)
OG00641.3(24.9 to 68.3)
OG0075.0(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
OG00876.5(60.5 to 96.8)
OG00911.2(8.0 to 15.9)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000831.7(332.7 to 2078.8)
OG001320.0(86.0 to 1191.4)
OG002954.7(280.8 to 3245.7)
OG003141.6(38.8 to 516.4)
OG004230.5(107.2 to 495.4)
OG00512.8(4.7 to 34.4)
OG006249.2(113.5 to 546.8)
OG0075.0(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0002521.2(1444.5 to 4400.4)
OG001226.3(48.9 to 1046.4)
OG0021515.6(593.7 to 3869.0)
OG003412.3(104.9 to 1620.6)
OG004642.5(325.9 to 1266.8)
OG00514.4(4.9 to 42.4)
OG006399.3(194.7 to 819.1)
OG0075.0(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000422.2(179.1 to 995.5)
OG001285.1(74.7 to 1087.6)
OG002321.2(101.3 to 1018.4)
OG003206.1(65.9 to 645.0)
OG004189.1(84.2 to 424.6)
OG00512.5(5.5 to 28.4)
OG00693.6(41.4 to 211.7)
OG0076.0(4.0 to 9.2)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000146.7(62.8 to 342.7)
OG00144.9(13.0 to 155.7)
OG00271.5(27.6 to 185.0)
OG00351.2(19.8 to 132.4)
OG00447.2(20.4 to 109.3)
OG0059.2(4.4 to 19.4)
OG00628.3(14.3 to 56.0)
OG0075.0(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0001417.4(474.5 to 4233.5)
OG001320.0(78.5 to 1304.5)
OG002642.5(179.5 to 2299.8)
OG003221.0(48.9 to 999.6)
OG004132.0(51.6 to 338.0)
OG00515.7(5.5 to 45.2)
OG006220.9(90.3 to 540.2)
OG0075.3(4.6 to 6.1)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0002410.7(1120.9 to 5185.0)
OG001271.8(60.9 to 1212.7)
OG002852.2(369.9 to 1963.3)
OG003523.6(113.4 to 2416.7)
OG004329.5(161.7 to 671.1)
OG00517.1(6.0 to 48.7)
OG006298.8(141.1 to 632.8)
OG0075.0(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000537.9(158.5 to 1825.3)
OG001256.2(70.2 to 935.3)
OG002171.3(51.1 to 574.0)
OG003209.5(55.4 to 792.9)
OG004103.1(40.0 to 265.6)
OG00511.8(5.3 to 26.0)
OG00689.9(43.9 to 184.1)
OG0075(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000163.6(56.2 to 476.4)
OG00144.9(13.5 to 149.1)
OG00273.8(26.9 to 202.8)
OG00359.9(19.4 to 184.4)
OG00427.0(11.9 to 61.0)
OG0057.5(4.0 to 14.0)
OG00620.0(10.8 to 37.0)
OG0075(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000924.9(289.1 to 2959.4)
OG001691.2(175.7 to 2720.1)
OG002452.5(124.5 to 1644.5)
OG003258.5(67.0 to 997.9)
OG004115.0(45.4 to 291.1)
OG00512.8(4.8 to 34.2)
OG006248.7(103.4 to 597.9)
OG0075.7(4.2 to 7.9)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0001399.4(704.8 to 2778.8)
OG001244.9(50.1 to 1197.1)
OG002714.0(247.9 to 2056.8)
OG003396.1(98.3 to 1595.4)
OG004280.4(135.1 to 582.2)
OG00513.0(5.0 to 33.9)
OG006219.3(106.7 to 450.7)
OG0075.4(4.6 to 6.3)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000515.4(140.6 to 1888.5)
OG001403.2(96.0 to 1692.5)
OG002154.3(36.7 to 649.1)
OG003303.4(70.9 to 1297.4)
OG00465.6(21.2 to 203.0)
OG0058.8(4.5 to 17.5)
OG006104.6(37.7 to 289.8)
OG0078.1(2.7 to 24.3)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000106.0(40.5 to 277.3)
OG00148.5(13.1 to 180.2)
OG00266.7(22.5 to 197.2)
OG00393.9(29.0 to 303.8)
OG00424.4(10.8 to 55.2)
OG0058.5(4.7 to 15.2)
OG00626.6(12.3 to 57.3)
OG0075.7(4.2 to 7.9)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00621
