Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
Official Title
Lot-to-Lot Consistency and Bridging Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
Acronym
Not provided
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
May 2019
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
Oct 5, 2010Actual
Primary Completion Date
Nov 2012Actual
Completion Date
Feb 2013Actual
First Submitted Date
May 27, 2010
First Submission Date that Met QC Criteria
May 27, 2010
First Posted Date
May 31, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
May 21, 2019
Results First Submitted that Met QC Criteria
May 21, 2019
Results First Posted Date
Jul 24, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 21, 2019
Last Update Posted Date
Jul 24, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Sanofi Pasteur, a Sanofi CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study was to demonstrate that different CYD dengue vaccine lots manufactured using the same method and in the same location but at different times produce an equivalent immunological response after 3 doses.
Primary Objective
To demonstrate that three different Phase III lots of CYD dengue vaccine induce an equivalent immune response in terms of post-Dose 3 geometric mean titers (GMTs) against the four parental serotypes.
Secondary Objectives:
To demonstrate that data from one Phase II lot and pooled data from Phase III lots of CYD dengue vaccine show an equivalent immune response in terms of post-Dose 3 GMTs against the four parental serotypes.
To describe the safety of the CYD dengue vaccine in all participants after each dose.
Detailed Description
All participants received 3 doses of their assigned vaccine or placebo and provided blood samples at defined timepoints for flavivirus status and immunogenicity assessment. Safety data were collected in all participants after each dose and throughout the study.
Conditions Module
Conditions
Dengue Fever
Dengue Hemorrhagic Fever
Keywords
Dengue Fever
Dengue Hemorrhagic Fever
CYD Dengue Vaccine
Lot Consistency
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
715Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
CYD Dengue Vaccine Phase III Lot 1
Experimental
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1),Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine
GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) assay. The lot-to-lot consistency between 3 Phase III lots was based on the use of the two-sided 95% confidence interval (CI) of the differences of the means of the log10 transformed post-vaccination titers between pairs of lots.
28 days post-injection 3
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine
GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using PRNT assay. Equivalence of Phase III vaccine with Phase II vaccine was assessed by Bridging between Phase III and Phase II Lot of CYD Dengue Vaccine.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Aged 18 to 60 years on the day of inclusion.
Informed consent form was signed and dated.
Able to attend all scheduled visits and to comply with all trial procedures.
For a woman of childbearing potential, use of an effective method of contraception, or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination (i.e., for 14 months).
Exclusion Criteria:
Known pregnancy, or a positive urine pregnancy test.
History of flavivirus infection or vaccination or prolonged habitation in a dengue endemic area.
Currently breastfeeding a child.
Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination.
Planned participation in another clinical trial during the present trial period.
Planned receipt of any vaccine in the 4 weeks following any trial vaccination, except for pandemic influenza vaccination.
Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
Self-reported seropositivity for human immunodeficiency virus (HIV).
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures.
Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
Identified as a site employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the site employees or the Investigator.
Torresi J, Heron LG, Qiao M, Marjason J, Chambonneau L, Bouckenooghe A, Boaz M, van der Vliet D, Wallace D, Hutagalung Y, Nissen MD, Richmond PC. Lot-to-lot consistency of a tetravalent dengue vaccine in healthy adults in Australia: a randomised study. Vaccine. 2015 Sep 22;33(39):5127-34. doi: 10.1016/j.vaccine.2015.08.008. Epub 2015 Aug 13.
A total of 715 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled in the study.
Recruitment Details
Study participants were enrolled from 05 October 2010 to 26 November 2010 at 8 study sites in Australia.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
CYD Dengue Vaccine Phase III Lot 1
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
FG001
CYD Dengue Vaccine Phase III Lot 2
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
An observer-blind procedure was followed for the three injections with CYD dengue vaccine or placebo. Neither the observer, Investigator, Sponsor, nor the participant knew which product was administered.
