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Safety and Immunogenicity Study to Assess TDV, a Live Attenuated Tetravalent Vaccine for Prevention of Dengue Fever

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ClinicalTrials.gov Identifier: NCT01224639
Recruitment Status : Completed
First Posted : October 20, 2010
Results First Posted : February 27, 2017
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda ( Inviragen Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Dengue Fever
Interventions Biological: TDV - Low Dose
Biological: TDV - High Dose
Biological: Placebo
Enrollment 96
Recruitment Details Participants took part in the study at 1 investigative site in Colombia from 11 October 2010 to 09 November 2011.
Pre-assignment Details Healthy male and female participants were enrolled in 1 of the 8 treatment groups: Low Dose Subcutaneous:TDV, Low Dose Subcutaneous: Placebo, Low Dose Intradermal:TDV, Low Dose Intradermal:Placebo, High Dose Subcutaneous:TDV, High Dose Subcutaneous:Placebo, High Dose Intradermal:TDV, High Dose Intradermal:Placebo.
Arm/Group Title Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo
Hide Arm/Group Description TDV 0.5 milliliter (mL), injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) (previously DENVax) comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 plaque forming units (PFU), TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU. TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU. TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU. TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU. TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
Period Title: Overall Study
Started 19 5 21 3 21 4 18 5
Completed 19 5 21 3 19 4 17 3
Not Completed 0 0 0 0 2 0 1 2
Reason Not Completed
Withdrawal by Subject             0             0             0             0             2             0             1             1
Adverse Event             0             0             0             0             0             0             0             1
Arm/Group Title Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo Total
Hide Arm/Group Description TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU. TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU. TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU. TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU. TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). Total of all reporting groups
Overall Number of Baseline Participants 19 5 21 3 21 4 18 5 96
Hide Baseline Analysis Population Description
The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 5 participants 21 participants 3 participants 21 participants 4 participants 18 participants 5 participants 96 participants
Less than (<) 18 years 0 0 0 0 0 0 0 0 0
Greater than or equal to (>=) 18 and <65 years 19 5 21 3 21 4 18 5 96
>=65 years 0 0 0 0 0 0 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 5 participants 21 participants 3 participants 21 participants 4 participants 18 participants 5 participants 96 participants
Female
14
  73.7%
4
  80.0%
11
  52.4%
2
  66.7%
17
  81.0%
3
  75.0%
12
  66.7%
4
  80.0%
67
  69.8%
Male
5
  26.3%
1
  20.0%
10
  47.6%
1
  33.3%
4
  19.0%
1
  25.0%
6
  33.3%
1
  20.0%
29
  30.2%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 5 participants 21 participants 3 participants 21 participants 4 participants 18 participants 5 participants 96 participants
White 2 0 4 0 0 0 0 1 7
Other 17 5 17 3 21 4 18 4 89
[1]
Measure Description: The baseline measure category "other" refers to mixed race.
1.Primary Outcome
Title Number of Participants With Local Injection Site Reaction by Severity
Hide Description Solicited local reactions were reported using a participant diary. Pain was categorized as Mild (aware of pain but it does not interfere with daily activity and no pain medication is taken); Moderate (aware of pain; there is interference with daily activity or it requires use of pain medication); Severe (aware of pain and it prevents daily activity), redness was categorized as Mild (greater than [>] 15 millimeter [mm]); Moderate as (15-30 mm); Severe (>30 mm), swelling was categorized as Mild (<15 mm); Moderate (15-30 mm); Severe (>30 mm), and itching was categorized as Mild (slight itching at injection site); Moderate (moderate itching at injection extremity); Severe (itching over entire body).
Time Frame Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.
Arm/Group Title Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo
Hide Arm/Group Description:
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
Overall Number of Participants Analyzed 19 5 21 3 21 4 18 5
Measure Type: Number
Unit of Measure: participants
Pain: Mild 12 1 8 2 8 0 10 1
Pain: Moderate 1 0 0 0 0 0 2 0
Redness: Mild 1 0 12 0 1 1 5 0
Redness: Moderate 1 0 8 0 5 0 9 0
Redness: Severe 4 0 0 0 7 0 3 0
Swelling: Mild 0 0 10 0 2 0 5 0
Swelling: Moderate 2 0 4 0 2 0 5 0
Swelling: Severe 4 0 0 0 3 0 0 0
Itching: Mild 4 0 12 1 7 1 13 1
Itching: Moderate 1 0 0 0 0 0 2 0
2.Primary Outcome
Title Number of Participants With Systemic Adverse Events (AEs) by Severity
Hide Description Solicited systemic AEs were reported using a participant diary. Solicited systemic AEs included fever (>= 37.8°C), headache, muscle pain, joint pain, eye pain, photophobia, fatigue, body rash, nausea, vomiting and other (any other symptom not listed in the diary) and were categorized as Mild: transient symptoms, discomfort noticed but easily tolerated, no interference to normal daily activities; Moderate: marked symptoms, moderate interference with daily activities; Severe: considerable interference with daily activities.
