Trial Outcomes & Findings for A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India (NCT NCT06060067)
NCT ID: NCT06060067
Last Updated: 2026-05-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
480 participants
Primary outcome timeframe
From first vaccination on Day 1 through the end of trial (up to Day 270)
Results posted on
2026-05-29
Participant Flow
Participants took part in the study at 10 investigative sites in India from 29 March 2024 to 05 May 2025.
Healthy children and adult participants were enrolled in the study in Cohort 1 (greater than or equal to \[≥\]18 to less than or equal to \[≤\]60 Years Age Group) and Cohort 2 (≥4 to less than \[\<\]18 Years Age Group) to receive either Dengue Tetravalent Vaccine (TDV) or placebo in a 3:1 ratio.
Participant milestones
| Measure |
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
Participants received TDV subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Years Age Group: TDV
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Years Age Group: Placebo
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
180
|
60
|
180
|
60
|
|
Overall Study
COMPLETED
|
175
|
59
|
178
|
58
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
Participants received TDV subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Years Age Group: TDV
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Years Age Group: Placebo
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
1
|
|
Overall Study
Reason Not Specified
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India
Baseline characteristics by cohort
| Measure |
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=180 Participants
Participants received Dengue Tetravalent Vaccine (TDV) subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=60 Participants
Participants received placebo-matching TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Years Age Group: TDV
n=180 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Years Age Group: Placebo
n=60 Participants
Participants received placebo-matching TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Total
n=480 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.2 years
STANDARD_DEVIATION 11.66 • n=51 Participants
|
36.5 years
STANDARD_DEVIATION 11.12 • n=14 Participants
|
9.7 years
STANDARD_DEVIATION 4.05 • n=65 Participants
|
10.3 years
STANDARD_DEVIATION 4.35 • n=57 Participants
|
23.4 years
STANDARD_DEVIATION 16.12 • n=39 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=51 Participants
|
14 Participants
n=14 Participants
|
79 Participants
n=65 Participants
|
29 Participants
n=57 Participants
|
176 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=51 Participants
|
46 Participants
n=14 Participants
|
101 Participants
n=65 Participants
|
31 Participants
n=57 Participants
|
304 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
180 Participants
n=51 Participants
|
60 Participants
n=14 Participants
|
180 Participants
n=65 Participants
|
59 Participants
n=57 Participants
|
479 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
1 Participants
n=57 Participants
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
180 Participants
n=51 Participants
|
60 Participants
n=14 Participants
|
180 Participants
n=65 Participants
|
59 Participants
n=57 Participants
|
479 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
1 Participants
n=57 Participants
|
1 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Within 7 days post-vaccination at Day 1Population: Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited local AEs were graded separately for the subgroups of age \<6 years old and age ≥6 years old to \<18 years old. Data for subgroup of age \<6 years old are reported in this outcome measure.
Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for infant/toddler/child (\<6 years of age).
Outcome measures
| Measure |
Cohort 2: ≥4 to <18 Age Group: Placebo
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=46 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=14 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Pain: None
|
—
|
42 Participants
|
10 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Pain: Mild
|
—
|
4 Participants
|
4 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Swelling: None
|
—
|
45 Participants
|
14 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Swelling: Moderate
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Swelling: Severe
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Pain: Moderate
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Pain: Severe
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Erythema: None
|
—
|
46 Participants
|
14 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Erythema: Mild
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Erythema: Moderate
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Erythema: Severe
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Swelling: Mild
|
—
|
1 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post-vaccination at Day 1Population: Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited local AEs were graded separately for the subgroups of age \<6 years old and age ≥6 years old to \<18 years old. Data for subgroup of age ≥6 years old to \<18 years old are reported in this outcome measure along with the data for ≥18 to ≤60 age group. Overall number of participants analyzed is the number of participants with data available for analysis.
Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for child/adolescent/adult (≥6 years of age).