Who Masked
ParticipantInvestigatorOutcomes Assessor
Placebo Comparator
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: Significant; prevents daily activity. Erythema and Swelling: Grade 3: > 10 cm. Participants with Injection Site Reactions of any Grade (1, 2 or 3) and grade 3 were reported.
7 days post any vaccination
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Solicited systemic reactions: Asthenia, Fever, Headache, Malaise and Myalgia. Fever: Grade 3: >=39.0°C (>=102.1°F). Headache, malaise, myalgia and asthenia: Grade 3: significant; prevents daily activity. Participants with systemic reactions of any Grade (1, 2 or 3) and grade 3 were reported.
14 days post any vaccination
Carina Heights
QLD 4152
Australia
Enoggera
QLD 4051
Australia
Heidelberg
VIC 3084
Australia
Herston
QLD 4006
Australia
Herston
QLD 4029
Australia
Subiaco
WA 6008
Australia
Westmead
NSW 2145
Australia
Derived
Torresi J, Richmond PC, Heron LG, Qiao M, Marjason J, Starr-Spires L, van der Vliet D, Jin J, Wartel TA, Bouckenooghe A. Replication and Excretion of the Live Attenuated Tetravalent Dengue Vaccine CYD-TDV in a Flavivirus-Naive Adult Population: Assessment of Vaccine Viremia and Virus Shedding. J Infect Dis. 2017 Oct 17;216(7):834-841. doi: 10.1093/infdis/jix314.
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
FG002
CYD Dengue Vaccine Phase III Lot 3
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
FG003
CYD Dengue Vaccine Phase II Lot
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
FG004
Placebo
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
FG000164 subjects
FG001163 subjects
FG002163 subjects
FG003168 subjects
FG00457 subjects
Received Vaccination 1
FG000163 subjects
FG001162 subjects
FG002163 subjects
FG003167 subjects
FG00457 subjects
Received Vaccination 2
FG000151 subjects
FG001152 subjects
FG002139 subjects
FG003154 subjects
FG00453 subjects
Received Vaccination 3
FG000140 subjects
FG001145 subjects
FG002134 subjects
FG003151 subjects
FG00449 subjects
Safety Population
Safety Population:All participants who received study drug, analyzed according to treatment received
FG000163 subjects
FG001161 subjects
FG002164 subjects1 participant randomized to the Phase III Lot 2 group, received Phase III Lot 3 vaccination.
FG003167 subjects
FG00457 subjects
COMPLETED
FG000140 subjects
FG001143 subjects
FG002134 subjects
FG003149 subjects
FG00448 subjects
NOT COMPLETED
FG00024 subjects
FG00120 subjects
FG00229 subjects
FG00319 subjects
FG0049 subjects
Type
Comment
Reasons
Serious adverse event
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
Other adverse event
FG0001 subjects
FG0012 subjects
FG0025 subjects
FG0033 subjects
FG004
Protocol Violation
FG0008 subjects
FG0017 subjects
FG0022 subjects
FG0034 subjects
FG004
Lost to Follow-up
FG0004 subjects
FG0013 subjects
FG0025 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG0008 subjects
FG0016 subjects
FG00216 subjects
FG0037 subjects
FG004
Enrolled, but not treated
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Analysis was performed on Full Analysis Set included all participants who received at least 1 injection of CYD Dengue Vaccine or placebo.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
CYD Dengue Vaccine Phase III Lot 1
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
BG001
CYD Dengue Vaccine Phase III Lot 2
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
BG002
CYD Dengue Vaccine Phase III Lot 3
Participants received 3 doses of 0.5 ml CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
BG003
CYD Dengue Vaccine Phase II Lot
Participants received 3 doses of 0.5 ml CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months, subcutaneously.
BG004
Placebo
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000163
BG001162
BG002163
BG003167
BG00457
BG005712
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00039.4± 13.3
BG00139.4± 12.9
BG00238.7± 14.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000103
BG00187
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
Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine
GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) assay. The lot-to-lot consistency between 3 Phase III lots was based on the use of the two-sided 95% confidence interval (CI) of the differences of the means of the log10 transformed post-vaccination titers between pairs of lots.