Time Frame Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.
Arm/Group Title Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo
Hide Arm/Group Description:
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
Overall Number of Participants Analyzed 19 5 21 3 21 4 18 5
Measure Type: Number
Unit of Measure: participants
Fever: Mild 2 1 2 0 0 0 1 0
Fever: Moderate 1 0 0 1 1 1 1 0
Fever: Severe 0 0 1 0 0 0 0 0
Headache: Mild 4 1 12 2 9 0 6 2
Headache: Moderate 7 1 4 0 2 1 5 1
Headache: Severe 1 0 0 0 1 0 1 0
Muscle pain: Mild 10 0 3 2 4 0 6 0
Muscle pain: Moderate 0 0 0 0 1 0 1 0
Muscle pain: Severe 1 0 1 0 0 0 0 0
Joint pain: Mild 4 0 2 0 3 0 3 0
Joint pain: Moderate 1 0 0 0 0 0 0 0
Joint pain: Severe 1 0 1 0 0 0 0 0
Eye pain: Mild 6 2 8 1 4 1 7 1
Eye pain: Moderate 2 0 1 0 0 0 1 1
Eye pain: Severe 1 0 0 0 0 0 0 0
Photophobia: Mild 5 1 6 1 2 1 3 2
Photophobia: Moderate 0 0 0 0 2 0 1 0
Photophobia: Severe 0 0 0 0 0 0 0 0
Fatigue: Mild 9 2 7 1 5 0 10 4
Fatigue: Moderate 3 0 4 0 2 0 2 0
Fatigue: Severe 1 0 0 0 0 0 2 0
Body Rash: Mild 0 0 1 1 0 0 4 0
Body Rash: Moderate 0 0 0 0 1 0 0 0
Body Rash: Severe 0 0 0 0 1 0 0 0
Nausea: Mild 4 2 4 1 4 0 4 2
Nausea: Moderate 0 0 2 0 1 0 3 0
Nausea: Severe 2 0 0 0 0 0 0 0
Vomiting: Mild 0 0 0 0 0 0 0 0
Vomiting: Moderate 0 0 0 0 1 0 2 0
Vomiting: Severe 1 0 0 0 0 0 1 0
Other: Mild 4 0 2 0 6 1 4 1
Other: Moderate 2 1 4 0 4 1 2 2
Other: Severe 1 0 0 0 1 0 0 0
3.Primary Outcome
Title Number of Participants With Solicited Local and Systemic AEs
Hide Description [Not Specified]
Time Frame Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.
Arm/Group Title Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo
Hide Arm/Group Description:
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
Overall Number of Participants Analyzed 19 5 21 3 21 4 18 5
Measure Type: Number
Unit of Measure: participants
Local solicited AEs 15 1 20 2 14 1 18 1
Systemic solicited AEs 17 4 17 2 17 3 17 4
4.Primary Outcome
Title Number of Participants With Unsolicited Local and Systemic AEs
Hide Description [Not Specified]
Time Frame Baseline up to 30 days after second vaccination (Day 120)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.
Arm/Group Title Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo
Hide Arm/Group Description:
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
Overall Number of Participants Analyzed 19 5 21 3 21 4 18 5
Measure Type: Number
Unit of Measure: participants
Local unsolicited AEs 0 0 3 0 1 0 4 0
Systemic unsolicited AEs 18 5 16 3 16 2 14 3
5.Secondary Outcome
Title Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Hide Description GMT was assessed for the four dengue serotypes: Dengue TDV-1, TDV-2, TDV-3 and TDV-4. GMTs and 95 percent (%) confidence interval (CIs) were calculated by taking the anti-logs of the means and 95% CI of the log transformed titers.
Time Frame Days 14, 30, 60 and 90 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received. Here 'n' is number of participants with non-missing microneutralization (MN) Assay samples.