ParticipantsOG0079
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000718.4(239.3 to 2156.7)
OG001905.1(243.2 to 3368.4)
OG002508.0(137.6 to 1874.9)
OG003219.3(41.2 to 1165.6)
OG00492.8(36.5 to 236.2)
OG00512.8(4.8 to 34.2)
OG006149.8(63.9 to 351.1)
OG0076.3(3.7 to 10.7)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00621
ParticipantsOG0079
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000702.0(403.1 to 1222.4)
OG001146.7(27.3 to 787.7)
OG002615.8(277.5 to 1366.8)
OG003256.7(61.0 to 1079.3)
OG004160.0(76.5 to 334.8)
OG00512.8(5.2 to 31.7)
OG006118.9(57.0 to 248.0)
OG0075.0(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00621
ParticipantsOG0079
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000291.8(82.5 to 1032.3)
OG001472.6(84.6 to 2641.0)
OG002201.6(54.6 to 744.0)
OG003264.9(53.4 to 1313.1)
OG00470.1(27.6 to 178.4)
OG0059.6(4.6 to 20.1)
OG00680.0(31.9 to 200.7)
OG0079.3(2.2 to 38.3)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00621
ParticipantsOG0079
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00081.9(30.9 to 216.9)
OG00180.0(17.5 to 364.8)
OG00261.1(21.7 to 172.3)
OG00380.0(18.9 to 338.6)
OG00417.5(8.4 to 36.6)
OG0057.2(4.2 to 12.3)
OG00617.0(8.6 to 33.3)
OG0075.4(4.5 to 6.4)
1.03
(0.67 to 1.56)
OG00429.47(11.70 to 74.22)
OG0051.00(0.88 to 1.13)
OG00627.94(13.64 to 57.23)
OG0071.05(0.94 to 1.18)
OG00827.58(20.91 to 36.38)
OG0090.97(0.82 to 1.16)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00623
ParticipantsOG00713
ParticipantsOG008158
ParticipantsOG00953
Title
Measurements
OG0007.89(2.01 to 31.00)
OG0010.71(0.45 to 1.11)
OG00220.26(5.34 to 76.93)
OG0031.05(0.69 to 1.59)
OG004181.02(47.86 to 684.60)
OG0051.39(0.81 to 2.37)
OG006128.00(44.62 to 367.22)
OG0071.00(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the lower limit of detection (LLOD).
OG008113.02(0.1 to 8192.0)
OG0090.94(0.0 to 2.0)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00623
ParticipantsOG00713
ParticipantsOG008158
ParticipantsOG00953
Title
Measurements
OG0002.34(1.22 to 4.52)
OG0010.97(0.74 to 1.28)
OG0024.40(1.85 to 10.48)
OG0031.08(0.71 to 1.63)
OG00424.17(10.16 to 57.49)
OG0051.02(0.98 to 1.07)
OG00613.76(6.01 to 31.50)
OG0071.00(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
OG00812.47(9.18 to 16.92)
OG0090.82(0.71 to 0.94)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00623
ParticipantsOG00713
ParticipantsOG008158
ParticipantsOG00953
Title
Measurements
OG0001.71(0.88 to 3.31)
OG0011.11(0.65 to 1.90)
OG0022.74(1.11 to 6.80)
OG0030.82(0.53 to 1.26)
OG0047.49(3.60 to 15.58)
OG0051.13(0.94 to 1.36)
OG0064.00(1.85 to 8.66)
OG0070.95(0.84 to 1.06)
OG00874.1(66.5 to 80.7)
OG00935.8(23.1 to 50.2)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008159
ParticipantsOG00953
Title
Measurements
OG0003.10(1.26 to 7.59)
OG0011.70(0.75 to 3.90)
OG0025.40(2.50 to 11.63)
OG0031.08(0.71 to 1.63)
OG00418.87(7.61 to 46.81)
OG0050.96(0.88 to 1.05)
OG00611.14(5.37 to 23.09)
OG0071.000(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
OG008324.2(239.1 to 439.6)