Outcome measures
| Measure |
Cohort 2: ≥4 to <18 Age Group: Placebo
n=46 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=179 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=60 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
n=133 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Swelling: Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Pain: Mild
|
4 Participants
|
25 Participants
|
7 Participants
|
13 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Swelling: None
|
46 Participants
|
179 Participants
|
60 Participants
|
132 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Pain: Moderate
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Pain: None
|
42 Participants
|
152 Participants
|
53 Participants
|
119 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Pain: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Erythema: None
|
46 Participants
|
177 Participants
|
60 Participants
|
133 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Erythema: Mild
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Erythema: Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Erythema: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Swelling: Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Swelling: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days post-vaccination at Day 90Population: Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited local AEs were graded separately for the subgroups of age \<6 years old and age ≥6 years old to \<18 years old. Data for subgroup of age \<6 years old are reported in this outcome measure.
Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for infant/toddler/child (\<6 years of age).
Outcome measures
| Measure |
Cohort 2: ≥4 to <18 Age Group: Placebo
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=46 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=14 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Swelling: None
|
—
|
46 Participants
|
14 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Swelling: Mild
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Pain: None
|
—
|
44 Participants
|
14 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Pain: Mild
|
—
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Pain: Moderate
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Pain: Severe
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Erythema: None
|
—
|
46 Participants
|
14 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Erythema: Mild
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Erythema: Moderate
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Erythema: Severe
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Swelling: Moderate
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Swelling: Severe
|
—
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post-vaccination at Day 90Population: Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited local AEs were graded separately for the subgroups of age \<6 years old and age ≥6 years old to \<18 years old. Data for subgroup of age ≥6 years old to \<18 years old are reported in this outcome measure along with the data for ≥18 to ≤60 age group. Overall number of participants analyzed is the number of participants with data available for analysis.
Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for child/adolescent/adult (≥6 years of age).
Outcome measures
| Measure |
Cohort 2: ≥4 to <18 Age Group: Placebo
n=45 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=176 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=59 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
n=132 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Pain: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Erythema: Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Swelling: None
|
45 Participants
|
176 Participants
|
59 Participants
|
132 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Swelling: Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Swelling: Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Pain: None
|
41 Participants
|
163 Participants
|
55 Participants
|
117 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Pain: Mild
|
4 Participants
|
12 Participants
|
3 Participants
|
14 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Pain: Moderate
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Erythema: None
|
45 Participants
|
176 Participants
|
59 Participants
|
132 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Erythema: Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Erythema: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Swelling: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 14 days post-vaccination at Day 1Population: Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited systemic AEs were graded separately for the subgroups of age \<6 years old and age ≥6 years old to \<18 years old. Data for subgroup of age \<6 years old are reported in this outcome measure.
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. Solicited systemic AEs assessments for children \<6 years old comprised: irritability/fussiness, drowsiness, loss of appetite (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated).
Outcome measures
| Measure |
Cohort 2: ≥4 to <18 Age Group: Placebo
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=46 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=14 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Drowsiness: Mild
|
—
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Loss of Appetite: None
|
—
|
46 Participants
|
14 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Loss of Appetite: Mild
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Loss of Appetite: Moderate
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Fever: 38.0-<38.5 °C
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Fever: 39.0-<39.5 °C
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Fever: 40.0-<40.5 °C
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Fever: 40.5-<41.0 °C
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Drowsiness: Moderate
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Drowsiness: Severe
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Loss of Appetite: Severe
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Fever: None
|
—
|
46 Participants
|
14 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Fever: 38.5-<39.0 °C
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Fever: 39.5-<40.0 °C
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Fever: ≥41.0 °C
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Irritability or Fussiness: None
|
—
|
45 Participants
|
13 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Irritability or Fussiness: Mild
|
—
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Irritability or Fussiness: Moderate
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Irritability or Fussiness: Severe
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Drowsiness: None
|
—
|
45 Participants
|
13 Participants
|
—
|
PRIMARY outcome
Timeframe: Within 14 days post-vaccination at Day 1Population: Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited systemic AEs were graded separately for the subgroups of age \<6 years old and age ≥ 6 years old to \< 18 years old. Data for subgroup of age ≥ 6 years old to \< 18 years old are reported in this outcome measure along with the data for ≥18 to ≤60 age group. Overall number of participants analyzed is the number of participants with data available for analysis.
