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Clinical Trial Results:
An Open Label, Phase 2 Study to Investigate Cell-mediated Immunity and Safety of a Tetravalent Dengue Vaccine Candidate (TDV) Administered Subcutaneously in Healthy Children Aged 4 to 16 Years

Summary
EudraCT number	2022-003456-13
Trial protocol	Outside EU/EEA
Global end of trial date	13 Dec 2020

Results information
Results version number	v1
This version publication date	26 Jan 2023
First version publication date	26 Jan 2023
Other versions	v2

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

DEN-313

ISRCTN number

US NCT number

NCT02948829

WHO universal trial number (UTN)

U1111-1184-1893

Sponsor organisation name

Takeda

Sponsor organisation address

95 Hayden Avenue, Lexington, United States, MA 02421

Public contact

Study Director, Takeda, TrialDisclosures@takeda.com

Scientific contact

Study Director, Takeda, TrialDisclosures@takeda.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

13 Dec 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

13 Dec 2020

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study is to assess the cellular immune responses following 2 doses given 3 months apart of tetravalent dengue vaccine candidate (TDV) in 4 to 16 years' healthy participants.

Protection of trial subjects

Study participants signed an Informed Consent Form. Assent is also obtained from the study participant where required.

Background therapy

Evidence for comparator

Actual start date of recruitment

03 Apr 2017

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Panama: 100

Country: Number of subjects enrolled

Philippines: 100

Worldwide total number of subjects

200

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

190

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Participants took part in the study at 2 investigative sites in Panama and Philippines from 03 April 2017 to 14 December 2020.

Screening details

Healthy participants were enrolled in a single arm in this study to receive 2 doses of Tetravalent Dengue Vaccine (TDV) injection subcutaneously (SC).

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Tetravalent Dengue Vaccine (TDV) 0.5 mL

Arm description

TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3).

Arm type

Experimental

Investigational medicinal product name

Tetravalent Dengue Vaccine (TDV) 0.5 mL

Investigational medicinal product code

TAK-003

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

TDV SC injection.

Number of subjects in period 1	Tetravalent Dengue Vaccine (TDV) 0.5 mL
Started	200
Completed	184
Not completed	16
Other	8
Pregnancy	1
Withdrawal by Subject	5
Lost to follow-up	2

Baseline characteristics

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Reporting group title

Tetravalent Dengue Vaccine (TDV) 0.5 mL

Reporting group description

TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3).

Reporting group values	Tetravalent Dengue Vaccine (TDV) 0.5 mL	Total
Number of subjects	200
Age Categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	6.7 ( 2.28 )	-
Gender categorical
Units: Subjects
Male	99	99
Female	101	101
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	99	99
Not Hispanic or Latino	101	101
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	76	76
Asian	100	100
Black or African American	8	8
White	9	9
More than one race	7	7
Baseline Seropositivity Status
Seropositive at Baseline was defined as a reciprocal neutralizing titer >=10 for one or more dengue serotypes. Seronegative at Baseline was defined as having a reciprocal neutralizing titer <10 for all dengue serotypes. The 4 dengue virus serotypes were dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4.
Units: Subjects
Seropositive	113	113
Seronegative	87	87
Height
Units: Cm
arithmetic mean (standard deviation)	118.38 ( 14.564 )	-
Weight
Units: Kg
arithmetic mean (standard deviation)	23.54 ( 10.258 )	-
Body Mass Index (BMI)
BMI = weight (kg)/[height (m)^2]
Units: Kg/m^2
arithmetic mean (standard deviation)	16.15 ( 3.104 )	-

Subject analysis set title

Tetravalent Dengue Vaccine (TDV) 0.5 mL: Panama

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants from Panama.

Subject analysis set title

Tetravalent Dengue Vaccine (TDV) 0.5 mL: Philippines

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants from Philippines.

Subject analysis set title

Tetravalent Dengue Vaccine (TDV) 0.5 mL: Seropositive

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants seropositive at Baseline.

Subject analysis set title

Tetravalent Dengue Vaccine (TDV) 0.5 mL: Seronegative

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants seronegative status at Baseline.

Subject analysis set title

Tetravalent Dengue Vaccine (TDV) 0.5 mL: CD4+ T Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): CD4+ T cells.

Subject analysis set title

Tetravalent Dengue Vaccine (TDV) 0.5 mL: CD8+ T Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): CD8+ T cells.

Subject analysis set title

TDV 0.5 mL: Panama: CD4+ T Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants from Panama, CD4+ T cells.

Subject analysis set title

TDV 0.5 mL: Philippines: CD4+ T Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants from Philippines, CD4+ T cells.

Subject analysis set title

TDV 0.5 mL: Panama: CD8+ T Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants from Panama, CD8+ T cells.

Subject analysis set title

TDV 0.5 ml: Philippines: CD8+ T Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants from Philippines, CD8+ T cells.

Subject analysis set title

TDV 0.5 mL: Seropositive: CD4+ T-Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants seropositive at Baseline, CD4+ T cells.

Subject analysis set title

TDV 0.5 mL: Seronegative: CD4+ T-Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants seronegative at Baseline, CD4+ T cells.

Subject analysis set title

TDV 0.5 mL: Seropositive: CD8+ T- Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants seropositive at Baseline, CD8+ T cells.

Subject analysis set title

TDV 0.5 mL: Seronegative: CD8+ T-Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants seronegative at Baseline, CD8+ T cells.

Subject analysis sets values	Tetravalent Dengue Vaccine (TDV) 0.5 mL: Panama	Tetravalent Dengue Vaccine (TDV) 0.5 mL: Philippines	Tetravalent Dengue Vaccine (TDV) 0.5 mL: Seropositive	Tetravalent Dengue Vaccine (TDV) 0.5 mL: Seronegative	Tetravalent Dengue Vaccine (TDV) 0.5 mL: CD4+ T Cells	Tetravalent Dengue Vaccine (TDV) 0.5 mL: CD8+ T Cells	TDV 0.5 mL: Panama: CD4+ T Cells	TDV 0.5 mL: Philippines: CD4+ T Cells	TDV 0.5 mL: Panama: CD8+ T Cells	TDV 0.5 ml: Philippines: CD8+ T Cells	TDV 0.5 mL: Seropositive: CD4+ T-Cells	TDV 0.5 mL: Seronegative: CD4+ T-Cells	TDV 0.5 mL: Seropositive: CD8+ T- Cells	TDV 0.5 mL: Seronegative: CD8+ T-Cells
Number of subjects	97	98	109	86	79	79	33	46	33	46	44	35	44	35
Age Categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	0 ( )	0 ( )	0 ( )	0 ( )
Gender categorical
Units: Subjects
Male											0	0	0	0
Female											0	0	0	0
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino											0	0	0	0
Not Hispanic or Latino											0	0	0	0
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native											0	0	0	0
Asian											0	0	0	0
Black or African American											0	0	0	0
White											0	0	0	0
More than one race											0	0	0	0
Baseline Seropositivity Status
Seropositive at Baseline was defined as a reciprocal neutralizing titer >=10 for one or more dengue serotypes. Seronegative at Baseline was defined as having a reciprocal neutralizing titer <10 for all dengue serotypes. The 4 dengue virus serotypes were dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4.
Units: Subjects
Seropositive											0	0	0	0
Seronegative											0	0	0	0
Height
Units: Cm
arithmetic mean (standard deviation)	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	0 ( )	0 ( )	0 ( )	0 ( )
Weight
Units: Kg
arithmetic mean (standard deviation)	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	0 ( )	0 ( )	0 ( )	0 ( )
Body Mass Index (BMI)
BMI = weight (kg)/[height (m)^2]
Units: Kg/m^2
arithmetic mean (standard deviation)	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	0 ( )	0 ( )	0 ( )	0 ( )

End points

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Reporting group title

Tetravalent Dengue Vaccine (TDV) 0.5 mL

Reporting group description

TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3).

Subject analysis set title

Tetravalent Dengue Vaccine (TDV) 0.5 mL: Panama

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants from Panama.

Subject analysis set title

Tetravalent Dengue Vaccine (TDV) 0.5 mL: Philippines

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants from Philippines.

Subject analysis set title

Tetravalent Dengue Vaccine (TDV) 0.5 mL: Seropositive

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants seropositive at Baseline.

Subject analysis set title

Tetravalent Dengue Vaccine (TDV) 0.5 mL: Seronegative

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants seronegative status at Baseline.

Subject analysis set title

Tetravalent Dengue Vaccine (TDV) 0.5 mL: CD4+ T Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): CD4+ T cells.

Subject analysis set title

Tetravalent Dengue Vaccine (TDV) 0.5 mL: CD8+ T Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): CD8+ T cells.

Subject analysis set title

TDV 0.5 mL: Panama: CD4+ T Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants from Panama, CD4+ T cells.

Subject analysis set title

TDV 0.5 mL: Philippines: CD4+ T Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants from Philippines, CD4+ T cells.

Subject analysis set title

TDV 0.5 mL: Panama: CD8+ T Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants from Panama, CD8+ T cells.

Subject analysis set title

TDV 0.5 ml: Philippines: CD8+ T Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants from Philippines, CD8+ T cells.

Subject analysis set title

TDV 0.5 mL: Seropositive: CD4+ T-Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants seropositive at Baseline, CD4+ T cells.

Subject analysis set title

TDV 0.5 mL: Seronegative: CD4+ T-Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants seronegative at Baseline, CD4+ T cells.

Subject analysis set title

TDV 0.5 mL: Seropositive: CD8+ T- Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants seropositive at Baseline, CD8+ T cells.

Subject analysis set title

TDV 0.5 mL: Seronegative: CD8+ T-Cells

Subject analysis set type

Sub-group analysis

Subject analysis set description

TDV 0.5 mL, SC injection, on Day 1 (Month 0) and Day 90 (Month 3): Participants seronegative at Baseline, CD8+ T cells.

Primary: Percentage of Participants With Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination

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End point title

Percentage of Participants With Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination ^[1]

End point description

Percentage of participants with cellular immune response were reported. Cellular immune response was defined as an interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included non-structural protein (NS) for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. Per-Protocol Set (PPS) included all participants from the Full Analysis Set (FAS) who have no major protocol violations. Overall number of participants analysed are participants with data available for analysis.

End point type

Primary

End point timeframe

1 month post second vaccination (Day 120)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed for this outcome measure.

