Trial Outcomes & Findings for Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) at the End of Shelf Life in Healthy Adults (NCT NCT03771963)
NCT ID: NCT03771963
Last Updated: 2021-06-07
Results Overview
GMTs of neutralizing antibodies for each of the 4 dengue serotypes were measured by microneutralization test 50% \[MNT50\]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3, and DENV-4.
COMPLETED
PHASE3
200 participants
One month post second dose (Day 120)
2021-06-07
Participant Flow
Participants took part in the study at 2 investigative sites in the United States from 28 March 2019 to 13 March 2020.
Healthy participants were enrolled in this study to receive Tetravalent Dengue Vaccine (TDV) on Days 1 and 90.
Participant milestones
| Measure |
Tetravalent Dengue Vaccine (TDV)
TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose).
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
COMPLETED
|
168
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
Tetravalent Dengue Vaccine (TDV)
TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose).
|
|---|---|
|
Overall Study
Lost to Follow-up
|
22
|
|
Overall Study
Withdrawal of Consent
|
10
|
Baseline Characteristics
Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) at the End of Shelf Life in Healthy Adults
Baseline characteristics by cohort
| Measure |
Tetravalent Dengue Vaccine (TDV)
n=200 Participants
TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose).
|
|---|---|
|
Age, Continuous
|
40.27 years
STANDARD_DEVIATION 12.035 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
136 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
148 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
200 Participants
n=5 Participants
|
|
Height
|
170.72 cm
STANDARD_DEVIATION 9.330 • n=5 Participants
|
|
Weight
|
80.23 kg
STANDARD_DEVIATION 15.220 • n=5 Participants
|
|
Body Mass Index (BMI)
|
27.45 kg/m^2
STANDARD_DEVIATION 4.248 • n=5 Participants
|
PRIMARY outcome
Timeframe: One month post second dose (Day 120)Population: Per-protocol Set (PPS) excludes all participants seropositive for dengue virus at Baseline and includes all participants in the Full Analysis Set (FAS- who received at least 1 dose of trial vaccine with valid pre-dose and post-dose measurement for immunogenicity assessment) who have no major protocol violations, with data available for analysis.
GMTs of neutralizing antibodies for each of the 4 dengue serotypes were measured by microneutralization test 50% \[MNT50\]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3, and DENV-4.
Outcome measures
| Measure |
Tetravalent Dengue Vaccine (TDV)
n=132 Participants
TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose).
|
|---|---|
|
Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120
DENV-1
|
557.4 titer
Interval 417.0 to 744.9
|
|
Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120
DENV-2
|
2047.4 titer
Interval 1739.7 to 2409.5
|
|
Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120
DENV-3
|
131.8 titer
Interval 105.0 to 165.4
|
|
Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120
DENV-4
|
119.6 titer
Interval 97.7 to 146.5
|
SECONDARY outcome
Timeframe: One month and six months post second dose (Days 120 and 270)Population: The PPS excludes all participants seropositive for dengue virus at Baseline and includes all participants in the FAS who have no major protocol violations. Number analyzed is the number of participants with data available for analysis at the given time point.
Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.
Outcome measures
| Measure |
Tetravalent Dengue Vaccine (TDV)
n=139 Participants
TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose).
|
|---|---|
|
Seropositivity Rates for Each of the 4 Dengue Serotypes at Days 120 and 270
Day 120: DENV-1
|
99.2 percentage of participants
Interval 95.9 to 100.0
|
|
Seropositivity Rates for Each of the 4 Dengue Serotypes at Days 120 and 270
Day 120: DENV-2
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
|
Seropositivity Rates for Each of the 4 Dengue Serotypes at Days 120 and 270
Day 120: DENV-3
|
97.7 percentage of participants
Interval 93.5 to 99.5
|
|
Seropositivity Rates for Each of the 4 Dengue Serotypes at Days 120 and 270
Day 120: DENV-4
|
99.2 percentage of participants
Interval 95.9 to 100.0
|
|
Seropositivity Rates for Each of the 4 Dengue Serotypes at Days 120 and 270
Day 270: DENV-1
|
97.0 percentage of participants
Interval 92.5 to 99.2
|
|
Seropositivity Rates for Each of the 4 Dengue Serotypes at Days 120 and 270
Day 270: DENV-2
|
98.5 percentage of participants
Interval 94.7 to 99.8
|
|
Seropositivity Rates for Each of the 4 Dengue Serotypes at Days 120 and 270
Day 270: DENV-3
|
85.7 percentage of participants
Interval 78.6 to 91.2
|
|
Seropositivity Rates for Each of the 4 Dengue Serotypes at Days 120 and 270
Day 270: DENV-4
|
86.5 percentage of participants
Interval 79.5 to 91.8
|
SECONDARY outcome
Timeframe: One month and six months post second dose (Days 120 and 270)Population: The PPS excludes all participants seropositive for dengue virus at Baseline and includes all participants in the FAS who have no major protocol violations. Number analyzed is the number of participants with data available for analysis at the given time point.
Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10. The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity for multiple dengue serotypes was summarized in the following categories: tetravalent and at least trivalent.
Outcome measures
| Measure |
Tetravalent Dengue Vaccine (TDV)
n=139 Participants
TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose).
|
|---|---|
|
Seropositivity Rates for Multiple (2, 3, or 4) Dengue Serotypes at Days 120 and 270
Day 120: At Least Trivalent
|
99.2 percentage of participants
Interval 95.9 to 100.0
|
|
Seropositivity Rates for Multiple (2, 3, or 4) Dengue Serotypes at Days 120 and 270
Day 120: Tetravalent
|
97.0 percentage of participants
Interval 92.4 to 99.2
|
|
Seropositivity Rates for Multiple (2, 3, or 4) Dengue Serotypes at Days 120 and 270
Day 270: At Least Trivalent
|
91.0 percentage of participants
Interval 84.8 to 95.3
|
|
Seropositivity Rates for Multiple (2, 3, or 4) Dengue Serotypes at Days 120 and 270
Day 270: Tetravalent
|
78.9 percentage of participants
Interval 71.0 to 85.5
|
SECONDARY outcome
Timeframe: Six months post second dose (Day 270)Population: PPS excludes all participants seropositive for dengue virus at Baseline and includes all participants in the FAS who have no major protocol violations, with data available for analysis.
GMTs of neutralizing antibodies were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50.
Outcome measures
| Measure |
Tetravalent Dengue Vaccine (TDV)
n=133 Participants
TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (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
|
311.6 titer
Interval 222.8 to 435.9
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270
DENV-2
|
1170.6 titer
Interval 953.9 to 1436.5
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270
DENV-3
|
63.0 titer
Interval 48.4 to 82.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270
DENV-4
|
57.6 titer
Interval 44.2 to 75.0
|
SECONDARY outcome
Timeframe: Up to 7 days (Day of vaccination + 6 subsequent days) after each of the vaccinationPopulation: Safety Set included all participants who received at least 1 dose of TDV trial vaccine. Number analyzed is the number of participants with data available for the specific category.
Solicited local adverse events (AEs) \[at injection site\] were collected by participants using diary cards within 7 days after each vaccination and included injection site pain \[Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)\], injection site erythema \[Grade 0 (\<25 mm), 1 (25 - ≤ 50 mm), 2 (\>50 - ≤ 100 mm), 3 (\> 100 mm)\] and injection site swelling \[Grade 0 (\<25 mm), 1 (25 - ≤ 50 mm), 2 (\>50 - ≤ 100 mm), 3 (\> 100 mm)\]. The percentages were rounded off to the first decimal place. Only categories with at least 1 participant are reported.
Outcome measures
| Measure |
Tetravalent Dengue Vaccine (TDV)
n=200 Participants
TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose).
|
|---|---|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After First Vaccination, Any Solicited Local AEs
|
35.9 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After First Vaccination, Pain: Any Severity
|
29.7 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After First Vaccination, Pain: Mild
|
25.5 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After First Vaccination, Pain: Moderate
|
3.6 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After First Vaccination, Pain: Severe
|
0.5 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After First Vaccination, Erythema: Any Severity
|
13.0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After First Vaccination, Erythema: Mild
|
12.0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After First Vaccination, Erythema: Moderate
|
1.0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After First Vaccination, Swelling: Any Severity
|
4.2 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After First Vaccination, Swelling: Mild
|
4.2 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After Second Vaccination, Any Solicited Local AEs
|
32.3 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After Second Vaccination, Pain: Any Severity
|
31.1 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After Second Vaccination, Pain: Mild
|
27.5 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After Second Vaccination, Pain: Moderate
|
2.4 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After Second Vaccination, Pain: Severe
|
1.2 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After Second Vaccination, Erythema: Any Severity
|
6.0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After Second Vaccination, Erythema: Mild
|
6.0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After Second Vaccination, Swelling: Any Severity
|
2.4 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
After Second Vaccination, Swelling: Mild
|
2.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 14 days (Day of vaccination + 13 subsequent days) after each vaccinationPopulation: Safety Set included all participants who received at least 1 dose of TDV trial vaccine. Number analyzed is the number of participants with data available for the specific category.
Solicited systemic AEs were collected by participants using diary cards within 14 days after each vaccination and included fever, headache, asthenia, malaise and myalgia. Severity grades were: Grade 0: none, Grade 1: mild (no interference with daily activity), Grade 2: moderate (interference with daily activity with or without treatment), Grade 3: severe (prevents normal daily activity with or without treatment). Fever is defined as body temperature greater than or equal to 38°C (100.4°F). Fever was excluded from the overall count as no severity grading was applied for it. The percentages were rounded off to the first decimal place. Only categories with at least 1 participant are reported.