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. Solicited systemic AEs assessments for children ≥ 6 years old/adolescents/adults comprised: headache, asthenia, malaise, myalgia (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated).
Outcome measures
| Measure |
Cohort 2: ≥4 to <18 Age Group: Placebo
n=46 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=179 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=60 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
n=133 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Asthenia: None
|
44 Participants
|
168 Participants
|
56 Participants
|
126 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Malaise: Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Fever: 38.5-<39.0 °C
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Headache: None
|
45 Participants
|
165 Participants
|
54 Participants
|
127 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Headache: Mild
|
1 Participants
|
11 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Headache: Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Headache: Severe
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Asthenia: Mild
|
2 Participants
|
11 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Asthenia: Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Asthenia: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Malaise: None
|
46 Participants
|
174 Participants
|
57 Participants
|
130 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Malaise: Mild
|
0 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Malaise: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Myalgia: None
|
45 Participants
|
168 Participants
|
56 Participants
|
128 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Myalgia: Mild
|
1 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Myalgia: Moderate
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Myalgia: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Fever: None
|
45 Participants
|
178 Participants
|
58 Participants
|
131 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Fever: 38.0-<38.5 °C
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Fever: 39.0-<39.5 °C
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Fever: 39.5-<40.0 °C
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Fever: 40.0-<40.5 °C
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Fever: 40.5-<41.0 °C
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Fever: ≥41.0 °C
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 14 days post-vaccination at Day 90Population: Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited systemic AEs were graded separately for the subgroups of age \<6 years old and age ≥6 years old to \<18 years old. Data for subgroup of age \<6 years old are reported in this outcome measure. Overall number of participants analyzed is the number of participants with data available for analysis for this outcome measure.
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. Solicited systemic AEs assessments for children \<6 years old comprised: drowsiness, irritability/fussiness, loss of appetite (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe). Data for drowsiness, irritability/fussiness and loss of appetite has been reported in this outcome measure.
Outcome measures
| Measure |
Cohort 2: ≥4 to <18 Age Group: Placebo
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=38 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=14 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Drowsiness: Moderate
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Loss of Appetite: Severe
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Irritability or Fussiness: None
|
—
|
38 Participants
|
14 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Irritability or Fussiness: Mild
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Irritability or Fussiness: Moderate
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Irritability or Fussiness: Severe
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Drowsiness: None
|
—
|
37 Participants
|
13 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Drowsiness: Mild
|
—
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Drowsiness: Severe
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Loss of Appetite: None
|
—
|
38 Participants
|
13 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Loss of Appetite: Mild
|
—
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Loss of Appetite: Moderate
|
—
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Within 14 days post-vaccination at Day 90Population: Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited systemic AEs were graded separately for the subgroups of age \<6 years old and age ≥6 years old to \<18 years old. Data for subgroup of age \<6 years old are reported in this outcome measure.
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. Solicited systemic AEs assessments for children \<6 years old also comprised of fever in °C (collected by temperature ranges as indicated). Data for fever has been reported in this outcome measure.
Outcome measures
| Measure |
Cohort 2: ≥4 to <18 Age Group: Placebo
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=46 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=14 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Systemic AEs of Fever by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Fever: 39.5-<40.0 °C
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs of Fever by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Fever: None
|
—
|
46 Participants
|
14 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs of Fever by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Fever: 38.0-<38.5 °C
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs of Fever by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Fever: 38.5-<39.0 °C
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs of Fever by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Fever: 39.0-<39.5 °C
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs of Fever by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Fever: 40.0-<40.5 °C
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs of Fever by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Fever: 40.5-<41.0 °C
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Solicited Systemic AEs of Fever by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Fever: ≥41.0 °C
|
—
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Within 14 days post-vaccination at Day 90Population: Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited systemic AEs were graded separately for the subgroups of age \<6 years old and age ≥6 years old to \<18 years old. Data for subgroup of age ≥6 years old to \<18 years old are reported in this outcome measure along with the data for ≥18 to ≤60 age group. Overall number of participants analyzed is the number of participants with data available for analysis.