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL
Number of subjects analysed	173
Units: percentage of participants
number (confidence interval 95%)	86.1 (80.1 to 90.9)

No statistical analyses for this end point

Secondary: Magnitude of Cellular Immune Response Assessed by Number of Spot Forming Cells (SFC)/Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by IFN-γ ELISPOT at 1 Month Post Second Vaccination

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End point title

Magnitude of Cellular Immune Response Assessed by Number of Spot Forming Cells (SFC)/Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by IFN-γ ELISPOT at 1 Month Post Second Vaccination

End point description

The magnitude of cellular immune response was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Data (SFC/million PBMC) for participants with a cellular immune response to any peptide pool is reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. PPS included all participants from the FAS who have no major protocol violations. Overall number of participants analysed are participants with data available for analysis.

End point type

Secondary

End point timeframe

1 month post second vaccination (Day 120)

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL
Number of subjects analysed	149
Units: SFC/million PBMCs
median (inter-quartile range (Q1-Q3))	1003.0 (443.0 to 2126.0)

No statistical analyses for this end point

Secondary: Percentage of Participants With Cellular Immune Response to TDV at 1 Month Post First Vaccination and 6 Months Post Second Vaccination

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End point title

Percentage of Participants With Cellular Immune Response to TDV at 1 Month Post First Vaccination and 6 Months Post Second Vaccination

End point description

Percentage of participants with cellular immune response were reported. Cellular immune response was defined as an IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1 [M0]) and >=5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. PPS included all participants from the FAS who have no major protocol violations. Number analysed is the number of participants with data available for analysis at the given timepoint.

End point type

Secondary

End point timeframe

1 month post first vaccination (Day 30); 6 month post second vaccination (Day 270)

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL
Number of subjects analysed	195
Units: percentage of participants
number (confidence interval 95%)
Day 30	86.0 (79.8 to 90.8)
Day 270	86.7 (80.7 to 91.4)

No statistical analyses for this end point

Secondary: Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First Vaccination and 6 Months Post Second Vaccination

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End point title

Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First Vaccination and 6 Months Post Second Vaccination

End point description

The magnitude of cellular immune response was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Data (SFC/million PBMC) for participants with a cellular immune response to any peptide pool is reported. The peptide pool included NS protein for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. PPS included all participants from the FAS who have no major protocol violations. Number analysed is the number of participants with data available for analysis at the given timepoint.

End point type

Secondary

End point timeframe

1 month post first vaccination (Day 30); 6 month post second vaccination (Day 270)

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL
Number of subjects analysed	195
Units: SFC/million PBMCs
median (inter-quartile range (Q1-Q3))
Day 30	1181.0 (585.0 to 2891.0)
Day 270	572.5 (250.0 to 1382.0)

No statistical analyses for this end point

Secondary: Percentage of Participants With Cellular Immune Responses to TDV at 1 Month Post First Vaccination, 1 and 6 Months Post Second Vaccination Post Second Vaccination Assessed by Country

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End point title

Percentage of Participants With Cellular Immune Responses to TDV at 1 Month Post First Vaccination, 1 and 6 Months Post Second Vaccination Post Second Vaccination Assessed by Country

End point description

Percentage of participants with cellular immune response by country (Panama and Philippines) were reported. Cellular immune response was defined as an IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1 [M0]) and >=5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. PPS 'by country' included all participants from the FAS who have no major protocol violations. Number analysed is the number of participants with data available for analysis at the given timepoint.

End point type

Secondary

End point timeframe

1 month post first vaccination (Day 30); 1 and 6 months post second vaccination (Days 120 Days 270)

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL: Panama	Tetravalent Dengue Vaccine (TDV) 0.5 mL: Philippines
Number of subjects analysed	97	98
Units: percentage of participants
number (confidence interval 95%)
Day 30	88.2 (78.7 to 94.4)	84.2 (75.3 to 90.9)
Day 120	84.0 (73.7 to 91.4)	87.8 (79.6 to 93.5)
Day 270	90.7 (81.7 to 96.2)	83.7 (74.8 to 90.4)

No statistical analyses for this end point

Secondary: Percentage of Participants With Cellular Immune Responses to TDV:1 Month Post First Vaccination, 1 and 6 Months Post Second Vaccination Post Second Vaccination, by Dengue Baseline Seropositivity Status

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End point title

Percentage of Participants With Cellular Immune Responses to TDV:1 Month Post First Vaccination, 1 and 6 Months Post Second Vaccination Post Second Vaccination, by Dengue Baseline Seropositivity Status

End point description

Percentage of participants with cellular immune response by dengue Baseline seropositivity status (Seropositive and Seronegative) were reported. Cellular immune response was defined as an IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1 [M0]) and >=5 spots per well. Seropositive at Baseline was defined as a reciprocal neutralizing titer >=10 for one or more dengue serotypes. Seronegative at Baseline was defined as having a reciprocal neutralizing titer <10 for all dengue serotypes. The 4 dengue virus serotypes were dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. PPS 'by Baseline seropositivity status' included all participants from the FAS who have no major protocol violations. Number analysed is the number of participants with data available for analysis at the given timepoint.

End point type

Secondary

End point timeframe

1 month post first vaccination (Day 30); 1 and 6 months post second vaccination (Days 120 Days 270)

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL: Seropositive	Tetravalent Dengue Vaccine (TDV) 0.5 mL: Seronegative
Number of subjects analysed	109	86
Units: percentage of participants
number (confidence interval 95%)
Day 30	81.4 (72.3 to 88.6)	91.9 (83.2 to 97.0)
Day 120	82.0 (73.1 to 89.0)	91.8 (83.0 to 96.9)
Day 270	80.2 (71.1 to 87.5)	95.8 (88.3 to 99.1)

No statistical analyses for this end point

Secondary: Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First, 1 and 6 Months Post Second Vaccination, by Country

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End point title

Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First, 1 and 6 Months Post Second Vaccination, by Country

End point description

The magnitude of cellular immune response by country (Panama and Philippines) was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Data (SFC/million PBMC) for participants with a cellular immune response to any peptide pool is reported. The peptide pool included NS protein for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. PPS 'by country' included all participants from the FAS who have no major protocol violations. Number analysed is the number of participants with data available at the given timepoint.

End point type

Secondary

End point timeframe

1 month post first vaccination (Day 30); 1and 6 months post second vaccination (Days 120 Days 270)

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL: Panama	Tetravalent Dengue Vaccine (TDV) 0.5 mL: Philippines
Number of subjects analysed	97	98
Units: SFC/million PBMCs
median (inter-quartile range (Q1-Q3))
Day 30	1091.0 (533.0 to 2988.0)	1268.5 (672.5 to 2797.0)
Day 120	919.0 (360.0 to 1679.0)	1086.0 (513.0 to 2304.0)
Day 270	439.0 (215.5 to 1428.5)	612.0 (263.0 to 1264.0)

No statistical analyses for this end point

Secondary: Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT 1 Month Post First; 1 and 6 Months Post Second Vaccination, by Dengue Baseline Seropositivity Status

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End point title

Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT 1 Month Post First; 1 and 6 Months Post Second Vaccination, by Dengue Baseline Seropositivity Status

End point description

The magnitude of cellular immune response by dengue Baseline seropositivity status (Seropositive and Seronegative) was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response:IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Seropositive at Baseline:a reciprocal neutralizing titer >=10 for one or more dengue serotypes. Seronegative at Baseline:having a reciprocal neutralizing titer <10 for all dengue serotypes. The 4 dengue virus serotypes were dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. PPS 'by Baseline seropositivity status' included all participants from the FAS who have no major protocol violations. Number analysed:number of participants with data available for analysis at the given timepoint.

End point type

Secondary

End point timeframe

1 month post first vaccination (Day 30); 1and 6 months post second vaccination (Days 120 Days 270)

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL: Seropositive	Tetravalent Dengue Vaccine (TDV) 0.5 mL: Seronegative
Number of subjects analysed	109	86
Units: SFC/million PBMCs
median (inter-quartile range (Q1-Q3))
Day 30	1735.0 (736.0 to 3461.0)	894.0 (527.0 to 2011.0)
Day 120	1216.0 (584.0 to 2774.0)	743.0 (377.0 to 1546.0)
Day 270	719.0 (287.0 to 1684.0)	416.0 (245.0 to 808.0)

No statistical analyses for this end point

Secondary: Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT in Participants >10 Years of Age

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End point title

Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT in Participants >10 Years of Age

End point description

The magnitude of cellular immune response was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. SFC/million PBMC for any peptide pool is reported in participants >10 years of age. The analysis of samples collected at Day 90 and annually at Years 1, 2 and 3 for outcome measures related to assessment of the cellular immune response is still ongoing because of the limited testing capacities of the laboratory due to COVID-19; the data will be reported when available.

End point type

Secondary

End point timeframe

Day 14

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL
Number of subjects analysed	0 ^[2]
Units: SFC/million PBMC
median (inter-quartile range (Q1-Q3))	( to )

Notes
[2] - Data for this outcome measure was not analysed as planned due to testing incapacities of laboratory.

No statistical analyses for this end point

Secondary: Percentage of Participants With Cellular Immune Response to TDV in Participants >10 Years of Age

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End point title

Percentage of Participants With Cellular Immune Response to TDV in Participants >10 Years of Age

End point description

Percentage of participants with cellular immune response in participants >10 years of age were reported. Cellular immune response was defined as an IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1 [M0]) and >=5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included NS for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4. SFC/million PBMC for any peptide pool is reported in participants >10 years of age. The analysis of samples collected at Day 90 and annually at Years 1, 2 and 3 for outcome measures related to assessment of the cellular immune response is still ongoing because of the limited testing capacities of the laboratory due to COVID-19; the data will be reported when available.

End point type

Secondary

End point timeframe

Day 14

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL
Number of subjects analysed	0 ^[3]
Units: percentage of participants
number (confidence interval 95%)	( to )

Notes
[3] - Data for this outcome measure was not analysed as planned due to testing incapacities of laboratory.

No statistical analyses for this end point

Secondary: Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response to DENV-2 NS Proteins at 1 Month Post First, 1 and 6 Months Post Second Vaccination

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End point title

Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response to DENV-2 NS Proteins at 1 Month Post First, 1 and 6 Months Post Second Vaccination

End point description

The phenotype characterization of cellular immune response was assessed by intracellular cytokine staining (ICS) by the frequency of total cluster of differentiation 4 (CD4)+ and CD8+ T cells and was performed in a subset of participants with IFN- γ ELISPOT responses >500 SFC/million cells and availability of sufficient cells. The peptide pools included NS for the DENV-2 serotype. Data are presented for the different expression profiles of interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor-alpha (TNF-α) cytokines for each peptide pool. Data is reported based on the type of T cells present in participants at the time of analysis (CD4+ T cells and CD8+ T cells). ICS Subset 'by T-cells' included participants from PPS who have IFN-γ ELISPOT responses >500 SFC/million PBMCs and availability of sufficient cells. Number analysed is the number of participants with data available for analysis for specific category.