Arm/Group Title Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo
Hide Arm/Group Description:
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
Overall Number of Participants Analyzed 19 5 21 3 21 4 18 5
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5)
12.45
(8.32 to 18.61)
5.00
(5.00 to 5.00)
22.08
(12.64 to 38.58)
5.00
(5.00 to 5.00)
111.29
(58.46 to 211.83)
5.00
(5.00 to 5.00)
72.66
(27.52 to 191.86)
5.00
(5.00 to 5.00)
Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5)
6.94
(4.31 to 11.19)
5.00
(5.00 to 5.00)
7.43
(4.89 to 11.29)
5.00
(5.00 to 5.00)
6.73
(4.72 to 9.59)
5.00
(5.00 to 5.00)
7.64
(3.39 to 17.20)
5.00
(5.00 to 5.00)
Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5)
17.93
(8.20 to 39.17)
5.00
(5.00 to 5.00)
20.00
(9.17 to 43.60)
5.00
(5.00 to 5.00)
26.04
(12.30 to 55.13)
5.00
(5.00 to 5.00)
117.58
(41.32 to 334.54)
5.00
(5.00 to 5.00)
Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5)
7.75
(5.02 to 11.96)
5.00
(5.00 to 5.00)
11.04
(6.26 to 19.46)
5.00
(5.00 to 5.00)
5.71
(4.72 to 6.90)
5.00
(5.00 to 5.00)
11.22
(5.40 to 23.32)
5.00
(5.00 to 5.00)
Day 30 TDV-1(n=19, 5, 21, 3, 21, 4, 18, 5)
49.79
(26.00 to 95.36)
5.00
(5.00 to 5.00)
48.76
(27.94 to 85.09)
5.00
(5.00 to 5.00)
208.37
(102.74 to 422.61)
5.00
(5.00 to 5.00)
153.96
(80.16 to 295.69)
5.00
(5.00 to 5.00)
Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5)
363.60
(73.44 to 1800.07)
5.00
(5.00 to 5.00)
475.52
(88.35 to 2559.42)
5.00
(5.00 to 5.00)
8682.13
(5174.46 to 14567.58)
5.00
(5.00 to 5.00)
2370.24
(718.63 to 7817.74)
5.00
(5.00 to 5.00)
Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5)
25.82
(9.77 to 68.26)
5.00
(5.00 to 5.00)
67.83
(25.66 to 179.29)
5.00
(5.00 to 5.00)
42.03
(22.35 to 79.05)
5.00
(5.00 to 5.00)
307.91
(115.76 to 819.04)
5.00
(5.00 to 5.00)
Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5)
33.33
(14.01 to 79.31)
5.00
(5.00 to 5.00)
57.51
(21.68 to 152.57)
5.00
(5.00 to 5.00)
9.06
(4.89 to 16.79)
5.00
(5.00 to 5.00)
22.88
(10.76 to 48.69)
5.00
(5.00 to 5.00)
Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5)
49.79
(23.98 to 103.39)
5.00
(5.00 to 5.00)
38.70
(19.18 to 78.08)
6.30
(2.33 to 17.02)
103.28
(50.97 to 209.26)
5.00
(5.00 to 5.00)
86.40
(39.48 to 189.10)
5.00
(5.00 to 5.00)
Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5)
230.44
(66.23 to 801.82)
5.00
(5.00 to 5.00)
262.51
(63.99 to 1076.87)
5.00
(5.00 to 5.00)
1280.00
(768.38 to 2132.27)
5.00
(5.00 to 5.00)
838.01
(375.38 to 1870.77)
5.00
(5.00 to 5.00)
Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5)
34.57
(14.13 to 84.59)
5.00
(5.00 to 5.00)
50.40
(20.72 to 122.56)
5.00
(5.00 to 5.00)
30.99
(18.33 to 52.37)
5.00
(5.00 to 5.00)
148.14
(50.82 to 431.83)
5.00
(5.00 to 5.00)
Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5)
13.39
(7.04 to 25.46)
5.00
(5.00 to 5.00)
26.48
(10.42 to 67.30)
5.00
(5.00 to 5.00)
5.58
(4.43 to 7.02)
5.00
(5.00 to 5.00)
10.60
(5.31 to 21.13)
5.00
(5.00 to 5.00)
Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3)
34.57
(16.17 to 73.92)
5.00
(5.00 to 5.00)
43.44
(18.91 to 99.80)
5.00
(5.00 to 5.00)
109.09
(49.55 to 240.18)
5.00
(5.00 to 5.00)
80.00
(33.72 to 189.78)
5.00
(5.00 to 5.00)
Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3)
181.80
(55.42 to 596.40)
5.00
(5.00 to 5.00)
309.61
(94.50 to 1014.43)
5.00
(5.00 to 5.00)
1912.01
(1254.58 to 2913.94)
5.00
(5.00 to 5.00)
666.63
(305.13 to 1456.45)
5.00
(5.00 to 5.00)
Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3)
30.99
(13.75 to 69.81)
5.00
(5.00 to 5.00)
60.43
(27.22 to 134.18)
5.00
(5.00 to 5.00)
34.57
(20.61 to 57.99)
5.00
(5.00 to 5.00)
135.92
(51.41 to 359.33)
5.00
(5.00 to 5.00)
Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3)
11.16
(6.11 to 20.38)
5.00
(5.00 to 5.00)
28.29
(11.62 to 68.86)
5.00
(5.00 to 5.00)
6.22
(5.12 to 7.56)
5.00
(5.00 to 5.00)
11.30
(5.86 to 21.81)
5.00
(5.00 to 5.00)
6.Secondary Outcome
Title GMTs of All Four Dengue Serotypes After Second Vaccination
Hide Description GMT was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. GMTs and 95% CIs were calculated by taking the anti-logs of the means and 95% CI of the log transformed titers.
Time Frame Days 14 and 30 after second vaccination (Day 104 and 120 respectively)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received. Here 'n' is number of participants with non-missing MN Assay samples.