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. Solicited systemic AEs assessments for children ≥ 6 years old/adolescents/adults comprised: headache, asthenia, malaise, myalgia (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated).
Outcome measures
| Measure |
Cohort 2: ≥4 to <18 Age Group: Placebo
n=45 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=176 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=59 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
n=132 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Asthenia: Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Malaise: Mild
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Myalgia: None
|
44 Participants
|
173 Participants
|
59 Participants
|
129 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Fever: None
|
44 Participants
|
172 Participants
|
57 Participants
|
129 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Fever: 38.5-<39.0 °C
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Fever: 39.0-<39.5 °C
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Fever: 40.0-<40.5 °C
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Fever: 40.5-<41.0 °C
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Fever: ≥41.0 °C
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Headache: None
|
45 Participants
|
169 Participants
|
59 Participants
|
129 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Headache: Mild
|
0 Participants
|
6 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Headache: Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Headache: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Asthenia: None
|
44 Participants
|
172 Participants
|
58 Participants
|
129 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Asthenia: Mild
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Asthenia: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Malaise: None
|
45 Participants
|
173 Participants
|
59 Participants
|
132 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Malaise: Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Malaise: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Myalgia: Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Myalgia: Moderate
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Myalgia: Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Fever: 38.0-<38.5 °C
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over
Fever: 39.5-<40.0 °C
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 28 days post-vaccination at Day 1Population: Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
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 |
Cohort 2: ≥4 to <18 Age Group: Placebo
n=60 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=180 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=60 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
n=180 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Percentage of Participants With Any Unsolicited AEs Within 28 Days Post-vaccination at Day 1
|
1.7 percentage of participants
|
2.2 percentage of participants
|
1.7 percentage of participants
|
2.2 percentage of participants
|
PRIMARY outcome
Timeframe: Within 28 days post-vaccination at Day 90Population: Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
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 |
Cohort 2: ≥4 to <18 Age Group: Placebo
n=60 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=180 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=60 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
n=180 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Percentage of Participants With Any Unsolicited AEs Within 28 Days Post-vaccination at Day 90
|
3.4 percentage of participants
|
1.7 percentage of participants
|
3.4 percentage of participants
|
4.5 percentage of participants
|
PRIMARY outcome
Timeframe: From first vaccination on Day 1 through the end of trial (up to Day 270)Population: Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
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 |
Cohort 2: ≥4 to <18 Age Group: Placebo
n=60 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=180 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=60 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
n=180 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Percentage of Participants With an AE Leading to Participant Withdrawal From Trial
|
0 percentage of participants
|
0.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: From first vaccination on Day 1 through the end of trial (up to Day 270)Population: Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
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 |
Cohort 2: ≥4 to <18 Age Group: Placebo
n=60 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=180 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=60 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
n=180 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Percentage of Participants With an AE Leading to TDV or Placebo Discontinuation
|
0 percentage of participants
|
0.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: From first vaccination on Day 1 through the end of trial (up to Day 270)Population: Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
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 |
Cohort 2: ≥4 to <18 Age Group: Placebo
n=60 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=180 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=60 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
n=180 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Percentage of Participants With a Medically-attended AE (MAAE)
|
13.3 percentage of participants
|
5.0 percentage of participants
|
3.3 percentage of participants
|
10.0 percentage of participants
|
PRIMARY outcome
Timeframe: From first vaccination on Day 1 through the end of trial (up to Day 270)Population: Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
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. 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, is an important medical event.