End point type

Secondary

End point timeframe

1 month post first vaccination (Day 30); 1and 6 months post second vaccination (Days 120 Days 270)

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL: CD4+ T Cells	Tetravalent Dengue Vaccine (TDV) 0.5 mL: CD8+ T Cells
Number of subjects analysed	79	79
Units: percentage of T cells
median (inter-quartile range (Q1-Q3))
IFNg+IL2+TNFa+, DENV-2, NS1-2, Day 30	0.008980 (0.003840 to 0.020000)	0.001470 (0.000000 to 0.008470)
IFNg+IL2+TNFa+, DENV-2, NS3-2, Day 30	0.005140 (0.001980 to 0.010000)	0.020000 (0.003400 to 0.039350)
IFNg+IL2+TNFa+, DENV-2, NS5-2, Day 30	0.005380 (0.002890 to 0.011000)	0.016000 (0.003190 to 0.049000)
IFNg+IL2+TNFa-, DENV-2, NS1-2, Day 30	0.000000 (0.000000 to 0.001170)	0.000000 (0.000000 to 0.000000)
IFNg+IL2+TNFa-, DENV-2, NS3-2, Day 30	0.000000 (0.000000 to 0.000000)	0.001210 (0.000000 to 0.002980)
IFNg+IL2+TNFa-, DENV-2, NS5-2, Day 30	0.000000 (0.000000 to 0.000000)	0.001610 (0.000000 to 0.004370)
IFNg+IL2-TNFa+, DENV-2, NS1-2, Day 30	0.004210 (0.000580 to 0.006770)	0.018180 (0.000190 to 0.054000)
IFNg+IL2-TNFa+, DENV-2, NS3-2, Day 30	0.002950 (0.000420 to 0.006480)	0.164350 (0.058000 to 0.448100)
IFNg+IL2-TNFa+, DENV-2, NS5-2, Day 30	0.003460 (0.000070 to 0.006280)	0.145490 (0.034000 to 0.390000)
IFNg-IL2+TNFa+, DENV-2, NS1-2, Day 30	0.002480 (0.000000 to 0.007470)	0.000000 (0.000000 to 0.000000)
IFNg-IL2+TNFa+, DENV-2, NS3-2, Day 30	0.002000 (0.000000 to 0.007290)	0.000000 (0.000000 to 0.000310)
IFNg-IL2+TNFa+, DENV-2, NS5-2, Day 30	0.003350 (0.000000 to 0.008000)	0.000000 (0.000000 to 0.000000)
IFNg+IL2-TNFa-, DENV-2, NS1-2, Day 30	0.000570 (0.000000 to 0.004590)	0.007250 (0.002000 to 0.028000)
IFNg+IL2-TNFa-, DENV-2, NS3-2, Day 30	0.000130 (0.000000 to 0.003030)	0.053000 (0.024540 to 0.208580)
IFNg+IL2-TNFa-, DENV-2, NS5-2, Day 30	0.000740 (0.000000 to 0.003520)	0.063490 (0.017000 to 0.215820)
IFNg-IL2+TNFa-, DENV-2, NS1-2, Day 30	0.001000 (0.000000 to 0.009000)	0.002000 (0.000000 to 0.009000)
IFNg-IL2+TNFa-, DENV-2, NS3-2, Day 30	0.000000 (0.000000 to 0.007000)	0.000000 (0.000000 to 0.008220)
IFNg-IL2+TNFa-, DENV-2, NS5-2, Day 30	0.000000 (0.000000 to 0.009000)	0.002000 (0.000000 to 0.010000)
IFNg-IL2-TNFa+, DENV-2, NS1-2, Day 30	0.000000 (0.000000 to 0.028000)	0.000000 (0.000000 to 0.013000)
IFNg-IL2-TNFa+, DENV-2, NS3-2, Day 30	0.010000 (0.000000 to 0.040000)	0.012000 (0.000000 to 0.030000)
IFNg-IL2-TNFa+, DENV-2, NS5-2, Day 30	0.010000 (0.000000 to 0.050000)	0.010000 (0.000000 to 0.030000)
IFNg+IL2+TNFa+, DENV-2, NS1-2, Day 120	0.008340 (0.003340 to 0.017000)	0.001320 (0.000000 to 0.004240)
IFNg+IL2+TNFa+, DENV-2, NS3-2, Day 120	0.003410 (0.001041 to 0.007190)	0.010000 (0.002650 to 0.018000)
IFNg+IL2+TNFa+, DENV-2, NS5-2, Day 120	0.002100 (0.000000 to 0.004710)	0.007850 (0.002230 to 0.027000)
IFNg+IL2+TNFa-, DENV-2, NS1-2, Day 120	0.001050 (0.000000 to 0.002420)	0.000000 (0.000000 to 0.000000)
IFNg+IL2+TNFa-, DENV-2, NS3-2, Day 120	0.000000 (0.000000 to 0.001420)	0.000000 (0.000000 to 0.001800)
IFNg+IL2+TNFa-, DENV-2, NS5-2, Day 120	0.000000 (0.000000 to 0.000935)	0.000960 (0.000000 to 0.002340)
IFNg+IL2-TNFa+, DENV-2, NS1-2, Day 120	0.002110 (0.000000 to 0.005070)	0.007340 (0.000000 to 0.029850)
IFNg+IL2-TNFa+, DENV-2, NS3-2, Day 120	0.002000 (0.000000 to 0.004160)	0.116110 (0.047000 to 0.317000)
IFNg+IL2-TNFa+, DENV-2, NS5-2, Day 120	0.000860 (0.000000 to 0.002820)	0.096230 (0.030050 to 0.207090)
IFNg-IL2+TNFa+, DENV-2, NS1-2, Day 120	0.007160 (0.002000 to 0.015040)	0.000000 (0.000000 to 0.000000)
IFNg-IL2+TNFa+, DENV-2, NS3-2, Day 120	0.000000 (0.000000 to 0.004710)	0.000000 (0.000000 to 0.000000)
IFNg-IL2+TNFa+, DENV-2, NS5-2, Day 120	0.003350 (0.000000 to 0.009000)	0.000000 (0.000000 to 0.001250)
IFNg+IL2-TNFa-, DENV-2, NS1-2, Day 120	0.002070 (0.000000 to 0.005030)	0.004080 (0.000000 to 0.011000)
IFNg+IL2-TNFa-, DENV-2, NS3-2, Day 120	0.000990 (0.000000 to 0.002630)	0.038000 (0.013270 to 0.094810)
IFNg+IL2-TNFa-, DENV-2, NS5-2, Day 120	0.000000 (0.000000 to 0.002480)	0.018850 (0.007000 to 0.060560)
IFNg-IL2+TNFa-, DENV-2, NS1-2, Day 120	0.009000 (0.000000 to 0.014000)	0.002000 (0.000000 to 0.014000)
IFNg-IL2+TNFa-, DENV-2, NS3-2, Day 120	0.001000 (0.000000 to 0.010000)	0.001000 (0.000000 to 0.017000)
IFNg-IL2+TNFa-, DENV-2, NS5-2, Day 120	0.000000 (0.000000 to 0.013000)	0.001000 (0.000000 to 0.015000)
IFNg-IL2-TNFa+, DENV-2, NS1-2, Day 120	0.002000 (0.000000 to 0.028000)	0.004000 (0.000000 to 0.020000)
IFNg+IL2+TNFa-, DENV-2, NS3-2, Day 270	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.001505)
IFNg+IL2+TNFa-, DENV-2, NS5-2, Day 270	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.001485)
IFNg+IL2-TNFa+, DENV-2, NS1-2, Day 270	0.001052 (0.000000 to 0.003300)	0.005185 (0.000030 to 0.023975)
IFNg+IL2-TNFa+, DENV-2, NS3-2, Day 270	0.001500 (0.000000 to 0.003455)	0.092000 (0.034045 to 0.264215)
IFNg+IL2-TNFa+, DENV-2, NS5-2, Day 270	0.000185 (0.000000 to 0.002785)	0.069500 (0.022135 to 0.204995)
IFNg-IL2+TNFa+, DENV-2, NS1-2, Day 270	0.005065 (0.001000 to 0.010945)	0.000000 (0.000000 to 0.000000)
IFNg-IL2+TNFa+, DENV-2, NS3-2, Day 270	0.001175 (0.000000 to 0.005160)	0.000000 (0.000000 to 0.000000)
IFNg-IL2+TNFa+, DENV-2, NS5-2, Day 270	0.001670 (0.000000 to 0.005240)	0.000000 (0.000000 to 0.000000)
IFNg+IL2-TNFa-, DENV-2, NS1-2, Day 270	0.000000 (0.000000 to 0.002675)	0.003665 (0.000000 to 0.008825)
IFNg+IL2-TNFa-, DENV-2, NS3-2, Day 270	0.000000 (0.000000 to 0.001870)	0.015325 (0.002385 to 0.030105)
IFNg+IL2-TNFa-, DENV-2, NS5-2, Day 270	0.000000 (0.000000 to 0.002565)	0.012000 (0.000530 to 0.028580)
IFNg-IL2+TNFa-, DENV-2, NS1-2, Day 270	0.000500 (0.000000 to 0.008500)	0.001000 (0.000000 to 0.006500)
IFNg-IL2+TNFa-, DENV-2, NS3-2, Day 270	0.000000 (0.000000 to 0.001000)	0.000000 (0.000000 to 0.003730)
IFNg-IL2+TNFa-, DENV-2, NS5-2, Day 270	0.000000 (0.000000 to 0.006000)	0.000000 (0.000000 to 0.006500)
IFNg-IL2-TNFa+-, DENV-2, NS1-2, Day 270	0.000000 (0.000000 to 0.019000)	0.004500 (0.000000 to 0.020000)
IFNg-IL2-TNFa+-, DENV-2, NS3-2, Day 270	0.008000 (0.000000 to 0.030000)	0.015500 (0.000000 to 0.045500)
IFNg-IL2-TNFa+-, DENV-2, NS5-2, Day 270	0.000000 (0.000000 to 0.040000)	0.016500 (0.000000 to 0.037000)

No statistical analyses for this end point

Secondary: Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response DENV-2 NS Proteins,1 Month Post First;1 and 6 Months Post Second Vaccination, by Country

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End point title

Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response DENV-2 NS Proteins,1 Month Post First;1 and 6 Months Post Second Vaccination, by Country

End point description

The phenotype characterization of cellular immune response by country was assessed by ICS by the frequency of total CD4+ and CD8+ T cells and was performed in a subset of participants with IFN- γ ELISPOT responses >500 SFC/million cells and availability of sufficient cells. The peptide pools included NS for the DENV-2 serotype. Data are presented for the different expression profiles of IFN-γ, IL-2 and TNF-α cytokines for each peptide pool. Data is reported per country (Panama and Philippines) based on the type of T cells present in participants at the time of analysis (CD4+ T cells and CD8+ T cells). ICS Subset 'by country based on T-cells' included participants from PPS who have IFN-γ ELISPOT responses >500 SFC/million PBMCs and availability of sufficient cells. Number analysed is the number of participants with data available for analysis for specific category.