Arm/Group Title Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo
Hide Arm/Group Description:
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
Overall Number of Participants Analyzed 19 5 21 3 21 4 18 5
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3)
111.09
(45.46 to 271.46)
5.00
(5.00 to 5.00)
137.92
(68.77 to 276.60)
5.00
(5.00 to 5.00)
244.39
(133.53 to 447.30)
5.00
(5.00 to 5.00)
230.93
(131.23 to 406.38)
5.00
(5.00 to 5.00)
Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3)
222.18
(76.63 to 644.18)
5.00
(5.00 to 5.00)
341.84
(102.43 to 1140.85)
5.00
(5.00 to 5.00)
1382.48
(935.89 to 2042.17)
5.00
(5.00 to 5.00)
589.88
(277.32 to 1254.75)
5.00
(5.00 to 5.00)
Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3)
73.03
(33.64 to 158.56)
5.00
(5.00 to 5.00)
144.92
(81.49 to 257.70)
5.00
(5.00 to 5.00)
63.50
(45.45 to 88.71)
5.00
(5.00 to 5.00)
250.56
(127.21 to 493.50)
5.00
(5.00 to 5.00)
Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3)
21.51
(11.58 to 39.95)
5.00
(5.00 to 5.00)
72.46
(35.46 to 148.05)
5.00
(5.00 to 5.00)
10.39
(7.09 to 15.24)
5.00
(5.00 to 5.00)
27.71
(14.56 to 52.77)
5.00
(5.00 to 5.00)
Day 120 TDV-1(n=19, 5, 21, 3, 19, 4, 17, 3)
128.55
(52.36 to 315.60)
5.00
(5.00 to 5.00)
92.81
(47.92 to 179.77)
5.00
(5.00 to 5.00)
181.82
(101.33 to 326.24)
5.00
(5.00 to 5.00)
160.00
(91.07 to 281.09)
5.00
(5.00 to 5.00)
Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3)
206.55
(64.16 to 664.90)
5.00
(5.00 to 5.00)
314.76
(95.01 to 1042.74)
5.00
(5.00 to 5.00)
1536.13
(972.63 to 2426.11)
5.00
(5.00 to 5.00)
543.69
(248.70 to 1188.55)
5.00
(5.00 to 5.00)
Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3)
69.14
(33.72 to 141.77)
5.00
(5.00 to 5.00)
88.33
(46.17 to 168.99)
5.00
(5.00 to 5.00)
78.56
(49.89 to 123.70)
5.00
(5.00 to 5.00)
271.84
(126.94 to 582.17)
5.00
(5.00 to 5.00)
Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3)
20.74
(10.59 to 40.64)
5.00
(5.00 to 5.00)
48.76
(24.58 to 96.74)
5.00
(5.00 to 5.00)
9.64
(6.41 to 14.51)
5.00
(5.00 to 5.00)
16.99
(9.34 to 30.90)
5.00
(5.00 to 5.00)
7.Secondary Outcome
Title Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Hide Description Seroconversion was defined as a Plaque Reduction Neutralization Test (PRNT) titer resulting in 50% reduction in plaques (PRNT[50]) >=10 (if the pre-vaccination PRNT[50] value was <10, indicated as a value of 5 in the immunogenicity data collection sheet) OR a PRNT(50) value that was >=4-fold the pre-vaccination titer value (if the pre-vaccination PRNT[50] value was >=10). Seroconversion was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution. Percentages are based on the number of participants in the FAS with non-missing MN assay samples at each visit.
Time Frame Days 14, 30, 60 and 90 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.
Arm/Group Title Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo
Hide Arm/Group Description:
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
Overall Number of Participants Analyzed 19 5 21 3 21 4 18 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5)
63.2
(38.4 to 83.7)
0
(0.0 to 52.2)
66.7
(43.0 to 85.4)
0
(0.0 to 70.8)
90.5
(69.8 to 98.8)
0
(0.0 to 60.2)
83.3
(58.6 to 96.4)
0
(0.0 to 52.2)
Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5)
10.5
(1.3 to 33.1)
0
(0.0 to 52.2)
19.0
(5.4 to 41.9)
0
(0 to 70.8)
14.3
(3.0 to 36.3)
0
(0.0 to 60.2)
11.1
(1.4 to 34.7)
0
(0.0 to 52.2)
Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5)
52.6
(28.9 to 75.6)
