Trial Outcomes & Findings for Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) in Adolescents in Non-Endemic Area(s) (NCT NCT03341637)
NCT ID: NCT03341637
Last Updated: 2019-08-15
Results Overview
GMTs of neutralizing antibodies were measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity is defined as reciprocal neutralizing titer ≥10.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
400 participants
Primary outcome timeframe
One month post second dose (Day 120)
Results posted on
2019-08-15
Participant Flow
Participants took part in the study at 5 investigative sites in Mexico from 14-Dec-2017 to 26-Jan-2019.
Healthy volunteers were enrolled in a 3:1 ratio into 2 parallel study groups: 1 study group received 2 doses of Tetravalent Dengue vaccine (TDV) and another group received 2 doses of TDV matching placebo subcutaneously (SC).
Participant milestones
| Measure |
Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Tetravalent Dengue Vaccine (TDV)
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
300
|
|
Overall Study
COMPLETED
|
95
|
296
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Tetravalent Dengue Vaccine (TDV)
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Reason not Specified
|
1
|
1
|
Baseline Characteristics
If a participant had documented more than 1 race category on the case report form, the participant was only included under the multiracial category.
Baseline characteristics by cohort
| Measure |
Placebo
n=100 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Tetravalent Dengue Vaccine (TDV)
n=300 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.3 years
STANDARD_DEVIATION 1.57 • n=5 Participants
|
14.3 years
STANDARD_DEVIATION 1.69 • n=7 Participants
|
14.3 years
STANDARD_DEVIATION 1.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
100 Participants
n=5 Participants
|
300 Participants
n=7 Participants
|
400 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
55 Participants
n=5 Participants • If a participant had documented more than 1 race category on the case report form, the participant was only included under the multiracial category.
|
148 Participants
n=7 Participants • If a participant had documented more than 1 race category on the case report form, the participant was only included under the multiracial category.
|
203 Participants
n=5 Participants • If a participant had documented more than 1 race category on the case report form, the participant was only included under the multiracial category.
|
|
Race/Ethnicity, Customized
Multiracial
|
45 Participants
n=5 Participants • If a participant had documented more than 1 race category on the case report form, the participant was only included under the multiracial category.
|
152 Participants
n=7 Participants • If a participant had documented more than 1 race category on the case report form, the participant was only included under the multiracial category.
|
197 Participants
n=5 Participants • If a participant had documented more than 1 race category on the case report form, the participant was only included under the multiracial category.
|
|
Region of Enrollment
Mexico
|
100 Participants
n=5 Participants
|
300 Participants
n=7 Participants
|
400 Participants
n=5 Participants
|
|
Height
|
159.6 cm
STANDARD_DEVIATION 8.94 • n=5 Participants
|
159.0 cm
STANDARD_DEVIATION 8.68 • n=7 Participants
|
159.2 cm
STANDARD_DEVIATION 8.74 • n=5 Participants
|
|
Weight
|
57.60 kg
STANDARD_DEVIATION 14.045 • n=5 Participants
|
56.84 kg
STANDARD_DEVIATION 12.708 • n=7 Participants
|
57.03 kg
STANDARD_DEVIATION 13.041 • n=5 Participants
|
|
Body Mass Index (BMI)
|
22.42 kg/m^2
STANDARD_DEVIATION 4.237 • n=5 Participants
|
22.39 kg/m^2
STANDARD_DEVIATION 4.266 • n=7 Participants
|
22.40 kg/m^2
STANDARD_DEVIATION 4.254 • n=5 Participants
|
PRIMARY outcome
Timeframe: One month post second dose (Day 120)Population: Per Protocol Set (PPS): all participants seronegative to all serotypes of dengue virus at baseline who received at least 1 dose of trial vaccine, who had a valid pre-dose (baseline) and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. Number analyzed: participants with data available at given time-point.
GMTs of neutralizing antibodies were measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity is defined as reciprocal neutralizing titer ≥10.
Outcome measures
| Measure |
Placebo
n=82 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Tetravalent Dengue Vaccine (TDV)
n=271 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120
DENV-1
|
5.3 titer
Interval 4.7 to 5.8
|
327.9 titer
Interval 281.7 to 381.8
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120
DENV-2
|
6.0 titer
Interval 5.2 to 7.0
|
1742.5 titer
Interval 1522.6 to 1994.3
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120
DENV-3
|
5.2 titer
Interval 4.8 to 5.6
|
119.5 titer
Interval 106.4 to 134.2
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120
DENV-4
|
5.1 titer
Interval 4.9 to 5.2
|
142.7 titer
Interval 126.4 to 161.0
|
SECONDARY outcome
Timeframe: Six months post second dose (Day 270)Population: PPS: all participants seronegative to all serotypes of dengue virus at baseline who received at least 1 dose of trial vaccine, who had a valid pre-dose (baseline) and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. Number analyzed: participants with data available at given time-point.