End point type

Secondary

End point timeframe

1 month post first vaccination (Day 30); 1and 6 months post second vaccination (Days 120 Days 270)

End point values	TDV 0.5 mL: Panama: CD4+ T Cells	TDV 0.5 mL: Philippines: CD4+ T Cells	TDV 0.5 mL: Panama: CD8+ T Cells	TDV 0.5 ml: Philippines: CD8+ T Cells
Number of subjects analysed	33	46	33	46
Units: percentage of T cells
median (inter-quartile range (Q1-Q3))
IFNg+IL2+TNFa+, DENV-2, NS1-2, Day 30	0.006290 (0.001180 to 0.020000)	0.010500 (0.005950 to 0.020500)	0.002020 (0.000000 to 0.032000)	0.001410 (0.000000 to 0.006160)
IFNg+IL2+TNFa+, DENV-2, NS3-2, Day 30	0.002780 (0.001700 to 0.006630)	0.007780 (0.002095 to 0.012520)	0.020000 (0.002210 to 0.036000)	0.020500 (0.005265 to 0.040175)
IFNg+IL2+TNFa+, DENV-2, NS5-2, Day 30	0.003870 (0.002140 to 0.007600)	0.005815 (0.003360 to 0.012000)	0.025000 (0.003530 to 0.043000)	0.014790 (0.003137 to 0.050000)
IFNg+IL2+TNFa-, DENV-2, NS1-2, Day 30	0.000000 (0.000000 to 0.001770)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)
IFNg+IL2+TNFa-, DENV-2, NS3-2, Day 30	0.000000 (0.000000 to 0.000927)	0.000000 (0.000000 to 0.000000)	0.001330 (0.000000 to 0.003000)	0.001080 (0.000000 to 0.002695)
IFNg+IL2+TNFa-, DENV-2, NS5-2, Day 30	0.000000 (0.000000 to 0.000373)	0.000000 (0.000000 to 0.000000)	0.001880 (0.000000 to 0.004370)	0.001490 (0.000000 to 0.004960)
IFNg+IL2-TNFa+, DENV-2, NS1-2, Day 30	0.004270 (0.000000 to 0.006690)	0.003965 (0.000660 to 0.009180)	0.031000 (0.001060 to 0.164020)	0.013450 (0.000095 to 0.030165)
IFNg+IL2-TNFa+, DENV-2, NS3-2, Day 30	0.002810 (0.000000 to 0.005090)	0.003200 (0.000525 to 0.006710)	0.134020 (0.039510 to 0.420000)	0.179260 (0.064360 to 0.539560)
IFNg+IL2-TNFa+, DENV-2, NS5-2, Day 30	0.003460 (0.000070 to 0.006000)	0.003515 (0.000505 to 0.006655)	0.150000 (0.062000 to 0.382000)	0.144180 (0.024090 to 0.429000)
IFNg-IL2+TNFa+, DENV-2, NS1-2, Day 30	0.002070 (0.000000 to 0.005110)	0.004246 (0.000000 to 0.010235)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)
IFNg-IL2+TNFa+, DENV-2, NS3-2, Day 30	0.002110 (0.000000 to 0.010630)	0.001680 (0.000000 to 0.006350)	0.000000 (0.000000 to 0.000760)	0.000000 (0.000000 to 0.000090)
IFNg-IL2+TNFa+, DENV-2, NS5-2, Day 30	0.003000 (0.000000 to 0.009000)	0.003390 (0.000000 to 0.007805)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)
IFNg+IL2-TNFa-, DENV-2, NS1-2, Day 30	0.000490 (0.000000 to 0.005030)	0.000710 (0.000000 to 0.003450)	0.027540 (0.005000 to 0.062490)	0.005115 (0.000820 to 0.013695)
IFNg+IL2-TNFa-, DENV-2, NS3-2, Day 30	0.001240 (0.000000 to 0.002890)	0.000000 (0.000000 to 0.003210)	0.060020 (0.025260 to 0.170000)	0.050360 (0.022270 to 0.301000)
IFNg+IL2-TNFa-, DENV-2, NS5-2, Day 30	0.000620 (0.000000 to 0.002690)	0.000825 (0.000000 to 0.003600)	0.085000 (0.021000 to 0.166000)	0.053260 (0.013595 to 0.226605)
IFNg-IL2+TNFa-, DENV-2, NS1-2, Day 30	0.005000 (0.000000 to 0.011290)	0.000000 (0.000000 to 0.005000)	0.003000 (0.000000 to 0.011000)	0.001810 (0.000000 to 0.008000)
IFNg-IL2+TNFa-, DENV-2, NS3-2, Day 30	0.001000 (0.000000 to 0.012000)	0.000000 (0.000000 to 0.002000)	0.000000 (0.000000 to 0.009000)	0.001000 (0.000000 to 0.006365)
IFNg-IL2+TNFa-, DENV-2, NS5-2, Day 30	0.006290 (0.000000 to 0.019000)	0.000000 (0.000000 to 0.004000)	0.007000 (0.000000 to 0.010000)	0.000000 (0.000000 to 0.009000)
IFNg-IL2-TNFa+, DENV-2, NS1-2, Day 30	0.000000 (0.000000 to 0.009000)	0.000000 (0.000000 to 0.035000)	0.005000 (0.000000 to 0.021000)	0.000000 (0.000000 to 0.010000)
IFNg-IL2-TNFa+, DENV-2, NS3-2, Day 30	0.008000 (0.000000 to 0.030000)	0.010000 (0.000000 to 0.046000)	0.009000 (0.003000 to 0.020000)	0.013000 (0.000000 to 0.037500)
IFNg-IL2-TNFa+, DENV-2, NS5-2, Day 30	0.000000 (0.000000 to 0.040000)	0.015000 (0.000000 to 0.055000)	0.010000 (0.000000 to 0.027000)	0.001000 (0.000000 to 0.034000)
IFNg+IL2+TNFa+, DENV-2, NS1-2, Day 120	0.005531 (0.003340 to 0.012780)	0.009230 (0.003860 to 0.018610)	0.001590 (0.000000 to 0.006910)	0.001100 (0.000000 to 0.002580)
IFNg+IL2+TNFa+, DENV-2, NS3-2, Day 120	0.002690 (0.001041 to 0.007190)	0.003495 (0.001420 to 0.006660)	0.010000 (0.002850 to 0.016000)	0.010000 (0.002650 to 0.019000)
IFNg+IL2+TNFa+, DENV-2, NS5-2, Day 120	0.000661 (0.000000 to 0.002990)	0.002598 (0.000000 to 0.005470)	0.013000 (0.004830 to 0.021000)	0.006905 (0.001180 to 0.028000)
IFNg+IL2+TNFa-, DENV-2, NS1-2, Day 120	0.000900 (0.000000 to 0.002580)	0.001135 (0.000000 to 0.002180)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)
IFNg+IL2+TNFa-, DENV-2, NS3-2, Day 120	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.001670)	0.000000 (0.000000 to 0.001440)	0.000000 (0.000000 to 0.001920)
IFNg+IL2+TNFa-, DENV-2, NS5-2, Day 120	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.001190)	0.000000 (0.000000 to 0.001650)	0.001175 (0.000000 to 0.003450)
IFNg+IL2-TNFa+, DENV-2, NS1-2, Day 120	0.002396 (0.000260 to 0.005000)	0.002045 (0.000000 to 0.005070)	0.011000 (0.001100 to 0.066340)	0.005500 (0.000000 to 0.019000)
IFNg+IL2-TNFa+, DENV-2, NS3-2, Day 120	0.002456 (0.000250 to 0.005980)	0.001800 (0.000000 to 0.003200)	0.092920 (0.038250 to 0.160000)	0.153500 (0.048520 to 0.353170)
IFNg+IL2-TNFa+, DENV-2, NS5-2, Day 120	0.001590 (0.000000 to 0.002636)	0.000702 (0.000000 to 0.002960)	0.094740 (0.030050 to 0.205000)	0.096615 (0.031580 to 0.220000)
IFNg-IL2+TNFa+, DENV-2, NS1-2, Day 120	0.005710 (0.000000 to 0.010000)	0.008335 (0.002900 to 0.017000)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)
IFNg-IL2+TNFa+, DENV-2, NS3-2, Day 120	0.000000 (0.000000 to 0.005520)	0.000000 (0.000000 to 0.004000)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)
IFNg-IL2+TNFa+, DENV-2, NS5-2, Day 120	0.003580 (0.000000 to 0.008000)	0.003275 (0.000000 to 0.010660)	0.00000 (0.00000 to 0.00000)	0.00000 (0.00000 to 0.001250)
IFNg+IL2-TNFa-, DENV-2, NS1-2, Day 120	0.002490 (0.000000 to 0.005560)	0.001520 (0.000000 to 0.004380)	0.006000 (0.001770 to 0.019000)	0.003750 (0.000000 to 0.007240)
IFNg+IL2-TNFa-, DENV-2, NS3-2, Day 120	0.001620 (0.000000 to 0.002630)	0.000365 (0.000000 to 0.002000)	0.033420 (0.009000 to 0.081860)	0.039000 (0.015000 to 0.104850)
IFNg+IL2-TNFa-, DENV-2, NS5-2, Day 120	0.000000 (0.000000 to 0.002000)	0.000205 (0.000000 to 0.002830)	0.022820 (0.012340 to 0.058000)	0.018425 (0.004130 to 0.060560)
IFNg-IL2+TNFa-, DENV-2, NS1-2, Day 120	0.010000 (0.000000 to 0.015000)	0.007000 (0.000000 to 0.012000)	0.000000 (0.000000 to 0.008000)	0.002000 (0.000000 to 0.017000)
IFNg-IL2+TNFa-, DENV-2, NS3-2, Day 120	0.000000 (0.000000 to 0.005000)	0.001500 (0.000000 to 0.011000)	0.005000 (0.000000 to 0.017000)	0.000000 (0.000000 to 0.012000)
IFNg-IL2+TNFa-, DENV-2, NS5-2, Day 120	0.001000 (0.000000 to 0.013000)	0.000000 (0.000000 to 0.013000)	0.005000 (0.000000 to 0.015000)	0.000000 (0.000000 to 0.014000)
IFNg-IL2-TNFa+, DENV-2, NS1-2, Day 120	0.001000 (0.000000 to 0.020000)	0.002000 (0.000000 to 0.030000)	0.004000 (0.000000 to 0.017000)	0.003000 (0.000000 to 0.020000)
IFNg-IL2-TNFa+, DENV-2, NS3-2, Day 120	0.000000 (0.000000 to 0.030000)	0.000000 (0.000000 to 0.028000)	0.010000 (0.000000 to 0.020000)	0.016500 (0.000000 to 0.033000)
IFNg-IL2-TNFa+, DENV-2, NS5-2, Day 120	0.020000 (0.000000 to 0.050000)	0.015000 (0.000000 to 0.049000)	0.013000 (0.000000 to 0.027340)	0.011000 (0.000000 to 0.031000)
IFNg+IL2+TNFa+, DENV-2, NS1-2, Day 270	0.009090 (0.003610 to 0.016000)	0.006190 (0.002930 to 0.015000)	0.000000 (0.000000 to 0.003860)	0.000000 (0.000000 to 0.002300)
IFNg+IL2+TNFa+, DENV-2, NS3-2, Day 270	0.004950 (0.001750 to 0.007780)	0.001510 (0.000000 to 0.004546)	0.006680 (0.000000 to 0.020000)	0.004630 (0.001540 to 0.009370)
IFNg+IL2+TNFa+, DENV-2, NS5-2, Day 270	0.002890 (0.001910 to 0.004530)	0.002466 (0.000000 to 0.005780)	0.007480 (0.001650 to 0.030780)	0.003690 (0.001120 to 0.019000)
IFNg+IL2+TNFa-, DENV-2, NS1-2, Day 270	0.000000 (0.000000 to 0.001320)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)
IFNg+IL2+TNFa-, DENV-2, NS3-2, Day 270	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.002690)	0.000000 (0.000000 to 0.000000)
IFNg+IL2+TNFa-, DENV-2, NS5-2, Day 270	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.001220)	0.000000 (0.000000 to 0.001540)
IFNg+IL2-TNFa+, DENV-2, NS1-2, Day 270	0.000200 (0.000000 to 0.002270)	0.001240 (0.000000 to 0.003680)	0.007010 (0.002000 to 0.041450)	0.003640 (0.000000 to 0.020000)
IFNg+IL2-TNFa+, DENV-2, NS3-2, Day 270	0.002290 (0.000000 to 0.005380)	0.000640 (0.000000 to 0.002180)	0.073630 (0.033000 to 0.189000)	0.104740 (0.035840 to 0.275040)
IFNg+IL2-TNFa+, DENV-2, NS5-2, Day 270	0.000000 (0.000000 to 0.001940)	0.000334 (0.000000 to 0.002990)	0.101450 (0.022180 to 0.197960)	0.061030 (0.022000 to 0.212030)
IFNg-IL2+TNFa+, DENV-2, NS1-2, Day 270	0.003000 (0.001000 to 0.013000)	0.005330 (0.001370 to 0.010000)	0.000000 (0.000000 to 0.000010)	0.000000 (0.000000 to 0.000000)
IFNg-IL2+TNFa+, DENV-2, NS3-2, Day 270	0.001030 (0.000000 to 0.005780)	0.001320 (0.000000 to 0.004830)	0.000000 (0.000000 to 0.001340)	0.000000 (0.000000 to 0.000000)
IFNg-IL2+TNFa+, DENV-2, NS5-2, Day 270	0.000000 (0.000000 to 0.004000)	0.002090 (0.000000 to 0.007050)	0.000000 (0.000000 to 0.001340)	0.000000 (0.000000 to 0.000000)
IFNg+IL2-TNFa-, DENV-2, NS1-2, Day 270	0.000000 (0.000000 to 0.002940)	0.000000 (0.000000 to 0.002060)	0.006890 (0.000000 to 0.017270)	0.001670 (0.000000 to 0.008070)
IFNg+IL2-TNFa-, DENV-2, NS3-2, Day 270	0.000000 (0.000000 to 0.002860)	0.000000 (0.000000 to 0.001630)	0.015000 (0.004570 to 0.029000)	0.016140 (0.001430 to 0.048550)
IFNg+IL2-TNFa-, DENV-2, NS5-2, Day 270	0.000000 (0.000000 to 0.003550)	0.000000 (0.000000 to 0.001350)	0.018200 (0.006240 to 0.033830)	0.009180 (0.000000 to 0.025120)
IFNg-IL2+TNFa-, DENV-2, NS1-2, Day 270	0.000000 (0.000000 to 0.012000)	0.001000 (0.000000 to 0.008000)	0.002000 (0.000000 to 0.009000)	0.001000 (0.000000 to 0.005360)
IFNg-IL2+TNFa-, DENV-2, NS3-2, Day 270	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.001980)	0.001000 (0.000000 to 0.009000)	0.000000 (0.000000 to 0.000000)
IFNg-IL2+TNFa-, DENV-2, NS5-2, Day 270	0.000000 (0.000000 to 0.003000)	0.000000 (0.000000 to 0.006000)	0.000000 (0.000000 to 0.008000)	0.000000 (0.000000 to 0.006000)
IFNg-IL2-TNFa+, DENV-2, NS1-2, Day 270	0.000000 (0.000000 to 0.010000)	0.000000 (0.000000 to 0.020000)	0.011000 (0.000000 to 0.024000)	0.000000 (0.000000 to 0.015000)
IFNg-IL2-TNFa+, DENV-2, NS3-2, Day 270	0.010000 (0.000000 to 0.030000)	0.005000 (0.000000 to 0.037000)	0.020000 (0.000000 to 0.042000)	0.010000 (0.000000 to 0.055000)
IFNg-IL2-TNFa+, DENV-2, NS5-2, Day 270	0.001000 (0.000000 to 0.050000)	0.000000 (0.000000 to 0.027000)	0.021000 (0.001000 to 0.047000)	0.011000 (0.000000 to 0.033000)