0
(0.0 to 52.2)
42.9
(21.8 to 66.0)
0
(0.0 to 70.8)
52.4
(29.8 to 74.3)
0
(0.0 to 60.2)
83.3
(58.6 to 96.4)
0
(0.0 to 52.2)
Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5)
21.1
(6.1 to 45.6)
0
(0.0 to 52.2)
33.3
(14.6 to 57.0)
0
(0.0 to 70.8)
9.5
(1.2 to 30.4)
0
(0.0 to 60.2)
38.9
(17.2 to 64.3)
0
(0.0 to 52.2)
Day 30 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5)
89.5
(66.9 to 98.7)
0
(0.0 to 52.2)
90.5
(69.6 to 98.8)
0
(0.0 to 70.8)
95.2
(76.2 to 99.9)
0
(0.0 to 60.2)
100
(81.5 to 100.0)
0
(0.0 to 52.2)
Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5)
68.4
(43.4 to 87.4)
0
(0.0 to 52.2)
66.7
(43.0 to 85.4)
0
(0.0 to 70.8)
100.0
(83.9 to 100.0)
0
(0.0 to 60.2)
88.9
(65.3 to 98.6)
0
(0.0 to 52.2)
Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5)
57.9
(33.5 to 79.7)
0
(0.0 to 52.2)
71.4
(47.8 to 88.7)
0
(0.0 to 70.8)
81.0
(58.1 to 94.6)
0
(0.0 to 60.2)
94.4
(72.7 to 99.9)
0
(0.0 to 52.2)
Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5)
63.2
(38.4 to 83.7)
0
(0.0 to 52.2)
71.4
(47.8 to 88.7)
0
(0.0 to 70.8)
23.8
(8.2 to 47.2)
0
(0.0 to 60.2)
66.7
(41.0 to 86.7)
0
(0.0 to 52.2)
Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5)
89.5
(66.9 to 98.7)
0
(0.0 to 52.2)
81.0
(58.1 to 94.6)
33.3
(0.8 to 90.6)
94.7
(74.0 to 99.9)
0
(0.0 to 60.2)
100
(81.5 to 100.0)
0
(0.0 to 52.2)
Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5)
78.9
(54.4 to 93.6)
0
(0.0 to 52.2)
66.7
(43.0 to 85.4)
0
(0.0 to 70.8)
100.0
(82.4 to 100.0)
0
(0.0 to 60.2)
94.4
(72.7 to 99.9)
0
(0.0 to 52.2)
Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5)
63.2
(38.4 to 83.7)
0
(0.0 to 52.2)
66.7
(43.0 to 85.4)
0
(0.0 to 70.8)
89.5
(66.9 to 98.7)
0
(0.0 to 60.2)
88.9
(65.3 to 98.6)
0
(0.0 to 52.2)
Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5)
47.4
(24.4 to 71.1)
0
(0.0 to 52.2)
42.9
(21.8 to 66.0)
0
(0.0 to 70.8)
5.3
(0.1 to 26.0)
0
(0.0 to 60.2)
33.3
(13.3 to 59.0)
0
(0.0 to 52.2)
Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3)
73.7
(48.8 to 90.9)
0
(0.0 to 52.2)
71.4
(47.8 to 88.7)
0
(0.0 to 70.8)
94.7
(74.0 to 99.9)
0
(0.0 to 60.2)
88.2
(63.6 to 98.5)
0
(0.0 to 70.8)
Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3)
73.7
(48.8 to 90.9)
0
(0.0 to 52.2)
76.2
(52.8 to 91.8)
0
(0.0 to 70.8)
100.0
(82.4 to 100.0)
0
(0.0 to 60.2)
94.1
(71.3 to 99.9)
0
(0.0 to 70.8)
Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3)
68.4
(43.4 to 87.4)
0
(0.0 to 52.2)
76.2
(52.8 to 91.8)
0
(0.0 to 70.8)
94.7
(74.0 to 99.9)
0
(0.0 to 60.2)
100.0
(80.5 to 100.0)
0
(0.0 to 70.8)
Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3)
36.8
(16.3 to 61.6)
0
(0.0 to 52.2)
52.4
(29.8 to 74.3)
0
(0.0 to 70.8)
26.3
(9.1 to 51.2)
0
(0.0 to 60.2)
41.2
(18.4 to 67.1)
0
(0.0 to 70.8)
8.Secondary Outcome
Title Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination
Hide Description Seroconversion was defined as a PRNT titer resulting in 50% reduction in plaques (PRNT[50]) >=10 (if the pre-vaccination PRNT[50] value was <10, indicated as a value of 5 in the immunogenicity data collection sheet) OR a PRNT(50) value that was >=4-fold the pre-vaccination titer value (if the pre-vaccination PRNT[50] value was >=10). Seroconversion was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution. Percentages are based on the number of participants in the FAS with non-missing MN assay samples at each visit (n).
Time Frame Days 14 and 30 after second vaccination (Days 104 and 120 respectively)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.