GMTs of neutralizing antibodies were measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity is defined as reciprocal neutralizing titer ≥10.
Outcome measures
| Measure |
Placebo
n=82 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Tetravalent Dengue Vaccine (TDV)
n=271 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270
DENV-1
|
5.4 titer
Interval 4.8 to 6.0
|
134.7 titer
Interval 114.5 to 158.5
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270
DENV-2
|
5.2 titer
Interval 4.8 to 5.5
|
740.9 titer
Interval 645.2 to 850.7
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270
DENV-3
|
5.3 titer
Interval 4.9 to 5.9
|
45.8 titer
Interval 40.7 to 51.5
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270
DENV-4
|
5.0 titer
Data for 95% CI was not evaluable at this time point.
|
37.5 titer
Interval 32.9 to 42.7
|
SECONDARY outcome
Timeframe: One month and six months post second dose (Day 120 and Day 270)Population: PPS: all participants seronegative to all serotypes of dengue virus at baseline who received at least 1 dose of trial vaccine, who had a valid pre-dose (baseline) and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. Number analyzed: participants with data available at given time-point.
Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Outcome measures
| Measure |
Placebo
n=82 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Tetravalent Dengue Vaccine (TDV)
n=271 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|
|
Seropositivity Rates for Each of the 4 Dengue Serotypes
Day 120 (Month 4): DENV-1
|
1.4 percentage of participants
Interval 0.0 to 7.5
|
100.0 percentage of participants
Interval 98.5 to 100.0
|
|
Seropositivity Rates for Each of the 4 Dengue Serotypes
Day 120 (Month 4): DENV-2
|
8.3 percentage of participants
Interval 3.1 to 17.3
|
100.0 percentage of participants
Interval 98.5 to 100.0
|
|
Seropositivity Rates for Each of the 4 Dengue Serotypes
Day 120 (Month 4): DENV-3
|
1.4 percentage of participants
Interval 0.0 to 7.5
|
100.0 percentage of participants
Interval 98.5 to 100.0
|
|
Seropositivity Rates for Each of the 4 Dengue Serotypes
Day 120 (Month 4): DENV-4
|
1.4 percentage of participants
Interval 0.0 to 7.5
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
|
Seropositivity Rates for Each of the 4 Dengue Serotypes
Day 270 (Month 9): DENV-1
|
2.7 percentage of participants
Interval 0.3 to 9.5
|
98.4 percentage of participants
Interval 96.0 to 99.6
|
|
Seropositivity Rates for Each of the 4 Dengue Serotypes
Day 270 (Month 9): DENV-2
|
1.4 percentage of participants
Interval 0.0 to 7.4
|
99.6 percentage of participants
Interval 97.8 to 100.0
|
|
Seropositivity Rates for Each of the 4 Dengue Serotypes
Day 270 (Month 9): DENV-3
|
2.7 percentage of participants
Interval 0.3 to 9.5
|
92.1 percentage of participants
Interval 88.1 to 95.1
|
|
Seropositivity Rates for Each of the 4 Dengue Serotypes
Day 270 (Month 9): DENV-4
|
0 percentage of participants
Interval 0.0 to 4.9
|
89.4 percentage of participants
Interval 84.9 to 92.9
|
SECONDARY outcome
Timeframe: One month and six months post second dose (Day 120 and Day 270)Population: PPS: all participants seronegative to all serotypes of dengue virus at baseline who received at least 1 dose of trial vaccine, who had a valid pre-dose (baseline) and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. Number analyzed: participants with data available at given time-point.
Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10.