No statistical analyses for this end point

Secondary: Phenotype Characterization of Cellular Immune Response by Percentage of Total T Cells DENV-2 NS Proteins at 1 Month Post First, 1 and 6 Months Post Second Vaccination, by Dengue Baseline Seropositivity Status

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End point title

Phenotype Characterization of Cellular Immune Response by Percentage of Total T Cells DENV-2 NS Proteins at 1 Month Post First, 1 and 6 Months Post Second Vaccination, by Dengue Baseline Seropositivity Status

End point description

Phenotype characterization of cellular immune response by dengue Baseline seropositivity status assessed by frequency of total CD4+ and CD8+ T cells and was performed in subset of participants with IFN- γ ELISPOT responses >500 SFC/million cells and availability of sufficient cells. Seropositive: reciprocal neutralizing titer (MNT50) >=10 for one or more dengue serotypes. Seronegative: titer value of <10 for all 4 serotypes. Peptide pools included NS for DENV-2 serotype. Data are presented fo different expression profiles of IFN-γ, IL-2 and TNF-α cytokines for each peptide pool. Data is reported per Baseline seropositivity status (Seropositive and Seronegative) based on type of T cells present in participants at time of analysis (CD4+ and CD8+ T cells). ICS Subset 'by Baseline seropositivity status based on T-cells'. Number analysed:participants with data available for analysis for specific category.

End point type

Secondary

End point timeframe

1 month post first vaccination (Day 30); 1and 6 months post second vaccination (Days 120 Days 270)

