Safety and Immunogenicity With Two Different Serotype 2 P... | NCT02425098

NCT02425098

ID	Type	Description	Link
U1111-1166-8884	Registry Identifier	WHO

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High-dose Tetravalent Dengue Vaccine (HD-TDV)	Experimental	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Biological: Takeda's High-Dose Tetravalent Dengue Vaccine Candidate (HD-TDV)
Tetravalent Dengue Vaccine (TDV)	Experimental	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)

Name	Type	Description	Arm Group Labels	Other Names
Takeda's Tetravalent Dengue Vaccine Candidate (TDV)	Biological	TDV subcutaneous injection	Tetravalent Dengue Vaccine (TDV)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15	GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by microneutralization test [MNT].	Day 15
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30	GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.	Day 30
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90	GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.	Day 90
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180	GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.	Day 180
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365	GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.	Day 365
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15	Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity	Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain [Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)], erythema [Grade 0 (<25 mm), 1 (25 - ≤ 50 mm), 2 (>50 - ≤ 100 mm), 3 (> 100 mm)] and swelling [Grade 0 (<25 mm), 1 (25 - ≤ 50 mm), 2 (>50 - ≤ 100 mm), 3 (> 100 mm)].

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant signs and dates a written informed consent form where applicable, and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
Is aged 21 to 45 years of age, inclusive.
Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the Investigator.
Can comply with trial procedures and are available for the duration of follow-up.
Has self-declared as never having been vaccinated against Yellow Fever or Japanese Encephalitis Virus.

Exclusion Criteria:

Has febrile illness (temperature ≥38°C or ≥100.4°F) or moderate or severe acute illness or infection at the time of enrollment.
Has history or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose an additional risk to the participant due to participation in the trial, including but not limited to:
1. Known hypersensitivity or allergy to any of the vaccine components.
2. Female participants who are pregnant or breastfeeding.
3. Individuals with any serious chronic or progressive disease according to judgment of the Investigator (e.g. neoplasm, insulin-dependent diabetes, cardiac, renal or hepatic disease, neurologic or seizure disorder or Guillain-Barré syndrome).
4. Known or suspected impairment/alteration of immune function, including:
  - i. Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (Month 0) (use of inhaled, intranasal, or topical corticosteroids is allowed).
  - ii. Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥ 2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (Month 0).
  - iii. Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (Month 0) or planned administration during the trial.
  - iv. Receipt of immunostimulants within 60 days prior to Day 1(Month 0).
  - v. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (Month 0).
  - vi. Human immunodeficiency virus (HIV) infection and HIV-related diseases.
  - vii. Hepatitis C virus (HCV) infection.
  - viii. Genetic immunodeficiency.
Has received any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccine within 28 days after Day 1 (Month 0).
Has participated in any clinical trial with another investigational product 30 days prior to Day 1 (Month 0) or intent to participate in another clinical trial at any time during the conduct of this trial.
Has previously participated in any clinical trial of a dengue candidate vaccine, or previous receipt of a dengue vaccine.
Is first-degree relative of individuals involved in trial conduct.
For females of childbearing potential who are sexually active, and who have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1 (Month 0).
1. Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: bilateral tubal ligation (at least 1 year previously), bilateral oophorectomy (at least 1 year previously) or hysterectomy.
2. Acceptable birth control methods are defined as one or more of the following:
  - i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring).
  - ii. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse.
  - iii. Intrauterine device (IUD).
  - iv. Monogamous relationship with vasectomized partner (partner must have been vasectomized for at least six months prior to Day 1 [Month 0]).
Females of childbearing potential who are sexually active, and who refuse to use an acceptable contraceptive method from signing the informed consent up to 6 weeks post-vaccination.

Contacts/Locations Module

Name	Affiliation	Role
Medical Director Clinical Science	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Singapore General Hospital		Singapore		169608	Singapore
Tan Tock Seng Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40099800	Derived	Rauscher M, Youard Z, Faccin A, Patel SS, Pang H, Zent O. Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine. Expert Rev Vaccines. 2025 Dec;24(1):221-229. doi: 10.1080/14760584.2025.2480297. Epub 2025 Mar 27.
33711074	Derived	White LJ, Young EF, Stoops MJ, Henein SR, Adams EC, Baric RS, de Silva AM. Defining levels of dengue virus serotype-specific neutralizing antibodies induced by a live attenuated tetravalent dengue vaccine (TAK-003). PLoS Negl Trop Dis. 2021 Mar 12;15(3):e0009258. doi: 10.1371/journal.pntd.0009258. eCollection 2021 Mar.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Dec 14, 2017	Sep 18, 2018

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Safety set included all randomized participants who received the study vaccine.