Arm/Group Title Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo
Hide Arm/Group Description:
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
Overall Number of Participants Analyzed 19 5 21 3 21 4 18 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3)
89.5
(66.9 to 98.7)
0
(0.0 to 52.2)
100.0
(83.9 to 100.0)
0
(0.0 to 70.8)
100.0
(81.5 to 100.0)
0
(0.0 to 60.2)
100.0
(80.5 to 100.0)
0
(0.0 to 70.8)
Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3)
78.9
(54.4 to 93.9)
0
(0.0 to 52.2)
76.2
(52.8 to 91.8)
0
(0.0 to 70.8)
100.0
(81.5 to 100.0)
0
(0.0 to 60.2)
100.0
(80.5 to 100.0)
0
(0.0 to 70.8)
Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3)
84.2
(60.4 to 96.6)
0
(0.0 to 52.2)
100.0
(83.9 to 100.0)
0
(0.0 to 70.8)
100.0
(81.5 to 100.0)
0
(0.0 to 60.2)
100.0
(80.5 to 100.0)
0
(0.0 to 70.8)
Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3)
73.7
(48.8 to 90.9)
0
(0.0 to 52.2)
90.5
(69.6 to 98.8)
0
(0.0 to 70.8)
55.6
(30.8 to 78.5)
0
(0.0 to 60.2)
88.2
(63.6 to 98.5)
0
(0.0 to 70.8)
Day 120 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3)
94.7
(74.0 to 99.9)
0
(0.0 to 52.2)
100.0
(83.9 to 100.0)
0
(0.0 to 70.8)
100.0
(82.4 to 100.0)
0
(0.0 to 60.2)
100.0
(80.5 to 100.0)
0
(0.0 to 70.8)
Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3)
78.9
(54.4 to 93.6)
0
(0.0 to 52.2)
76.2
(52.8 to 91.8)
0
(0.0 to 70.8)
100.0
(81.5 to 100.0)
0
(0.0 to 60.2)
94.1
(71.3 to 99.9)
0
(0.0 to 70.8)
Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3)
94.7
(74.0 to 99.9)
0
(0.0 to 52.2)
95.2
(76.2 to 99.9)
0
(0.0 to 70.8)
100.0
(82.4 to 100.0)
0
(0.0 to 60.2)
100.0
(80.5 to 100.0)
0
(0.0 to 70.8)
Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3)
73.7
(48.8 to 90.9)
0
(0.0 to 52.2)
95.2
(76.2 to 99.9)
0
(0.0 to 70.8)
47.4
(24.4 to 71.1)
0
(0.0 to 60.2)
76.5
(50.1 to 93.2)
0
(0.0 to 70.8)
9.Secondary Outcome
Title Percentage of Participants With Durability of Immune Response
Hide Description Immune response was considered durable if the participant had detectable neutralizing antibodies (seroconversion) to all 4 dengue serotypes at 90 and 180 days after the second dose (i.e. Days 180 and 270, respectively). Seroconversion is defined as post-vaccination PRNT(50) titer >=10 where pre-vaccination PRNT 50 titer <10, or post-vaccination PRNT(50) Titer >=4-fold the pre-vaccination PRNT(50) titer value where pre-vaccination PRNT(50) titer >=10. Percentage of participants with seroconversion on Days 180 and 270 are based on the number of participants in the FAS with non-missing MN assay samples at each visit. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution.
Time Frame Days 180 and 270
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.
Arm/Group Title Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo
Hide Arm/Group Description:
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
Overall Number of Participants Analyzed 19 5 21 3 19 4 17 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 180 TDV-1
78.9
(54.4 to 93.9)
0
(0 to 52.2)
90.5
(69.6 to 98.8)
0
(0 to 70.8)
100.0
(82.4 to 100.0)
0
(0 to 60.2)
100.0
(80.5 to 100.0)
0
(0 to 70.8)
Day 180 TDV-2
73.7
(48.8 to 90.9)
0
(0.0 to 52.2)
81.0
(58.1 to 94.6)
0
(0.0 to 70.8)
100.0
(82.4 to 100.0)
0
(0.0 to 60.2)
94.1
(71.3 to 99.9)
0
(0.0 to 70.8)
Day 180 TDV-3
94.7
(74.0 to 99.9)
20.0
(0.5 to 71.6)
100.0
(83.9 to 100.0)
0
(0.0 to 70.8)
94.7
(74.0 to 99.9)
0
(0.0 to 60.2)
100.0
(80.5 to 100.0)
0
(0.0 to 70.8)
Day 180 TDV-4
63.2
(38.4 to 83.7)
0
(0.0 to 52.2)
71.4
(47.8 to 88.7)
0
(0.0 to 70.8)
31.6
(12.6 to 56.6)
0
(0.0 to 60.2)
52.9
(27.8 to 77.0)
0
(0.0 to 70.8)
Day 270 TDV-1
68.4
(43.4 to 87.4)
0
(0 to 52.2)
66.7
(43.0 to 85.4)
0
(0 to 70.8)
89.5
(66.9 to 98.7)
0
(0 to 60.2)
94.1
(71.3 to 99.9)
0
(0 to 70.8)
Day 270 TDV-2
73.7
(48.8 to 90.9)
0
(0.0 to 52.2)
81.0
(58.1 to 94.6)
0
(0.0 to 70.8)
100.0
(82.4 to 100.0)
0
(0.0 to 60.2)
94.1
(71.3 to 99.9)
0
(0.0 to 70.8)
Day 270 TDV-3
68.4
(43.4 to 87.4)
0
(0.0 to 52.2)
76.2
(52.8 to 91.8)
0
(0.0 to 70.8)
57.9
(33.5 to 79.7)
0
(0.0 to 60.2)
88.2
(63.6 to 98.5)
0
(0.0 to 70.8)
Day 270 TDV-4
42.1
(20.3 to 66.5)
0
(0.0 to 52.2)
57.1
(34.0 to 78.2)
0
(0.0 to 70.8)
15.8
(3.4 to 39.6)
0
(0.0 to 60.2)
35.3
(14.2 to 61.7)
0
(0.0 to 70.8)
10.Secondary Outcome
Title Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Hide Description Serotype-specific vaccine viremia was assessed for the four vaccine strain serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. Only those serotypes and time-points where at least 1 participant had serotype-specific vaccine viremia detection were reported.