End point values	TDV 0.5 mL: Seropositive: CD4+ T-Cells	TDV 0.5 mL: Seronegative: CD4+ T-Cells	TDV 0.5 mL: Seropositive: CD8+ T- Cells	TDV 0.5 mL: Seronegative: CD8+ T-Cells
Number of subjects analysed	44	35	44	35
Units: percentage of T cells
median (inter-quartile range (Q1-Q3))
IFNg+IL2+TNFa+, DENV-2, NS1-2, Day 30	0.013745 (0.005555 to 0.023190)	0.008110 (0.001850 to 0.012000)	0.002485 (0.000000 to 0.008035)	0.000000 (0.000000 to 0.011000)
IFNg+IL2+TNFa+, DENV-2, NS3-2, Day 30	0.005720 (0.001970 to 0.015000)	0.005000 (0.002300 to 0.009290)	0.020500 (0.002375 to 0.037175)	0.020000 (0.006800 to 0.041000)
IFNg+IL2+TNFa+, DENV-2, NS5-2, Day 30	0.005525 (0.002520 to 0.012000)	0.005380 (0.002890 to 0.009420)	0.020175 (0.002295 to 0.053500)	0.011000 (0.004400 to 0.031000)
IFNg+IL2+TNFa-, DENV-2, NS1-2, Day 30	0.000000 (0.000000 to 0.001071)	0.000000 (0.000000 to 0.001350)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)
IFNg+IL2+TNFa-, DENV-2, NS3-2, Day 30	0.000000 (0.000000 to 0.001047)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.002645)	0.001370 (0.000000 to 0.003000)
IFNg+IL2+TNFa-, DENV-2, NS5-2, Day 30	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.001030)	0.001515 (0.000000 to 0.004265)	0.001770 (0.000000 to 0.005340)
IFNg+IL2-TNFa+, DENV-2, NS1-2, Day 30	0.004800 (0.000835 to 0.008530)	0.003540 (0.000380 to 0.006230)	0.019145 (0.000420 to 0.067605)	0.012900 (0.000190 to 0.032000)
IFNg+IL2-TNFa+, DENV-2, NS3-2, Day 30	0.002830 (0.000000 to 0.007420)	0.002960 (0.001120 to 0.005090)	0.121135 (0.045870 to 0.469050)	0.186520 (0.067540 to 0.435160)
IFNg+IL2-TNFa+, DENV-2, NS5-2, Day 30	0.003085 (0.001255 to 0.005765)	0.004110 (0.000000 to 0.007100)	0.162115 (0.028000 to 0.344500)	0.127550 (0.046350 to 0.512900)
IFNg-IL2+TNFa+, DENV-2, NS1-2, Day 30	0.003945 (0.000000 to 0.011215)	0.002310 (0.000000 to 0.006270)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)
IFNg-IL2+TNFa+, DENV-2, NS3-2, Day 30	0.002130 (0.000000 to 0.007810)	0.001230 (0.000000 to 0.004790)	0.000000 (0.000000 to 0.000155)	0.000000 (0.000000 to 0.001020)
IFNg-IL2+TNFa+, DENV-2, NS5-2, Day 30	0.003790 (0.000500 to 0.007985)	0.002270 (0.000000 to 0.008000)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)
IFNg+IL2-TNFa-, DENV-2, NS1-2, Day 30	0.000630 (0.000000 to 0.003095)	0.000570 (0.000000 to 0.004640)	0.007750 (0.001750 to 0.032860)	0.007160 (0.002000 to 0.027540)
IFNg+IL2-TNFa-, DENV-2, NS3-2, Day 30	0.000165 (0.000000 to 0.003210)	0.000130 (0.000000 to 0.002580)	0.060770 (0.012905 to 0.163835)	0.050000 (0.029540 to 0.255820)
IFNg+IL2-TNFa-, DENV-2, NS5-2, Day 30	0.000450 (0.000000 to 0.003105)	0.000960 (0.000000 to 0.003680)	0.053260 (0.019500 to 0.115390)	0.105000 (0.014920 to 0.230980)
IFNg-IL2+TNFa-, DENV-2, NS1-2, Day 30	0.001500 (0.000000 to 0.009500)	0.000000 (0.000000 to 0.009000)	0.002500 (0.000000 to 0.008000)	0.002000 (0.000000 to 0.010000)
IFNg-IL2+TNFa-, DENV-2, NS3-2, Day 30	0.000000 (0.000000 to 0.009000)	0.000000 (0.000000 to 0.002000)	0.001000 (0.000000 to 0.008200)	0.000000 (0.000000 to 0.008220)
IFNg-IL2+TNFa-, DENV-2, NS5-2, Day 30	0.001000 (0.000000 to 0.010000)	0.000000 (0.000000 to 0.008000)	0.000000 (0.000000 to 0.010000)	0.004000 (0.000000 to 0.009000)
IFNg-IL2-TNFa+, DENV-2, NS1-2, Day 30	0.004500 (0.000000 to 0.035000)	0.000000 (0.000000 to 0.014000)	0.004500 (0.000000 to 0.018000)	0.000000 (0.000000 to 0.004000)
IFNg-IL2-TNFa+, DENV-2, NS3-2, Day 30	0.010000 (0.000000 to 0.045000)	0.006000 (0.000000 to 0.030000)	0.017500 (0.002000 to 0.033000)	0.005000 (0.000000 to 0.020000)
IFNg-IL2-TNFa+, DENV-2, NS5-2, Day 30	0.033000 (0.000000 to 0.070000)	0.000000 (0.000000 to 0.032000)	0.013500 (0.000000 to 0.032000)	0.000000 (0.000000 to 0.027000)
IFNg+IL2+TNFa+, DENV-2, NS1-2, Day 120	0.011000 (0.003860 to 0.017000)	0.005531 (0.003340 to 0.016010)	0.001400 (0.000000 to 0.004030)	0.001320 (0.000000 to 0.004240)
IFNg+IL2+TNFa+, DENV-2, NS3-2, Day 120	0.003480 (0.000000 to 0.008830)	0.003300 (0.001670 to 0.005510)	0.010000 (0.002650 to 0.028000)	0.010000 (0.002740 to 0.015000)
IFNg+IL2+TNFa+, DENV-2, NS5-2, Day 120	0.002705 (0.000000 to 0.005470)	0.001460 (0.000000 to 0.003000)	0.012000 (0.002670 to 0.035000)	0.006000 (0.002230 to 0.013000)
IFNg+IL2+TNFa-, DENV-2, NS1-2, Day 120	0.000975 (0.000000 to 0.002670)	0.001220 (0.000000 to 0.001840)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)
IFNg+IL2+TNFa-, DENV-2, NS3-2, Day 120	0.000000 (0.000000 to 0.001580)	0.000000 (0.000000 to 0.001150)	0.000000 (0.000000 to 0.001920)	0.000000 (0.000000 to 0.001460)
IFNg+IL2+TNFa-, DENV-2, NS5-2, Day 120	0.000000 (0.000000 to 0.000908)	0.000000 (0.000000 to 0.000953)	0.001540 (0.000000 to 0.003450)	0.000000 (0.000000 to 0.001650)
IFNg+IL2-TNFa+, DENV-2, NS1-2, Day 120	0.002885 (0.000760 to 0.005320)	0.002070 (0.000000 to 0.003680)	0.007155 (0.000000 to 0.036000)	0.007850 (0.000000 to 0.028000)
IFNg+IL2-TNFa+, DENV-2, NS3-2, Day 120	0.002915 (0.001090 to 0.004370)	0.000450 (0.000000 to 0.002670)	0.144565 (0.039110 to 0.447000)	0.093000 (0.053410 to 0.163270)
IFNg+IL2-TNFa+, DENV-2, NS5-2, Day 120	0.000702 (0.000000 to 0.003690)	0.001570 (0.000000 to 0.002150)	0.102525 (0.039880 to 0.291210)	0.078900 (0.025190 to 0.134400)
IFNg-IL2+TNFa+, DENV-2, NS1-2, Day 120	0.004735 (0.000280 to 0.013000)	0.011430 (0.003910 to 0.017000)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)
IFNg-IL2+TNFa+, DENV-2, NS3-2, Day 120	0.000530 (0.000000 to 0.005520)	0.000000 (0.000000 to 0.003730)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.001140)
IFNg-IL2+TNFa+, DENV-2, NS5-2, Day 120	0.003100 (0.000000 to 0.007000)	0.006490 (0.000000 to 0.010660)	0.000000 (0.000000 to 0.001420)	0.000000 (0.000000 to 0.000000)
IFNg+IL2-TNFa-, DENV-2, NS1-2, Day 120	0.001520 (0.000000 to 0.004710)	0.002490 (0.000000 to 0.005030)	0.004280 (0.001060 to 0.009270)	0.004080 (0.000000 to 0.016790)
IFNg+IL2-TNFa-, DENV-2, NS3-2, Day 120	0.001235 (0.000000 to 0.002480)	0.000190 (0.000000 to 0.002720)	0.046825 (0.015000 to 0.111210)	0.024000 (0.000000 to 0.056110)
IFNg+IL2-TNFa-, DENV-2, NS5-2, Day 120	0.000020 (0.000000 to 0.002480)	0.000000 (0.000000 to 0.002260)	0.034610 (0.011000 to 0.101210)	0.016280 (0.006480 to 0.030630)
IFNg-IL2+TNFa-, DENV-2, NS1-2, Day 120	0.009500 (0.000000 to 0.011000)	0.006000 (0.000000 to 0.015000)	0.001500 (0.000000 to 0.017000)	0.002000 (0.000000 to 0.014000)
IFNg-IL2+TNFa-, DENV-2, NS3-2, Day 120	0.000000 (0.000000 to 0.007000)	0.002000 (0.000000 to 0.011000)	0.000500 (0.000000 to 0.019000)	0.003000 (0.000000 to 0.012000)
IFNg-IL2+TNFa-, DENV-2, NS5-2, Day 120	0.000000 (0.000000 to 0.013000)	0.000000 (0.000000 to 0.013000)	0.000000 (0.000000 to 0.011000)	0.006000 (0.000000 to 0.020000)
IFNg-IL2-TNFa+, DENV-2, NS1-2, Day 120	0.007000 (0.000000 to 0.040000)	0.000000 (0.000000 to 0.019000)	0.004500 (0.000000 to 0.028000)	0.000000 (0.000000 to 0.014000)
IFNg-IL2-TNFa+, DENV-2, NS3-2, Day 120	0.008000 (0.000000 to 0.030000)	0.000000 (0.000000 to 0.028000)	0.018000 (0.000000 to 0.034000)	0.009000 (0.000000 to 0.019000)
IFNg-IL2-TNFa+, DENV-2, NS5-2, Day 120	0.020000 (0.000000 to 0.050000)	0.010000 (0.000000 to 0.040000)	0.016500 (0.000000 to 0.040000)	0.008000 (0.000000 to 0.023050)
IFNg+IL2+TNFa+, DENV-2, NS1-2, Day 270	0.009520 (0.004340 to 0.022820)	0.004410 (0.002620 to 0.012000)	0.000000 (0.000000 to 0.002800)	0.000000 (0.000000 to 0.002390)
IFNg+IL2+TNFa+, DENV-2, NS5-2, Day 270	0.002890 (0.000334 to 0.005160)	0.002840 (0.000030 to 0.005730)	0.005070 (0.001500 to 0.026000)	0.004940 (0.000000 to 0.016000)
IFNg+IL2+TNFa+, DENV-2, NS3-2, Day 270	0.003410 (0.000000 to 0.006810)	0.002330 (0.000190 to 0.005380)	0.008760 (0.002480 to 0.020000)	0.003020 (0.000000 to 0.008470)
IFNg+IL2+TNFa-, DENV-2, NS1-2, Day 270	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)
IFNg+IL2+TNFa-, DENV-2, NS3-2, Day 270	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.001830)	0.000000 (0.000000 to 0.000000)
IFNg+IL2+TNFa-, DENV-2, NS5-2, Day 270	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.001570)	0.000000 (0.000000 to 0.001170)
IFNg+IL2-TNFa+, DENV-2, NS1-2, Day 270	0.001660 (0.000000 to 0.004540)	0.000080 (0.000000 to 0.002160)	0.004600 (0.000090 to 0.024000)	0.007010 (0.000000 to 0.023950)
IFNg+IL2-TNFa+, DENV-2, NS3-2, Day 270	0.001470 (0.000000 to 0.003600)	0.001790 (0.000000 to 0.003280)	0.104740 (0.036000 to 0.297940)	0.080870 (0.029000 to 0.189000)
IFNg+IL2-TNFa+, DENV-2, NS5-2, Day 270	0.000000 (0.000000 to 0.002500)	0.001070 (0.000000 to 0.002810)	0.070000 (0.029000 to 0.258000)	0.062400 (0.020880 to 0.135040)
IFNg-IL2+TNFa+, DENV-2, NS1-2, Day 270	0.004000 (0.000000 to 0.009560)	0.006000 (0.001370 to 0.014040)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)
IFNg-IL2+TNFa+, DENV-2, NS3-2, Day 270	0.000000 (0.000000 to 0.005560)	0.001350 (0.000000 to 0.004830)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.000000)
IFNg-IL2+TNFa+, DENV-2, NS5-2, Day 270	0.000000 (0.000000 to 0.004190)	0.002640 (0.000000 to 0.006150)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.001590)
IFNg+IL2-TNFa-, DENV-2, NS1-2, Day 270	0.000000 (0.000000 to 0.002940)	0.000000 (0.000000 to 0.001240)	0.003620 (0.000000 to 0.011000)	0.004000 (0.000000 to 0.008430)
IFNg+IL2-TNFa-, DENV-2, NS3-2, Day 270	0.000080 (0.000000 to 0.002860)	0.000000 (0.000000 to 0.001600)	0.023630 (0.001910 to 0.032080)	0.006880 (0.002440 to 0.016140)
IFNg+IL2-TNFa-, DENV-2, NS5-2, Day 270	0.000000 (0.000000 to 0.003160)	0.000000 (0.000000 to 0.002170)	0.013750 (0.000000 to 0.031280)	0.009000 (0.003400 to 0.027560)
IFNg-IL2+TNFa-, DENV-2, NS1-2, Day 270	0.000000 (0.000000 to 0.007240)	0.001000 (0.000000 to 0.011000)	0.000000 (0.000000 to 0.005360)	0.001000 (0.000000 to 0.009000)
IFNg-IL2+TNFa-, DENV-2, NS3-2, Day 270	0.000000 (0.000000 to 0.004240)	0.000000 (0.000000 to 0.000000)	0.000000 (0.000000 to 0.003460)	0.000000 (0.000000 to 0.005000)
IFNg-IL2+TNFa-, DENV-2, NS5-2, Day 270	0.000000 (0.000000 to 0.006000)	0.000000 (0.000000 to 0.004000)	0.000000 (0.000000 to 0.007460)	0.000000 (0.000000 to 0.006000)
IFNg-IL2-TNFa+, DENV-2, NS1-2, Day 270	0.000000 (0.000000 to 0.020000)	0.000000 (0.000000 to 0.010000)	0.005000 (0.000000 to 0.029000)	0.002000 (0.000000 to 0.015000)
IFNg-IL2-TNFa+, DENV-2, NS3-2, Day 270	0.019000 (0.000000 to 0.050000)	0.000000 (0.000000 to 0.013000)	0.033000 (0.006000 to 0.072000)	0.005000 (0.000000 to 0.032000)
IFNg-IL2-TNFa+, DENV-2, NS5-2, Day 270	0.009000 (0.000000 to 0.050000)	0.000000 (0.000000 to 0.020000)	0.020000 (0.006000 to 0.051000)	0.015000 (0.000000 to 0.025000)