OG00927.9(14.6 to 53.4)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008159
ParticipantsOG00953
Title
Measurements
OG0007.09(2.20 to 22.83)
OG0011.27(0.78 to 2.08)
OG00213.45(4.52 to 40.08)
OG0031.16(0.74 to 1.83)
OG00474.25(30.35 to 181.64)
OG0051.00(0.88 to 1.13)
OG00651.33(20.33 to 129.62)
OG0071.00(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
OG008463.5(364.0 to 590.2)
OG00915.2(8.9 to 25.9)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008159
ParticipantsOG00953
Title
Measurements
OG0002.29(1.29 to 4.05)
OG0011.17(0.74 to 1.85)
OG0022.57(1.14 to 5.80)
OG0031.19(0.67 to 2.13)
OG00414.98(6.11 to 36.75)
OG0051.02(0.92 to 1.13)
OG0066.83(3.13 to 14.93)
OG0071.07(0.93 to 1.23)
OG008139.5(99.7 to 195.1)
OG00917.1(10.2 to 28.5)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008159
ParticipantsOG00953
Title
Measurements
OG0001.64(1.02 to 2.66)
OG0010.73(0.52 to 1.01)
OG0023.70(1.78 to 7.66)
OG0031.22(0.72 to 2.07)
OG0043.81(1.73 to 8.36)
OG0051.18(0.90 to 1.54)
OG0062.45(1.39 to 4.32)
OG0071.00(0.81 to 1.23)
OG00833.7(25.4 to 44.7)
OG00911.8(8.2 to 16.9)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008156
ParticipantsOG00953
Title
Measurements
OG0003.64(1.09 to 12.10)
OG0010.81(0.56 to 1.16)
OG00212.63(5.56 to 28.70)
OG0030.82(0.34 to 2.01)
OG00442.36(19.57 to 91.70)
OG0051.23(0.72 to 2.09)
OG00639.27(24.12 to 63.94)
OG0071.00(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
OG00835.44(26.46 to 47.48)
OG0091.01(0.79 to 1.28)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008156
ParticipantsOG00953
Title
Measurements
OG0008.79(2.81 to 27.47)
OG0011.08(0.79 to 1.49)
OG00220.59(6.45 to 65.66)
OG0031.00(0.67 to 1.50)
OG00475.48(29.82 to 191.08)
OG0051.73(0.56 to 5.38)
OG00650.53(24.11 to 105.89)
OG0071.00(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
OG00844.16(33.51 to 58.20)
OG0090.92(0.67 to 1.28)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008156
ParticipantsOG00953
Title
Measurements
OG0002.78(1.44 to 5.37)
OG0011.24(0.70 to 2.20)
OG0024.54(2.02 to 10.17)
OG0031.03(0.60 to 1.75)
OG00428.98(14.52 to 57.87)
OG0051.73(0.73 to 4.14)
OG00620.26(12.02 to 34.17)
OG0071.00(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
OG00819.20(14.75 to 24.98)
OG0090.80(0.64 to 1.01)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG008156
ParticipantsOG00953
Title
Measurements
OG0002.45(1.44 to 4.19)
OG0010.73(0.43 to 1.23)
OG0024.00(2.00 to 8.00)
OG0031.22(0.72 to 2.07)
OG0047.87(4.25 to 14.57)
OG0052.17(0.99 to 4.76)
OG0066.02(3.81 to 9.53)
OG0070.94(0.82 to 1.08)
OG0087.43(5.96 to 9.27)
OG0091.03(0.91 to 1.16)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0003.94(1.35 to 11.54)
OG0010.89(0.59 to 1.35)
OG0029.16(2.89 to 29.05)
OG0030.71(0.45 to 1.10)
OG00417.70(10.04 to 31.22)
OG0051.13(0.77 to 1.66)
OG00616.81(9.56 to 29.53)
OG0071.00(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00011.53(3.61 to 36.83)
OG0010.94(0.55 to 1.63)
OG00217.16(5.15 to 57.17)
OG0031.03(0.58 to 1.84)
OG00449.34(22.02 to 110.57)
OG0051.44(0.66 to 3.17)
OG00643.89(21.22 to 90.80)
OG0071.00(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0002.42(1.23 to 4.76)
OG0011.26(0.95 to 1.68)