Outcome measures
| Measure |
Cohort 2: ≥4 to <18 Age Group: Placebo
n=60 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=180 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=60 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
n=180 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Percentage of Participants With a Serious Adverse Event (SAE)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 120 (Month 4)Population: FAS included all randomized participants who received at least 1 dose of TDV or placebo, and for whom a valid pre dose measurement, and at least 1 valid post dose measurement were received for immunogenicity assessments. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis for the specified categories.
GMTs of neutralizing antibodies were measured by microneutralization test 50% (MNT50) for each of the 4 dengue serotypes for all participants. The 4 dengue virus serotypes (DENV) are DENV-1, DENV-2, DENV-3 and DENV-4.
Outcome measures
| Measure |
Cohort 2: ≥4 to <18 Age Group: Placebo
n=59 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=176 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=59 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
n=178 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
GMTs of Neutralizing Antibodies by Microneutralization Test (MNT50) for Each of the 4 Dengue Virus Serotypes at Day 120
DENV-1
|
267.9 titers
Standard Deviation 14.31
|
3196.9 titers
Standard Deviation 5.36
|
676.6 titers
Standard Deviation 13.70
|
2968.0 titers
Standard Deviation 4.50
|
|
GMTs of Neutralizing Antibodies by Microneutralization Test (MNT50) for Each of the 4 Dengue Virus Serotypes at Day 120
DENV-4
|
135.8 titers
Standard Deviation 10.97
|
999.0 titers
Standard Deviation 4.65
|
265.9 titers
Standard Deviation 8.42
|
1018.4 titers
Standard Deviation 4.15
|
|
GMTs of Neutralizing Antibodies by Microneutralization Test (MNT50) for Each of the 4 Dengue Virus Serotypes at Day 120
DENV-2
|
316.6 titers
Standard Deviation 15.66
|
2547.3 titers
Standard Deviation 4.34
|
624.2 titers
Standard Deviation 12.63
|
2869.1 titers
Standard Deviation 3.78
|
|
GMTs of Neutralizing Antibodies by Microneutralization Test (MNT50) for Each of the 4 Dengue Virus Serotypes at Day 120
DENV-3
|
196.8 titers
Standard Deviation 14.67
|
1616.0 titers
Standard Deviation 5.13
|
452.3 titers
Standard Deviation 10.42
|
1596.7 titers
Standard Deviation 4.82
|
SECONDARY outcome
Timeframe: Day 1 and 270Population: FAS included all randomized participants who received at least 1 dose of TDV or placebo, and for whom a valid pre dose measurement, and at least 1 valid post dose measurement were received for immunogenicity assessments. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis for the specified categories at the specified timepoints.
GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 dengue serotypes for all participants. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Outcome measures
| Measure |
Cohort 2: ≥4 to <18 Age Group: Placebo
n=59 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=176 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=59 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
n=178 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
GMTs by MNT50 Against Each of the 4 Dengue Virus Serotypes at Day 1 and Day 270
Day 1: DENV-2
|
314.1 titers
Standard Deviation 19.00
|
797.9 titers
Standard Deviation 9.95
|
460.1 titers
Standard Deviation 13.63
|
418.4 titers
Standard Deviation 12.92
|
|
GMTs by MNT50 Against Each of the 4 Dengue Virus Serotypes at Day 1 and Day 270
Day 1: DENV-3
|
202.4 titers
Standard Deviation 17.11
|
618.9 titers
Standard Deviation 9.23
|
463.9 titers
Standard Deviation 10.91
|
238.2 titers
Standard Deviation 11.60
|
|
GMTs by MNT50 Against Each of the 4 Dengue Virus Serotypes at Day 1 and Day 270
Day 1: DENV-4
|
147.3 titers
Standard Deviation 17.29
|
392.4 titers
Standard Deviation 8.61
|
275.3 titers
Standard Deviation 10.61
|
166.8 titers
Standard Deviation 10.05
|
|
GMTs by MNT50 Against Each of the 4 Dengue Virus Serotypes at Day 1 and Day 270
Day 270: DENV-1
|
393.9 titers
Standard Deviation 12.85
|
2557.9 titers
Standard Deviation 4.80
|
703.3 titers
Standard Deviation 10.97
|
1531.5 titers
Standard Deviation 6.27
|
|
GMTs by MNT50 Against Each of the 4 Dengue Virus Serotypes at Day 1 and Day 270
Day 270: DENV-2