Analysis was performed on Per-protocol analysis set which included participants who received at least 1 dose of the study vaccine or placebo and had no protocol deviations. Data for this outcome measure was not planned to be collected and analyzed for Phase II Lot and placebo.
Posted
Geometric Mean
95% Confidence Interval
Titer (1/dilution)
28 days post-injection 3
ID
Title
Description
OG000
CYD Dengue Vaccine Phase III Lot 1
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
OG001
CYD Dengue Vaccine Phase III Lot 2
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month12 (vaccination 3), subcutaneously.
OG002
CYD Dengue Vaccine Phase III Lot 3
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month12 (vaccination 3) , subcutaneously.
Units
Counts
Participants
OG000129
OG001123
OG002124
Title
Denominators
Categories
Dengue Virus Serotype 1
Title
Measurements
OG00020.6(16.9 to 25.1)
OG00118.1(14.8 to 22.2)
OG00217.1(13.9 to 21.2)
Dengue Virus Serotype 2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Dengue Virus Serotype 1: Phase III Lot 1 vs Lot 2
Difference of Log10 GMT
0.055
2-Sided
95
-0.067
0.178
Equivalence
Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
Secondary
Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine
GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using PRNT assay. Equivalence of Phase III vaccine with Phase II vaccine was assessed by Bridging between Phase III and Phase II Lot of CYD Dengue Vaccine.
Analysis was performed on Per Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for placebo.
Posted
Geometric Mean
95% Confidence Interval
Titer (1/dilution)
28 days post-Injection 3
ID
Title
Description
OG000
CYD Dengue Vaccine Pooled Phase III Lot
Participants received 3 doses of CYD dengue vaccine one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3) from any of the Phase III Lots 1, 2 or 3.
OG001
CYD Dengue Vaccine Phase II Lot
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Secondary
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: Significant; prevents daily activity. Erythema and Swelling: Grade 3: > 10 cm. Participants with Injection Site Reactions of any Grade (1, 2 or 3) and grade 3 were reported.
Analysis was performed on Safety Analysis Set which included all participants who received the study dose, and participants were analyzed according to the treatment received. Here, 'number analyzed' = participants with available data for each specified category.
Posted
Count of Participants
Participants
7 days post any vaccination
ID
Title
Description
OG000
CYD Dengue Vaccine Phase III Lot 1
Participants received 3 doses of 0.5 ml CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
OG001
CYD Dengue Vaccine Phase III Lot 2
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
OG002
CYD Dengue Vaccine Phase III Lot 3
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Secondary
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Solicited systemic reactions: Asthenia, Fever, Headache, Malaise and Myalgia. Fever: Grade 3: >=39.0°C (>=102.1°F). Headache, malaise, myalgia and asthenia: Grade 3: significant; prevents daily activity. Participants with systemic reactions of any Grade (1, 2 or 3) and grade 3 were reported.
Analysis was performed on Safety Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.
Posted
Count of Participants
Participants
14 days post any vaccination
ID
Title
Description
OG000
CYD Dengue Vaccine Phase III Lot 1
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
OG001
CYD Dengue Vaccine Phase III Lot 2
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
OG002
CYD Dengue Vaccine Phase III Lot 3
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Time Frame
Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Description
Analysis was performed on Safety Analysis Set.