Outcome measures
| Measure |
Tetravalent Dengue Vaccine (TDV)
n=200 Participants
TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose).
|
|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Any Solicited Systemic Local AEs
|
42.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Headache: Any Severity
|
30.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Headache: Mild
|
22.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Headache: Moderate
|
5.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Headache: Severe
|
1.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Myalgia: Any Severity
|
25.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Myalgia: Mild
|
20.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Myalgia: Moderate
|
3.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Myalgia: Severe
|
1.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Asthenia: Any Severity
|
16.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Asthenia: Mild
|
10.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Asthenia: Moderate
|
5.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Asthenia: Severe
|
1.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Malaise: Any Severity
|
19.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Malaise: Mild
|
13.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Malaise: Moderate
|
4.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Malaise: Severe
|
2.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Fever: Any
|
2.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Fever: 38.0-<38.5
|
2.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After First Vaccination, Fever: 38.5-<39.0
|
0.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Any Solicited Systemic Local AEs
|
34.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Headache: Any Severity
|
22.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Headache: Mild
|
16.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Headache: Moderate
|
5.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Headache: Severe
|
1.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Myalgia: Any Severity
|
22.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Myalgia: Mild
|
20.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Myalgia: Moderate
|
1.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Myalgia: Severe
|
0.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Asthenia: Any Severity
|
12.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Asthenia: Mild
|
7.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Asthenia: Moderate
|
3.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Asthenia: Severe
|
1.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Malaise: Any Severity
|
13.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Malaise: Mild
|
9.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Malaise: Moderate
|
3.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Malaise: Severe
|
1.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Fever: Any
|
1.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Fever: 38.0-<38.5
|
0.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
After Second Vaccination, Fever: 38.5-<39.0
|
0.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 28 days after each vaccination (Day of vaccination + 27 subsequent days)Population: Safety Set included all participants who received at least 1 dose of TDV trial vaccine. Number analyzed is the number of participants with data available for the specific category.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a study vaccine; it does not necessarily have to have a causal relationship with study vaccine administration.
Outcome measures
| Measure |
Tetravalent Dengue Vaccine (TDV)
n=200 Participants
TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose).
|
|---|---|
|
Percentage of Participants With Any Unsolicited Adverse Events Following Each Vaccination
After First Vaccination
|
11.5 percentage of participants
|
|
Percentage of Participants With Any Unsolicited Adverse Events Following Each Vaccination
After Second Vaccination
|
10.8 percentage of participants
|
SECONDARY outcome
Timeframe: From first vaccination (Day 1) through end of study (Day 270)Population: Safety Set included all participants who received at least 1 dose of TDV trial vaccine.
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, leads to a congenital anomaly / birth defect in the offspring of a participant, or is an important medical event which may require intervention to prevent the items listed above or may expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization.
Outcome measures
| Measure |
Tetravalent Dengue Vaccine (TDV)
n=200 Participants
TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose).
|
|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs)
|
2.5 percentage of participants
|
SECONDARY outcome
Timeframe: From first vaccination (Day 1) through end of study (Day 270)Population: Safety Set included all participants who received at least 1 dose of TDV trial vaccine.
MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria.
Outcome measures
| Measure |
Tetravalent Dengue Vaccine (TDV)
n=200 Participants
TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose).
|
|---|---|
|
Percentage of Participants With Medically Attended Adverse Events (MAAEs)
|
26.0 percentage of participants
|
Adverse Events
Tetravalent Dengue Vaccine (TDV)
Serious adverse events
| Measure |
Tetravalent Dengue Vaccine (TDV)
n=200 participants at risk
TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose).
|
|---|---|
|
Cardiac disorders
Bradycardia
|
0.50%
1/200 • All-cause mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 270). Other (Non-serious) adverse events: Up to 28 days after each vaccination (Day of vaccination + 27 subsequent days).
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
Inguinal hernia
|
0.50%
1/200 • All-cause mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 270). Other (Non-serious) adverse events: Up to 28 days after each vaccination (Day of vaccination + 27 subsequent days).
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.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.50%
1/200 • All-cause mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 270). Other (Non-serious) adverse events: Up to 28 days after each vaccination (Day of vaccination + 27 subsequent days).
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
Sepsis
|
0.50%
1/200 • All-cause mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 270). Other (Non-serious) adverse events: Up to 28 days after each vaccination (Day of vaccination + 27 subsequent days).
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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.50%
1/200 • All-cause mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 270). Other (Non-serious) adverse events: Up to 28 days after each vaccination (Day of vaccination + 27 subsequent days).
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
Adverse event data not reported
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