Outcome measures
| Measure |
Placebo
n=82 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Tetravalent Dengue Vaccine (TDV)
n=271 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|
|
Seropositivity Rates for Multiple (2, 3 or 4) Dengue Serotypes
Day 270 (Month 9): Tetravalent
|
0 percentage of participants
Interval 0.0 to 4.9
|
85.8 percentage of participants
Interval 80.9 to 89.9
|
|
Seropositivity Rates for Multiple (2, 3 or 4) Dengue Serotypes
Day 120 (Month 4): At Least Bivalent
|
1.4 percentage of participants
Interval 0.0 to 7.5
|
100.0 percentage of participants
Interval 98.5 to 100.0
|
|
Seropositivity Rates for Multiple (2, 3 or 4) Dengue Serotypes
Day 120 (Month 4): At Least Trivalent
|
1.4 percentage of participants
Interval 0.0 to 7.5
|
100.0 percentage of participants
Interval 98.5 to 100.0
|
|
Seropositivity Rates for Multiple (2, 3 or 4) Dengue Serotypes
Day 120 (Month 4): Tetravalent
|
1.4 percentage of participants
Interval 0.0 to 7.5
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
|
Seropositivity Rates for Multiple (2, 3 or 4) Dengue Serotypes
Day 270 (Month 9): At Least Bivalent
|
0 percentage of participants
Interval 0.0 to 4.9
|
99.2 percentage of participants
Interval 97.2 to 99.9
|
|
Seropositivity Rates for Multiple (2, 3 or 4) Dengue Serotypes
Day 270 (Month 9): At Least Trivalent
|
0 percentage of participants
Interval 0.0 to 4.9
|
94.5 percentage of participants
Interval 90.9 to 97.0
|
SECONDARY outcome
Timeframe: Within 7 days after each vaccinationPopulation: Safety Set included of all participants who received at least 1 dose of trial vaccine. Number analyzed is the number of participants with data available at the given timepoint. Only categories for which there was at least 1 participant are reported.
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), redness (erythema) (\<2.5 cm, mild: 2.5-5 cm, moderate: \>5 to \<=10 cm, severe: \>10 cm) and swelling (edema/induration) (\<2.5 cm, mild: 2.5-5 cm, moderate: \>5 to \<=10 cm, severe: \>10 cm).
Outcome measures
| Measure |
Placebo
n=100 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Tetravalent Dengue Vaccine (TDV)
n=300 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination, Any Solicited Local AEs
|
34.3 percentage of participants
|
56.2 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination, Pain:Mild
|
26.3 percentage of participants
|
44.8 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination, Pain:Moderate
|
7.1 percentage of participants
|
9.7 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination, Pain:Severe
|
1.0 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination, Swelling:Moderate
|
0 percentage of participants
|
0.3 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination, Erythema:Mild
|
0 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination, Swelling:Mild
|
0 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination, Any Solicited Local AEs
|
30.9 percentage of participants
|
52.2 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination, Pain:Mild
|
24.5 percentage of participants
|
35.6 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination, Pain:Moderate
|
5.3 percentage of participants
|
13.2 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination, Pain:Severe
|
1.1 percentage of participants
|
3.1 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination, Erythema:Mild
|
0 percentage of participants
|
4.1 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination, Swelling:Mild
|
0 percentage of participants
|
1.7 percentage of participants
|
SECONDARY outcome
Timeframe: Within 14 days after each vaccinationPopulation: Safety Set included of all participants who received at least 1 dose of trial vaccine. Number analyzed is the number of participants with data available at the given timepoint. Only categories for which there was at least 1 participant are reported.
Solicited systemic AEs were collected by participants using diary cards within 14 days after vaccination and included fever, headache, tiredness or weakness (asthenia), feeling of discomfort (malaise) and muscle pain (myalgia). Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it.