No statistical analyses for this end point

Secondary: Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination, Pre Second Vaccination, and 1, 6 Months Post Second Vaccination and Then Annually Up to 3 Years

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End point title

Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination, Pre Second Vaccination, and 1, 6 Months Post Second Vaccination and Then Annually Up to 3 Years

End point description

GMT of neutralizing antibodies was measured by microneutralization test (MTN). The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. PPS included all participants from the FAS who have no major protocol violations. Number analysed is the number of participants with data available for analysis at the given timepoint.

End point type

Secondary

End point timeframe

1 month post first vaccination (Day 30); pre second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); annually up to 3 years (Years 1, 2 and 3)

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL
Number of subjects analysed	195
Units: titer
geometric mean (confidence interval 95%)
DENV-1, Day 30	402.3 (287.5 to 562.9)
DENV-2, Day 30	5482.2 (4626.4 to 6496.3)
DENV-3, Day 30	436.1 (326.9 to 581.7)
DENV-4, Day 30	253.9 (182.6 to 353.1)
DENV-1, Day 90	271.7 (193.9 to 380.7)
DENV-2, Day 90	2736.3 (2295.1 to 3262.5)
DENV-3, Day 90	218.7 (162.0 to 295.2)
DENV-4, Day 90	177.4 (129.6 to 242.8)
DENV-1, Day 120	550.6 (408.0 to 743.1)
DENV-2, Day 120	2808.2 (2395.0 to 3292.8)
DENV-3, Day 120	404.2 (312.6 to 522.7)
DENV-4, Day 120	427.1 (335.4 to 543.8)
DENV-1, Day 270	343.3 (249.8 to 471.6)
DENV-2, Day 270	1729.9 (1435.7 to 2084.4)
DENV-3, Day 270	203.8 (153.5 to 270.7)
DENV-4, Day 270	186.6 (141.6 to 246.0)
DENV-1, Year 1	243.8 (176.4 to 337.0)
DENV-2, Year 1	896.2 (729.9 to 1100.5)
DENV-3, Year 1	148.6 (111.6 to 197.7)
DENV-4, Year 1	142.4 (108.8 to 186.3)
DENV-1, Year 2	290.8 (200.8 to 421.1)
DENV-2, Year 2	724.7 (564.2 to 930.8)
DENV-3, Year 2	172.7 (120.6 to 247.1)
DENV-4, Year 2	157.7 (114.0 to 218.0)
DENV-1, Year 3	178.7 (127.3 to 250.8)
DENV-2, Year 3	546.4 (435.2 to 686.0)
DENV-3, Year 3	125.2 (92.8 to 169.0)
DENV-4, Year 3	91.6 (69.4 to 120.7)

No statistical analyses for this end point

Secondary: Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination, Pre-second Vaccination, and 1, 6 Months Post Second Vaccination and Then Annually up to 3 Years

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End point title

Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination, Pre-second Vaccination, and 1, 6 Months Post Second Vaccination and Then Annually up to 3 Years

End point description

Seropositive was defined as a reciprocal neutralizing titer ≥10. The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. PPS included all participants from the FAS who have no major protocol violations. Number analysed is the number of participants with data available at the given timepoint.

End point type

Secondary

End point timeframe

1 month post first vaccination (Day 30); pre second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); annually up to 3 years (Years 1, 2 and 3)

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL
Number of subjects analysed	195
Units: percentage of participants
number (confidence interval 95%)
DENV-1, Day 30	96.8 (93.1 to 98.8)
DENV-2, Day 30	99.5 (97.0 to 100.0)
DENV-3, Day 30	99.5 (97.0 to 100.0)
DENV-4, Day 30	93.0 (88.3 to 96.2)
DENV-1, Day 90	90.8 (85.8 to 94.4)
DENV-2, Day 90	99.5 (97.2 to 100.0)
DENV-3, Day 90	94.4 (90.1 to 97.2)
DENV-4, Day 90	91.8 (87.0 to 95.2)
DENV-1, Day 120	99.5 (97.0 to 100.0)
DENV-2, Day 120	100.0 (98.0 to 100.0)
DENV-3, Day 120	100.0 (98.0 to 100.0)
DENV-4, Day 120	100.0 (98.0 to 100.0)
DENV-1, Day 270	96.8 (93.1 to 98.8)
DENV-2, Day 270	100.0 (98.0 to 100.0)
DENV-3, Day 270	97.9 (94.6 to 99.4)
DENV-4, Day 270	96.8 (93.1 to 98.8)
DENV-1, Year 1	91.1 (86.2 to 94.8)
DENV-2, Year 1	100.0 (98.1 to 100.0)
DENV-3, Year 1	93.8 (89.3 to 96.7)
DENV-4, Year 1	96.4 (92.6 to 98.5)
DENV-1, Year 2	93.5 (88.4 to 96.8)
DENV-2, Year 2	100.0 (97.6 to 100.0)
DENV-3, Year 2	89.6 (83.7 to 93.9)
DENV-4, Year 2	95.5 (90.9 to 98.2)
DENV-1, Year 3	84.4 (78.3 to 89.4)
DENV-2, Year 3	100.0 (98.0 to 100.0)
DENV-3, Year 3	86.7 (80.8 to 91.3)
DENV-4, Year 3	86.1 (80.2 to 90.8)

No statistical analyses for this end point

Secondary: Percentage of Participants Seropositive for Multiple Dengue Serotypes at 1 Month Post First Vaccination, Pre Second Vaccination, 1, 6 Months Post Second Vaccination and Annually up to 3 Years

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End point title

Percentage of Participants Seropositive for Multiple Dengue Serotypes at 1 Month Post First Vaccination, Pre Second Vaccination, 1, 6 Months Post Second Vaccination and Annually up to 3 Years

End point description

Seropositive was defined as a reciprocal neutralizing titer ≥10. The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositive for multiple dengue serotypes were summarized in the following categories: tetravalent and at least trivalent. Seropositive was defined as a reciprocal neutralizing titer ≥10. The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositive for multiple dengue serotypes were summarized in the following categories: tetravalent and at least trivalent.PPS included all participants from the FAS who have no major protocol violations. Number analysed is the number of participants with data available for analysis at the given timepoint.

End point type

Secondary

End point timeframe

1 month post first vaccination (Day 30); pre second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); annually up to 3 years (Years 1, 2 and 3)

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL
Number of subjects analysed	195
Units: percentage of participants
number (confidence interval 95%)
Tetravalent, Day 30	90.8 (85.7 to 94.6)
At Least Trivalent, Day 30	98.4 (95.3 to 99.7)
Tetravalent, Day 90	83.6 (77.6 to 88.5)
At Least Trivalent, Day 90	95.4 (91.4 to 97.9)
Tetravalent, Day 120	99.5 (97.0 to 100.0)
At Least Trivalent, Day 120	100.0 (98.0 to 100.0)
Tetravalent, Day 270	93.0 (88.4 to 96.2)
At Least Trivalent, Day 270	98.4 (95.4 to 99.7)
Tetravalent, Year 1	87.5 (82.0 to 91.8)
At Least Trivalent, Year 1	95.3 (91.3 to 97.8)
Tetravalent, Year 2	86.4 (79.9 to 91.4)
At Least Trivalent, Year 2	93.5 (88.4 to 96.8)
Tetravalent, Year 3	76.7 (69.8 to 82.6)
At Least Trivalent, Year 3	87.2 (81.4 to 91.7)

No statistical analyses for this end point

Secondary: Percentage of Participants Experiencing Unsolicited Adverse Events (AE)

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End point title

Percentage of Participants Experiencing Unsolicited Adverse Events (AE)

End point description

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. Safety Set included all enrolled participants who received at least 1 dose of TDV. Number analysed is the number of participants with data available for analysis at the given timepoint.