|
441.7 titers
Standard Deviation 16.56
|
2454.6 titers
Standard Deviation 3.69
|
548.9 titers
Standard Deviation 12.17
|
1740.7 titers
Standard Deviation 5.61
|
|
GMTs by MNT50 Against Each of the 4 Dengue Virus Serotypes at Day 1 and Day 270
Day 270: DENV-3
|
287.8 titers
Standard Deviation 13.11
|
1067.8 titers
Standard Deviation 5.19
|
402.9 titers
Standard Deviation 10.99
|
765.2 titers
Standard Deviation 7.63
|
|
GMTs by MNT50 Against Each of the 4 Dengue Virus Serotypes at Day 1 and Day 270
Day 270: DENV-4
|
172.6 titers
Standard Deviation 11.28
|
708.7 titers
Standard Deviation 4.94
|
188.9 titers
Standard Deviation 9.79
|
452.0 titers
Standard Deviation 6.61
|
|
GMTs by MNT50 Against Each of the 4 Dengue Virus Serotypes at Day 1 and Day 270
Day 1: DENV-1
|
223.1 titers
Standard Deviation 16.76
|
1038.5 titers
Standard Deviation 10.63
|
699.8 titers
Standard Deviation 12.42
|
362.0 titers
Standard Deviation 14.27
|
SECONDARY outcome
Timeframe: Day 1, Day 120 and Day 270Population: FAS included all randomized participants who received at least 1 dose of TDV or placebo, and for whom a valid pre dose measurement, and at least 1 valid post dose measurement were received for immunogenicity assessments. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis for the specified categories at the specified timepoints.
Seroconversion rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositive is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Outcome measures
| Measure |
Cohort 2: ≥4 to <18 Age Group: Placebo
n=59 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=176 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=59 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
n=178 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes
Day 1: DENV-1
|
76.3 percentage of participants
|
90.9 percentage of participants
|
86.4 percentage of participants
|
82.6 percentage of participants
|
|
Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes
Day 1: DENV-4
|
69.5 percentage of participants
|
85.8 percentage of participants
|
79.7 percentage of participants
|
78.1 percentage of participants
|
|
Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes
Day 120: DENV-2
|
78.0 percentage of participants
|
98.3 percentage of participants
|
86.4 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes
Day 120: DENV-3
|
71.2 percentage of participants
|
98.9 percentage of participants
|
86.4 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes
Day 270: DENV-3
|
81.0 percentage of participants
|
98.3 percentage of participants
|
83.1 percentage of participants
|
96.6 percentage of participants
|
|
Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes
Day 270: DENV-4
|
75.9 percentage of participants
|
95.4 percentage of participants
|
78.0 percentage of participants
|
92.7 percentage of participants
|
|
Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes
Day 1: DENV-2
|
83.1 percentage of participants
|
91.5 percentage of participants
|
83.1 percentage of participants
|
87.1 percentage of participants
|
|
Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes
Day 1: DENV-3
|
72.9 percentage of participants
|
88.6 percentage of participants
|
86.4 percentage of participants
|
79.2 percentage of participants
|
|
Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes
Day 120: DENV-1
|
83.1 percentage of participants
|
98.3 percentage of participants
|
83.1 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes
Day 120: DENV-4
|
72.9 percentage of participants
|
97.7 percentage of participants
|
84.7 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes
Day 270: DENV-1
|
86.2 percentage of participants
|
98.9 percentage of participants
|
89.8 percentage of participants
|
99.4 percentage of participants
|
|
Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes
Day 270: DENV-2
|
81.0 percentage of participants
|
99.4 percentage of participants
|
89.8 percentage of participants
|
98.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1, Day 120 and Day 270Population: FAS included all randomized participants who received at least 1 dose of TDV or placebo, and for whom a valid pre dose measurement, and at least 1 valid post dose measurement were received for immunogenicity assessments. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis for the specified categories at the specified timepoints.