Arm/Group Information

ID	Title	Description
BG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
BG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000176 BG001175 BG002351

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

DENV-1

- ParticipantsOG000170
- ParticipantsOG001170

Title	Measurements
	OG000156.2(98.0 to 249.1)

Primary

Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30

GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.

The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here 'number analyzed' refers to participants with valid MNT results available at given time-point.

Posted

Geometric Mean

95% Confidence Interval

Titer

Day 30

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.

Primary

Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90

GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.

Posted

Geometric Mean

95% Confidence Interval

Titer

Day 90

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.

Primary

Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180

GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.

Posted

Geometric Mean

95% Confidence Interval

Titer

Day 180

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.

Primary

Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365

GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.

Posted

Geometric Mean

95% Confidence Interval

Titer

Day 365

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.

Primary

Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15

Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.

Posted

Number

95% Confidence Interval

percentage of participants

Day 15

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.

Primary

Seropositivity Rate for Each of the Four Dengue Serotypes at Day 30

Posted

Number

95% Confidence Interval

percentage of participants

Day 30

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.

Primary

Seropositivity Rate for Each of the Four Dengue Serotypes at Day 90

Posted

Number

95% Confidence Interval

percentage of participants

Day 90

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.

Primary

Seropositivity Rate for Each of the Four Dengue Serotypes at Day 180

Posted

Number

95% Confidence Interval

percentage of participants

Day 180

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.

Primary

Seropositivity Rate for Each of the Four Dengue Serotypes at Day 365

Posted

Number

95% Confidence Interval

percentage of participants

Day 365

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.

Secondary

Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity

Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain [Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)], erythema [Grade 0 (<25 mm), 1 (25 - ≤ 50 mm), 2 (>50 - ≤ 100 mm), 3 (> 100 mm)] and swelling [Grade 0 (<25 mm), 1 (25 - ≤ 50 mm), 2 (>50 - ≤ 100 mm), 3 (> 100 mm)].

The safety set included all randomized participants who received the study vaccine. Here 'number analyzed' is the number of participants with data available for analysis. Only categories for which there was at least 1 participant are reported.

Posted

Count of Participants

Participants

Within 7 days after Vaccination

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)

Secondary

Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity

Solicited systemic AEs were collected by participants using diary cards within 14 days after vaccination and included fever, headache, asthenia, malaise and myalgia. Severity grades were: Grade 0: none, Grade 1: mild (no interference with daily activity), Grade 2: moderate (interference with daily activity with or without treatment), Grade 3: severe (prevents normal daily activity with or without treatment). A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination.

Posted

Count of Participants

Participants

Within 14 days after Vaccination

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)

Secondary

Number of Participants With at Least One Unsolicited Adverse Events (AEs) Following Vaccination

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a study vaccine; it does not necessarily have to have a causal relationship with study vaccine administration.

The safety set included all randomized participants who received the study vaccine.

Posted

Count of Participants

Participants

Within 28 days after Vaccination

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.

Secondary

Number of Participants With Serious Adverse Events (SAEs)

A serious adverse event (SAE) is 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.

The safety set included all randomized participants who received the study vaccine.

Posted

Count of Participants

Participants

From first vaccination through end of study (Day 365)

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.

Secondary

Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status

Baseline dengue seropositivity was based on the microneutralization test (MNT) result and was defined as a reciprocal neutralizing titer ≥10 for one or more dengue serotype at baseline. The four DENV serotypes are DENV-1, DENV-2, DENV-3, and DENV-4.

Posted

Geometric Mean

95% Confidence Interval

Titer

Days 15, 30, 90, 180 and 365

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.

Secondary

Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status

Baseline dengue seropositivity was based on the MNT result and was defined as a reciprocal neutralizing titer ≥10 for one or more dengue serotype at baseline. Seropositive rate was defined as a reciprocal neutralizing titer ≥ 10. Seropositivity was assessed for the four Dengue serotypes are DENV-1, DENV-2, DENV-3, and DEN-4.