OG0024.58(1.72 to 12.21)
OG0030.73(0.44 to 1.20)
OG00414.52(7.70 to 27.38)
OG0051.50(0.86 to 2.64)
OG0069.66(4.84 to 19.30)
OG0071.21(0.79 to 1.84)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0002.38(1.43 to 3.95)
OG0011.00(0.63 to 1.58)
OG0023.35(1.60 to 7.01)
OG0030.91(0.60 to 1.37)
OG0045.76(3.14 to 10.55)
OG0051.44(0.88 to 2.36)
OG0064.13(2.29 to 7.43)
OG0070.94(0.82 to 1.08)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0005.51(2.13 to 14.26)
OG0010.67(0.47 to 0.95)
OG0026.17(2.36 to 16.14)
OG0031.09(0.50 to 2.37)
OG00410.14(4.81 to 21.39)
OG0051.39(0.91 to 2.12)
OG00614.90(7.48 to 29.66)
OG0071.07(0.93 to 1.23)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0009.04(2.76 to 29.60)
OG0010.93(0.64 to 1.34)
OG0029.65(3.34 to 27.83)
OG0031.16(0.54 to 2.46)
OG00425.30(10.10 to 63.38)
OG0051.71(0.81 to 3.59)
OG00632.84(15.76 to 68.42)
OG0071.00(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0002.56(1.21 to 5.39)
OG0010.95(0.71 to 1.27)
OG0022.44(1.00 to 5.96)
OG0030.83(0.44 to 1.57)
OG0047.92(3.28 to 19.10)
OG0051.41(0.88 to 2.29)
OG0069.28(4.55 to 18.92)
OG0071.00(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0002.32(1.15 to 4.70)
OG0010.75(0.53 to 1.06)
OG0023.45(1.66 to 7.17)
OG0031.03(0.45 to 2.38)
OG0043.29(1.83 to 5.89)
OG0051.18(0.96 to 1.44)
OG0062.92(1.71 to 4.98)
OG0070.94(0.82 to 1.08)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0004.65(1.45 to 14.97)
OG0010.63(0.43 to 0.92)
OG0023.65(1.68 to 7.96)
OG0031.27(0.64 to 2.54)
OG0048.83(4.69 to 16.64)
OG0051.13(0.87 to 1.46)
OG00616.77(7.12 to 39.51)
OG0071.15(0.84 to 1.57)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0009.13(2.52 to 33.07)
OG0010.80(0.51 to 1.24)
OG0028.61(3.28 to 22.56)
OG0030.88(0.52 to 1.48)
OG00421.53(9.91 to 46.81)
OG0051.30(0.73 to 2.32)
OG00624.10(11.73 to 49.52)
OG0071.07(0.92 to 1.25)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0003.15(1.38 to 7.21)
OG0010.93(0.67 to 1.28)
OG0022.00(0.76 to 5.28)
OG0031.21(0.72 to 2.02)
OG0045.04(2.21 to 11.50)
OG0051.06(0.80 to 1.41)
OG00610.79(4.16 to 28.00)
OG0071.62(0.54 to 4.87)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00622
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0001.54(0.77 to 3.10)
OG0010.56(0.39 to 0.82)
OG0022.88(1.41 to 5.90)
OG0031.62(0.76 to 3.43)
OG0042.97(1.56 to 5.66)
OG0051.33(0.95 to 1.86)
OG0063.88(1.89 to 7.96)
OG0071.07(0.74 to 1.55)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00621
ParticipantsOG0079
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0003.91(1.40 to 10.94)
OG0010.77(0.45 to 1.31)
OG0023.43(1.66 to 7.08)
OG0031.33(0.73 to 2.41)
OG0047.13(3.86 to 13.17)
OG0051.13(0.79 to 1.62)
OG0069.59(4.72 to 19.48)
OG0071.26(0.74 to 2.15)
ParticipantsOG00421
ParticipantsOG00517
ParticipantsOG00621
ParticipantsOG0079
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0004.59(1.45 to 14.59)
OG0010.68(0.51 to 0.90)
OG0026.35(2.54 to 15.87)
OG0030.83(0.51 to 1.34)
OG00412.29(5.76 to 26.22)
OG0051.28(0.73 to 2.24)
OG00612.70(5.92 to 27.25)
OG0071.00(NA to NA)Lower and upper limits of CI could not be evaluated as titers were below the LLOD.