End point type

Secondary

End point timeframe

Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 [Month 0] and Day 90 [Month 3]

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL
Number of subjects analysed	200
Units: percentage of participants
number (not applicable)
After First Vaccination	26.5
After Second Vaccination	25.3

No statistical analyses for this end point

Secondary: Percentage of Participants With Medically Attended AEs (MAAEs)

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End point title

Percentage of Participants With Medically Attended AEs (MAAEs)

End point description

MAAEs were defined as AEs leading to a medical visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria. Safety Set included all enrolled participants who received at least 1 dose of TDV.

End point type

Secondary

End point timeframe

From first vaccination (Day 1) up to 6 months post second vaccination (Day 270)

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL
Number of subjects analysed	200
Units: percentage of participants
number (not applicable)	50.5

No statistical analyses for this end point

Secondary: Percentage of Participants With Serious Adverse Events (SAEs)

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End point title

Percentage of Participants With Serious Adverse Events (SAEs)

End point description

A SAE was defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Safety Set included all enrolled participants who received at least 1 dose of TDV.

End point type

Secondary

End point timeframe

From first vaccination (Day 1) up to end of study (Approximately 3 years)

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL
Number of subjects analysed	200
Units: percentage of participants
number (not applicable)	5.5

No statistical analyses for this end point

Secondary: Percentage of Participants With Virologically Confirmed Dengue

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End point title

Percentage of Participants With Virologically Confirmed Dengue

End point description

Participants with febrile illness defined as fever ≥38°C on any 2 of 3 consecutive days were evaluated for dengue. Virologically confirmed dengue was defined as febrile illness with a positive serotype-specific RT-PCR (i.e. positive dengue detection RT-PCR). Safety Set included all enrolled participants who received at least 1 dose of TDV.

End point type

Secondary

End point timeframe

From first vaccination (Day 1) up to 6 months post second vaccination (Day 270)

End point values	Tetravalent Dengue Vaccine (TDV) 0.5 mL
Number of subjects analysed	200
Units: percentage of participants
number (not applicable)	6.0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

All-cause mortality and SAEs: From first vaccination(Day 1) up to end of study (Approximately 3 years);Non-SAEs: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1[Month 0] and Day 90[Month 3]

Adverse event reporting additional 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.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.0

Reporting group title

Tetravalent Dengue Vaccine (TDV) 0.5 mL

Reporting group description

TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3).

Serious adverse events	Tetravalent Dengue Vaccine (TDV) 0.5 mL
Total subjects affected by serious adverse events
subjects affected / exposed	11 / 200 (5.50%)
number of deaths (all causes)	0
number of deaths resulting from adverse events	0
Injury, poisoning and procedural complications
Foot fracture
subjects affected / exposed	1 / 200 (0.50%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Nervous system disorders
Febrile convulsion
subjects affected / exposed	1 / 200 (0.50%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Social circumstances
Victim of sexual abuse
subjects affected / exposed	1 / 200 (0.50%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastrointestinal disorders
Faecaloma
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 200 (0.50%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastritis
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 200 (0.50%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Hepatobiliary disorders
Biliary colic
alternative dictionary used: MedDRA 21.0
subjects affected / exposed	1 / 200 (0.50%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	1 / 200 (0.50%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Infections and infestations
Cellulitis
subjects affected / exposed	1 / 200 (0.50%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pneumonia
subjects affected / exposed	3 / 200 (1.50%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Typhoid fever
subjects affected / exposed	1 / 200 (0.50%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Urosepsis
subjects affected / exposed	1 / 200 (0.50%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Dengue fever
subjects affected / exposed	1 / 200 (0.50%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastroenteritis
subjects affected / exposed	1 / 200 (0.50%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Systemic viral infection
subjects affected / exposed	1 / 200 (0.50%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	Tetravalent Dengue Vaccine (TDV) 0.5 mL
Total subjects affected by non serious adverse events
subjects affected / exposed	66 / 200 (33.00%)
Infections and infestations
Nasopharyngitis
subjects affected / exposed	29 / 200 (14.50%)
occurrences all number	33
Upper respiratory tract infection
subjects affected / exposed	20 / 200 (10.00%)
occurrences all number	21
Gastroenteritis
subjects affected / exposed	12 / 200 (6.00%)
occurrences all number	13
Systemic viral infection
subjects affected / exposed	9 / 200 (4.50%)
occurrences all number	9
Pneumonia
subjects affected / exposed	8 / 200 (4.00%)
occurrences all number	9
Conjunctivitis
subjects affected / exposed	4 / 200 (2.00%)
occurrences all number	4

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Analysis of samples collected at Day 90 and at Years 1, 2 and 3 for outcome measures related to assessment of cellular immune response is ongoing due to limited testing capacities of laboratory (COVID-19); data will be reported when available.

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Clinical trials

Clinical Trial Results: An Open Label, Phase 2 Study to Investigate Cell-mediated Immunity and Safety of a Tetravalent Dengue Vaccine Candidate (TDV) Administered Subcutaneously in Healthy Children Aged 4 to 16 Years

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants With Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination

Primary: Percentage of Participants With Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination

Secondary: Magnitude of Cellular Immune Response Assessed by Number of Spot Forming Cells (SFC)/Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by IFN-γ ELISPOT at 1 Month Post Second Vaccination

Secondary: Magnitude of Cellular Immune Response Assessed by Number of Spot Forming Cells (SFC)/Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by IFN-γ ELISPOT at 1 Month Post Second Vaccination

Secondary: Percentage of Participants With Cellular Immune Response to TDV at 1 Month Post First Vaccination and 6 Months Post Second Vaccination

Secondary: Percentage of Participants With Cellular Immune Response to TDV at 1 Month Post First Vaccination and 6 Months Post Second Vaccination

Secondary: Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First Vaccination and 6 Months Post Second Vaccination

Secondary: Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First Vaccination and 6 Months Post Second Vaccination

Secondary: Percentage of Participants With Cellular Immune Responses to TDV at 1 Month Post First Vaccination, 1 and 6 Months Post Second Vaccination Post Second Vaccination Assessed by Country

Secondary: Percentage of Participants With Cellular Immune Responses to TDV at 1 Month Post First Vaccination, 1 and 6 Months Post Second Vaccination Post Second Vaccination Assessed by Country

Secondary: Percentage of Participants With Cellular Immune Responses to TDV:1 Month Post First Vaccination, 1 and 6 Months Post Second Vaccination Post Second Vaccination, by Dengue Baseline Seropositivity Status

Secondary: Percentage of Participants With Cellular Immune Responses to TDV:1 Month Post First Vaccination, 1 and 6 Months Post Second Vaccination Post Second Vaccination, by Dengue Baseline Seropositivity Status

Secondary: Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First, 1 and 6 Months Post Second Vaccination, by Country

Secondary: Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First, 1 and 6 Months Post Second Vaccination, by Country

Secondary: Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT 1 Month Post First; 1 and 6 Months Post Second Vaccination, by Dengue Baseline Seropositivity Status

Secondary: Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT 1 Month Post First; 1 and 6 Months Post Second Vaccination, by Dengue Baseline Seropositivity Status

Secondary: Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT in Participants >10 Years of Age

Secondary: Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT in Participants >10 Years of Age

Secondary: Percentage of Participants With Cellular Immune Response to TDV in Participants >10 Years of Age

Secondary: Percentage of Participants With Cellular Immune Response to TDV in Participants >10 Years of Age

Secondary: Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response to DENV-2 NS Proteins at 1 Month Post First, 1 and 6 Months Post Second Vaccination

Secondary: Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response to DENV-2 NS Proteins at 1 Month Post First, 1 and 6 Months Post Second Vaccination

Secondary: Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response DENV-2 NS Proteins,1 Month Post First;1 and 6 Months Post Second Vaccination, by Country

Secondary: Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response DENV-2 NS Proteins,1 Month Post First;1 and 6 Months Post Second Vaccination, by Country

Secondary: Phenotype Characterization of Cellular Immune Response by Percentage of Total T Cells DENV-2 NS Proteins at 1 Month Post First, 1 and 6 Months Post Second Vaccination, by Dengue Baseline Seropositivity Status

Secondary: Phenotype Characterization of Cellular Immune Response by Percentage of Total T Cells DENV-2 NS Proteins at 1 Month Post First, 1 and 6 Months Post Second Vaccination, by Dengue Baseline Seropositivity Status

Secondary: Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination, Pre Second Vaccination, and 1, 6 Months Post Second Vaccination and Then Annually Up to 3 Years

Secondary: Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination, Pre Second Vaccination, and 1, 6 Months Post Second Vaccination and Then Annually Up to 3 Years

Secondary: Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination, Pre-second Vaccination, and 1, 6 Months Post Second Vaccination and Then Annually up to 3 Years

Secondary: Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination, Pre-second Vaccination, and 1, 6 Months Post Second Vaccination and Then Annually up to 3 Years

Secondary: Percentage of Participants Seropositive for Multiple Dengue Serotypes at 1 Month Post First Vaccination, Pre Second Vaccination, 1, 6 Months Post Second Vaccination and Annually up to 3 Years

Secondary: Percentage of Participants Seropositive for Multiple Dengue Serotypes at 1 Month Post First Vaccination, Pre Second Vaccination, 1, 6 Months Post Second Vaccination and Annually up to 3 Years

Secondary: Percentage of Participants Experiencing Unsolicited Adverse Events (AE)

Secondary: Percentage of Participants Experiencing Unsolicited Adverse Events (AE)

Secondary: Percentage of Participants With Medically Attended AEs (MAAEs)

Secondary: Percentage of Participants With Medically Attended AEs (MAAEs)

Secondary: Percentage of Participants With Serious Adverse Events (SAEs)

Secondary: Percentage of Participants With Serious Adverse Events (SAEs)

Secondary: Percentage of Participants With Virologically Confirmed Dengue

Secondary: Percentage of Participants With Virologically Confirmed Dengue

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
An Open Label, Phase 2 Study to Investigate Cell-mediated Immunity and Safety of a Tetravalent Dengue Vaccine Candidate (TDV) Administered Subcutaneously in Healthy Children Aged 4 to 16 Years