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
CYD Dengue Vaccine Phase III Lot 1
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
0
163
10
163
136
163
EG001
CYD Dengue Vaccine Phase III Lot 2
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
0
161
9
161
131
161
EG002
CYD Dengue Vaccine Phase III Lot 3
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
0
164
5
164
135
164
EG003
CYD Dengue Vaccine Phase II Lot
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
0
167
9
167
140
167
EG004
Placebo
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
0
57
1
57
41
57
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Stress Cardiomyopathy
Cardiac disorders
MedDra version 13.0
Systematic Assessment
EG0001 events1 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG0030 events0 affected167 at risk
EG0040 events0 affected57 at risk
Abdominal Pain
Gastrointestinal disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0011 events1 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0010 events0 affected161 at risk
EG0021 events1 affected164 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0010 events0 affected161 at risk
EG0021 events1 affected164 at risk
EG003
Pancreatitis Acute
Gastrointestinal disorders
MedDra version 13.0
Systematic Assessment
EG0001 events1 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Chest Pain
General disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Pyrexia
General disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0010 events0 affected161 at risk
EG0021 events1 affected164 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0011 events1 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Hypersensitivity
Immune system disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0011 events1 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Appendicitis
Infections and infestations
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Bartholin's Abscess
Infections and infestations
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0011 events1 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Cellulitis
Infections and infestations
MedDra version 13.0
Systematic Assessment
EG0001 events1 affected163 at risk
EG0011 events1 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Groin Abscess
Infections and infestations
MedDra version 13.0
Systematic Assessment
EG0001 events1 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Skin Infection
Infections and infestations
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Foreign Body
Injury, poisoning and procedural complications
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Ligament Rupture
Injury, poisoning and procedural complications
MedDra version 13.0
Systematic Assessment
EG0001 events1 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Muscle Rupture
Injury, poisoning and procedural complications
MedDra version 13.0
Systematic Assessment
EG0001 events1 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Diabetic Ketoacidosis
Metabolism and nutrition disorders
MedDra version 13.0
Systematic Assessment
EG0001 events1 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Type 2 Diabetes Mellitus
Metabolism and nutrition disorders
MedDra version 13.0
Systematic Assessment
EG0001 events1 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Haemarthrosis
Musculoskeletal and connective tissue disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0011 events1 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDra version 13.0
Systematic Assessment
EG0001 events1 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Polymyalgia Rheumatica
Musculoskeletal and connective tissue disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0011 events1 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Hypergammaglobulinaemia Benign Monoclonal
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra version 13.0
Systematic Assessment
EG0001 events1 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Malignant Melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra version 13.0
Systematic Assessment
EG0001 events1 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Malignant Melanoma In Situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0011 events1 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Headache
Nervous system disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0011 events1 affected161 at risk
EG0021 events1 affected164 at risk
EG003
Paraesthesia
Nervous system disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0010 events0 affected161 at risk