Time Frame Baseline and at multiple time points up to Day 14 after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.
Arm/Group Title Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo
Hide Arm/Group Description:
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
Overall Number of Participants Analyzed 19 5 21 3 21 4 18 5
Measure Type: Number
Unit of Measure: participants
Day 5 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) 0 0 0 0 1 0 1 0
Day 7 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) 1 0 2 0 6 0 4 0
Day 9 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) 5 0 6 0 9 0 5 0
Day 11 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) 4 0 7 0 17 0 5 0
Day 14 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) 3 0 3 0 10 0 8 0
Day 97 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) 1 0 0 0 0 0 0 0
Day 99 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) 1 0 0 0 0 0 0 0
Day 101 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) 1 0 0 0 0 0 0 0
Day 104 TDV-2 (n= 19, 5, 21, 3, 18, 4, 17, 3) 1 0 0 0 0 0 0 0
Day 5 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) 0 0 0 0 0 0 1 0
Day 7 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) 0 0 1 0 0 0 1 0
Day 9 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) 0 0 0 0 0 0 1 0
Day 97 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) 1 0 0 0 0 0 0 0
Day 99 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) 0 0 0 0 1 0 0 0
Day 101 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) 0 0 0 0 1 0 0 0
Day 7 TDV-4 (n= 19, 5, 21, 3, 21, 4, 18, 5) 0 0 1 0 0 0 0 0
Day 97 TDV-4 (n= 19, 5, 21, 3, 19, 4, 17, 3) 1 0 0 0 0 0 0 0
11.Secondary Outcome
Title Duration of Vaccine Viremia
Hide Description [Not Specified]
Time Frame 14 Days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the low prevalence of vaccine viremia, estimates of average titer duration of viral RNA within study groups would not be meaningful. Therefore as per change in planned analysis only number of participants with positive vaccine viremia of all four vaccine strain serotypes after first and second vaccination was reported.
Arm/Group Title Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo
Hide Arm/Group Description:
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Titers of Vaccine Viremia
Hide Description [Not Specified]
Time Frame 14 Days after each vaccination
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Hide Analysis Population Description
Due to the low prevalence of vaccine viremia, estimates of average titer levels of viral RNA within study groups would not be meaningful. Therefore as per change in planned analysis only number of participants with positive vaccine viremia of all four vaccine strain serotypes after first and second vaccination was reported.
Arm/Group Title Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo
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TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
Adverse Event Reporting Description A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
 
Arm/Group Title Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo
Hide Arm/Group Description TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU. TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU. TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU. TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU. TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
All-Cause Mortality
Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/5 (0.00%)   0/21 (0.00%)   1/3 (33.33%)   1/21 (4.76%)   0/4 (0.00%)   0/18 (0.00%)   0/5 (0.00%) 
Injury, poisoning and procedural complications                 
Ankle fracture * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  1/21 (4.76%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
Psychiatric disorders                 
Suicide attempt * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  1/3 (33.33%)  0/21 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Low Dose Subcutaneous: TDV Low Dose Subcutaneous: Placebo Low Dose Intradermal: TDV Low Dose Intradermal: Placebo High Dose Subcutaneous: TDV High Dose Subcutaneous: Placebo High Dose Intradermal: TDV High Dose Intradermal: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/19 (63.16%)   5/5 (100.00%)   13/21 (61.90%)   3/3 (100.00%)   15/21 (71.43%)   2/4 (50.00%)   13/18 (72.22%)   3/5 (60.00%) 
Blood and lymphatic system disorders                 
ANAEMIA * 1  3/19 (15.79%)  1/5 (20.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  1/4 (25.00%)  0/18 (0.00%)  0/5 (0.00%) 
LYMPHADENOPATHY * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/5 (0.00%) 
THROMBOCYTOSIS * 1  1/19 (5.26%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
Ear and labyrinth disorders                 
EAR PAIN * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/5 (0.00%) 
Eye disorders                 
EYE PAIN * 1  0/19 (0.00%)  1/5 (20.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/5 (20.00%) 
PHOTOPHOBIA * 1  0/19 (0.00%)  0/5 (0.00%)  1/21 (4.76%)  0/3 (0.00%)  0/21 (0.00%)  1/4 (25.00%)  0/18 (0.00%)  1/5 (20.00%) 
Gastrointestinal disorders                 