Posted

Number

95% Confidence Interval

percentage of participants

Days 15, 30, 90, 180, and 365

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.

Secondary

Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination

Vaccine Viremia was assessed for each of the four vaccine strains: TDV-1, TDV-2, TDV-3 and TDV-4. Vaccine viral ribonucleic acid (RNA) was detected by reverse transcription-polymerase chain reaction (RT-PCR) assay.

Participants from the safety analysis set, all randomized participants who received at least 1 dose of study vaccine, with data available at the given time-point.

Posted

Number

95% Confidence Interval

percentage of participants

Days 5, 7, 9, 11, 15, 17, 21 and 30

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.

Secondary

Duration of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination

The duration of vaccine viremia for each vaccine strain was defined as the date when vaccine viremia was last detected (positive result) to date when vaccine viremia was first detected (positive result) + 1 day. It was assessed for each of the four vaccine strains: TDV-1, TDV-2, TDV-3 and TDV-4. Vaccine viral ribonucleic acid (RNA) was detected by reverse transcription-polymerase chain reaction (RT-PCR) assay.

Participants from the safety analysis set, all randomized participants who received at least 1 dose of study vaccine. Here 'number analyzed' refers to participants with a positive vaccine viremia test result.

Posted

Median

Full Range

days

Days 5, 7, 9, 11, 15, 17, 21 and 30

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.

Secondary

Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination

Posted

Mean

Standard Deviation

log10 [genome equivalents per mL]

Days 5, 7, 9, 11, 15, 17, 21 and 30

ID	Title	Description
OG000	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
OG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.

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	High-dose Tetravalent Dengue Vaccine (HD-TDV)	High-dose Tetravalent Dengue Vaccine [HD-TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^4 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	0	176	3	176	45	176
EG001	Tetravalent Dengue Vaccine (TDV)	Tetravalent Dengue Vaccine [TDV], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 210^4 plaque forming units (PFU), 510^3 PFU, 110^5 PFU, and 310^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	0	175	3	175	49	175

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Retinal tear	Eye disorders	MedDRA version 20.0	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
Gastroenteritis	Infections and infestations	MedDRA version 20.0	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
Urinary tract infection	Infections and infestations	MedDRA version 20.0	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
Barotrauma	Injury, poisoning and procedural complications	MedDRA version 20.0	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 20.0	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA version 20.0	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
Renal impairment	Renal and urinary disorders	MedDRA version 20.0	Systematic Assessment	EG0001 affected176 at risk EG0010 affected175 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA version 20.0	Systematic Assessment	EG0000 affected176 at risk EG0011 affected175 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA version 20.0	Systematic Assessment	EG0006 affected176 at risk EG0017 affected175 at risk
Nausea	Gastrointestinal disorders	MedDRA version 20.0	Systematic Assessment	EG0004 affected176 at risk EG0014 affected175 at risk
Injection site pruritus	General disorders	MedDRA version 20.0	Systematic Assessment	EG0006 affected176 at risk EG0016 affected175 at risk
Vessel puncture site bruise	General disorders	MedDRA version 20.0	Systematic Assessment	EG0004 affected176 at risk EG0018 affected175 at risk
Influenza	Infections and infestations	MedDRA version 20.0	Systematic Assessment	EG0004 affected176 at risk EG0014 affected175 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version 20.0	Systematic Assessment	EG0002 affected176 at risk EG0016 affected175 at risk
Headache	Nervous system disorders	MedDRA version 20.0	Systematic Assessment	EG0004 affected176 at risk EG0012 affected175 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA version 20.0	Systematic Assessment	EG00011 affected176 at risk EG0018 affected175 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 20.0	Systematic Assessment	EG0009 affected176 at risk EG0018 affected175 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 20.0	Systematic Assessment	EG0005 affected176 at risk EG00110 affected175 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA version 20.0	Systematic Assessment	EG0004 affected176 at risk EG0011 affected175 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA version 20.0	Systematic Assessment	EG0004 affected176 at risk EG0011 affected175 at risk

ID	Term
D003715	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

OG001110.2(73.8 to 164.6)