EG0023 events1 affected164 at risk
EG003
Anxiety
Psychiatric disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0014 events1 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Calculus Ureteric
Renal and urinary disorders
MedDra version 13.0
Systematic Assessment
EG0001 events1 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Nephritis
Renal and urinary disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0011 events1 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Pelvic Pain
Reproductive system and breast disorders
MedDra version 13.0
Systematic Assessment
EG0000 events0 affected163 at risk
EG0010 events0 affected161 at risk
EG0020 events0 affected164 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Toothache
Gastrointestinal disorders
MedDra version 13.0
Systematic Assessment
EG0001 events1 affected163 at risk
EG0013 events2 affected161 at risk
EG0024 events4 affected164 at risk
EG0034 events1 affected167 at risk
EG0043 events3 affected57 at risk
Asthenia
General disorders
MedDra version 13.0
Systematic Assessment
EG00066 events49 affected163 at risk
EG00172 events51 affected161 at risk
EG00274 events58 affected164 at risk
EG003
Injection Site Erythema
General disorders
MedDra version 13.0
Systematic Assessment
EG00026 events22 affected163 at risk
EG00120 events15 affected161 at risk
EG00231 events25 affected164 at risk
EG003
Injection Site Haematoma
General disorders
MedDra version 13.0
Systematic Assessment
EG00012 events12 affected163 at risk
EG00111 events9 affected161 at risk
EG00213 events12 affected164 at risk
EG003
Injection Site Pain
General disorders
MedDra version 13.0
Systematic Assessment
EG000122 events73 affected163 at risk
EG001114 events74 affected161 at risk
EG002122 events73 affected164 at risk
EG003
Malaise
General disorders
MedDra version 13.0
Systematic Assessment
EG000110 events72 affected163 at risk
EG001116 events75 affected161 at risk
EG002146 events97 affected164 at risk
EG003
Pyrexia
General disorders
MedDra version 13.0
Systematic Assessment
EG0007 events6 affected163 at risk
EG00111 events9 affected161 at risk
EG00210 events9 affected164 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDra version 13.0
Systematic Assessment
EG00013 events11 affected163 at risk
EG0016 events6 affected161 at risk
EG00211 events9 affected164 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDra version 13.0
Systematic Assessment
EG00013 events13 affected163 at risk
EG00115 events14 affected161 at risk
EG00218 events16 affected164 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDra version 13.0
Systematic Assessment
EG000100 events70 affected163 at risk
EG001105 events69 affected161 at risk
EG002111 events72 affected164 at risk
EG003
Headache
Nervous system disorders
MedDra version 13.0
Systematic Assessment
EG000188 events103 affected163 at risk
EG001186 events97 affected161 at risk
EG002208 events108 affected164 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDra version 13.0
Systematic Assessment
EG0009 events7 affected163 at risk
EG0019 events5 affected161 at risk
EG0022 events2 affected164 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDra version 13.0
Systematic Assessment
EG00010 events9 affected163 at risk
EG0013 events3 affected161 at risk
EG0023 events3 affected164 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDra version 13.0
Systematic Assessment
EG00017 events16 affected163 at risk
EG0015 events5 affected161 at risk
EG0027 events7 affected164 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
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Point of Contact
Title
Organization
Phone
Extension
Email
Trial Transparency Team
Sanofi Pasteur
Contact-US@sanofi.com
ID
Term
D003715
Dengue
D019595
Severe Dengue
Ancestor Terms
ID
Term
D000096724
Mosquito-Borne Diseases
D000079426
Vector Borne Diseases
D007239
Infections
D001102
Arbovirus Infections
D014777
Virus Diseases
D018177
Flavivirus Infections
D018178
Flaviviridae Infections
D012327
RNA Virus Infections
D006482
Hemorrhagic Fevers, Viral
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
2 subjects
1 subjects
5 subjects
0 subjects
38.4
± 13.2
BG00439.7± 13.5
BG00539.0± 13.4
84
BG00384
BG00433
BG005391
Male
BG00060
BG00175
BG00279
BG00383
BG00424
BG005321
Title
Measurements
OG00065.9(50.6 to 85.7)
OG00144.1(33.3 to 58.3)
OG00258.1(43.2 to 78.2)
Dengue Virus Serotype 3
Title
Measurements
OG00074.2(60.1 to 91.7)
OG00165(53.2 to 79.3)
OG00271.6(58.2 to 88.2)
Dengue Virus Serotype 4
Title
Measurements
OG000131.8(101.4 to 171.3)
OG00194.6(75.3 to 118.7)