Seroconversion rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositive is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Outcome measures
| Measure |
Cohort 2: ≥4 to <18 Age Group: Placebo
n=59 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: TDV
n=176 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: ≥18 to ≤60 Years Age Group: Placebo
n=59 Participants
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: ≥4 to <18 Age Group: TDV
n=178 Participants
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes
Day 1: Bivalent
|
5.1 percentage of participants
|
2.3 percentage of participants
|
1.7 percentage of participants
|
4.5 percentage of participants
|
|
Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes
Day 270: Monovalent
|
10.3 percentage of participants
|
0.6 percentage of participants
|
13.6 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes
Day 1: Monovalent
|
8.5 percentage of participants
|
5.7 percentage of participants
|
5.1 percentage of participants
|
8.4 percentage of participants
|
|
Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes
Day 1: Trivalent
|
1.7 percentage of participants
|
1.1 percentage of participants
|
5.1 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes
Day 1: Tetravalent
|
69.5 percentage of participants
|
85.8 percentage of participants
|
78.0 percentage of participants
|
77.0 percentage of participants
|
|
Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes
Day 120: Monovalent
|
13.6 percentage of participants
|
0.0 percentage of participants
|
1.7 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes
Day 120: Bivalent
|
3.4 percentage of participants
|
0.6 percentage of participants
|
3.4 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes
Day 120: Trivalent
|
0 percentage of participants
|
1.1 percentage of participants
|
0.0 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes
Day 120: Tetravalent
|
71.2 percentage of participants
|
97.2 percentage of participants
|
83.1 percentage of participants
|
99.4 percentage of participants
|
|
Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes
Day 270: Bivalent
|
5.2 percentage of participants
|
0.6 percentage of participants
|
0.0 percentage of participants
|
1.7 percentage of participants
|
|
Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes
Day 270: Trivalent
|
0 percentage of participants
|
4.0 percentage of participants
|
5.1 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes
Day 270: Tetravalent
|
75.9 percentage of participants
|
94.3 percentage of participants
|
78.0 percentage of participants
|
91.6 percentage of participants
|
Adverse Events
Cohort 1: >=18 to <=60 Age Group: TDV
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
Cohort 1: >=18 to <=60 Age Group: Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Cohort 2: >=4 to <18 Age Group: TDV
Serious events: 0 serious events
Other events: 52 other events
Deaths: 0 deaths
Cohort 2: >=4 to <18 Age Group: Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: >=18 to <=60 Age Group: TDV
n=180 participants at risk
Participants randomized to receive TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 1: >=18 to <=60 Age Group: Placebo
n=60 participants at risk
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: >=4 to <18 Age Group: TDV
n=180 participants at risk
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
Cohort 2: >=4 to <18 Age Group: Placebo
n=60 participants at risk
Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
|
|---|---|---|---|---|
|
General disorders
Asthenia
|
8.3%
15/180 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
8.3%
5/60 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
5.6%
10/180 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
5.0%
3/60 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
|
Investigations
Body temperature
|
2.8%
5/180 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
6.7%
4/60 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
2.8%
5/180 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
1.7%
1/60 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
|
Nervous system disorders
Headache
|
11.1%
20/180 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
11.7%
7/60 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
4.4%
8/180 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
1.7%
1/60 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.8%
14/180 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
6.7%
4/60 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
3.9%
7/180 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
3.3%
2/60 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
|
General disorders
Pain
|
21.1%
38/180 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
13.3%
8/60 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
22.8%
41/180 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
25.0%
15/60 • All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place