ABDOMINAL PAIN LOWER * 1  1/19 (5.26%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
ABDOMINAL PAIN UPPER * 1  1/19 (5.26%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/5 (0.00%) 
NAUSEA * 1  1/19 (5.26%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  2/21 (9.52%)  0/4 (0.00%)  0/18 (0.00%)  1/5 (20.00%) 
General disorders                 
CHEST PAIN * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/5 (20.00%) 
FATIGUE * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  1/3 (33.33%)  0/21 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
INJECTION SITE ERYTHEMA * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/5 (0.00%) 
INJECTION SITE HAEMATOMA * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/5 (0.00%) 
PYERXIA * 1  0/19 (0.00%)  0/5 (0.00%)  1/21 (4.76%)  1/3 (33.33%)  0/21 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
VACCINATION SITE HAEMATOMA * 1  0/19 (0.00%)  0/5 (0.00%)  3/21 (14.29%)  0/3 (0.00%)  1/21 (4.76%)  0/4 (0.00%)  2/18 (11.11%)  0/5 (0.00%) 
VACCINATION SITE SCAB * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/5 (0.00%) 
Infections and infestations                 
ASYMPTOMATIC BACTERIURIA * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  1/3 (33.33%)  2/21 (9.52%)  1/4 (25.00%)  1/18 (5.56%)  0/5 (0.00%) 
GASTROENTERITIS * 1  0/19 (0.00%)  0/5 (0.00%)  1/21 (4.76%)  0/3 (0.00%)  2/21 (9.52%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
NASOPHARYNGITIS * 1  3/19 (15.79%)  2/5 (40.00%)  4/21 (19.05%)  0/3 (0.00%)  5/21 (23.81%)  0/4 (0.00%)  4/18 (22.22%)  1/5 (20.00%) 
ORAL HERPES * 1  1/19 (5.26%)  0/5 (0.00%)  1/21 (4.76%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
OTITIS EXTERNA * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/5 (20.00%) 
PHARYNGITIS * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/5 (0.00%) 
RESPIRATORY TRACT INFECTION * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  1/3 (33.33%)  0/21 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
RHINITIS * 1  0/19 (0.00%)  1/5 (20.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/5 (0.00%) 
TONSILLITIS * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  2/21 (9.52%)  0/4 (0.00%)  1/18 (5.56%)  0/5 (0.00%) 
URINARY TRACT INFECTION * 1  2/19 (10.53%)  0/5 (0.00%)  2/21 (9.52%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  1/5 (20.00%) 
VAGINITIS BACTERIAL * 1  0/19 (0.00%)  0/5 (0.00%)  2/21 (9.52%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
Injury, poisoning and procedural complications                 
TOXICITY TO VARIOUS AGENTS * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  1/3 (33.33%)  0/21 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
Investigations                 
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED * 1  1/19 (5.26%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
BLOOD FIBRINOGEN INCREASED * 1  1/19 (5.26%)  0/5 (0.00%)  1/21 (4.76%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders                 
BACK PAIN * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  1/21 (4.76%)  0/4 (0.00%)  1/18 (5.56%)  0/5 (0.00%) 
BURSITIS * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/5 (0.00%) 
Nervous system disorders                 
DIZZINESS * 1  1/19 (5.26%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  1/21 (4.76%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
HEADACHE * 1  1/19 (5.26%)  1/5 (20.00%)  4/21 (19.05%)  1/3 (33.33%)  6/21 (28.57%)  1/4 (25.00%)  4/18 (22.22%)  1/5 (20.00%) 
Respiratory, thoracic and mediastinal disorders                 
COUGH * 1  1/19 (5.26%)  0/5 (0.00%)  2/21 (9.52%)  0/3 (0.00%)  2/21 (9.52%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
OROPHARYNGEAL PAIN * 1  1/19 (5.26%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  1/21 (4.76%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
RHINORRHOEA * 1  2/19 (10.53%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders                 
ERYTHEMA * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/5 (0.00%) 
PRURITUS * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  1/4 (25.00%)  0/18 (0.00%)  0/5 (0.00%) 
RASH * 1  1/19 (5.26%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  3/21 (14.29%)  0/4 (0.00%)  1/18 (5.56%)  0/5 (0.00%) 
URTICARIA * 1  0/19 (0.00%)  0/5 (0.00%)  2/21 (9.52%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
Vascular disorders                 
HAEMATOMA * 1  0/19 (0.00%)  1/5 (20.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/5 (0.00%) 
PERIPHERAL COLDNESS * 1  0/19 (0.00%)  0/5 (0.00%)  0/21 (0.00%)  0/3 (0.00%)  0/21 (0.00%)  1/4 (25.00%)  0/18 (0.00%)  0/5 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
No publication related to study results will be made without Sponsor’s prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda ( Inviragen Inc. )
ClinicalTrials.gov Identifier: NCT01224639     History of Changes
Other Study ID Numbers: INV-DEN-102
U1111-1181-8290 ( Registry Identifier: WHO )
First Submitted: October 9, 2010
First Posted: October 20, 2010
Results First Submitted: January 9, 2017
Results First Posted: February 27, 2017
Last Update Posted: June 19, 2018