OG002108.5(84.2 to 139.7)
OG001
OG002
Dengue Virus Serotype 1: Phase III Lot 2 vs Lot 3
Difference of Log10 GMT
0.024
2-Sided
95
-0.102
0.151
Equivalence
Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
OG000
OG002
Dengue Virus Serotype 1: Phase III Lot 3 vs Lot 1
Difference of Log10 GMT
-0.080
2-Sided
95
-0.204
0.045
Equivalence
Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
OG000
OG001
Dengue Virus Serotype 2: Phase III Lot 1 vs Lot 2
Difference of Log10 GMT
0.174
2-Sided
95
0.009
0.340
Equivalence
Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
OG001
OG002
Dengue Virus Serotype 2: Phase III Lot 2 vs Lot 3
Difference of Log10 GMT
-0.120
2-Sided
95
-0.297
0.056
Equivalence
Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
OG000
OG002
Dengue Virus Serotype 2: Phase III Lot 3 vs Lot 1
Difference of Log10 GMT
-0.054
2-Sided
95
-0.225
0.117
Equivalence
Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
OG000
OG001
Dengue Virus Serotype 3: Phase III Lot 1 vs Lot 2
Difference of Log10 GMT
0.058
2-Sided
95
-0.068
0.184
Equivalence
Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
OG001
OG002
Dengue Virus Serotype 3: Phase III Lot 2 vs Lot 3
Difference of Log10 GMT
-0.042
2-Sided
95
-0.167
0.082
Equivalence
Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
OG000
OG002
Dengue Virus Serotype 3: Phase III Lot 3 vs Lot 1
Difference of Log10 GMT
-0.016
2-Sided
95
-0.144
0.113
Equivalence
Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
OG000
OG001
Dengue Virus Serotype 4: Phase III Lot 1 vs Lot 2
Difference of Log10 GMT
0.144
2-Sided
95
-0.006
0.295
Equivalence
Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
OG001
OG002
Dengue Virus Serotype 4: Phase III Lot 2 vs Lot 3
Difference of Log10 GMT
-0.060
2-Sided
95
-0.207
0.088
Equivalence
Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
OG000
OG002
Dengue Virus Serotype 4: Phase III Lot 3 vs Lot 1
Difference of Log10 GMT
-0.085
2-Sided
95
-0.242
0.073
Equivalence
Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
Units
Counts
Participants
OG000376
OG001128
Title
Denominators
Categories
Dengue Virus Serotype 1
ParticipantsOG000376
ParticipantsOG001128
Title
Measurements
OG00018.6(16.5 to 20.9)
OG00115.1(12.4 to 18.4)
Dengue Virus Serotype 2
ParticipantsOG000376
ParticipantsOG001128
Title
Measurements
OG00055.4(47.2 to 65.1)
OG001
Dengue Virus Serotype 3
ParticipantsOG000376
ParticipantsOG001128
Title
Measurements
OG00070.2(62.4 to 79.1)
OG001
Dengue Virus Serotype 4
ParticipantsOG000376
ParticipantsOG001127
Title
Measurements
OG000110.9(96.1 to 127.9)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Dengue Virus Serotype 1
Difference of Log10 GMT
0.091
2-Sided
95
-0.009
0.192
Equivalence
Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was > -0.301 and the upper limit was < 0.301.
OG000
OG001
Dengue Virus Serotype 2
Difference of Log10 GMT
0.334
2-Sided
95
0.202
0.466
Equivalence
Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was > -0.301 and the upper limit was < 0.301.
OG000
OG001
Dengue Virus Serotype 3
Difference of Log10 GMT
-0.076
2-Sided
95
-0.173
0.021
Equivalence
Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was > -0.301 and the upper limit was < 0.301.
OG000
OG001
Dengue Virus Serotype 4
Difference of Log10 GMT
-0.017
2-Sided
95
-0.137
0.103
Equivalence
Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was > -0.301 and the upper limit was < 0.301.
OG003
CYD Dengue Vaccine Phase II Lot
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
OG004
Placebo
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Units
Counts
Participants
OG000163
OG001161
OG002164
OG003167
OG00457
Title
Denominators
Categories
Pain: Any
ParticipantsOG000162
ParticipantsOG001160
ParticipantsOG002159
ParticipantsOG003164
ParticipantsOG00457
Title
Measurements
OG00073
OG00174
OG00273
OG003
Pain: Grade 3
ParticipantsOG000162
ParticipantsOG001160
ParticipantsOG002159
ParticipantsOG003164
Erythema: Any
ParticipantsOG000162
ParticipantsOG001160
ParticipantsOG002159
ParticipantsOG003164
Erythema: Grade 3
ParticipantsOG000162
ParticipantsOG001160
ParticipantsOG002159
ParticipantsOG003164
Swelling: Any
ParticipantsOG000162
ParticipantsOG001160
ParticipantsOG002159
ParticipantsOG003164
Swelling: Grade 3
ParticipantsOG000162
ParticipantsOG001160
ParticipantsOG002159
ParticipantsOG003164
OG003
CYD Dengue Vaccine Phase II Lot
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0(vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
OG004
Placebo
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.