Outcome measures
| Measure |
Placebo
n=100 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Tetravalent Dengue Vaccine (TDV)
n=300 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination: Any Solicited Systemic AE
|
58.6 percentage of participants
|
66.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination: Headache-Severe
|
1.0 percentage of participants
|
2.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination: Asthenia-Moderate
|
13.1 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination: Malaise-Moderate
|
11.1 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination: Myalgia-Severe
|
1.0 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination:Fever (38.0°C-<38.5°C)
|
3.0 percentage of participants
|
3.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination:Fever (38.5°C-<39.0°C)
|
2.0 percentage of participants
|
2.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination: Headache-Moderate
|
6.4 percentage of participants
|
8.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination: Malaise-Mild
|
12.8 percentage of participants
|
16.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination: Myalgia-Mild
|
21.3 percentage of participants
|
25.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination: Myalgia-Moderate
|
8.5 percentage of participants
|
6.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination:Fever-Any
|
3.2 percentage of participants
|
6.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination:Fever (39.5°C-<40.0°C)
|
0.0 percentage of participants
|
0.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination:Fever (38.0°C-<38.5°C)
|
1.1 percentage of participants
|
3.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination:Fever (38.5°C-<39.0°C)
|
1.1 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination:Fever (39.0°C-<39.5°C)
|
1.1 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination: Headache-Mild
|
25.3 percentage of participants
|
31.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination: Headache-Moderate
|
18.2 percentage of participants
|
10.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination: Asthenia-Mild
|
20.2 percentage of participants
|
24.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination: Asthenia-Severe
|
2.0 percentage of participants
|
2.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination: Malaise-Mild
|
20.2 percentage of participants
|
18.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination: Malaise-Severe
|
2.0 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination: Myalgia-Mild
|
26.3 percentage of participants
|
36.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination: Myalgia-Moderate
|
13.1 percentage of participants
|
10.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination:Fever-Any
|
5.1 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination:Fever (39.0°C-<39.5°C)
|
0.0 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After First Vaccination:Fever (39.5°C-<40.0°C)
|
0.0 percentage of participants
|
0.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccine: Any Solicited Systemic AEs
|
45.7 percentage of participants
|
49.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination: Headache-Mild
|
20.2 percentage of participants
|
24.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination: Headache-Severe
|
3.2 percentage of participants
|
2.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination: Asthenia-Mild
|
22.3 percentage of participants
|
19.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination: Asthenia-Moderate
|
4.3 percentage of participants
|
6.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination: Asthenia-Severe
|
1.1 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination: Malaise-Moderate
|
6.4 percentage of participants
|
5.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination: Malaise-Severe
|
4.3 percentage of participants
|
2.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
After Second Vaccination: Myalgia-Severe
|
1.1 percentage of participants
|
2.4 percentage of participants
|
SECONDARY outcome
Timeframe: Within 28 days after each vaccinationPopulation: Safety Set included of all participants who received at least 1 dose of trial vaccine. Number analyzed is the number of participants with data available at the given timepoint. Only categories for which there was at least 1 participant are reported.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Placebo
n=100 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Tetravalent Dengue Vaccine (TDV)
n=300 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|
|
Percentage of Participants With Any Unsolicited Adverse Events (AEs) Following Each Vaccination
After First Vaccination
|
25.0 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants With Any Unsolicited Adverse Events (AEs) Following Each Vaccination
After Second Vaccination
|
17.9 percentage of participants
|
23.2 percentage of participants
|
SECONDARY outcome
Timeframe: From first vaccination (Day 1) through end of study (Day 270)Population: Safety Set included of all participants who received at least 1 dose of trial vaccine.
MAAEs were defined as AEs leading to a medical visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria.
Outcome measures
| Measure |
Placebo
n=100 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Tetravalent Dengue Vaccine (TDV)
n=300 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|
|
Percentage of Participants With Medically Attended AEs (MAAEs) Throughout the Study
|
38.0 percentage of participants
|
47.3 percentage of participants
|
SECONDARY outcome
Timeframe: From first vaccination (Day 1) through end of study (Day 270)Population: Safety Set included of all participants who received at least 1 dose of trial vaccine.
An SAE was defined as any untoward medical occurrence or effect that 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.
Outcome measures
| Measure |
Placebo
n=100 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Tetravalent Dengue Vaccine (TDV)
n=300 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study
|
2.0 percentage of participants
|
0.3 percentage of participants
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Tetravalent Dengue Vaccine (TDV)
Serious events: 1 serious events
Other events: 112 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=100 participants at risk
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Tetravalent Dengue Vaccine (TDV)
n=300 participants at risk
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/100 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Appendicitis
|
1.0%
1/100 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/100 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.0%
1/100 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Placebo
n=100 participants at risk
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Tetravalent Dengue Vaccine (TDV)
n=300 participants at risk
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
14.0%
14/100 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
43/300 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
6/100 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.0%
24/300 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Viral pharyngitis
|
7.0%
7/100 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
15/300 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pharyngitis
|
4.0%
4/100 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
10/300 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pharyngitis bacterial
|
2.0%
2/100 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
9/300 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
2.0%
2/100 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.7%
8/300 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
3.0%
3/100 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.3%
7/300 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
1.0%
1/100 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
9/300 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Syncope
|
2.0%
2/100 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
9/300 • Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER